1. HIV Medication Overview John J
HIV Medication Overview John J. Faragon, PharmD, BCPS, AAHIV-P Albany Medical Center Hospital NY/NJ AIDS Education and Training Center

2. When to Start

3. DHHS: Changing Criteria for Initiating ART
CD4+ Count, cells/mm3
1998
2001
2006
2008
2009
> 500
Offer if VL > 20,000
Offer if VL > 55,000
Consider if VL ≥ 100,000
Consider in certain groups
Consider
Treat
Consider if VL > 55,000
Offer, but controversy exists
Offer after discussion with patient
< 200 or symptomatic disease
ART, antiretroviral therapy; DHHS, Department of Health and Human Services; VL, viral load.
An overview of the DHHS guidelines over time highlights the evolution in both our understanding of the natural history of HIV and the advances in HIV therapy. Generally, there has been a movement toward recommending antiretroviral therapy for broader populations of patients over time. Looking specifically at patients with high CD4+ cell counts (> 500 cells/mm3), one sees that the threshold for considering initiation of antiretroviral therapy increased from , reflecting an increasing recognition of the long-term toxicities associated with the available regimens. However, more recent data indicate that there are benefits to starting antiretroviral therapy at high CD4+ cell counts both for maintaining strong immune function and reducing the likelihood of treatment-related adverse events. Moreover, the introduction of less toxic antiretroviral agents has somewhat diminished that concern. These factors have led to the movement toward treating nearly all patients, including those with higher CD4+ cell counts.
At the other end of the spectrum, antiretroviral therapy has always been recommended for patients with low CD4+ cell counts or, notably, those with symptomatic disease. Thus, even before the recommendation to initiate antiretroviral therapy regardless of CD4+ cell count, a patient with a high CD4+ cell count would still be recommended to start antiretroviral therapy on the basis of even subtle HIV-related symptoms, which could include chronic fatigue, night sweats, diarrhea, weight loss, or others.

4. Current Guidelines for Initiating ART – Other Guidelines
Symptomatic/ AIDS
CD4+ Count < 200
CD4+ Count
CD4+ Count
CD4+ Count > 500
DHHS (5/2014)
Yes
IAS-USA (7/2012)
British HIV Association (9/2012)
Defer*
European AIDS Clinical Society (11/2012)
Consider
Defer
WHO (7/2010)
No†
Not addressed
ART, antiretroviral therapy; DHHS, Department of Health and Human Services; IAS-USA, International Antiviral Society-USA; WHO, World Health Organization.
Other organizations have also recently updated their guidelines on when to start antiretroviral therapy. The International Antiviral Society (IAS)-USA guidelines, updated in 2012, also recommend initiating antiretroviral therapy regardless of CD4+ cell count.[1] European guidelines still do not actively recommend treatment at CD4+ cell counts > 350 cells/mm3,[2,3] although the British HIV Association does recognize the case for treating patients with high CD4+ cell counts to reduce the risk of transmission.[2] The World Health Organization guidelines are more conservative, as they must account for the limited resources that exist in many areas with a high prevalence of HIV.[4] In those areas, the primary focus remains on treating individuals with CD4+ cell counts < 350 cells/mm3.
*If a patient with CD4+ count > 350 cells/mm³ wishes to start ART to reduce the risk of transmission to partners, that wish should be respected and ART started.
†With the exception of an HIV-positive partner in a serodiscordant relationship, who should be offered antiretroviral therapy at CD4+ count > 350 cells/mm³ to prevent transmission to the uninfected partner.

5. Potential Benefits of Early Therapy: Supporting Data (2)
CD4 count >500 cells/µL
Cohort study data are not consistent; some show survival benefit if ART initiated early
Other considerations (eg, potential benefit of ART on non-AIDS complications, HIV transmission risk) support recommendation for ART
Data not entirely conclusive, especially for patients with very high CD4 counts…

6. Why treat at CD4 >500 cells/mm3?
Untreated HIV infection and ongoing viremia associated with development of non-AIDS defining diseases such as
Cardiovascular Disease
Renal disease
Liver disease
Neurologic complications
Malignancy

7. Community Viral Load Mirrors Reduced Rate of New HIV Cases in San Francisco
Retrospective analysis of relationship between community viral load (CVL; mean of summed individual HIV-1 RNA results per yr) and new HIV diagnoses
30,000
P = .005 for association*
Mean CVL
1200
Newly diagnosed and reported HIV cases
25,000
1000
20,000
800
Mean Community Viral Load (copies/mL)
798
Number of Newly Diagnosed HIV Cases
15,000
600
642
10,000
523
518
434
400
5000
200
2004
2005
2006
2007
2008 Yr
*Data insufficient to prove significant association with reduced HIV incidence.
Das-Douglas M, et al. CROI Abstract 33. Reproduced with permission.

8. http://insight.ccbr.umn.edu- START Protocol Synopsis
START Study
INSIGHT Network: multinational
Study population: adults with CD4 >500
Study treatment:
Immediate ART
CD4 <350
Study endpoints:
Serious AIDS-defining illness, non-AIDS illness, death
Sample size:
N=900 (pilot for feasibility; enrollment completed)
N=3100 (definitive)
Duration: ~6 yrs.
START Protocol Synopsis

9. What to Start

10. Current ARV Medications
NRTI
Abacavir (ABC)
Didanosine (ddI)
Emtricitabine (FTC)
Lamivudine (3TC)
Stavudine (d4T)
Tenofovir (TDF)
Zidovudine (AZT)
NNRTI
Delavirdine (DLV)
Efavirenz (EFV)
Etravirine (ETR)
Nevirapine (NVP)
Rilpivirine (RPV) PI
Atazanavir (ATV)
Darunavir (DRV)
Fosamprenavir (FPV)
Indinavir (IDV)
Lopinavir (LPV)
Nelfinavir (NFV)
Ritonavir (RTV)
Saquinavir (SQV)
Tipranavir (TPV)
Integrase Inhibitor
Raltegravir (RAL)
Elvitegravir (EVG)
Dolutegravir (DTG)
Fusion Inhibitor
Enfuvirtide (ENF, T-20)
CCR5 Antagonist
Maraviroc (MVC)
26 medications, but we use only
about ½ of them usually

11. 3-Drug Combination ART 1996: Crixivan/Retrovir/Epivir
8AM
4PM
12 MID
Fasting (1 hour before/2 hours after meals)1.5 liters of hydration/day

12. HIV Lifecycle And Drug Targets
Fusion
Entry Inhibitors
Nukes and Non Nukes
Budding
Reverse transcription
Uncoating
Viral DNA
Assembly
3’-processing
Pre-Integration Complex
Viral proteins
Integrase Inhibitors
Protein chains
Viral RNA
Integration (strand transfer)
Nucleus
Translation
Transcription
Human Genomic DNA
Viral DNA
RNA
Protease Inhibitors

13. DHHS Guidelines Update 2014: Recommended Regimens in ARV Naives Regardless of Baseline CD4 and Viral Load
NNRTI – Based Regimen
Efavirenz/tenofovir/emtricitabine (AI)
PI – Based Regimens:
Atazanavir/ritonavir + tenofovir/emtrictiabine (AI)
Darunavir/ritonavir + tenofovir/emtricitabine (AI)
INSTI – Based Regimens:
Dolutegravir plus abacavir/lamivudine – ONLY if patient HLA-B*5701 negative (AI)
Dolutegravir plus tenofovir/emtricitabine (AI)
Elvitegravir/cobicistat/tenofovir/emtricitabine – ONLY if pre-ART CrCl >70ml/min (AI)
Raltegravir plus tenofovir/emtricitabine (AI)
May 2014 updated regimens and removed the previous designation of preferred regimens and now call them “recommended” regimens, and are classified as NNRTI, boosted PI, or INSTI based. In general regimens recommended consist of 2 NRTIs and one of the 3 other classes in addition.
Read regimens above and include caveats
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14

14. DHHS Guidelines Initial Recommended Regimens - 2014
Atripla
1/day
Reyataz/Norvir/Truvada
3/day
This slide provides the pill burden of preferred regimens and pictures of what the pills actually look like
Prezista/Norvir/Truvada
3/day
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14.

15. DHHS Guidelines Initial Recommended Regimens - 2014
Isentress (BID)/Truvada
3/day
Tivicay/Truvada OR Epzicom
2/day OR
This slide provides the pill burden of preferred regimens and pictures of what the pills actually look like
Stribild
1/day
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14.

16. Atripla Key Points 3 drugs in one tablet
Efavirenz/tenofovir/emtricitabine
AKA Sustiva+Truvada
Dosed at bedtime usually
Pregnancy Category D
CNS side effects common in first few weeks
Renal side effects possible with tenofovir

17. Reyataz Norvir Truvada Key Points
3 pills daily
“Boosted” PI regimen
Dosed once a day with food
GI side effects, minimal effect on lipids
Hyperbilirubinemia, nephrolithiasis
Proton Pump Inhibitor interaction
Renal side effects possible with tenofovir

18. Prezista Norvir Truvada Key Points
3 tablets daily
“Boosted” PI regimen
Dosed once a day with food
GI side effects, minimal effect on lipids
Sulfa moeity
Renal side effects possible with tenofovir
400mg off market now!

19. Ritonavir (Norvir®, RTV, r)
Dosing / Administration
For PI-boosting: mg PO BID or daily
Full dose - 600mg PO Q12H (usually wrong)
Take with food to improve tolerability
Refrigerate capsules
Adverse effects
GI effects, taste perversion, circumoral tingling
 [cholesterol] &  [triglycerides]
Drug interactions
Potent CYP3A4 inhibitor and inducer

20. Single-Dose Pharmacokinetics of Lopinavir With and Without Ritonavir
Lopinavir/ritonavir
Lopinavir Concentration (mg/mL)
While Kaletra is the only co-formulated boosted PI, most PI’s are today using RTV-enhancement to significantly improve drug concentrations. One difference that may be important, is that not only is lopinavir uniquely susceptible to boosting, but it also could not be used as a sole PI. As you can see, without boosting, this is a drug that would not have likely come to market due to poor PK. However with RTV, it’s concentration are about 70-fold the IC50 for WT virus
IC50 wt HIV
Lopinavir alone
Time After Dosing (hr)
Sham HL, et al. Antimicrob Agents Chemother. 1998;42(12): ; Lal R, et al., 37th ICAAC, 1997, # I-194

21. Why Norvir Boosted Protease Inhibitors
Less resistance – nearly no resistance reported in naïve trials with all boosted PI regimens currently on guidelines
Lower pill burdens
Reduced frequency – now all are once daily, versus 2-3 times daily for unboosted protease inhibitors
“Ritonaphobia” is the REAL downside

22. Isentress Truvada Key Points
3 tablets
Isentress dosed twice a day
Once daily dosing possible, but inferior to BID
Well tolerated, no effect on lipids
Renal side effects possible with tenofovir

23. Stribild Key Points 4 drugs in one tablet
Elvitegravir – a new integrase inhibitor
Cobicistat – a new booster (does the same thing as RTV)
Tenofovir – preferred NRTI
Emtricitiabine – preferred NRTI
Head to head data with Atripla and Reyataz/Norvir/Truvada showed similar results (non- inferior at 48 weeks)
Sax P, et al. CROI Abstract 101.
DeJesus E, et al. CROI Abstract 627.

24. Stribild – Additional Information
Contains cobicistat
Booster for the elvitegravir
Similar to Norvir for drug interactions
Increased creatinine levels due to inhibition of tubular secretion of creatinine back into bloodstream in the kidney
Similar to cimetidine

25. X Tubular Reabsorption
Substances reabsorbed back into blood from the renal tubule
Tubular Secretion
Substances secreted from the blood back into renal tubule for elimination
Blocking Tubular Secretion
Cobicistat BLOCKS tubular secretion of creatinine, causing an increase in blood levels of creatinine X

26. Tivicay Key Points OR FDA-approved August 12, 2013
Approved for wide range of HIV populations, adults and children aged 12 and above and at least 40kg
New integrase inhibitor dosed as a 50 mg tablet
Once daily for treatment-naïve patients
Twice daily for integrase treatment-experienced patients
Can be taken with or without food
Pregnancy category B
Adverse events > 2% were insomnia and headache
Contra-indicated to be given with dofetilide, an anti-arrhythmic
Submitted to FDA STR of Epzicom/dolutegravir

27. Tivicay Dosing
Treatment naïve or treatment experienced, integrase inhibitor naïve
50mg once daily
Treatment naïve or treatment experienced, with UGT1A/CYP3A4 inducers: Efavirenz, fosamprenavir/ritonavir, tipranavir, or rifampin
50mg twice daily
Integrase inhibitor with II resistance
No food restrictions
Separate from cations – ie Magnesium, Calcium, Iron

28. DHHS Guidelines Update 2014: Recommended Regimens, ARV Naives, ONLY if Pre ART Viral Load <100,000 copies/ml
NNRTI – Based Regimen
Efavirenz + abacavir/lamivudine – ONLY if patient HLA-B*5701 negative (AI)
Rilpivirine/tenofovir/emtricitabine – ONLY if patient has CD4 count>200 cells/mm3 (AI)
PI – Based Regimens:
Atazanavir/ritonavir + abacavir/lamivudine (AI) – ONLY if patient is HLA-B*5701 negative
The regimens listed here are also from the 2014 DHHS Guidelines and are the recommended regimens, but only if viral loads are less than 100,000 copies/ml at baseline. In this class there are 2 NNRTI based regimens, and one PI based option.
Of concern here is that some regimens do not perform as well in patients with higher viral loads so the viral load cutoff designation is important to recognize with these regimens.
Read regimens above with caveats
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14

29. Complera Rilpivirine/tenofovir/emtricitabine
STR once daily
Food required
Take antacids at least 2 hours before or at least 4 hours after
Take H-2 blockers at least 12 hours before or at least 4 hours after
PPIs are contraindicated

30. DHHS Guidelines Update 2014 Alternative Regimens in ARV Naives
PI – Based Regimen
Darunavir/ritonavir + abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative (BII)
Lopinavir/ritonavir (once or twice daily) plus abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative (BI)
Lopinavir/ritonavir (once or twice daily) plus tenofovir/emtricitabine (BI)
INSTI – Based Regimens:
Raltegravir + abacavir/lamivudine – ONLY for patients who are HLA-B*5701 negative
The following regimens are listed on DHHS as Alternative regimens and should be used if patients can not use or tolerate a recommended regimen.
Read regimens on slide
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at Accessed 5/2/14

31. Preferred NRTI Backbones in Pregnancy – DHHS Perinatal Guidelines, March 2014
Abacavir/lamivudine
Available as fixed dose combination, once daily dosing. Do NOT use in patients testing positive for HLAB*5701
Tenofovir/emtricitabine or lamivudine
Available as fixed dose combination, once daily dosing. Tenofovir may cause renal impairment
Zidovudine/lamivudine
Available as fixed dose combination. Most experience in pregnancy to date, but twice daily adminstration, and potential for hematologic toxicity
In this slide, I have summarized in table format the changes to the DHHS guidelines. READ CHART with caveats on right side.
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 at Accessed 5/2/14

32. Preferred PI, NNRTI Regimens in Pregnancy – DHHS Perinatal Guidelines, March 2014
Preferred PI Regimens
Atazanavir/ritonavir + preferred dual NRTI backbone
Once daily administration
Lopinavir/ritonavir + preferred dual NRTI backbone
Twice daily administration. Once daily dosing not recommended in pregnancy. May need to increase dosage in 3rd trimester
Preferred NNRTI Regimens
Efavirenz + preferred dual NRTI backbone initiated AFTER first 8 weeks of pregnancy
Teratogenicity in primates.
Preferred PI and NNRTI regimens in Pregnancy are also listed here and include comments/cavetas. Read Slidewith caveats on right
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 at Accessed 5/2/14

33. What to Avoid

34. ARV Medications: Should NOT Be Offered at ANY Time
ARV regimens not recommended:
Monotherapy with NRTI*
Monotherapy with boosted PI
Dual-NRTI therapy
3-NRTI regimen (except ABC + 3TC + ZDV or possibly TDF + 3TC + ZDV)
* ZDV monotherapy is not recommended for prevention of perinatal HIV transmission but might be considered in certain circumstances; see Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States.

35. ARV Medications: Should NOT Be Offered at ANY Time
ARV components not recommended:
Didanosine + stavudine
Didanosine + tenofovir
Emtricitabine + lamivudine
Stavudine + zidovudine
Darunavir, saquinavir, or tipranavir as single, unboosted PIs
Atazanavir + Indinavir

36. ARV Medications: Should NOT Be Offered at ANY Time
ARV components not recommended:
Efavirenz during first trimester of pregnancy and in women with significant potential for pregnancy
Nevirapine initiation in women with CD4 counts of >250 cells/µL or in men with CD4 counts of >400 cells/µL
Etravirine + unboosted PI
Etravirine + boosted Atazanavir, fosamprenavir or tipranavir
Any combination of 2 NNRTIs

37. PrEP Guidelines

38. 2014 CDC PrEP Guidelines Guidelines for PrEP were released in May 2014
Addresses the role of PrEP in the following adult populations
Men who have sex with men
Heterosexual men and woman
Injection Drug Users
Sero-discordant couples
ONLY medication to be used in this setting is tenofovir/emtricitabine (Turvada)
In May 2014, the CDC released final guidelines on PrEP in the US. Prior to this there were only interim guidance in select populations. This guidelines discusses the role of PrEP in men who have sex with men, heterosexual men and woman, injection Drug Users and in sero-discordant couples
Accessed 5/15/14.

39. Results of PrEP Trials, CDC
Results from randomized, placebo-controlled, clinical trials of the efficacy of daily oral antiretroviral preexposure prophylaxis (PrEP) for preventing human immunodeficiency virus (HIV) infection
Clinical trial
Participants
Type of medication
mITT efficacy*
Adherence-adjusted efficacy based on TDF detection in blood %
(95% CI)
Bangkok Tenofovir Study
Injecting drug users
TDF 49
(10–72) 70
(2–91)
Partners PrEP
HIV discordant couples 67
(44–81) 86
(67–94)
TDF/FTC 75
(55–87) 90
(58–98)
TDF2
Heterosexually active men and women 62
(22–83) 84 NS
iPrEx
Men who have sex with men 42
(18–60) 92
(40–99)
Fem-PrEP
Heterosexually active women — NA
VOICE
Abbreviations: mITT = modified intent to treat analysis, excluding persons determined to have had HIV infection at enrollment; CI = confidence interval; TDF = tenofovir disoproxil fumarate; FTC = emtricitabine; NS = not statistically significant; NA = data not available. * % reduction in acquisition of HIV infection.
This is a nice summary slide of all results of the PrEP studies in various populations for your review.
Center for Disease Control. MMWR. June 14, 2013 / 62(23);

40. 2014 CDC PrEP Guidelines – Recommended Indications for PrEP Use in MSM
Adult man
Without acute or established HIV infection
Any male sex partners in past 6 months
Not in a monogamous partnership with a recently tested, HIV-negative man
AND at least one of the following
Any anal sex without condoms (receptive or insertive) in past 6 months
Any STI diagnosed or reported in past 6 months
Is in an ongoing sexual relationship with an HIV-positive male partner
An for indication for PrEP for MSM the guidelines recommend daily PrEP for MSM who are:
An Adult man
Without acute or established HIV infection
Any male sex partners in past 6 months
Not in a monogamous partnership with a recently tested, HIV-negative man
AND at least one of the following
Any anal sex without condoms (receptive or insertive) in past 6 months
Any STI diagnosed or reported in past 6 months
Is in an ongoing sexual relationship with an HIV-positive male partner
Accessed 5/15/14.

41. 2014 CDC PrEP Guidelines – Recommended Indications for PrEP Use in Heterosexual Men and Women
Adult person
Without acute or established HIV infection
Any sex with opposite sex partners in past 6 months
Not in a monogamous partnership with a recently tested HIV-negative partner
AND at least one of the following
Is a man who has sex with both women and men (behaviorally bisexual)
Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner)
Is in an ongoing sexual relationship with an HIV-positive partner
As for indications for PrEP in heterosexual men and women, the guidelines recommend daily Truvada for those who are:
Adult person
Without acute or established HIV infection
Any sex with opposite sex partners in past 6 months
Not in a monogamous partnership with a recently tested HIV-negative partner
AND at least one of the following
Is a man who has sex with both women and men (behaviorally bisexual)
Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner)
Is in an ongoing sexual relationship with an HIV-positive partner
Accessed 5/15/14.

42. 2014 CDC PrEP Guidelines – Recommended Indications for PrEP Use Injection Drug Users
Adult person
Without acute or established HIV infection
Any injection of drugs not prescribed by a clinician in past 6 months
AND at least one of the following
Any sharing of injection or drug preparation equipment in past 6 months
Been in a methadone, buprenorphine, or suboxone treatment program in past 6 months
Risk of sexual acquisition
And for indications, the CDC recommends the following in IVDUs:
Adult person
Without acute or established HIV infection
Any injection of drugs not prescribed by a clinician in past 6 months
AND at least one of the following
Any sharing of injection or drug preparation equipment in past 6 months
Been in a methadone, buprenorphine, or suboxone treatment program in past 6 months
Risk of sexual acquisition
Accessed 5/15/14.

43. 2014 CDC PrEP Guidelines – Monitoring
All patients receiving PrEP should be seen as follows:
At least every 3 months to
Repeat HIV testing and assess for signs or symptoms of acute infection to document that patients are still HIV negative
Repeat pregnancy testing for women who may become pregnant
Provide a prescription or refill authorization of daily TDF/FTC for no more than 90 days (until the next HIV test)
Assess side effects, adherence, and HIV acquisition risk behaviors
Provide support for medication adherence and risk-reduction behaviors
Respond to new questions and provide any new information about PrEP use
As for monitoring, patients on PREP should be seen every 3 months to
Repeat HIV testing and assess for signs or symptoms of acute infection to document that patients are still HIV negative
Repeat pregnancy testing for women who may become pregnant
Provide a prescription or refill authorization of daily TDF/FTC for no more than 90 days (until the next HIV test)
Assess side effects, adherence, and HIV acquisition risk behaviors
Provide support for medication adherence and risk-reduction behaviors
Respond to new questions and provide any new information about PrEP use
Accessed 5/15/14.

44. 2014 CDC PrEP Guidelines – Monitoring
At least every 6 months to
Monitor eCrCl
If other threats to renal safety are present renal function may require more frequent monitoring or may need to include additional tests
A rise in serum creatinine is not a reason to withhold treatment if eCrCl remains ≥60 ml/min.
If eCrCl is declining steadily (but still ≥60 ml/min), consultation with a nephrologist may be indicated.
Conduct STI testing recommended for sexually active adolescents and adults (i.e., syphilis, gonorrhea, chlamydia)
At least every 12 months to
Evaluate the need to continue PrEP as a component of HIV prevention
Monitoring is also recommended at various intervals, In particular:
At least every 6 months to
Monitor eCrCl
If other threats to renal safety are present renal function may require more frequent monitoring or may need to include additional tests
A rise in serum creatinine is not a reason to withhold treatment if eCrCl remains ≥60 ml/min.
If eCrCl is declining steadily (but still ≥60 ml/min), consultation with a nephrologist may be indicated.
Conduct STI testing recommended for sexually active adolescents and adults (i.e., syphilis, gonorrhea, chlamydia)
At least every 12 months to
Evaluate the need to continue PrEP as a component of HIV prevention
Accessed 5/15/14.

45. PEP Guidelines

46. HIV Prophylaxis Following Exposure
The Medical Care Criteria Committee now recommends tenofovir + emtricitabine* plus raltegravir as the preferred initial PEP regimen
excellent tolerability, proven potency, and ease of administration.
Zidovudine is no longer recommended
no clear advantage in efficacy over tenofovir
higher rates of treatment-limiting side effects.

47. HIV Prophylaxis Following Occupational Exposure
Recommendations place emphasis on the importance of initiating occupational PEP as soon as possible, ideally within 2 hours of exposure.
First dose of PEP should be offered while evaluation is underway.
PEP should not be delayed while awaiting source patient or results of the exposed baseline HIV test.

48. Updated Public Health Service Occupational PEP Guidelines, November 2013
Preferred HIV PEP Regimen Raltegravir (Isentress; RAL) 400 mg PO twice daily PLUS Truvada, 1 PO once daily (Tenofovir DF [Viread; TDF] 300 mg + emtricitabine [Emtriva; FTC] 200 mg) Fixed Dose Combination
Guidelines for Occupational Exposure of HIV infection were recently updated form the 2 and 3 drug regimen in previous versions to a more simple regimen of Isentress and Truvada – This regimen is also on the NYS DOH guidelines and has been shown to have favorable tolerability. In addition, the approval of Truvada for PrEP also supports the use of this regimen. Finally, the fact that isentress works pre-transcritiptional in the life cycle of HIV supports its role in this setting.
Kuhar DT. Infect Control Hosp Epidemiol. 2013;34(9):

49. Resources

50. Web Resources of Interest
DHHS Guideline Tables
NY/NJ AIDS Education and Training Center
University of Liverpool
Toronto HIV Clinic

53. www.hiv-druginteractions.org Upper Left Corner New data, reports
Top middle – Charts and
Recommendations

54.
Good reference

56.
CLICK HERE

57.
CLICK HERE

58. NY/NJ AETC – www.nynjaetc.org

59. NY/NJ AETC – www.nynjaetc.org

60. NY/NJ AETC – www.nynjaetc.org

61. NY/NJ AETC – www.nynjaetc.org

63. HIV Medication Overview John J
HIV Medication Overview John J. Faragon, PharmD, BCPS, AAHIV-P Albany Medical Center Hospital NY/NJ AIDS Education and Training Center