Michael Hughes, MD Assistant Clinical Professor UCR Eisenhower Medical Associates
HIV Incidence (new infections): The estimated incidence of HIV has remained stable overall in recent years, at about 50,000 new HIV infections per year. Within the overall estimates, however, some groups are affected more than others. MSM continue to bear the greatest burden of HIV infection, and among races/ethnicities, African Americans continue to be disproportionately affected.
Behavioral strategies Treatment as prevention PrEP (Pre-exposure Prophylaxis) PEP (Post-exposure Prophylaxis)
PrEP is a combination of two antiretroviral medications tenovir disoproxil fumarate (TDF) and emtricitabine (FTC), taken in a single daily pill for HIV prevention This combination pill (brand name Truvada) was approved by the FDA for use as HIV treatment in 2004, and approved for PrEP in July 2012
No significant differences in serious adverse events, renal function markers or deaths among patients taking study drug compared to those taking placebo Adverse events more common on TDF or TDF/FTC than placebo in any study included : Short-duration nausea, vomiting; dizziness Back pain; decreased weight Mild elevation in liver enzymes; mild neutropenia (more with TDF/FTC than TDF) Small but statistically significant decreases in bone mineral density; no difference in atraumatic fractures Among women who became pregnant, study drug was not associated with increased pregnancy complications
STUDYOVERALL Reduction in risk of HIV infection Detectable level of medication in the blood Reduction in risk of HIV infection iPrEx44%>90% TDF262%--- Partners PrEP75%90% BTS49%74% Adapted from summary of research at
Men Who Have Sex with Men Heterosexual Women and Men Injection Drug Users Detecting substantial risk of acquiring HIV infection: *Sexual Partner with HIV *Recent bacterial STI *High number of sex partners *History of inconsistent or no condom use *Commercial sex work *Sexual Partner with HIV *Recent bacterial STI *High number of sex partners *History of inconsistent or no condom use *Commercial sex work *Lives in high-prevalence area or network *HIV-positive injecting partner *Sharing injection equipment *Recent drug treatment (but currently injecting) Clinically eligible: *Documented negative HIV test before prescribing PrEP *No signs/symptoms of acute HIV infection *Normal renal function, no contraindicated medicines *Documented Hep B virus infection and vaccination status *Documented negative HIV test before prescribing PrEP *No signs/symptoms of acute HIV infection *Normal renal function, no contraindicated medicines *Documented Hep B virus infection and vaccination status *Documented negative HIV test before prescribing PrEP *No signs/symptoms of acute HIV infection *Normal renal function, no contraindicated medicines *Documented Hep B virus infection and vaccination status Prescription Daily, Continuing, oral doses of TDF/FTC (Truvada), < 90 day supply Other Services: *Follow-up visits every 3 months to provide: HIV test, medication adherence counseling, behavior risk reduction support, side effect assessment *At 3 months and then every 6 months assess renal function *Every 6 months test for bacterial STI *Follow-up visits every 3 months to provide: HIV test, medication adherence counseling, behavior risk reduction support, side effect assessment *At 3 months and then every 6 months assess renal function *Every 6 months test for bacterial STI *Follow-up visits every 3 months to provide: HIV test, medication adherence counseling, behavior risk reduction support, side effect assessment *At 3 months and then every 6 months assess renal function *Every 6 months test for bacterial STI * Do oral/rectal STI Screening*assess pregnancy intent *pregnancy test every three months *access to clean needles/syringes and drug treatment services
Substantial risk of acquiring HIV infection Men who have sex with men (MSM) HIV-positive sexual partner Recent bacterial STI High number of sex partners History of inconsistent/no condom use Commercial sex work
In the past 6 months: Have you had sex with men, women, or both? (if men or both sexes) How many men have you had sex with? How many times did you have receptive anal sex (you were the bottom) with a man who was not wearing a condom? How many of your male sex partners were HIV-positive? (if any positive) With these HIV-positive male partners, how many times did you have insertive anal sex (you were the top) without you wearing the condom? Have you used methamphetamines (such as crystal or speed)?
Substantial risk of acquiring HIV infection Heterosexual women and men HIV-positive sexual partner Recent bacterial STI High number of sex partners History of inconsistent/no condom use Commercial sex work High-prevalence area or network
Substantial risk of acquiring HIV infection Transgender individuals Engaging in high-risk sexual behaviors
Substantial risk of acquiring HIV infection Injection drug users (IDU) HIV-positive injecting partner Sharing injection equipment Recent drug treatment (but currently injecting)
Documented negative HIV test No signs/symptoms of acute HIV infection Normal renal function No contraindicated medications Documented hepatitis B infection & vaccination status
Are signs/symptoms of acute HIV present now or in prior 4 weeks? Option 1: retest antibody in one month Option 2: HIV antibody/antigen assay Option 3: HIV-1 viral load
Symptoms Fever Fatigue Myalgia Skin rash Headache Pharyngitis Cervical Lymphadenopathy Arthralgia Night sweats Diarrhea Daar ES, Pilcher CD, Hecht FM. Curr Opin HIV AIDS. 2008;3(1):10-15.
Age Reproductive plan Osteopenia/osteoporosis
Before starting PrEP: Clinical eligibility Educate Side effects Limitations Daily adherence Symptoms of seroconversion Monitoring schedule Safety Criteria for discontinuation Partner information Social history: housing, substance use, mental health, domestic violence Every visit: Assess adherence Risk reduction counseling
After confirmation of clinical eligibility: Prescribe no more than 90-day supply of PrEP Truvada 1 tablet PO daily (tenofovir 300mg + emtricitabine 200mg) Insurance prior approval Truvada for PrEP Medication Assistance Program Every visit: Assess adherence Risk reduction counseling
3-month visit: HIV test Assess for acute infection Check for side effects Pregnancy testing Prescribe 90-day supply of medication Every visit: Assess adherence Risk reduction counseling
6-month HIV test STI test Pregnancy test Renal function 90 day prescription 9-month HIV test Pregnancy test 90 day prescription 12-month HIV test STI tests Pregnancy test Renal function 90 day prescription Assess the need to continue PrEP Every visit: Assess adherence Risk reduction counseling
Develop trust, avoid judgment Plan Monitor Educate Identify barriers Assess for side effects
CDC: pdf pdf NYSDOH AI: PrEP Watch/ AVAC: REMS clinician materials prep-resources prep-resources