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Table of Contents Perinatal HIV Epidemic: Situation Analysis

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0 Eliminating Perinatal HIV Transmission
Slide Eliminating Perinatal HIV Transmission This curriculum is sponsored by the Centers for Disease Control and Prevention’s (CDC’s) One Test. Two Lives. program. The goals of the curriculum are perinatal HIV prevention and promotion of the health of pregnant women infected with HIV in the United States. [Note to speaker: Add any additional introductory notes based on the audience/purpose of meeting. Students can reference full sources on the One Test. Two Lives. curriculum website.] This curriculum is based on the most current recommendations of the United States Public Health Service Perinatal Guidelines, the CDC Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings, and the American College of Obstetricians and Gynecologists (ACOG), ACOG Committee on Obstetric Practice. Prenatal and perinatal human immunodeficiency virus testing: expanded recommendations.1,2,3 Sources: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 2. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings. MMWR Morb Mortal Wkly Rep Sept 22; [cited 2009 Sep 29]; 55 (RR14):1-17. Available from: 3. American College of Obstetricians and Gynecologists (ACOG), ACOG Committee on Obstetric Practice. Prenatal and perinatal human immunodeficiency virus testing: expanded recommendations. Washington, DC: ACOG; 2004;304: Committee opinion no. 418. A Curriculum for OB/GYN Resident and Midwifery Programs

1 Table of Contents Perinatal HIV Epidemic: Situation Analysis
Slide Table of Contents Perinatal HIV Epidemic: Situation Analysis Reducing Perinatal HIV Transmission Lessons from Clinical Trials Antepartum Care Intrapartum Care Postpartum/Newborn Care and Testing Psychosocial, Legal, and Ethical Issues HIV-Infected Women of Childbearing Age Case Discussions Resources Talking Points: The listed “chapters” will be covered in this presentation: Situation Analysis – A Landscape View of HIV and its Impact on Women What We Know About Reducing Perinatal HIV Transmission Lessons from Clinical Trials – Antiretroviral (ARV) Interventions to Reduce Perinatal HIV Transmission Antepartum Care for HIV-Infected Women Intrapartum Care for HIV-Infected Women Postpartum/Newborn Care and Testing Psychosocial, Legal, and Ethical Issues HIV-Infected Women of Childbearing Age Case Discussions Resources [Note to speaker: If desired, you may choose to cover only applicable chapter topics. To receive Continuing Education credit, please note that listeners/students will be tested on full curriculum content.] 1

2 Slide Learning Objectives Discuss current epidemiology of HIV infection in the United States Describe how current trends in the HIV epidemic impact HIV infection in women and children in the United States Discuss current standards of care for preventing mother-to-child HIV transmission Recognize psychosocial issues related to HIV infection in pregnancy Using case scenarios, apply best practices to offer opt-out HIV testing Describe and identify resources for current information on national guidelines for preventing perinatal HIV transmission Complete list of learning objectives: Discuss current epidemiology of HIV infection in the United States Describe how current trends in the HIV epidemic impact HIV infection in women and children in the United States Relate issues surrounding HIV transmission to their impact on the care of pregnant women and newborns State current national recommendations for HIV testing of pregnant women Discuss current standards of care for preventing mother-to-child HIV transmission Describe national recommendations and guidelines for antiretroviral (ARV) therapy in pregnancy and for preventing perinatal HIV transmission Identify national recommendations and their rationale to reduce perinatal HIV transmission that takes place during antenatal, intrapartum and post-partum periods Recognize and discuss psychosocial issues related to HIV infection in pregnancy, including fear, stigma, confidentiality, legal and ethical issues Using case scenarios, apply best practices to offer opt-out HIV testing that include advising a pregnant woman about routine and/or rapid HIV testing; giving results; preventing perinatal transmission; and managing antenatal, intrapartum, and post-partum care of a woman with HIV infection Identify resources for current information on national guidelines for preventing perinatal HIV transmission, for ARV therapy and care in pregnancy, and for educating patients and communities 2

3 Perinatal HIV Epidemic: Situation Analysis
Slide Perinatal HIV Epidemic: Situation Analysis Chapter title slide; no notes. Note: Images used throughout this presentation do not represent actual events or people living with HIV.

4 Epidemic in the United States Among Women and Children
Slide Epidemic in the United States Among Women and Children AIDS cases in women have risen from 7% in 1985 to 25% in 2010 220,955 AIDS cases in women reported through December 2010 The number of HIV-infected infants born each year has decreased from ~1750 (in the mid-1990s) to ~143 in 2010 In 2010, an estimated 217 children <13 years were diagnosed with HIV and 23 were diagnosed with AIDS Talking Points: In the media, HIV/AIDS in the United States is receiving less attention than it has in the past, but the epidemic is still with us. Incidence numbers were recently revised. An estimated 50,000 new HIV cases are diagnosed each year. 15,000 are in women.1 HIV/AIDS in women has risen from 7% in 1985 to a quarter of HIV/AIDS cases in 2010. The number of infants with HIV infection, however, has decreased dramatically. In 2007, in 25 states with name-based reporting, 159 children <13 years were diagnosed with HIV and 28 with AIDS.3 The estimated number of HIV-infected infants born each year has decreased from approximately 1,750 (mid-1990s) to approximately 143 in Supporting Information: The HIV epidemic in women is centered in the Northeastern and Southern United States. African American and Hispanic women have been disproportionately affected by the epidemic and account for 80% of AIDS cases reported in US women. An estimated 80% of HIV-infected women living in the United States are of childbearing age. And 5,000–6,000 infected women give birth annually. Sources: 1. Prejean J, Song R, Hernandez A, et al. Estimated HIV incidence in the United States, PLoS ONE 2011;6(8):e17502. 2. McKenna, MT, Hu, X. Recent trends in the incidence and morbidity that are associated with perinatal human immunodeficiency virus infection in the United States. American Journal of Obstetrics and Gynecology. 2007;197 (3Suppl): S10-S16. 3. Centers for Disease Control and Prevention. HIV Surveillance Report, 2010, vol Published March Accessed February 9, Table 2a. 4

5 Estimated Numbers and Percentages
Estimated Numbers and Percentages* of AIDS Cases Among Female Adults and Adolescents 1985–2010—United States and Dependent Areas Slide Talking Points: About the graph: Bars represent the number of AIDS cases diagnosed annually and the line represents the proportion of cases among female adults and adolescents when compared to all reported cases from 1985 to The proportion of AIDS cases among female adults and adolescents (age ≥13 years) increased from 7% of adult cases in 1985 to 25% in 2010. Supporting Information: AIDS incidence among female adults and adolescents rose steadily through 1993, when the AIDS surveillance case definition was expanded and leveled off at approximately 13,000 AIDS cases each year from 1993 through In 1996, incidence among women and adolescent girls began to decline, primarily because of the success of ARV therapies. Cases have leveled since 2000. The data have been adjusted for reporting delays. Per the 2008 JAMA HIV incidence projections, women comprise: 27% incidence for the US and the District of Columbia using 2006 data at 15,000 projected cases. Among females, incidence increased more slowly until the late 1980s, decreased toward the early 1990s and the then has shown a plateau remaining stable.2 Source: 1. Centers for Disease Control and Prevention. HIV Surveillance Report, 2010, vol Published March Accessed February 9, Table 2a. 2. Hall HI, Song R, Rhodes P, Prejean J, Quian, A, Lee LM, Karon J, Brookmeyer R, Kaplan EH, McKenna MT, Janssen RS for the HIV Incidence Surveillance Group. Estimation of HIV incidence in the United States. JAMA. 2008;300(5): 5 Note: Data have been adjusted for reporting delays. *Percentage of all cases that were diagnosed among females.

6 Percentages of HIV Cases Diagnosed Among Female Adults and Adolescents, by Transmission Category 2010—46 States and 5 US-Dependent Areas Slide Talking Points: Among female adults and adolescents diagnosed with HIV/AIDS in 2010, 86% of the 10,168 HIV cases were attributed to high-risk heterosexual contact. Supporting Information: 14% to injection drug use <1% to other or unidentified risk factors The following 46 states and 5 US-dependent areas have had laws or regulations requiring confidential name-based HIV infection surveillance since at least 2003: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming, American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the US Virgin Islands. Data have been adjusted for reporting delays and missing risk-factor information. Source: Centers for Disease Control and Prevention. HIV Surveillance Report, 2010, vol Published March Accessed February 9, Cover. Note: Data include persons with a diagnosis of HIV infection regardless of their AIDS status at diagnosis. Data from 46 states with confidential name-based HIV infection reporting since at least Data have been adjusted for reporting delays and missing risk-factor information. *Heterosexual contact with a person known to have, or to be at high risk for, HIV infection. †Includes blood transfusion, perinatal exposure, and risk factor not reported or not identified. 6

7 AIDS Cases Among Female Adults and Adolescents Attributed to Injection Drug Use or High-Risk Heterosexual Contact, by Region, 2003–2007—50 States and DC Slide Talking Point: From 2003 through 2007, an estimated 48,104 AIDS cases diagnosed among female adults and adolescents were attributed to either injection drug use or high-risk heterosexual contact. High-risk heterosexual contact accounted for the majority of HIV/AIDS cases among females, particularly in the South. Supporting Information: Most AIDS cases were among female adults and adolescents who reside in the Northeast and South. Regions of residence are defined as follows: ・ Northeast – Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont ・ Midwest – Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin ・ South – Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, West Virginia ・ West – Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming Source: 1. Centers for Disease Control and Prevention (CDC). Pediatric HIV/AIDS surveillance (through 2007). Available from: Published Accessed September 29, 2009. 7 Note: Data have been adjusted for reporting delays and missing risk-factor information. * Heterosexual contact with a person known to have, or to be at high risk for, HIV infection.

8 Estimated Numbers of Perinatally Acquired AIDS Cases by Year of Diagnosis, 1985–2010 — United States and Dependent Areas Slide Talking Points: The estimated number of AIDS cases diagnosed among persons perinatally exposed to HIV peaked in 1992 and has decreased in recent years. This is the classic prevention of perinatal HIV transmission slide showing the great public health success. Even though perinatal HIV transmission has been a great public health success, clinicians must remain diligent with perinatal testing for all pregnant women so no case goes undetected. Supporting Information: The decline in these cases is likely associated with the implementation of Public Health Service guidelines for the universal counseling and voluntary HIV testing of pregnant women and the use of ARV therapy for pregnant women and newborn infants. Other contributing factors are the effective treatment of HIV infections that slow progression to AIDS and the use of prophylaxis to prevent AIDS opportunistic infections among children. Sources: 1. Centers for Disease Control and Prevention (CDC). U.S. Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. MMWR Morb Mortal Wkly Rep. 2002;51(RR18):1-38. 2. Centers for Disease Control and Prevention. HIV Surveillance Report, 2010, vol Published March Accessed February 9, Table 2a. 8 Note: Data have been adjusted for reporting delays and missing risk-factor information.

9 Slide Global HIV Rates There are an estimated 34 million people infected with HIV Worldwide, of people living with HIV, the percentage of women with HIV remains at 50% Nearly 68% of all people with HIV globally live in sub-Saharan Africa 70% of AIDS deaths in 2011 occurred in sub-Saharan Africa In sub-Saharan Africa, women make up nearly 60% of those with HIV infection Nearly 15 million children <18 years of age in sub-Saharan Africa have lost one or both parents to HIV Talking Points: HIV/AIDS is a growing threat to health globally. This information is highly relevant for residents and midwifery students who will practice in communities with immigrant populations and for clinicians who have international training or plan to work in developing countries. Sources: UNAIDS. Global report: UNAIDS report on the global AIDS epidemic Available from: Accessed February 11, World Health Organization. Global summary of the AIDS epidemic Available from: Accessed February 11, 2013. 9

10 Global HIV Rates (continued)
Slide Global HIV Rates (continued) Adults and children estimated to be living with HIV in 2011 Talking Points: Globally, adult women (15 years and older) account for more than half of people living with HIV. In sub-Saharan Africa, for every 10 adult men living with HIV, there are about 16 adult women who are infected with the virus—i.e., 61% of adults living with HIV in sub-Saharan Africa in 2007 were women. Women represent nearly one-half of those with HIV infection in the Caribbean and one-quarter or more of those in Eastern Europe and Asia. Worldwide, heterosexual transmission is the number one mode of transmission. The most effective way to prevent HIV transmission to children is to prevent HIV infection in women, and that is the long-term goal both in the United States and globally. Supporting Information: In the Caribbean, 43% (compared with 37% in 2001) of adult HIV infections were in women. In Eastern Europe and Central Asia, it is estimated that women accounted for 26% of adults with HIV in 2007 (compared with 23% in 2001), while in Asia that proportion reached 29% in 2007 (compared with 26% in 2001). The proportions of women living with HIV in Latin America, Asia, and Eastern Europe are slowly growing as HIV is transmitted to the female partners of men who are likely to have been infected through injecting drug use, during unprotected paid sex, or sex with other men. Source: 1. UNAIDS. Core Epidemiology Slides. Available from: November Accessed February 10 Total: 34 million (31.4–35.9 million)

11 Prevention of Perinatal HIV
Slide Prevention of Perinatal HIV With maternal diagnosis and prophylaxis during the perinatal period, perinatal HIV transmission is usually preventable in all but 2% or less cases In order to reach this goal, HIV testing and antiretroviral (ARV) prophylaxis and treatment are essential Talking Points: Perinatal HIV transmission rates are 2% or less when ARV therapy is initiated and adhered to during pregnancy.1,2 The figure is a 25% transmission rate among infants born to women who receive no preventive treatment.1,3 With maternal diagnosis and ARV prophylaxis during the perinatal period, perinatal HIV is almost 100% preventable. When ARV therapy is begun intrapartum, the rate of transmission is approximately 10%.4,5 Supporting Information: There are lower transmission rates achievable if the maternal viral load is <50. These data are obtained in non-breastfeeding populations, but are irrespective of delivery mode.  Sources: 1. Centers for Disease Control and Prevention (CDC). HIV testing among pregnant women—United States and Canada, MMWR Morb Mortal Wkly Rep. 2002;51: 2. Dorenbaum A, Cunningham CK, Gelber RD, et al. Two-dose intrapartum/newborn nevirapine and standard antiretroviral therapy to reduce perinatal HIV transmission: a randomized trial. JAMA. 2002;2088: 3. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med. 1994;331: 4. American College of Obstetricians and Gynecologists (ACOG), ACOG Committee on Obstetric Practice. Prenatal and perinatal human immunodeficiency virus testing: expanded recommendations. Washington, DC: ACOG; 2004;304: Committee opinion no. 418. 5. Wade NA, Birkhead GS, Warren BL, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of human immunodeficiency virus. N Engl J Med. 1998;339: 11

12 What We Know About Reducing Perinatal HIV Transmission
Slide What We Know About Reducing Perinatal HIV Transmission Chapter title slide; no notes.

13 Perinatal HIV Transmission
Slide Perinatal HIV Transmission Without ARV drugs during pregnancy, risk of transmission from mother to infant is 1 in 4 Pediatric AIDS Clinical Trials Group (PACTG) 076 found that by giving zidovudine (ZDV) to the pregnant woman during pregnancy, labor, and delivery, and to her newborn, transmission could be reduced to 8% The risk of perinatal transmission can now be less than 2% (1 in 50) with: Highly effective ARV therapy (HAART) Elective Cesarean section as appropriate Formula feeding Talking Points: In 1994, a landmark clinical trial—PACTG 076—demonstrated that the risk of perinatal HIV transmission could be cut by 2/3 if the mother and newborn were prophylaxed with zidovudine (ZDV). With appropriate management, the risk or perinatal transmission can now be less than 2%. Supporting Information: In February 1994, a clinical trial examining a strategy to decrease perinatal HIV transmission, PACTG 076, was halted when interim results showed a significant difference in transmission rates between the intervention and placebo groups. In the trial of more than 477 pregnant women with HIV infection, women in the intervention group received ZDV during pregnancy from 34-weeks gestation, during labor and delivery, and their infants received oral ZDV for 6 weeks after birth. Interim results showed a significant difference in transmission rate between ZDV (8%) and the placebo group (26%).1 1995: Transmission rate was 11% after adoption of “076” ZDV regimen into practice.2 In a longitudinal epidemiologic United States study since 1990, transmission was:3 ・ 20% in women receiving no ARV treatment in pregnancy ・ 10.4% in women on ZDV alone ・ 3.8% in women receiving combination therapy without protease inhibitors (PIs) ・ 1.2% in women on combination therapy with Pis Sources: 1. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med. 1994;331: 2. Bertolli, J. (1996). Estimating the timing of mother-to-child transmission of human immunodeficiency virus in a breast-feeding population in Kinshasa, Zaire. J Infect Dis. 174(4):722. 3. Cooper ER, Charurat M, Mofenson LM, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1 infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr Hum Retrovirol. 2002;29(5): 13

14 Timing of Perinatal HIV Transmission: Non-Breastfeeding Women
Slide Timing of Perinatal HIV Transmission: Non-Breastfeeding Women Intrauterine (before 36 weeks) ~20% of cases Virologic detection of HIV in newborn at 1–2 days of life Peripartum ~80% of cases Onset of placental separation Mother-to-fetus microtransfusions Labor and rupture of membranes Most transmission occurs close to or during labor and delivery (L&D) Talking points: Transmission can occur at multiple points during pregnancy, peripartum and postpartum. Most transmission occurs around the time of labor and delivery. Supporting Information: Using highly sensitive diagnostic tests, HIV culture or polymerase chain reaction (PCR) helps determine when infection occurs in a fetus/infant. ・ In-utero transmission is presumed if specimen taken in first 48 hours after birth is positive for HIV. ・ Intrapartum transmission is presumed if specimen taken in the first week of life in non-breastfed infant is negative and later sample is positive. Mechanisms of transmission in-utero: ・ Most likely transplacental, possibly due to placental membrane inflammation through maternofetal transfusion (placental disruption). ・ Much of this transmission happens relatively late in gestation; although in some cases, rapid disease progression in infants points to infection earlier in gestation. ・ Early trimester transmission may result in early fetal loss. ・ There is an increased risk of transmission if a woman becomes HIV infected during pregnancy, possibly in-utero or during intrapartum. Mechanisms of transmission intrapartum: ・ Through maternofetal transfusion of blood during labor ・ Infant skin or mucous membranes coming in contact with infected blood or other maternal secretions during delivery Important risk factors: ・ Increased duration of membrane rupture ・ Vaginal delivery (in a woman with viral load (VL) >1000) Sources: 1. Kourtis AP, Bulterys M, Nesheim SR, Lee FK. Understanding the timing of HIV transmission from mother to infant. JAMA. 2001;285: 2. American College of Obstetricians and Gynecologists (ACOG), Committee on Obstetric Practice. Scheduled cesarean delivery and the prevention of vertical transmission of HIV infection. Washington, DC: ACOG; 2000 May. ACOG committee opinion no. 234. 14

15 Factors Influencing Perinatal Transmission
Slide Factors Influencing Perinatal Transmission Maternal Factors High HIV-1 RNA levels (viral load [VL]) Low CD4+ lymphocyte count (“T-cells”) Co-infections: Hepatitis C, cytomegalovirus (CMV) bacterial vaginosis Maternal injection drug use No ARV therapy or prophylaxis Talking Point: The maternal factors listed can influence whether transmission occurs: clinical status with HIV infection, co-morbidity, and behavioral factors such as non-prescription injection drug use or noncompliance with recommended treatment. Supporting Information: The viral load level provides important information that is used to monitor the status of HIV disease and to guide recommendations for therapy. Evidence shows that maintaining the viral load level as low as possible for as long as possible decreases the complications of HIV disease and prolongs life. The higher the maternal viral load or HIV-RNA level, the higher the risk is of perinatal HIV transmission. Other maternal factors correlated with increased risk of transmission: ・ Frequent, unprotected sex with multiple partners (possibly leading to increased risk of sexually transmitted diseases (STDs), other inflammatory processes ・ Smoking ・ Illicit drug use Source: 1. Centers for Disease Control and Prevention (CDC). US Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. MMWR Morb Mortal Wkly Rep. 2002;51(RR18):1-38. 15

16 Factors Influencing Perinatal Transmission (continued)
Slide Factors Influencing Perinatal Transmission (continued) Obstetrical Factors Length of ruptured membranes and/or chorioamnionitis Vaginal delivery (if VL > 1000) Invasive procedures Infant Factors Prematurity Breastfeeding Talking Points: The obstetrical and infant factors listed can increase the risk of HIV transmission. OB factors include rupture of membranes-timing and increased risk with women diagnosed with AIDS infection. ・ Each hour increase in duration of rupture of membrane (ROM) has a small but high statistically significant and stable association with perinatal transmission. Supporting Information: Meta-analysis of 15 prospective cohort studies (4,721 mother-infant pairs) suggests that an elective Cesarean section reduces the risk of perinatal transmission; the meta-analysis also found that perinatal transmission increased with increasing duration of ruptured membranes. Association remained after adjusting for mode of delivery, ARVs (generally the 3-part zidovudine prophylaxis), or maternal CD4 count and infant birth weight.1 ・ Greatest risk with duration of rupture was in women with AIDS. ・ Several studies reported that women with clinical chorioamnionitis had an increased transmission risk.2 ・ Amniocentesis and fetal scalp electrodes should be avoided in women with HIV infection.3 ・ In a study to assess amniotic fluid as a marker of intrauterine infection and evaluate amniocentesis as a risk factor in vertical transmission, amniotic fluid VL was undetectable, and no perinatal transmission was found in HIV-infected women on HAART with undetectable maternal blood samples.4 Infant factors: ・ Skin integrity of preterm infants is more fragile, less of a barrier. ・ Gastric acid secretion is lower in preterm and newborn infants and is less protective against swallowed organisms. ・ Functional immune responsiveness is decreased. Sources: 1. The International Perinatal HIV Group. The mode of delivery and the risk of vertical transmission of human immunodeficiency virus type 1—a meta-analysis of 15 prospective cohort studies. N Engl J Med. 1999;340(13): 2. Heyward WL, Batter VL, Malulu M, St. Louis ME, et al. Impact of HIV counseling and testing among child-bearing women in Kinshasa, Zaire. AIDS. 1993;7(12): 3. Mofenson LM. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. N Engl J Med. 1999;341(6):385. 4. Maiques V, Garca-Tejedor A, Perales A, Cordoba J, Esteban RJ. HIV detection in amniotic fluid samples—amniocentesis can be performed in HIV pregnant women? Eur J Obstet Gynecol Reprod Biol. 2003;108; 5. American College of Obstetricians and Gynecologists (ACOG), Committee on Obstetric Practice. Scheduled cesarean delivery and the prevention of vertical transmission of HIV infection. Washington, DC: ACOG; 2000 May. ACOG committee opinion no. 234. 6. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 16

17 Mechanisms to Reduce Perinatal HIV Transmission
Slide Mechanisms to Reduce Perinatal HIV Transmission ARV drugs Lower maternal antepartum viral load Provide pre- and post-exposure prophylaxis for the infant Prophylaxis is recommended Antepartum Intrapartum Neonatal Talking Points: There are a number of mechanisms through which ZDV or other ARV drugs can reduce perinatal transmission. ・ One important mechanism is by decreasing maternal viral load in the blood and genital secretions via antenatal drug administration, particularly in women with high viral loads. ・ Another is pre-exposure infant prophylaxis by administration of ARV drugs that cross the placenta during labor, resulting in adequate systemic drug levels in the infant at a time of intensive exposure to the maternal genital tract virus during passage through the birth canal. Post-exposure infant prophylaxis is provided through administration of drug to the infant after birth; this would protect against cell-free or cell-associated virus that might have obtained access to the fetal/infant systemic circulation through maternal-fetal transfusion during uterine contractions in labor or through systemic dissemination of virus swallowed by the infant during passage through the birth canal. Supporting Information: For prophylaxis recommendations, see notes for slides 35 and 43. Source: 1. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings. MMWR Morb Mortal Wkly Rep Sept 22; [cited 2009 Sep 29]; 55 (RR14):1-17. Available from: 17

18 Slide National Recommendations for HIV Testing of Pregnant Women CDC (USPHS) and ACOG Prenatal: routine, universal HIV screening with the right to decline 3rd trimester: repeat if woman has risk factors, is in area of high prevalence, or has previously refused Labor and delivery: routine rapid testing for women with unknown HIV status Postnatal: rapid testing for infants whose mother’s status is unknown State regulations, laws, policies about HIV screening of pregnant women vary Talking Points: In September 2006, CDC revised their recommendations for testing in pregnancy as listed in the slide. American College of Obstetrics and Gynecology (ACOG) and AAP is the American Academy of Pediatrics (AAP) (1999) support routine HIV testing in pregnancy and encourage counseling. In a “Dear Colleague” letter of April 22, 2003, CDC cited data on HIV prenatal testing rates utilizing three different methods and changed their recommendations for HIV screening in pregnancy to “opt-out” screening. Health care providers should be familiar with and adhere to state and local laws, regulations, and policies concerning HIV screening of pregnant women and newborns. Many current state laws require HIV counseling and informed consent and would prevent implementing “opt-out” HIV testing in pregnancy. Supporting Information: In 1998, the Institute of Medicine recommended universal HIV testing of pregnant women. For 3rd-trimester retesting, see the listing of geographic areas of elevated incidence for HIV or AIDS among women aged 15–45 (slide 7), see speaker notes on slide 19. Retesting also is recommended for women who receive health care in facilities in which prenatal screening identifies at least one HIV-infected pregnant woman per 1,000 women screened.1 Sources: 1. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings. MMWR Morb Mortal Wkly Rep Sept 22; [cited 2009 Sep 29]; 55 (RR14):1-17. Available from: 2. American College of Obstetricians and Gynecologists (ACOG), ACOG Committee on Obstetric Practice. Prenatal and perinatal human immunodeficiency virus testing: expanded recommendations. Washington, DC: ACOG; 2004;304: Committee opinion no. 418. 3. American Academy of Pediatrics (AAP), American College of Obstetricians and Gynecologists. Joint statement on human immunodeficiency virus screening. Elk Grove Village (IL): AAP; Washington (DC): ACOG; 1999; reaffirmed 2006. 18

19 Recommendations for 3rd Trimester Repeat HIV Testing
Slide Recommendations for 3rd Trimester Repeat HIV Testing In jurisdictions with an elevated incidence of HIV/AIDS among women Women known to be at high risk for HIV Facilities that identify HIV infection in at least 1/1,000 women screened Women who have signs or symptoms of acute HIV infection (acute retroviral syndrome) Talking Point: In the 2006 revised recommendations, CDC described who should be retested in the third trimester as detailed on the slide. Supporting Information: Identified jurisdictions with an elevated incidence of HIV/AIDS in 2004: Alabama, Connecticut, Delaware, Washington, D.C., Florida, Georgia, Illinois, Louisiana, Maryland, Massachusetts, Mississippi, Nevada, New Jersey, New York, North Carolina, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia. A second HIV test in the 3rd trimester is as cost-effective as other common health interventions when HIV incidence among women of childbearing age is greater than or equal to 17 HIV cases per 100,000 person-years. Women at high risk: injection drug users, their sex partners, women who exchange sex for money or drugs, women who are sex partners of HIV-positive persons, women who have had a new or more than one sex partner during this pregnancy, other risk factors. Signs or symptoms of acute retroviral syndrome – see slide 20. Source: 1. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings. MMWR Morb Mortal Wkly Rep Sept 22; [cited 2009 Sep 29]; 55 (RR14):1-17. Available from: 19

20 Acute HIV Infection Can present like mononucleosis Symptoms include
Slide Acute HIV Infection Can present like mononucleosis Symptoms include Fever Rash, often erythematous maculopapular Fatigue Pharyngitis Generalized lymphadenopathy Use a plasma RNA PCR test as well as HIV antibody to diagnose Urticaria Myalgia/arthralgia Anorexia Mucocutaneous ulceration Headache, retroorbital pain Neurologic symptoms (e.g., aseptic meningitis, radiculitis, myelitis) Talking Points: Acute HIV infection should be considered when a patient presents with mononucleosis symptoms. When acute retroviral syndrome is a possibility, a plasma RNA test is recommended in addition to an HIV antibody test to diagnose acute HIV infection. Plasma RNA (PCR) is more sensitive than antibody tests because standard HIV enzyme-linked immunoassay (ELISA) testing determines the presence of HIV antibodies. ・ The body may take 10 days to 4 weeks to develop antibodies to HIV after exposure (the “window period” between transmission and seroconversion). ・ Standard testing often misses patients with acute infection who typically have extremely high levels of circulating virus. ・ HIV-RNA (PCR) testing is more likely to detect acute or early infection. Source: 1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Washington, DC: Department of Health and Human Services; 2008 Nov 3 [cited 2009 Sep 29]. Available from: 20

21 Acute HIV Infection in Pregnancy
Slide Acute HIV Infection in Pregnancy Increased risk of transmission to the fetus during gestational acute retroviral syndrome is hypothesized due to: High viral titers in plasma and genital fluid Absence of immune factors that may neutralize infection Treatment should include interventions to reduce perinatal HIV transmission Appropriate ARV prophylaxis Consideration of elective Cesarean delivery Consult with HIV expert Talking Points: Increased risk of transmission to the fetus during gestational acute retroviral syndrome is hypothesized due to high viral titers and absence of immune factors. The risk of transmission from an individual with primary HIV infection may be 20-fold greater per exposure than the risk of transmission from someone with chronic infection. Supporting Information: An HIV expert can be an obstetrician/gynecologist (OB/GYN) specializing in infectious diseases or maternal-fetal medicine. An expert could also be a specialist in infectious diseases. The professional organizations representing these specialties are: The Infectious Diseases Society for Obstetrics and Gynecology (IDSOG), The Society of Maternal Fetal Medicine (SMFM), and The Infectious Disease Society of America (IDSA). Source: 1. Weintrob AC, Giner J, Menezes P, et al. Infrequent diagnosis of primary human immunodeficiency virus infection. Arch Intern Med. 2003;163: 21

22 Why Aren’t All Pregnant Women Tested?
Slide Why Aren’t All Pregnant Women Tested? Provider Language barriers Late entry or no prenatal care Patient perceived as not at risk Provider does not strongly recommend testing to all women Patient Women’s reasons for not being tested Do not think they are at risk Have been tested “recently” Test not offered or recommended Negative consequences of testing rarely mentioned Talking Points: Most frequent barriers reported by obstetricians and by patients themselves that prevented them from offering an HIV test to a prenatal patient are listed on the slide. Providers’ strong recommendation was associated with more testing. Negative social consequences of testing could include fear of learning HIV diagnosis, stigma and discrimination, loss of employment, housing, health insurance and personal relationships. Based on formative research supporting new CDC women’s health program, many women reported they thought if they received a blood draw during a medical visit, then they were getting an HIV test, too. Supportive Information: The Institute of Medicine (IOM) survey of obstetricians found the three most common reasons for not testing were: ・ Language (15%) ・ Late entry into prenatal care (13%) ・ Perception that patient population is at low risk (13%)¹ According to a study of 1,362 parturient women in four locations (Miami, New Haven, Brooklyn, and central North Carolina) who were interviewed in the hospital after giving birth² ・ Perception that patient population is at low risk (89% were offered testing; 69.6% were tested). ・ Proportions of women who were tested increased incrementally with increased perception that the provider considered testing important. ・ Private insurance for prenatal care was also associated with not being tested. ・ The women with private insurance were 3 times more likely to NOT get tested than women with public funding. ・ Women not tested ranged from 12% (Miami) to 54% (New Haven). ・ Concerns about negative consequences such as loss of health insurance were rarely mentioned. All women have the right to decline HIV testing regardless of opt-in/opt-out options. CDC’s One Test. Two Lives. program provides guidance on responding to a patient’s reluctance to be tested in its brochure, When pregnant patients are unsure about HIV screening Available from: Sources: 1. Office of the Inspector General, Department of Health and Human Services. Reducing obstetrician barriers to offering HIV testing. Washington, DC: Office of the Inspector General Apr. 2. Royce AR, Walter EB, Fernandez MI, et al. Barriers to universal prenatal HIV testing in US locations in Am J Public Health. 2001;91:

23 Routine Prenatal HIV Testing
Slide Routine Prenatal HIV Testing Educate all women about the importance of HIV testing Written or electronic information Wall posters Individual or “whole office” approach Materials written at a low reading level and in various languages Talking Points: Providers should assure that all women are educated about the importance of HIV testing. The whole office approach to HIV testing is one where all staff from the receptionist to the obstetrician play a role in incorporating routine HIV testing into practice. Education materials should match the literacy needs of the population served. If needed, low literacy materials and materials in various languages should be available to support that education. 23

24 Opt-in Prenatal HIV Testing
Slide Opt-in Prenatal HIV Testing Opt-in requires pretest counseling or education and consent for the HIV test May require a separate written consent Studies show the majority of women agree/consent May depend on the skill, comfort, and recommendations of the clinician Women may feel singled out: to admit to “risky behavior” Contributes to ongoing HIV “specialism” Talking Points: Information on opt-in testing is included in this presentation because some states still require this type of consent; however, CDC recommends opt-out testing. By requiring a “special” consent, HIV is singled out as a unique risk rather than including HIV testing in the standard battery of prenatal tests. Including HIV testing as routine helps to “normalize” it rather than identifying individuals as “special” based on perceived risk. Supporting Information: There are two different ways to approach pregnant women about HIV testing: • Opt-in: ・ Pregnant women are given pre-HIV test counseling. ・ They must agree to receiving an HIV test, usually in writing. • Opt-out: ・ Pregnant women are told that an HIV test will be included in the standard group of prenatal tests (that is to say, tests given to all pregnant women), and that they may decline the test. ・ Unless they decline, they will receive an HIV test. For more information and free patient education materials, healthcare providers are encouraged to visit the One Test. Two Lives. website at: Sources: 1. Walsmley S. Opt in or opt out: what is optimal for prenatal screening for HIV infection? CMAJ. 2003;168: 2. Centers for Disease Control and Prevention (CDC).One Test Two Lives fact sheet. Reducing HIV transmission from mother-to-child: an opt-out approach to HIV screening. Atlanta: CDC; 2008 May. 24

25 Routine Prenatal HIV Testing – Opt-Out
Slide Routine Prenatal HIV Testing – Opt-Out Recommended by CDC Notification of the test with the option to decline Include with other routine prenatal tests State laws regulate consent process Talking Points: In the 2006 recommendations, CDC encouraged using an opt-out approach for routine testing in the perinatal period. With opt-out testing a patient is notified that the test will be done, unless she declines. State law may govern whether informed consent must be written, how consent is documented, and how opt-out testing can be put into practice. Supporting Information: Studies show the opt-out approach can: ・ Increase testing rates among pregnant women, thereby increasing the number of pregnant women who know their HIV status. ・ Increase the number of HIV-infected women who are offered treatment. ・ Reduce HIV transmission to their babies. Updated information on state laws related to HIV testing is available in the Compendium of State HIV Testing Laws at http//:www.ucsf/hivcntr/StateLaws/Index.htm. One Test. Two Lives. provides a fact sheet in both English and Spanish to OBs and CNMs on an opt-out approach to HIV screening. The kit is available through CDC-INFO, on the campaign website at or via at Source: 1. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings. MMWR Morb Mortal Wkly Rep Sept 22; [cited 2009 Sep 29]; 55 (RR14):1-17. Available from: 25

26 Slide What Women Need to Know HIV testing is important: HIV can be passed from a mother to her baby in pregnancy, during birth, and by breastfeeding If a woman has HIV, there is treatment for her and she can help prevent transmission to her baby HIV testing is recommended for all pregnant women An HIV test is a routine prenatal test A woman can have her questions answered; she can decline testing Talking Points: CDC has identified the information on this slide as the essential information each woman should receive. This information can also be provided by brochure, video, or electronic means. Resource for providers about HIV screening of pregnant women to help prevent perinatal transmission: One Test. Two Lives. Provider Resource Kit. The kit can be ordered from CDC-INFO, on the campaign website at or via at Source: 1. Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings. MMWR Morb Mortal Wkly Rep Sept 22; [cited 2009 Sep 29]; 55 (RR14):1-17. Available from: 26

27 Interpreting HIV Test Results
Slide Interpreting HIV Test Results EIA (enzyme-linked immunosorbent assay, ELISA) is a standard HIV-antibody screening blood test Rapid HIV screening tests detect HIV antibody A positive (reactive) ELISA or a rapid HIV test is always confirmed with a Western blot (WB) test A positive WB can usually confirm HIV infection During pregnancy, there may be a lower predictive value of a positive EIA Talking Points: ELISA and rapid HIV tests both detect the presence of HIV antibodies. Some of the rapid tests detect antibody at an earlier time after infection. Laboratories generally report a positive HIV antibody test only after it has been confirmed by a WB. Supporting Information: Resource on HIV testing: False positive ELISA test results can be caused by alloantibodies resulting from transfusions, transplantation, pregnancy, autoimmune disorders, malignancies, alcoholic liver disease, or for reasons that are unclear. Source: 1. Doran TI, Parra E. False positive and indeterminate human immunodeficiency virus test results in pregnant women. Arch Fam Med. 2000;9: 27

28 Indeterminate WB Results
Slide Indeterminate WB Results Causes of indeterminate WB results Patient in process of seroconversion Cross-reacting non-specific antibodies Late-stage HIV infection Infection with O strain or HIV-2 Technical error Management: risk assessment, repeat testing Follow up with HIV RNA testing Talking Points: An indeterminate WB can occur because of the issues detailed on the slide. Repeat testing should be done and may need to include HIV RNA testing. The National HIV/AIDS Clinicians’ Consultation Center operated by the University of California at San Francisco at San Francisco General Hospital has a live perinatal hotline ( ) that offers information on caring for pregnant women and HIV-exposed infants, including referral services. Guidance can also be given about indeterminate WB results with pregnant patients. Supporting Information: For more information, see slide 108. Source: 1. Doran TI, Parra E. False positive and indeterminate human immunodeficiency virus test results in pregnant women. Arch Fam Med. 2000;9: 28

29 Giving a Pregnant Woman Negative HIV Test Results
Slide Giving a Pregnant Woman Negative HIV Test Results Meaning of a negative test result: “Your HIV test was negative…you are most likely not infected with HIV, though the test may not detect recent infection” Refer women at risk for HIV infection for counseling and risk-reduction interventions Repeat HIV testing in 3rd trimester in areas or jurisdictions of high-HIV incidence or for women with risk factors Talking Points: The slide provides a possible script for giving negative results. If her result is negative, explain the meaning of test results and the possibility of a false negative test if she was recently infected and antibody has not had time to develop. A repeat HIV test may be needed. A very important prevention message for women is that safer sex practices are important in pregnancy (and during lactation). Many women think, “I am already pregnant; I don’t need to use condoms.” Supporting Information: “Positive” and “negative” are confusing terms since a “negative” result is the “good” outcome. Explain that a negative result does not ensure immunity to future infection. Post-test counseling offers an important opportunity to discuss and reinforce risk-reduction strategies including safer sex practices and avoidance of exposure through substance misuse.1 STDs can increase the risk of sexual transmission of HIV in women. Becoming infected during pregnancy can significantly increase the risk that a woman will transmit HIV to her fetus or infant during pregnancy, delivery, or during breastfeeding--the rationale for repeat 3rd-trimester testing. Explain the need for follow-up testing: “It may take up to three months for HIV antibodies (made by your body to fight the virus) to show up in a test. If you get tested sooner, you could have HIV, but it won’t show up. You can still pass the virus on to others during this time. If you think you may have been infected with HIV and you know when it happened, you should have a test three months later.” Source: 1.Paul SM, Burr CK, DiFerdinando GT. Updated recommendations for reducing vertical HIV transmission. N J Med Sept;98:35-38. 2.Centers for Disease Control and Prevention (CDC). Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR Morb Mortal Wkly Rep. 2008;57;RR09:1-63. 29

30 Counseling a Pregnant Woman with a Positive HIV Test
Slide Counseling a Pregnant Woman with a Positive HIV Test Meaning of a positive test result: “Your HIV test was positive. This means you have HIV infection.” “The important thing to know is that there is treatment for HIV that can help your health and reduce the risk of transmission to your baby.” Focus on the woman’s feelings and immediate support system: “Do you have someone you can talk to about this?” Talking Points: The slide suggests a “script” that can be used when giving positive HIV test results. A preliminary positive should be confirmed with a follow-up test. A positive test result means that she has HIV infection, even though she may feel well and have no symptoms. Discuss the importance of medical treatment for maintaining and improving her own health. Describe available interventions to reduce risk of transmission to her infant. Supporting Information: Experienced HIV counselors have long recognized that once an individual hears the words, “Your HIV test is positive; you have HIV infection,” very little else is heard by the patient. A simple hopeful message of the value of treatment is important to convey with plans to give more detailed information at follow-up counseling sessions. HIV is perceived as a “death sentence” to many people. It is very important to tell women that there is effective treatment for people with HIV that is helping them to live longer, productive lives. There is effective treatment for her and to reduce the risk of HIV for her baby. With appropriate treatment, the transmission rate can be as low as 2%. Source: 1. Centers for Disease Control and Prevention (CDC). Recommendations for partner services programs for HIV infection, syphilis, gonorrhea, and chlamydial infection. MMWR Morb Mortal Wkly Rep. 2008;57;RR09:1-63. 30

31 Positive HIV Results (continued)
Slide Positive HIV Results (continued) Referral for HIV care/consult with HIV/OB expert Evaluation for ARV treatment ARVs for preventing perinatal transmission Referral for post-test counseling and partner services Reinforce that there is treatment for her and for reducing the risk to her baby Talking Points: The HIV specialist is often an OB/GYN trained in infectious diseases or a perinatologist or maternal-fetal medicine specialist. Your local HIV care providers may also be able to recommend an HIV/OB. Tell her about Partner Services – the service through the Health Department that helps a newly diagnosed patient contact others she may have infected. It is important to know your institution, agency, and community resources for HIV care, post-test counseling and support. Supporting Information: The National Perinatal HIV Consultation and Referral Service provides round-the-clock advice from HIV experts on interpreting HIV test results as well as consultation on treating HIV-infected pregnant women and their infants and maintains a resource list of HIV experts. Available 24 hours a day, seven days a week at: You can locate a clinic providing HIV care through the Ryan White HIV/AIDS Program at: For Ryan White Part C grantees such as ambulatory medical clinics that support outpatient HIV early intervention services and ambulatory care: For Ryan White Part D grantees who provide family-centered comprehensive care involving outpatient or ambulatory care to children, youth, women, and their families: 31

32 Pregnant Woman with an HIV-Infected Male Partner
Slide Pregnant Woman with an HIV-Infected Male Partner Test for HIV If positive: initiate interventions to reduce perinatal transmission risk If negative: counsel to reduce risk of transmission from partner 2nd HIV test in 3rd trimester, before 36 weeks, if possible Talking Points: Clinicians may be faced with an HIV-uninfected woman who presents during pregnancy and relates that she has an HIV-infected partner. If results from either conventional or rapid HIV testing are positive, then the woman should receive interventions to reduce perinatal HIV transmission, including immediate appropriate ARV prophylaxis and consideration of elective Cesarean delivery according to established guidelines. If HIV testing results are negative, then pregnant women with HIV-infected partners should be regularly counseled regarding the ongoing risk of HIV transmission. If the partner’s HIV status is at all uncertain, he should be encouraged to seek testing and appropriate care. All women and their partners should be counseled about the importance of correct and consistent condom use. A second HIV test should be done in the 3rd trimester. There is a possibility of Pre-exposure Prophylaxis (PrEP) for HIV-negative women whose partners are positive; new recommendations will be forthcoming. The perinatal network through the National HIV/AIDS Clinicians’ Consultation Center (www.nccc.ucsf.edu) can connect clinicians to local and regional services. Supporting Information: Reference current Perinatal Guidelines Sources: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 2. Sauer, MV, Wang JG, Douglas NC, Nakhuda GS, Vardhana P, Jovanovic V, Guarnaccia MM. Providing fertility care to men seropositive for human immunodeficiency virus: reviewing 10 years of experience and 420 consecutive cycles of in vitro fertilization and intracytoplasmic sperm injection. Fertil Steril. 2009;91(6): 32

33 Pregnant Woman with an HIV-Infected Male Partner (cont.)
Slide Pregnant Woman with an HIV-Infected Male Partner (cont.) Counsel woman about symptoms of acute HIV infection (fever, pharyngitis, rash, myalgia, diarrhea, headache, flu-like symptoms) Counsel on importance of seeking medical care and testing if she has these symptoms If HIV infection is suspected, do HIV RNA and antibody test; repeat in 4–6 weeks If patient presents in labor: rapid HIV test Talking Points: Women should be counseled regarding the symptoms of acute retroviral syndrome. If the clinician suspects that a pregnant woman may be in the “window” period of seroconversion or she has signs or symptoms consistent with acute HIV infection, then a plasma HIV RNA test can be used in conjunction with an HIV antibody test, and HIV testing may be repeated in 4–6 weeks. If woman presents in labor with incomplete HIV test results (e.g., undocumented HIV test results or only one rather than two HIV tests), then she should be screened with a rapid HIV test in labor and delivery. In cases where confirmatory testing results are not readily available (e.g., rapid testing during labor), then it is appropriate to initiate interventions to reduce perinatal transmission even in the absence of confirmatory testing. 33

34 Slide Lessons from Clinical Trials of ARV Interventions to Reduce Perinatal HIV Transmission Chapter title slide; no notes.

35 Pediatric AIDS Clinical Trials Group 076
Slide Pediatric AIDS Clinical Trials Group 076 A phase III randomized placebo-controlled trial of zidovudine (ZDV) for preventing maternal-fetal HIV transmission. Treatment Regimen Antepartum: 100 mg ZDV po 5x day, started at 14–34 weeks gestation Intrapartum: During labor, 1-hour initial dose 2 mg/kg IV followed by continuous infusion of 1 mg/kg until delivery Postpartum/Infant: 2 mg/kg po q 6 hr for 6 weeks, start 8–12 hours after birth Talking Points: What can we do to prevent perinatal transmission? Answer came from a clinical trial that was halted in 1994. Pediatric AIDS Clinical Trials Group 076 (PACTG 076) was a trial of more than 477 pregnant women with HIV infection. Women in the experimental group received ZDV during pregnancy from 34-weeks gestation, during labor and delivery, and their infants received oral ZDV for 6 weeks after birth. Study was halted in February 1994 when interim results showed a significant difference in transmission rate between ZDV and placebo groups.1 Supporting Information: In practice, maternal or infant ZDV dosing may be modified. To improve compliance, maternal doses of 200 mg po tid or 300 mg po bid are commonly used in practice. The half-life of intracellular ZDV is >4 hours and can improve adherence. Adjustments to infant dosing: ・ For infants who cannot tolerate oral intake, intravenous (IV) dose is 1.5 mg/kg body weight IV every 6 hours ・ Premature infants require different ZDV dosing Source: 1. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med. 1994;331: 35

36 Results of Pediatric AIDS Clinical Trials Group 076
Slide Results of Pediatric AIDS Clinical Trials Group 076 Intervention led to a 66% reduction in risk for transmission (P= <0.001) Efficacy was observed in all study subgroups Talking Points: PACTG 076 found that women in the ZDV group decreased the risk of transmission to their infants by 2/3, from a risk of 22.5% to less than 8%. 3-part ZDV regimen of PACTG 076 is the “gold standard” against which other interventions to reduce perinatal transmission are measured. Source: 1. Sperling RS, Shapiro, DE, et al. Maternal viral load zidovudine treatment and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. N Engl J Med. 1996;335: 36

37 Reducing HIV Transmission with Partial ZDV Regimens (NY cohort)
Slide Reducing HIV Transmission with Partial ZDV Regimens (NY cohort) Talking Points: The 3-part regimen is ideal and the goal, but receiving even part of the regimen decreases the risk of perinatal transmission significantly. One of the studies that provides the evidence for intervention during labor and delivery and with the newborn is a retrospective epidemiological study from New York State a few years after the 076 regimen. This a study found that even partial use of the 076 regimen helped reduce rates of perinatal transmission. Supporting Information: Transmission rates were: ・ 6.1% with prenatal, intrapartum, and infant ZDV ・ 10% with only intrapartum ZDV ・ 9.3% if only infant ZDV started within first 48 hours ・ 26.6% with no ZDV Majority of infants started ZDV within 12 hours of birth. If ZDV was started within 24 hours of birth, infants were less likely to be infected. Source: 1. Wade NA, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of human immunodeficiency virus. N Engl J Med. 1999;339: 37

38 International Studies: Short-Course Regimens to Prevent Transmission
Slide International Studies: Short-Course Regimens to Prevent Transmission Combination ARV regimens are more effective than single-drug therapy Longer duration of antepartum prophylaxis is more effective than shorter (e.g., starting at 28 weeks gestation versus 36 weeks) If no maternal therapy, give postnatal infant ARV prophylaxis: a minimum of ZDV for 6 weeks Talking Points: A number of simple regimens have been identified that are effective in reducing perinatal transmission in resource-limited countries. Comparison of results between trials is difficult since they involved different populations and different locations; patients were infected with different viral subtypes and have different infant feeding practices. General conclusions: ・ Short-term efficacy has been demonstrated for a number of short-course ARV regimens, those with ZDV alone; ZDV plus 3TC; single-dose nevirapine (NVP); and more recently, combining single-dose NVP with either short-course ZDV or ZDV/3TC.1 ・ In general, combination regimens are more effective than single-drug regimens and, when it is feasible and affordable, a longer 3-part regimen given antenatally, intrapartum, and postpartum is superior in preventing perinatal transmission than a shorter 2-part antepartum/intrapartum or intrapartum/postpartum regimen. Supporting Information: Longer duration of antenatal therapy (starting at 28-weeks gestation) is more effective than shorter (starting at 36-weeks gestation), suggesting that a significant proportion of in-utero transmission occurs between 28- and 36-weeks gestation. More prolonged post-exposure prophylaxis of the infant does not appear to substitute for longer duration of maternal therapy. Sources: 1. Jackson JB, Musoke P, Fleming T, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet. 2003;362(9387): Available from: 2. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 38

39 Antepartum Care for HIV-Infected Women
Slide Antepartum Care for HIV-Infected Women Chapter title slide; no notes.

40 Standard Precautions and Obstetric Practice
Slide Standard Precautions and Obstetric Practice Barrier devices for specific procedures recommended by hospital infection control guidelines Talking Points: In formative testing done by CDC as educational materials for obstetricians were being developed, one of the concerns frequently raised was regarding standard precautions needed in the OB setting.1 General questions were raised through informed research about the type of precautions needed based on various clinical procedures. Personal protective equipment (PPE) outlined on the slide are precautions to used and include gloves, facial protection, and isolation gowns. Note that facial protection includes masks and goggles for eye protection. Sources: 1. CDC, Alan Newman Research, HIV Prevention materials Focus Group and In-Depth Interviews Summary Report, Nov. 9, 2004. 2. Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 40

41 Review: Goals of ARV Therapy
Slide Review: Goals of ARV Therapy Suppress HIV to below the limits of detection or as low as possible for as long as possible Prolong life and improve quality of life Preserve or restore immune function Reduce risk of perinatal transmission Talking Points: The primary goals of ARV treatment are the same for a pregnant woman as for any person living with HIV. An added benefit/goal of ARV treatment for a pregnant woman is the unique opportunity to reduce the risk of transmission to the baby. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 41

42 Perinatal ARV Guidelines
Slide Perinatal ARV Guidelines USPHS Task Force Recommendations for the Use of ARV Drugs in Pregnant HIV-1 Infected Women for Maternal Health and to Reduce Perinatal HIV-1 Transmission in the United States Developed in 1994 in response to PACTG 076 Working group meets monthly Updated recommendations available online at AIDSInfo website (http://www.aidsinfo.nih.gov) Talking Point: The United States Public Health Service (USPHS) first convened a panel of experts including clinicians, researchers, women living with HIV, and government officials in 1994 to develop guidelines for the use of ARV drugs in pregnant women for their own health and to reduce the risk of perinatal HIV transmission. 42

43 Guidelines for ARV Drugs in Pregnancy
Slide Guidelines for ARV Drugs in Pregnancy Use optimal ARVs for woman’s health; consider potential impact on fetus/infant Include 3-part ZDV regimen to reduce perinatal transmission as part of 3-drug ARV regimen Use of ZDV alone is controversial but may be considered when HIV RNA levels are <1000 copies/mL Talking Points: Therapies with known benefit should not be withheld during pregnancy unless there are adverse effects for mother, fetus, or infant, and unless adverse effects outweigh benefit to the woman. Unique considerations for treating pregnant women include: ・ Potential changes in dosing due to physiologic changes in pregnancy ・ Potential short- and long-term effects of drugs on the fetus and newborn, which may not be known for many ARVs Supporting Information: Discussion regarding use of ARV in pregnancy should include: ・ Known and unknown effects of drugs on the woman, on the fetus and newborn, and lack of data on long-term effects ・ Recommended treatment for woman’s health ・ Known ZDV efficacy for reducing perinatal transmission Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 43

44 Guidelines for ARV Drugs in Pregnancy (continued)
Slide Guidelines for ARV Drugs in Pregnancy (continued) Discuss preventable risk factors for perinatal transmission Support woman’s decision Acceptance or refusal of ARVs should not negatively affect care Talking Points: Decisions regarding the use and choice of ARV drugs during pregnancy are complex and should be made by the woman in consultation with her healthcare provider. Coercive or punitive policies are potentially counterproductive in that they may undermine provider-patient trust and could discourage women from seeking prenatal care and adopting health care behaviors that optimize fetal and neonatal well-being. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 44

45 General Principles: Use of ARVs During Pregnancy
Slide General Principles: Use of ARVs During Pregnancy Initial evaluation should include: Assessment of HIV disease status Recommendations for ARV therapy or assessment of current ARV regimen Recommend ARV therapy/prophylaxis to all pregnant women with HIV infection Discuss known benefits and potential risks of ARVs during pregnancy Talking Points: In addition to the standard antenatal assessments, the initial evaluation should include an assessment of HIV disease status and recommendations regarding ARV treatment or alteration of her current ARV regimen: ・ Evaluation of the degree of existing immunodeficiency determined by past and current CD4 count ・ Evaluation of the risk for disease progression and perinatal HIV transmission as determined by current plasma HIV RNA copy number ・ Assessment of the need for prophylaxis against opportunistic infections such as Pneumocystis jirovecii pneumonia (PCP) or Mycobacterium avium complex (MAC) ・ Baseline evaluation with complete blood cell count, and renal and liver function testing Supporting Information: History of prior and current ARV therapy History of prior ARV drug use for prevention Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 45

46 General Principles: Use of ARVs During Pregnancy (continued)
Slide General Principles: Use of ARVs During Pregnancy (continued) Treatment is complex: Consult with an HIV expert If HIV RNA is detectable, do resistance testing before starting/modifying therapy If HIV is diagnosed during second half of pregnancy, initiate ARV regimen without waiting for results of resistance test Individualize ARV treatment Emphasize the importance of adherence to treatment and prophylaxis Assure coordination of comprehensive services Talking Points: Medical care of HIV-infected pregnant women requires coordination and communication between HIV specialists and obstetrical providers. In general, if plasma HIV RNA is detectable, ARV drug resistance studies should be performed before starting ARV therapy or prophylaxis; however, if HIV is diagnosed late in pregnancy, therapy should be initiated while awaiting results of resistance testing. A pregnant woman may need additional services in her community and should be referred to a social worker. Sources: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 46

47 Special Considerations: ARV Use by Pregnant Women and Infants
Slide Special Considerations: ARV Use by Pregnant Women and Infants Pregnancy may alter ARV absorption, distribution, and metabolism Dosing and toxicity risk may be affected Limited data to guide treatment in pregnancy Report all cases of ARV drug exposure to ARV Pregnancy Registry at Talking Points: Recommendations regarding the choice of ARV drugs for treatment of HIV-infected pregnant women are subject to unique considerations. These include: ・ Possible changes in dosing requirements resulting from physiologic changes associated with pregnancy ・ Possible toxicities of ARV drugs that may be magnified in the pregnant woman ・ Potential short- and long-term effects of the ARV drug on the fetus and newborn, including the potential for teratogenicity, mutagenicity, or carcinogenicity, which may not be known for certain ARV drugs ・ Pharmacokinetics and toxicity of transplacentally transferred drugs; some protease inhibitors may require altered dosing. Supporting Information: Treatment recommendations for pregnant women infected with HIV are based on the concept that therapies of known benefit to women should not be withheld during pregnancy unless there are known adverse effects on the mother, fetus, or infant and unless these adverse effects outweigh the benefit to the woman.1 Pregnancy should not preclude the use of optimal therapeutic regimens. The decision to use any ARV drug during pregnancy should be made by the woman after discussing with her healthcare provider the known and potential benefits and risks to her and her fetus. The Antiretroviral Pregnancy Registry is intended to provide an early signal of any major teratogenic effect associated with a prenatal exposure to the products monitored through the Registry. The Registry is a voluntary prospective, exposure-registration, observational study designed to collect and evaluate data on the outcomes of pregnancy exposures to ARV products. Telephone: (800) Fax: (800) Internet: Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 47

48 Special Considerations for ARV in Pregnancy (continued)
Slide Special Considerations for ARV in Pregnancy (continued) Potential adverse effects during pregnancy, including teratogenicity During pregnancy avoid: Combination of stavudine (d4T) + didanosine (ddI): increased risk of lactic acidosis and hepatic steatosis Talking Points: Didanosine should be used with stavudine only if no other alternatives are available. Cases of lactic acidosis, some fatal, have been reported in pregnant women receiving didanosine and stavudine together. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 48

49 ARVs to Use With Caution During Pregnancy
Slide ARVs to Use With Caution During Pregnancy Nevirapine (NVP) – increased risk of hepatotoxicity Do not start NVP in women with CD4 counts of >250 cells/µL unless benefits clearly outweigh risks Nucleoside Reverse Transcriptase Inhibitors (NRTIs) – risk of lactic acidosis/hepatic steatosis; monitor liver enzymes, electrolytes monthly in 3rd trimester; assess often for new symptoms Talking Points: Some ARVS as outlined on the slide should only be used with caution during pregnancy. Women initiating NVP with CD4 counts >250 cells/mm3, including pregnant women receiving ARV drugs solely for prevention of transmission, have an increased risk of developing symptomatic, often rash-associated, NVP-related hepatotoxicity, which can be severe, life-threatening, and in some cases fatal. NVP should therefore be used as a component of a combination regimen only if the benefit clearly outweighs the risk. Regardless of maternal CD4 count, if NVP is used, providers should do frequent, careful monitoring of symptoms and hepatic transaminases (i.e., ALT and AST), particularly during the first 18 weeks of therapy. Some clinicians do serum transaminases at baseline, every 2 weeks for the first month, monthly through month 4, and every 1 to 3 months thereafter. Supporting Information: Increases in hepatic transaminase levels (ALT and AST) associated with rash or systemic symptoms may be observed during the first 18 weeks of treatment with Nevirapine (NVP). Signs and symptoms of systemic toxicity may be nonspecific: fatigue, malaise, anorexia, nausea, jaundice, liver tenderness, or hepatomegaly, with/without initially abnormal hepatic transaminases. Nucleoside Reverse Transcriptase Inhibitor (NRTI) drugs are known to induce mitochondrial dysfunction. Mitochondrial toxicity has been reported in patients on long-term treatment with NRTI drugs and generally resolved with discontinuation of the drug(s). These toxicities may be of concern for pregnant women and infants with in-utero exposure to NRTI drugs. Clinical disorders linked to mitochondrial toxicity include neuropathy, myopathy, cardiomyopathy, pancreatitis, hepatic steatosis, and lactic acidosis. These syndromes have similarities to rare life-threatening syndromes that occur during pregnancy, most often during the 3rd trimester: acute fatty liver, the syndrome of hemolysis, elevated liver enzymes, and low platelets (the HELLP syndrome). The frequency in pregnant HIV-infected women receiving NRTI drugs is unknown. Because pregnancy can mimic some of the early symptoms of the lactic acidosis/hepatic steatosis syndrome or be associated with other disorders of liver metabolism, physicians caring for HIV-infected pregnant women receiving NRTI drugs need to be alert for early signs of this syndrome. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 49

50 Hyperglycemia and Protease Inhibitor (PI)-based ARV Therapy
Slide Hyperglycemia and Protease Inhibitor (PI)-based ARV Therapy Potential for hyperglycemia Screening for hyperglycemia: Standard glucose loading test at 24–28 weeks Consider earlier screening if on chronic PI-based therapy Talking Points: Hyperglycemia, new onset diabetes mellitus, exacerbation of existing diabetes mellitus, and diabetic ketoacidosis have been reported in patients treated with PI ARV drugs. ・ Pregnancy itself is a risk factor for hyperglycemia. ・ Majority of data to date have not shown an increased risk of glucose intolerance with PI therapy in pregnancy. HIV-infected women receiving ARV therapy during pregnancy should receive standard glucose screening with a standard 1-hour, 50-gram glucose loading test at 24–28 weeks of gestation. Supporting Information: Some experts would perform earlier glucose screening in women on ongoing PI-based therapy started before pregnancy similar to women with high-risk factors for glucose intolerance. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 50

51 Slide Types of ARV Regimens Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)-based (1 NNRTI + 2 NRTI backbone) PI-based (1 or 2 PIs + 2 NRTI backbone) NRTI-based (3 NRTIs: inferior virologic efficacy; consider if NNRTI- or PI-based regimen is not appropriate) Talking Points: There are three primary types of ARV regimens: ・ Non-nucleoside reverse transcriptor (NNRTI) in combination with a “backbone” of two NRTIs. ・ PI-based: one or two PIs in combination with a “backbone” of two NRTIs. ・ NRTI-based: 3 NRTIs have inferior virologic efficacy and should only be considered if NNRTI- or PI-based regimen is not appropriate. Supporting Information: Any HIV-infected pregnant woman who meets standard criteria for ARV therapy as per adult ARV guidelines should receive potent combination ARV therapy, generally consisting of two NRTIs plus a NNRTI or PI(s), with continuation of therapy postpartum. ARV prophylaxis is recommended for all pregnant women regardless of viral load. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 51

52 HIV-Infected, Pregnant, ARV Naive
Slide HIV-Infected, Pregnant, ARV Naive If patient meets criteria for treatment, potent combination therapy is the standard of care In consultation with an HIV expert, start as soon as possible, including in 1st trimester Consult data on specific ARVs in pregnancy If patient does not require treatment for her own health: 3-drug combination ARV regimen for perinatal prophylaxis Consider delay until after 1st trimester in women with high CD4 cell counts and low HIV RNA levels ZDV monotherapy for prophylaxis not recommended, but may be considered if VL <1,000 copies/mL Talking Points: Pregnant women with HIV should receive standard clinical, immunologic, and virologic evaluation. Decisions about the need for ARV therapy should be based on standard guidelines in non-pregnant adults. Supporting Information: A pregnant woman who meets criteria for treatment should be started on a potent standard regimen. A pregnant woman who does not need treatment for her own health should receive a 3-drug combination ARV regimen for prophylaxis. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 52

53 HIV-Infected Pregnant Women Currently on ARVs
Slide HIV-Infected Pregnant Women Currently on ARVs Continue ARVs, if possible; avoid treatment interruption Continue efavirenz in women receiving efavirenz-based ART who present in 1st trimester of HIV RNA is suppressed Order ARV resistance tests if detectable viremia (>500–1000 copies/mL) If on NVP with suppressed VL and tolerating it, continue NVP Include ZDV, unless contraindicated Talking Points: In general, women who have been on ARV treatment should continue during pregnancy. Discontinuing therapy could lead to an increase in viral load, which could result in a decline in immune status and disease progression as well as adverse consequences for the fetus/newborn and the woman, including increased risk of HIV transmission. Counsel women on ARVs who present during the first trimester regarding the benefits and potential risks of ARVs during this period, but continuation of therapy should be recommended if HIV RNA is suppressed. Order ARV resistance tests if detectable viremia (> mL). Supporting Information: While ZDV should be a component of the ARV regimen, there may be circumstances, such as severe ZDV-related toxicity or documented ZDV resistance, when this is not possible. Women receiving an ARV regimen that does not contain ZDV but who have HIV undetectable RNA levels have a very low risk of perinatal transmission. Substituting ZDV for another drug or the addition of ZDV could compromise adherence. In such cases, continuing a non-ZDV-containing regimen that is fully suppressive is reasonable. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 53

54 Women with Past History of ARVs But Not Currently on Treatment
Slide Women with Past History of ARVs But Not Currently on Treatment Obtain history of prior ARV regimens and results of resistance testing Get drug resistance testing before starting ARVs Consult an HIV specialist regarding choice of regimen Select ARVs based on ARV history and resistance testing; monitor virologic response closely Repeat resistance testing and consult experts if poor virologic response Talking Points: Appropriate choice of ARVs will vary according to the history of ARV use, the indication for stopping therapy, whether the drugs are currently needed for treatment or prophylaxis, and results of resistance testing. In addition to obtaining genotypic resistance testing consult, specialists in the treatment of HIV infection about the choice of ARV therapy for these women. Selection of an appropriate ARV regimen for women with advanced HIV disease, a history of extensive prior ARV therapy, or history of significant toxicity to ARV drugs in the past may be challenging even for health care providers experienced in HIV care. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 54

55 Stopping ARV Therapy During Pregnancy
Slide Stopping ARV Therapy During Pregnancy Avoid interruption of therapy, if possible Interruption is likely to increase risk of ARV resistance If discontinuation required, stop and reinitiate all drugs at the same time, except: If on NNRTI, if possible stop NNRTI first, continue others for approximately 7 days If restarting NVP after interruption of >2 weeks, restart with standard 2-week dosage escalation Talking Points: Interruption of therapy should be avoided if possible. If therapy must be stopped, all drugs should be stopped and re-intitiated at the same time except that an NNRTI should be stopped first and the others continued for 7 days. NNRTIs have a long half-life; the optimal interval between stopping NNRTI and other ARV drugs not known. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 55

56 Slide Prenatal Monitoring Monitor CD4 cell count at initial visit and every 3 months thereafter Monitor plasma HIV RNA levels to assess rapid and sustained decrease At initial visit 2–4 weeks after starting/changing ARV regimen Monthly until RNA levels undetectable At least every 3 months during pregnancy At 34–36 weeks for decision on mode of delivery Talking Points: CD4 cell count and plasma HIV RNA levels should be monitored regularly as outlined on the slide. Due to physiologic changes such as hemodilution during pregnancy, CD4 percentage may be more stable than absolute CD4 count during pregnancy. Since parameters for initiating therapy are based primarily on absolute CD4 count, most clinicians still rely on CD4 count to evaluate immune status during pregnancy. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 56

57 Prenatal Monitoring (continued)
Slide Prenatal Monitoring (continued) Obtain resistance testing for women with suboptimal VL suppression or rebound Monitor for ARV drug complications Assess and support ARV adherence Talking Points: Resistance testing should be done if VL rebounds or is not optimally suppressed. Monitoring for potential complications of ARV drugs during pregnancy should be based on what is known about the side effects of the drugs the woman is receiving. Adherence should be assessed and supported at each visit. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 57

58 Monitoring Women and Fetus: Ultrasound Recommendations
Slide Monitoring Women and Fetus: Ultrasound Recommendations 1st trimester: confirmation of gestational age Potential timing for Cesarean delivery, if needed, performed at 38 weeks 2nd trimester: assess fetal anatomy for women on combination ARVs Talking Points: First-trimester ultrasound is recommended for confirmation of gestational age and to guide timing of scheduled Cesarean delivery, if needed, since scheduled Cesarean deliveries for prevention of perinatal HIV transmission should be performed at 38 weeks gestation. ・ First-trimester ultrasound has been shown in research studies and is recommended by ACOG as most accurate for dating of pregnancy. If the patient is not seen until later in gestation, then second-trimester ultrasound can be used for anatomy scanning and gestational age. Because less is known about the effect of combination ARV therapy on the fetus during pregnancy, some experts consider more intensive fetal assessment for these mothers. Supporting Information: Most experts would recommend second-trimester ultrasound assessment of fetal anatomy in women who are on combination ARVs during the first trimester, particularly if the regimen included EFV. Some experts would also recommend ultrasound assessment of fetal growth and well-being during the third trimester in addition to standard clinical monitoring, if the woman was receiving an ARV regimen for which there is limited experience with use in pregnancy. Additional assessments such as non-stress testing should be determined based on ultrasound findings and any maternal co-morbidities. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 58

59 Failure of Viral Suppression
Slide Failure of Viral Suppression Assess resistance, adherence, dosing and problems with absorption Consider modification of ARV regimen Consult with an HIV expert Scheduled Cesarean delivery recommended if HIV RNA >1,000 copies/mL near time of delivery Talking Points: Management of women on chronic ARV therapy who have suboptimal suppression of HIV RNA (i.e., detectable virus at any time during pregnancy) should include evaluation for resistant virus, assessment of adherence, incorrect dosing or potential problems with absorption (e.g., with nausea/vomiting or lack of attention to food requirements), and consideration of modification of ARV therapy. Experts in the care of ARV-experienced adults should be consulted, in particular when a change in drug regimen is necessary. If VL is >1000, a scheduled Cesarean delivery is recommended. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 2. American College of Obstetricians and Gynecologists (ACOG), Committee on Obstetric Practice. Scheduled cesarean delivery and the prevention of vertical transmission of HIV infection. Washington, DC: ACOG; 2000 May. ACOG committee opinion no. 234. 59

60 ARV Resistance in Pregnancy
Slide ARV Resistance in Pregnancy Resistance to ARVs may: Decrease efficacy of perinatal prophylaxis Limit future maternal treatment options Limit treatment options in infected infants Talking Points: Antiretroviral resistance may: ・ Decrease the efficacy of perinatal prophylaxis ・ Limit the woman’s future treatment options ・ Limit treatment options if the infant is infected Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 60

61 ZDV Resistance in Pregnancy
Slide ZDV Resistance in Pregnancy Women with ZDV resistance should receive IV ZDV during labor (if they have an HIV RNA >400 copies/mL near delivery), along with their ARV regimen The optimal prophylactic regimen for newborns of women with ARV resistance is unknown Consult pediatric HIV specialist Talking Points: Women who have documented ZDV resistance should still receive IV ZDV during labor. Some experts would give additional ARVs to these infants, so a pediatric HIV specialist should be consulted. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 61

62 ARV Therapy and Pregnancy Outcome
Slide ARV Therapy and Pregnancy Outcome Preterm delivery—conflicting data Most US data do not demonstrate increased risk Mitochondrial dysfunction in neonates due to in utero ARV exposure Conflicting data: appears to occur very rarely HIV-infected women should receive combination ARVs according to current USPHS guidelines Talking Points: Data are conflicted on whether ARV exposure has an influence of pregnancy outcome. Until more information is known, HIV-infected pregnant women who are receiving combination therapy for their HIV infection should continue their provider-recommended regimen. They should receive careful, regular monitoring for pregnancy complications and for potential toxicities. Supporting Information: Some European studies found an increased incidence of preterm pregnancy in women with HIV infection. In contrast, the majority of data from the United States and Latin America do not suggest an increased risk of preterm birth associated with HAART during pregnancy. In a meta-analysis of seven clinical studies that included 2,123 HIV-infected pregnant women who delivered infants during 1990–1998 and had received antenatal ARV therapy and 1,143 women who did not receive antenatal ARV therapy, use of multiple ARV drugs as compared with no treatment or treatment with one drug was not associated with increased rates of preterm labor. Some European data suggested that mitochondrial dysfunction might develop in infants exposed to NRTIs in-utero, however a review of >16,000 infants born to HIV-infected women with and without ARV drug exposure found no deaths similar to those in the European studies or with clinical findings attributable to mitochondrial dysfunction. Most infants had been exposed to ZDV alone and few had been exposed to ZDV/3TC. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 62

63 Intrapartum Care for HIV-Infected Women
Slide Intrapartum Care for HIV-Infected Women Chapter title slide; no notes.

64 Which Pregnant Women Will Need Rapid HIV Testing in Labor?
Slide Which Pregnant Women Will Need Rapid HIV Testing in Labor? Women: With no or limited prenatal care Who were not offered testing Whose results are unavailable Who declined testing previously Who live in high-incidence areas, are at risk, and have not had a repeat test in 3rd trimester Talking Points: Some women may need rapid HIV testing in labor including: Women with no or limited prenatal care. ・ There are many reasons why women do not access prenatal care. Women with more prenatal visits have a greater likelihood of being offered HIV counseling and testing. Royce, et al. (2001) found that entering care in the 3rd trimester was a predictor for NOT being tested. ・Ask all women with no prenatal/limited prenatal care or no documented HIV status on their chart “if they know if they have HIV infection.” A woman is more likely to tell you her HIV+ status if asked directly. Women whose results aren’t available: administrative “red tape” or tested late. Women who declined testing: ・ Thought they weren’t at risk ・ Provider didn’t recommend to them ・ Know they are HIV positive and are fearful to disclose Women who should have had a 3rd trimester test but did not. Sources: 1. Royce R. et al. Barriers to universal prenatal HIV testing in 4 US locations in Am J Public Health. 2001;92: 2. Gross EG, Burr CK. HIV counseling and testing in pregnancy. N J Med. 2003;Suppl 100:21-26. 64

65 Rapid HIV Tests Six tests currently FDA approved for blood/serum
Slide Rapid HIV Tests Six tests currently FDA approved for blood/serum Four point-of-care tests (CLIA waived) One test available for oral fluid All are very specific and sensitive Talking Points: HIV testing on blood specimens is preferred; of the currently approved CLIA-waived rapid tests, rapid tests performed on blood are slightly better (have greater sensitivity) than oral fluid tests at detecting true positives. Oral fluid testing continues to play an important role in HIV testing and prevention where blood testing is not practical, or where oral fluid is preferred. It allows more people to be tested and receive their test results. Persons tested with any rapid test need to be informed before testing that the results are preliminary only and need to be confirmed. All reactive screening tests (oral fluid or blood) should be followed by a confirmatory test using serum specimens. Source: 1. 2. American College of Obstetricians and Gynecologists (ACOG), ACOG Committee on Obstetric Practice. Prenatal and perinatal human immunodeficiency virus testing: expanded recommendations. Washington, DC: ACOG; 2004;304: Committee opinion no. 418. 65

66 Rapid HIV Testing in Labor and Delivery
Slide Rapid HIV Testing in Labor and Delivery Provides results quickly; if positive, treatment can be started to reduce transmission to infant Message: It is a screening test If negative, no further testing is necessary at this time If positive, results are “preliminary,” a confirmatory test is always done Talking Points: HIV testing in labor gives results quickly. It is recommended for all women who have not had a test in prenatal care, it is voluntary, and a woman can decline testing or consent to it. The messages to the pregnant woman should include: ・ HIV can be passed from mother to baby during pregnancy, delivery, and through breastfeeding. ・ HIV is spread by unprotected sexual intercourse; therefore, all pregnant women may be at risk for HIV infection. ・ If test is positive, ARVs during labor and delivery can reduce risk of transmission to baby. ・ A pregnant woman with HIV has a 1in 4 chance of passing HIV to her baby if she is not treated. ・ If a woman with HIV takes ARVs during labor and delivery and her baby takes the medicine after birth, the chance of passing HIV to her baby is 1 in 10. Supporting Information: Explain when she can expect results. ・ Results should be given while maintaining confidentiality. Some women request that positive results be given to them after the infant is born. ・ Positive preliminary tests will be confirmed. Obtain consent for prophylactic treatment based on preliminary test results. 66

67 Giving Positive Rapid HIV Results in Labor
Slide Giving Positive Rapid HIV Results in Labor “Your preliminary HIV test was positive…this means that you may have HIV infection. We always do another test to confirm a positive rapid test.” “It is best that we start medicine to reduce the risk to your baby while we wait for the confirmatory results.” Treatment to reduce transmission to her baby Need to postpone breastfeeding until results of confirmatory test Talking Points: Explain that a positive HIV test means that she may (or is likely to) have HIV infection, but the test is preliminary and another test will be done to confirm the first test to be sure. Describe the available interventions to reduce the risk of transmission to her baby. Discuss delaying/postponing breastfeeding until after results of confirmatory test are available. Supporting Information: If she planned to breastfeed, explain how you will support her (breast-milk pumping, etc.) until the results of the confirmatory test are available. Engage a lactation specialist to assist the new mother with her pumping options for breast milk until the confirmatory results are received; this will allow her the option to breastfeed if she is HIV-negative. Tell her when to expect the confirmatory results. Explain the resources you will have for her in postpartum after the baby is born. 67

68 Intrapartum ARV Prophylaxis with a Positive Rapid Test
Slide Intrapartum ARV Prophylaxis with a Positive Rapid Test If test is positive, give maternal IV ZDV and initiate infant combination ARV prophylaxis (that includes ZDV) Maternal confirmatory HIV test done postpartum If positive, continue infant combination ARV prophylaxis (that includes ZDV) for 6 weeks If negative, stop infant ARV therapy Talking Points: All women with a positive rapid HIV test in labor should have intravenous ZDV started immediately to prevent perinatal HIV transmission and begin infant combination ARV prophylaxis. Whether the addition of other ARV drugs to the intravenous intrapartum/newborn ZDV regimen when no maternal antepartum drugs have been received increases efficacy in preventing perinatal transmission has not been directly studied. Supporting Information: Several intrapartum/neonatal prophylaxis regimens have been found to be effective in international studies. None of these regimens has been compared to intravenous ZDV. These include oral ZDV/3TC during labor followed by one week of oral ZDV/3TC to the infant single-dose intrapartum/newborn NVP. Consult with an OB and/or pediatric HIV specialist. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 68

69 Caring for the Woman Newly Diagnosed with HIV in Labor
Slide Caring for the Woman Newly Diagnosed with HIV in Labor Psychosocial support during labor and postpartum follow-up for mother and baby Confidentiality of results and treatment for mother and infant Communication and documentation of preliminary positive results Delivery and newborn records Communication with pediatrician Plan for follow-up of confirmatory results Talking Points: Comprehensive care and support services are very important for women with HIV infection and their families who often face multiple social and medical challenges. Women with a positive rapid antibody test should be presumed to be infected until confirmatory testing clarifies their status. The woman should have appropriate assessments (e.g., CD4 count and HIV RNA copy number) in the immediate postpartum period to determine maternal health status and whether ARV therapy is recommended for her own health. Arrangements for establishing HIV care and providing ongoing psychosocial support after discharge should also be provided. Most states have laws governing the confidentiality of HIV diagnosis and treatment. Often, specific written consent is required to share a patient’s HIV information with others outside the healthcare team. Supporting Information: The State HIV Testing Laws Compendium available from the National HIV/AIDS Clinicians’ Consultation Center (www.nccc.ucsf.edu) describes key HIV testing laws and policies by state. Each state’s HIV testing laws are unique and many have been revised since the release of the CDC’s 2006 HIV testing guidelines. The Compendium is designed to help clinicians understand HIV testing laws and to implement sound HIV testing policies. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 69

70 Intrapartum ARV Management for Women on ARVs in Pregnancy
Slide Intrapartum ARV Management for Women on ARVs in Pregnancy At onset of labor, IV ZDV is recommended for all HIV-positive women with HIV RNA ≥400 copies/mL (or unknown HIV RNA) near delivery, regardless of antepartum regimen or mode of delivery 2 mg/kg body weight over 1 hour followed by continuous infusion of 1mg/kg/body weight per hour until delivery of infant IV AZT is not required if woman is receiving combination ARV regimens and HIV RNA < 400 copies/mL near delivery Continue other ARVs orally on schedule as possible When administering ZDV, discontinue d4T Talking Points: HIV-positive women who are receiving an antepartum ARV regimen should continue the regimen on schedule as much as possible during the intrapartum period, regardless of route of delivery, to provide maximal virologic effect and to minimize the chance of development of drug resistance. If a woman is receiving combination ARV regimens and HIV RNA < 400 copies/mL near delivery, IV AZT is not required. When Cesarean delivery is planned, oral medications may be continued preoperatively with sips of water. Supporting Information: Medications requiring food ingestion for absorption could be taken with liquid dietary supplements, but consultation with the attending anesthesiologist should be obtained before administering in the preoperative period. If maternal ARVs must be interrupted temporarily (i.e., for less than 24 hours) in the peripartum period, all drugs (except for intrapartum intravenous ZDV) should be stopped and reinstituted simultaneously to minimize the chance of developing resistance. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 70

71 HIV Transmission and Cesarean Delivery
Slide HIV Transmission and Cesarean Delivery Cesarean section recommended: For women with HIV RNA levels >1,000 near time of delivery For women with unknown HIV RNA levels Schedule at 38 weeks Benefits of Cesarean unclear after ROM or onset of labor: base decision on clinical factors Benefits of Cesarean unclear for women with HIV RNA levels <1,000 on combination ARVs Talking Points: ACOG’s Committee on Obstetric Practice Committee Opinion (2000) recommended consideration of scheduled Cesarean delivery (prior to labor and rupture of membranes) for HIV-infected pregnant women with HIV RNA levels >1,000 copies/mL near the time of delivery. For women with HIV RNA <1,000 copies/mL, the data regarding the benefit of scheduled Cesarean are insufficient to draw definitive conclusions; therefore, decisions regarding mode of delivery should be individualized. Supporting Information: HIV-infected women who present late in pregnancy and are not on ARVs may not have HIV RNA results available before delivery. Without current ARV therapy, HIV viral load levels are unlikely to be <1000 copies/mL. Scheduled Cesarean is likely to provide additional benefit in reducing perinatal transmission risk. Pregnant women on combination ARV with VL of <1,000 near the time of delivery have transmission rates of 1.2–1.5%. Given this very low rate of transmission, the benefit of scheduled Cesarean is difficult to evaluate in this group of women. Scheduled Cesarean may not further reduce risk of transmission. Sources: 1. American College of Obstetrics and Gynecology (ACOG) Committee on Obstetric Practice. ACOG Committee Opinion No. 234 Scheduled Cesarean Delivery and the Prevention of Vertical Transmission of HIV infection. Int J Gynaecol Obstet. 2000;234;73(3); 2. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 71

72 Maternal Risks by Mode of Delivery
Slide Maternal Risks by Mode of Delivery Counsel women about potential risks/benefits of Cesarean versus vaginal delivery Cesarean associated with somewhat greater risk of obstetrical complications in HIV-infected women Complications do not outweigh benefits of reduced HIV transmission for those at increased risk Prophylactic narrow-spectrum antibiotic generally recommended Talking Points: Data indicate that Cesarean delivery is associated with a somewhat greater risk of complications among HIV-infected women than observed among uninfected women, the difference is most notable among women with more advanced disease. Scheduled Cesarean delivery for prevention of HIV transmission poses a risk of obstetrical complications greater than that of vaginal delivery and less than that of urgent or emergent Cesarean delivery. Complication rates in most studies were within the range reported in populations of HIV-uninfected women with similar risk factors and were not of sufficient frequency or severity to outweigh the potential benefit of reduced transmission among women at heightened risk of transmission. Supporting Information: Complications included endometritis, postpartum fever, wound infections, mild anemia, and pneumonia. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 72

73 Management of Membrane Rupture
Slide Management of Membrane Rupture Risk of transmission with rupture of membranes (ROM) increases with time If labor is progressing and membranes are intact, avoid artificial ROM and invasive monitoring Women scheduled for Cesarean who present with premature rupture of membranes (PROM): individualize management Duration of rupture, progress of labor HIV RNA level, current ARV regimen Talking Points: ROM increases the risk of HIV transmission over time. If spontaneous rupture of membranes occurs before or early during the course of labor, interventions to decrease the time to delivery, such as administration of oxytocin, may be considered. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 73

74 Other Intrapartum Issues
Slide Other Intrapartum Issues Avoid artificial ROM or invasive monitoring unless obstetrically indicated and duration is expected to be short Use forceps or vacuum extractor only in select circumstances Avoid use of methergine for postpartum hemorrhage in women receiving PIs, efavirenz, or delavirdine Risk of exaggerated vasoconstrictive response Use if no other alternative, at low dosage, and for short duration Talking Points: Obstetric procedures increasing the risk of fetal exposure to maternal blood, such as amniocentesis and invasive monitoring, have been implicated in increasing vertical transmission rates by some, but not all, investigators. None of the studies assessing these risks has controlled for VL or have been in women on potent combination ARV therapy. Delivery with forceps or vacuum extractor may increase the risk of transmission and should be avoided if possible. May be considered to shorten time to delivery or for firm obstetric indications. If labor is progressing and membranes are intact, artificial rupture of membranes (AROM) and use of fetal scalp electrodes should be considered only when obstetrically indicated and time of ruptured membranes or monitoring is expected to be short. Supporting Information: Methergine should not be co-administered with drugs that are potent CYP3A4 enzyme inhibitors, including PI and the NNRTI drugs efavirenz (EFV) and delavirdine. ・ The concomitant use of ergotamines and PIs has been associated with exaggerated vasoconstrictive responses. When uterine atony results in excessive postpartum bleeding in women with HIV infection receiving PIs or EFV or delavirdine as a component of an ARV regimen, methergine should not be used unless alternative treatments (e.g., prostaglandin F2 alpha, misoprostol, or oxytocin) are not available. ・ If there are no alternative medications available and the need for pharmacologic treatment outweighs the risks, methergine should be used in as low a dosage and for as short a duration as possible. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 74

75 Slide Case Discussions Chapter title slide; no notes. Note: Images used throughout this presentation do not represent actual events or people living with HIV.

76 Case 1: OB/GYN Office, Young Couple
Slide 92 Case 1: OB/GYN Office, Young Couple Alonzo and Rita, in their late 20s, are being seen for their first prenatal visit and are very excited about their first baby. They have been together for 3 years. Rita reads the material about the routine prenatal tests and says she will decline the HIV test. When questioned by the nurse, Rita says, “I don’t need an HIV test—I don’t do drugs, and Alonzo is the only one I’ve been with.” No notes 76

77 Case 1: Questions What are the issues in this case?
Slide 93 Case 1: Questions What are the issues in this case? How do you present HIV prenatal testing? Key Points: Risk-based prenatal HIV testing often fails to identify pregnant women with HIV infection. Pregnancy is a sexually transmitted condition. A woman may not know she is at risk for HIV. Alonzo may have had previous partners and/or risk factors in his history that Rita is unaware of. Responses to “I’m not at risk” statements may include: ・ “You’re probably right, but we can’t be sure unless you get tested.” ・ You can also say, “HIV testing is routine and included with the other prenatal tests that are important. Experts recommend that all pregnant women be tested for HIV in prenatal care.” The consequences of a positive HIV test are serious, even though there is effective treatment that can prolong a woman’s life and improve her quality of life. All women should be given information about HIV and how to prevent infection. If all the office staff (the “whole office approach”) are aware of the importance of HIV testing, the message will be conveyed to patients that this is routine; we recommend it (we tell all our patients why it is important) because there is treatment for the woman and to protect her baby. If Rita declines the test, inform her that you will approach her again about HIV testing later in the pregnancy and, as recommended by experts, at the time of labor and delivery. 77

78 Case 2: 1st Prenatal Visit, Private OB Practice
Slide 94 Case 2: 1st Prenatal Visit, Private OB Practice Mrs. Mary M., G2P1, is a 32-year-old professional woman. An immigrant from Western Africa, Mrs. M. is married and has a 6-year-old daughter. When presented with the routine prenatal tests, she declines HIV testing, saying she was “recently tested and it was negative.” No notes 78

79 Slide 95 Case 2: Questions How do you or your office present routine prenatal HIV testing? What is your response to Mrs. M’s decline of HIV testing and her recent negative HIV test? What are the legal and ethical issues in this case? Talking Points: Based on formative research supporting new CDC women’s health program, many women reported they thought if they received a blood draw during a medical visit, then they were getting an HIV test, too. Key Points: This patient comes from a region that has a high prevalence of HIV infection. Legally, documentation of the “recent” negative test is needed to verify that indeed the test was negative and recent. (You need documentation for any medical test before accepting a patient’s verbal statement that something is “negative” or “normal.”) For this woman, it is also important to strongly consider repeat HIV testing in the 3rd trimester. In many high prevalence countries, the highest risk for women is heterosexual transmission – often in married women. Having Mrs. M.’s husband tested for HIV is also important. Because of the intense stigma surrounding HIV found in many African countries, this woman may feel singled out because of her country of origin. Present HIV testing is routine for all pregnant women in your practice because of a national US recommendation. Ethically, by recommending HIV testing to all your patients, you help to normalize and destigmatize HIV testing. If your practice is in a state or jurisdiction that has routine “opt-out” HIV testing, it is important that the woman knows that HIV testing is routinely done as part of the prenatal tests, but that she has the right to decline. 79

80 Case 3: Hospital Prenatal Clinic, 3rd Trimester
Slide 96 Case 3: Hospital Prenatal Clinic, 3rd Trimester Ms. Joan J. (a former injection drug user [IDU]), G3P2, 32-weeks gestation. First prenatal visit was at 20 weeks; tested HIV negative. She has a history of STDs and genital herpes. Reports that her partner sometimes refuses to wear a condom for sex. “He gets very angry about it sometimes, especially when he’s had a few drinks.” She complains about an itchy, yellowish vaginal discharge. No notes 80

81 Case 3: Questions What are the issues in this case?
Slide 97 Case 3: Questions What are the issues in this case? How have you prepared Joan for 3rd-trimester HIV retesting? What are the issues if Joan’s HIV test is positive at 32 weeks? How will you present the results of an HIV-positive test? Key Points: There are many issues in this case: ・ Diagnosis and treatment for the vaginal infection ・ Careful risk assessment and risk-reduction counseling by referral if necessary ・ Careful assessment of risk for domestic violence ・ Partner testing for STDs, HIV (This is particularly sensitive if she is HIV-positive. Counseling and support to assess the best method for disclosure of her HIV status and partner notification and testing is very important.) Clinically, Joan should have a repeat 3rd-trimester test. She can decline; however, you need to strongly recommend a test if she does decline. She has a history of risk behavior, STDs, and unprotected sex. If her test is positive, she needs referral to HIV care and evaluation ASAP. She is at high risk for perinatal transmission due to a high viral load if she became HIV infected during this pregnancy. There is some urgency, at 32 weeks, to start ARV treatment to prevent perinatal transmission. 81

82 Case 4: OB/GYN Practice, Indeterminate HIV Test Results
Slide 98 Case 4: OB/GYN Practice, Indeterminate HIV Test Results Ms. Jennifer W. is a 26-year-old primigravida now at 16-weeks gestation. Her prenatal HIV screening ELISA (EIA) was positive and the Western blot was indeterminate. You repeated the HIV test 6 weeks later with the same results. Your practice is in a city with a low incidence of HIV in women. No notes 82

83 Case 4: Questions Does Jennifer have HIV infection?
Slide 99 Case 4: Questions Does Jennifer have HIV infection? Does she need to be started on ARVs for perinatal HIV prevention? How do you discuss these results with her? Key Points: This is likely to be a false-positive antibody test. Pregnancy itself can increase the rate of false-positive HIV antibody tests.1 About 0.2 percent of EIA tests give positive results that are proven false by WB. An EIA can be falsely positive for several reasons, including a patient’s autoimmune disease, multiple pregnancies, blood transfusions, liver disease, parenteral substance abuse, hemodialysis, vaccinations for hepatitis B, rabies, or influenza.2 When confronted with an indeterminate WB test result, gestational stage is important. This woman is in the 2nd trimester, which presents less urgency to begin treatment than in the 3rd trimester. Further testing should include polymerase chain reaction (PCR) test for viral nucleic acid sequences. The DNA-PCR is considered the method of choice. However, some laboratories offer only RNA-PCR testing, also called viral load, which is used to follow the course of HIV disease. It is reasonable to use this method as a diagnostic tool. Sources: 1. Doran TI, Parra E. False positive and indeterminate human immunodeficiency virus test results in pregnant women. Arch Fam Med. 2000;9: 2. Mylonakis E, Paliou M, Greenbough TC, Flaningan TP, Letvin NL, Rich JD. Report of a false-positive HIV test result and the potential use of additional tests in establishing HIV serostatus. Arch Intern Med. 2000;160: 83

84 Slide 101 Case 5: Questions What are recommendations for HIV testing for this woman? How do you present the HIV test? Do you have information about the test in Spanish? When will HIV test results be available? Is rapid testing an option? What are the issues if Ms. H.’s HIV test is positive? What is important to tell her? Key Points: This mother is in her 3rd trimester. The recommendations for HIV testing apply, regardless of when a woman presents in pregnancy. It is important to educate her about the importance of learning her status so that if she is positive, she can get treatment and prevent transmitting HIV to her baby. If she declines testing, it is important to tell her that rapid HIV testing will be recommended in labor and delivery. This mother has preterm deliveries. Getting quick results of her prenatal tests including HIV is important. If rapid testing is an option, it will provide results quickly. While it may not show recent infection, a negative rapid test is reassuring. Document results, negative and positive, and make sure that labor and delivery has a copy of her records because she may go into labor early. What else is going on in this woman’s life that she presents late for care? Why didn’t she have “time”? Is it cultural belief, distrust, or disconnection with the health care system, worries about immigration, or other issues? Building a relationship so that she continues in care and educating her about the importance of prenatal care for a healthy pregnancy are both important. If the HIV test is positive, she needs reassurance that there is effective treatment for herself and to prevent transmission to her baby. She needs to be referred to and seen by an HIV expert quickly to evaluate the need for ARV therapy for her and for preventing perinatal HIV transmission. This mother may know that she is HIV positive and is reluctant to disclose for any number of reasons. Sometimes women will agree to screening even though they have known of their HIV-positive status for some time. 84

85 Case 5: Prenatal Clinic, Late Presenter
Slide 100 Case 5: Prenatal Clinic, Late Presenter Ms. Ana H., G3P2, a 22-year-old Latina, presents for prenatal care at 32 weeks. Her English seems to be pretty good. She says she moved here recently and had no time to see a doctor. Her other babies were born “early” but “they are fine.” She is reluctant to have an HIV test. No notes 85

86 Case 6: Labor and Delivery, No Prenatal Care
Slide 102 Case 6: Labor and Delivery, No Prenatal Care Ms. Cathy C., G4P3, approximately 28–32-weeks gestation, is admitted in active labor. She states her water broke “about an hour ago.” She had no prenatal care. Urine+ for cocaine, Group B streptococcus positive (GBS+) [urine, cervix], other STDs negative. No notes 86

87 Slide 103 Case 6: Questions What are the recommendations for this mother and infant, including rapid HIV testing? If the rapid HIV test is positive, what are the management issues? What about follow-up? What other clinical and psychosocial issues does this case present? Key Points: This mother is at high risk for HIV and therefore perinatal HIV transmission. In addition to standard care for women with no prenatal care and GBS+ status, rapid HIV testing is important. If her preliminary HIV test result is positive, it may change your management of her preterm labor. You may want to minimize length of time or expedite delivery to decrease the risk of perinatal HIV transmission. If the preliminary HIV test is positive, it is likely this mother has a high viral load and is at risk for perinatal transmission. Consult with an HIV/OB and pediatric HIV expert, regarding the addition of ARV medications during labor or for the infant at risk and for specific virologic testing. It is important not to lose this mother and infant for a follow-up. Have a plan in place before discharge for follow-up of confirmatory HIV testing and referral for care for both mother and infant. Connect this mother to HIV community resources. If the preliminary HIV test is confirmed as positive, it will be important to assess the HIV status of her three other children. 87

88 Case 7: L&D, Community Hospital, Non-Disclosure
Slide 104 Case 7: L&D, Community Hospital, Non-Disclosure Ms. Denise S., G2P1, is admitted to your community hospital L&D at 8 pm Saturday; contractions 5–6 minutes apart and membranes ruptured. States she has not had prenatal care. (She’s registered in the prenatal clinic at University Hospital but does not want to deliver there.) Denise opts to have a rapid HIV test. It’s positive; she’s not surprised. Says, “I know I’m positive.” Admits she’s taken HIV medicines but “didn’t take any this year.” No notes 88

89 Case 7: Questions What are the management issues in this case?
Slide 105 Case 7: Questions What are the management issues in this case? What are the recommendations for perinatal HIV prevention? What resources do you have to assist in managing this mother during labor, postpartum? Key Points: What resources are available for you on a Saturday night? Do you know the numbers for expert OB consultation for managing this mother? ・ The Perinatal Guidelines are available online at ・ The Perinatal Hotline – National Perinatal HIV Consultation and Referral Service is available 24 hours a day at Because this mother has had previous ARV therapy, treating her is complex. She has an unknown viral load and is at unknown risk for transmitting HIV to her baby. Intrapartum ZDV and ZDV for the infant are recommended regardless of her previous treatment. Consult with an HIV/OB expert regarding management of the delivery. The recommendations for this mother to prevent perinatal HIV transmission include IV ZDV during labor and until the cord is clamped. Consult with a pediatric HIV expert regarding newborn prophylaxis. 89

90 Case 8: L&D, Previously Refused HIV Testing, Rapid Test is Positive
Slide 106 Case 8: L&D, Previously Refused HIV Testing, Rapid Test is Positive Ms. Marla G., G3P1, is in early labor. Her (new) partner is her labor coach. She refused HIV testing during prenatal care but consents to a rapid test; preliminary results are positive. Her contractions are now 2 minutes apart. She plans to breastfeed her baby. Partner wants to know “what’s going on?” No notes 90

91 Case 8: Questions What are the issues in this case?
Slide 107 Case 8: Questions What are the issues in this case? What are the treatment options? What are the issues related to confidentiality? How do you discuss the risk of transmission through breastfeeding? How will you support Marla’s plans for breastfeeding? Is there access to ZDV syrup for the baby? What follow-up should be done? Key Points: The positive rapid HIV test result is preliminary and needs to be confirmed by WB; however, recommendations are to start IV ZDV during labor and to administer ZDV to the baby after birth while waiting for confirmatory test results. It is likely the baby will be born shortly and will not benefit from 3–4 hours of intrapartum maternal IV ZDV. Therefore, starting infant ZDV as soon as possible after birth – and within 6–12 hours of birth is very important. You have no history to indicate that this mother is at risk for HIV and that the preliminary test is likely to be a true positive. The mother did refuse HIV testing in prenatal care. Patient confidentiality: It is important to maintain confidentiality of this woman’s preliminary HIV test results. Provide privacy while discussing HIV testing and giving results. This is a new partner. Ask the woman if she is willing to have her partner present when you discuss sensitive information such as the HIV test. Consider how to maintain confidentiality when administering IV ZDV (e.g., IV bag label). Inform the woman of the need for and reasons to postpone breastfeeding until she receives negative confirmatory HIV results. Provide support via breast milk pumping and discarding the milk until confirmatory negative results are available. Follow up for assessment of risk factors for HIV and possible referrals in the postpartum unit. 91

92 Case 9: HIV-Exposed Infant
Slide 108 Case 9: HIV-Exposed Infant Mrs. Angela G.’s baby was born at 3 am Sunday morning by precipitous delivery. It is now 9 am and the results of Mom’s rapid HIV test come back positive. She tested negative early in prenatal care and in the 3rd trimester, but a rapid test was done in L&D because she reported that her husband was “back to using IV drugs.” Angela is shocked and frightened about the results of her rapid HIV test. No notes 92

93 Case 9: Questions What do you tell her about her rapid test results?
Slide 109 Case 9: Questions What do you tell her about her rapid test results? What treatment is recommended for Angela’s newborn? What resources do you have for this mother and her family? Key Points: Even though Angela’s rapid HIV test is a preliminary positive, her history points to a risk that she may be truly infected and her infant exposed to HIV. If she became infected in the last weeks of pregnancy, her viral load may be very high, putting her infant at increased risk of perinatal transmission. It is still important to stress to her that the rapid test results are preliminary, and there is a need to confirm the results with a second test. The recommendation is to start this infant on ZDV within 6–12 hours of birth—in this case, the sooner the better, as the mother did not have intrapartum ZDV. Consult with a pediatric HIV expert ASAP. Additional ARV medications may be recommended for newborn post-exposure prophylaxis. The Perinatal Hotline – National Perinatal HIV Consultation and Referral Service is available 24 hours a day at Consult with your institution or local/state health department for resources and referral, particularly for psychosocial support for this mother. 93

94 Postpartum/Newborn Care and Testing
Slide Postpartum/Newborn Care and Testing Chapter title slide; no notes.

95 Breastfeeding and Transmission
Slide Breastfeeding and Transmission An additional 15–29% of infants will be infected if there is breastfeeding HIV is found in breast milk, both cell-associated and cell-free Recommendations: Women with HIV infection in the United States should not breastfeed Women considering breastfeeding should know their HIV status Consider cultural norms in supporting the non-breastfeeding woman with HIV Talking Points: Worldwide, HIV transmission through breastfeeding accounts for about 1/3–1/2 of all transmissions from mothers to their infants.1 Women in the United States who have HIV should not breastfeed, and every breastfeeding woman should know her HIV status. Decisions NOT to breastfeed may raise issues related to confidentiality and disclosure of a mother’s HIV diagnosis and require sensitive and supportive interventions. Women who are in a discordant relationship and are breastfeeding should use protective measures while breastfeeding. Supporting Information: In resource-limited settings, where safe water is not readily available, the risks of breastfeeding must be weighed against the risk of replacement feeding. A meta-analysis suggested a constant risk of HIV transmission through breastfeeding of about 0.9% per month after the first month of life.2 There are ongoing international studies investigating the role of ARVs in HIV-infected breastfeeding women in reducing HIV transmission. In the United States, breastfeeding is the norm among many cultural groups, particularly among recent immigrants from resource-limited countries. Sources: 1. The Breastfeeding and HIV International Transmission Study Group. Late postnatal transmission of HIV-1 in breast-fed children: an individual patient data meta-analysis. J Infect Dis. 2004;15; 189: 2. Fowler, MG, Newell, ML. Breast-feeding and HIV-1 transmission in resource-limited settings. J Acquir Immune Defic Syndr. 2002;30: 3. Fowler MG, Lampe MA, Jamieson DJ, Kourtis AP, Rogers MF. Reducing the risk of mother-to-child human immunodeficiency virus transmission: past successes, current progress and challenges, and future directions. Am J Obstet Gynecol. 2007;197 Suppl 3:S3-S9. 4. Miotti PG, Taha T, Kumwenda NI, Broadhead R, et al. HIV transmission through breastfeeding: a study in Malawi. JAMA. 1999:282: 95

96 Follow-Up Care for the Mother
Slide Follow-Up Care for the Mother Refer mother for specialty HIV care Possible changes in mother’s ARV therapy Monitor for adherence and postpartum depression: consider first follow-up visit at 2 weeks, then at 6 and 12 weeks HIV testing and follow-up of older children Follow-up of sexual/needle-sharing partners Talking Points: A woman should be referred for HIV specialty care postpartum, if she has not been receiving it, since she may need her ARV regimen modified. Maternal medical services during the postpartum period must be coordinated between obstetric care providers and HIV specialists. Continuity of ARV treatment when such treatment is required for the woman’s HIV infection is especially critical and must be ensured. The decision to continue or stop ARV therapy after delivery depends on the nadir CD4 counts, clinical symptoms, presence of other indications for ARV therapy, and patient and provider preference. The immediate postpartum period poses unique challenges for adherence: new or continued supportive services should be assured before the mother and infant are discharged from the hospital. If the mother is newly diagnosed, older children need to have HIV testing if that has not been done. Her sexual and needle-sharing partners will also need to be referred for testing. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 96

97 Follow-Up Care for the Mother (continued)
Slide Follow-Up Care for the Mother (continued) Primary, gynecologic/obstetric, and family planning services Mental health services Substance abuse treatment Coordination of care through case management for the woman, her children, and other family members Talking Points: All women with HIV infection need to be referred for ongoing OB/GYN services and interconception care. Contraceptive counseling is a critical aspect of postpartum care. Although condoms are universally recommended for prevention of STD/HIV transmission, the unintended pregnancy rate with condom use alone is high. The postpartum period provides an opportunity to review and optimize women’s health care, including cervical cancer screening, routine immunizations, mental health and substance abuse treatment as indicated, and assessment for signs of postpartum depression. Care coordination services and case management are available in most communities through HIV services funded through the Ryan White Program. See slide 112. Supporting Information: Support services should be tailored to the individual woman’s needs and may include case management, child care, respite care, assistance with basic life needs (e.g., housing, food, and transportation), peer counseling, and legal and advocacy services. Ideally, this care should begin before pregnancy and should be continued throughout pregnancy and postpartum. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 97

98 Clinical Management of the Perinatally HIV-Exposed Infant
Slide Clinical Management of the Perinatally HIV-Exposed Infant 6-week neonatal component of the ZDV chemoprophylaxis regimen is recommended for all HIV-exposed neonates Initiate ZDV for neonate (at gestational age-appropriate doses), as close to the time of birth as possible If mother has not received antepartum ARV, infant should receive ZDV for 6 weeks combined with three doses of nevirapine in the first week of life (at birth, 48 hours later, and 96 hours after the second dose) Decision to combine other drugs with the 6-week ZDV regimen should be made in consultation with a pediatric HIV specialist Talking Points: 6-week neonatal component of ZDV regimen is recommended for all HIV-exposed neonates. Start ZDV at age-appropriate doses as close as possible to birth. If mother has not received antepartum ARV, give the infant ZDV for 6 weeks combined with doses of nevirapine noted. Consult a pediatric HIV specialist about combining a ZDV regimen with other drugs. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 98

99 ZDV Dosing in the Perinatally HIV-Exposed Infant
Slide ZDV Dosing in the Perinatally HIV-Exposed Infant Administration of neonatal ZDV Oral: 2mg/kg/dose every 6 hours for 6 weeks Give first dose as soon as possible after delivery: within 6–12 hours IV dose for full-term infant is 1.5 mg/kg every 6 hours Dose is adjusted for preterm infants Consult a pediatric HIV specialist For ZDV dosing for premature infants For additional ARV drugs for prophylaxis in infants Talking Points: The first dose of neonatal ZDV should be administered as soon as possible after delivery and within 6-12 hours. Consult a pediatric HIV specialist for ZDV dosage in premature infants and for recommendations regarding the use of additional ARVs for infants whose mothers were diagnosed late in pregnancy. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 99

100 Evaluation and Follow-up of HIV-Exposed Infants
Slide Evaluation and Follow-up of HIV-Exposed Infants Referral to a pediatric HIV specialist Support for ZDV prophylaxis for 6 weeks Diagnostic testing to establish or rule out HIV infection as early as possible PCP prophylaxis initiated at 6 weeks of age until HIV presumptively excluded Long-term follow-up of HIV- and ARV-exposed infants Support services for the family Talking Points: Refer the mother and infant to a pediatric HIV specialist for diagnostic follow-up and monitoring. Arrange follow-up to support the family’s adherence to infant’s prophylactic ARV regimen. For newborns, before beginning ZDV, perform a CBC and differential as a baseline. Supporting Information: HIV DNA PCR or HIV RNA assays are the preferred virologic assays. ・ Testing is recommended at 14–21 days, 1–2 months, and 3–6 months. ・ HIV is diagnosed by two positive virologic tests on separate blood samples regardless of age. Start prophylaxis for P. carinii pneumonia for all infants exposed to HIV and continue until HIV is ruled out or to age 1 year. HIV can be presumptively excluded in a non-breast fed infant with two or more negative tests: one at >14 days and one at >1 month. Data are currently insufficient to address the effect of exposure to ZDV or other ARVs in utero. Educate families to include child’s exposure to HIV and to ARVs in utero as an important element of child’s medical history. Continue to follow children exposed to ARVs into adulthood because of the theoretical concerns regarding potential for carcinogenicity of nucleoside analogue ARVs. Long-term follow-up should include yearly physical exams and for adolescent females, gynecologic evaluation with Pap smears. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 100

101 Psychosocial, Legal, and Ethical Issues
Slide Psychosocial, Legal, and Ethical Issues Chapter title slide; no notes.

102 HIV-Positive Pregnant Women: Psychosocial Issues
Slide HIV-Positive Pregnant Women: Psychosocial Issues Stigma: in community and in health care Non-disclosure: to partners, health-care team Domestic partner violence Mental health Substance abuse Worry about infection status of infant For more information, see or Talking Points: Women living with HIV face many psychosocial challenges, some related to HIV infection, others related to complex life circumstances. The issues outlined on the slide are examples of the complex issues which many women with HIV infection confront. A number of these issues are raised in the case studies that follow. Additional information on these issues can be accessed by contacting your local AIDS Education and Training Center (AETC) or through the AETC National Resource Center website (www.aids-ed.org) or the Women, Children HIV website (www.womenchildrenhiv.org) and searching on the topic of interest. 102

103 Legal and Ethical Issues with Impact on HIV Care
Slide Legal and Ethical Issues with Impact on HIV Care Confidentiality and HIV reporting Non-disclosure to sexual partners Reproductive health and family planning Immigration issues Access to prenatal/HIV care For more information see: and search on the topic of interest Talking Points: Caring for patients with HIV infection can frequently raise legal and ethical issues such as those listed on the slide. Additional information on these issues can be accessed by contacting your local AETC or through the AETC National Resource Center website (www.aids-ed.org) and searching on the topic of interest. 103

104 HIV-Infected Women of Childbearing Age: Pre- and Interconception Care
Slide HIV-Infected Women of Childbearing Age: Pre- and Interconception Care Chapter title slide; no notes.

105 Pre- and Interconception Care for Women with HIV Infection
Slide Pre- and Interconception Care for Women with HIV Infection Contraception counseling to avoid unintended pregnancy Counsel on safe sexual practices, eliminating alcohol, illicit drug use, and smoking Educate about risk factors for perinatal HIV transmission and strategies for reducing them Encourage testing and counseling of partners Counsel on reproductive options that prevent HIV exposure to uninfected partner Talking Points: The next two slides outline a number of important topics thatshould be discussed with a woman prior to pregnancy. Contraceptive counseling is an essential component of care for HIV-infected women of reproductive age. Selecting effective and appropriate contraceptive methods helps reduce the likelihood of unintended pregnancy Preconception counseling on safe sexual practices and eliminating alcohol, illicit drug use, and smoking are important both for maternal health as well as for fetal/infant health should the woman become pregnant. Evaluate for appropriate prophylaxis for opportunistic infections and administration of medical immunizations (e.g., influenza, pneumococcal, or hepatitis B vaccines) as indicated. Encourage sexual partners to receive HIV testing and counseling and appropriate HIV care. Counsel regarding available reproductive options, such as intrauterine or intravaginal insemination, that prevent HIV exposure to an uninfected partner; expert consultation is recommended. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 105

106 Pre- and Interconception Care (continued)
Slide Pre- and Interconception Care (continued) For women of childbearing potential, consider effectiveness of ARVs as well as teratogenic effects In women who intend to become pregnant, avoid efavirenz and other drugs with potential teratogenicity Attain a stable, maximally suppressed VL prior to conception Talking Points: Choice of an ARV regimen for treatment of HIV-infected women of childbearing potential needs to include consideration of effectiveness for treatment of maternal disease and the drug’s potential for teratogenicity should pregnancy occur. Attainment of a stable, maximally-suppressed viral load prior to conception is recommended for HIV-infected women who are on ARV therapy and wish to become pregnant. Source: 1. Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: Last updated July 31, Accessed February 8, 2013. 106

107 Resources for Clinicians
Slide Resources for Clinicians Offering information on AIDS treatment, prevention, and research Clinical guidelines for ARV treatment Perinatal/Mother-to-Child Transmission Pediatrics Adults and Adolescents Talking Points: AIDSinfo is a federally-sponsored web site that provides the most current guidelines for the treatment of HIV/AIDS which are reviewed and updated regularly by experts in the field. 107

108 Perinatal Hotline – National Perinatal HIV Consultation and Referral Service
Around-the-clock advice on testing and care of HIV-infected pregnant women and their infants Provides referral to HIV specialists and regional resources For additional resources:

109 Health Marketing Program for Obstetrical Providers
Slide Health Marketing Program for Obstetrical Providers Launched One Test. Two Lives.™ program in 2007 Supports 2006 revised recommendations for HIV testing Encourages OBs and certified nurse-midwives (CNMs) to test all pregnant patients for HIV to reduce transmission to the baby Provides free materials and resources for providers to encourage patient acceptance of HIV testing Website: Talking Points: In 2007, CDC launched the One Test. Two Lives. (OTTL) social marketing program, which was developed to support the recommendations in the 2006 MMWR Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings to test all pregnant women early in their pregnancy to decrease mother-to-child HIV transmission. CDC has many projects and initiatives to fund and support perinatal HIV prevention including surveillance and epidemiology programs, funding of perinatal state grantees, and multiple training programs as examples. OTTL is a specific health marketing program targeting obstetrical providers, which is a part of the overall perinatal services. Supporting Information: CDC conducted formative research with the primary target audiences of the program, obstetricians (OBs) and certified nurse-midwives (CNMs), to increase understanding of OBs’ and CNMs’ current obstetrical practices and their beliefs and behaviors around HIV testing. Based on this research, and within the constructs of Albert Bandura’s social cognitive theory, program goals including the following were developed: ・ Increase the number of obstetrical providers in all settings who offer early HIV testing as an opt-out practice for their pregnant patients and who counsel their pregnant patients to accept HIV testing after an initial decline. ・ Increase acceptance of an HIV test by pregnant patients. ・ Increase the number of rapid tests offered at labor and delivery to women with unknown HIV status. One Test. Two Lives. provides free materials in both English and Spanish to OBs and CNMs to encourage them to test all pregnant patients for HIV. Materials can be ordered through CDC-INFO, on the campaign website at or via at 109

110 Program Materials Kit Cover Provider Materials Patient Brochure
Slide 25 Program Materials Kit Cover Provider Materials Patient Brochure Resource Sheet Poster Talking Points: The One Test. Two Lives. program gives obstetric providers new tools to help ensure all patients get tested for HIV early in their pregnancy. One Test. Two Lives. provides free materials in both English and Spanish to OBs and CNMs to encourage them to test all pregnant patients for HIV. Materials can be ordered through CDC-INFO, on the campaign website at or via at 110

111 Information Resources
Slide Information Resources CDC’s One Test. Two Lives.™ program ( ) National HIV Testing Resources Act Against AIDS Talking Points: The One Test. Two Lives. program from the Centers for Disease Control and Prevention (CDC) gives obstetric providers new tools to help ensure all patients get tested for HIV early in their pregnancy. One Test. Two Lives. provides a variety of resources for providers—as well as materials for their patients—to help encourage universal prenatal testing for HIV. 111

112 Slide Information Resources (continued) US Department of Health and Human Services HRSA Health Resources & Services Administration PART C: Early Intervention Services PART D: Services for Women, Infants, Children, Youth and their Families Talking Points: Overview of the Ryan White HIV/AIDS Program: The Ryan White HIV/AIDS Program is a federal program that provides HIV-related health services. The program works with cities, states, and local community-based organizations to provide services to more than half a million people each year. The program is for those who do not have sufficient health care coverage or financial resources for coping with HIV disease. Ryan White fills gaps in care not covered by these other sources. The majority of Ryan White HIV/AIDS Program funds support primary medical care and essential support services. A smaller but equally critical portion is used to fund technical assistance, clinical training, and research on innovative models of care. Ryan White is administered by the United States Department of Health and Human Services, Health Resources & Services Administration, HIV/AIDS Bureau. Federal funds are awarded to agencies located around the country, which in turn deliver care to eligible individuals under funding categories called Parts, as outlined below. First authorized in 1990, the Ryan White HIV/AIDS Program is currently funded at $2.1 billion. Part C: The Part C Early Intervention Services (EIS) program of the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program) funds comprehensive primary health care in an outpatient setting for people living with HIV disease. Part D: Services for Women, Infants, Children, Youth, and their Families. Part D grantees provide family-centered care involving outpatient or ambulatory care (directly or through contracts) for women, infants, children, and youth with HIV/AIDS. Grantees are expected to provide primary medical care, treatment, and support services to improve access to health care. You can locate a clinic providing HIV care through the Ryan White Program at: 112

113 Slide This curriculum was developed by the François-Xavier Bagnoud Center through funding from the Centers for Disease Control and Prevention. Special thanks to: Natali Aziz, MD, MS, Stanford University Richard Beigi, MD, MSc, University of Pittsburgh Jan Kriebs, CNM, MSN, FACNM, University of Maryland Yvonne Green, Director, Office of Women’s Health, Centers for Disease Control and Prevention Steven Nesheim, MD, Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention Chapter title slide; no notes.


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