The UC San Diego AntiViral Research Center sponsors weekly
presentations by infectious disease clinicians, physicians and
...
Introduction
 Antiretroviral medication for HIV prevention are an
attractive additional to existing interventions:
 Beha...
Outline of Recent Advances
 Introduction
 Update on data on PrEP HIV negatives
 Efficacy in men and women
 Pharmacolog...
People Living With HIV
(1,039,000-1,185,000)
New Sexual infections/Year
(~32,000)
Percent
Marks G. AIDS. 2006;20:1447-1450...
Viral Suppression among HIV
infected in United States Smith PLoS 2012
Marks G. AIDS. 2006;20:1447-1450.
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Status New infections
Aware (ART)
Aware (no ART)
Unaware
Awareness of HIV Serostat...
Update on PrEP
PrEP Elf
Past and Current PrEP Trials
(July 2011)
Available at: www.avac.org.
People Living With HIV
(1,039,000-1,185,000)
New Sexual infections/Year
(~32,000)
Percent
Marks G. AIDS. 2006;20:1447-1450...
Poynten 2012
Percent Important New PrEP Studies
Trial Population Study
HPTN 067
Heterosexual
women and
MSM
TDF/FTC daily v...
iPrEx Study Results:
Cumulative Probability of HIV Infection
0 12 24 36 48 60 72 84 96 108 120 132
Weeks
Placebo
(n=1248)
...
Partner PrEP Study
Double-Blind
Randomization
1:1
Adapted from Baeten J. et al. IAS 2011; Rome. Oral #MOAX0106
Modified In...
People Living With HIV
(1,039,000-1,185,000)
New Sexual infections/Year
(~32,000)
Percent
Marks G. AIDS. 2006;20:1447-1450...
Phamacology of PrEP
TDF dosing in HIV-uninfected individuals
 Oral dosing results in 20+ higher plasma levels compared to...
Adverse Events with PrEP
TDF/FTC
 Nausea, back pain, weight loss>5% (iPREX)
 1% drop in bone density (iPREX)
 Resistanc...
Sexual Behavior in PnP Celum IAS 2011
Marks G. AIDS. 2006;20:1447-1450.
Sexual Behavior in iPREX Liu IAS 2011
Marks G. AIDS. 2006;20:1447-1450.
Summary of PrEP
 TDF/FTC oral appears superior to topical
 TDF/FTC oral may be superior to TDF alone
 TDF/FTC oral is s...
Marks G. AIDS. 2006;20:1447-1450.
Truvada Updated Monograph
INDICATIONS AND USAGE of TRUVADA
 TRUVADA is indicated in combination with other
antiretroviral...
Truvada Updated Monograph
WARNINGS
 LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH
STEATOSIS, POST-TREATMENT ACUTE EXACERBATION...
Truvada Updated Monograph
 Many HIV-1 tests, such as rapid tests, detect anti-HIV antibodies
and may not identify HIV-1 d...
Truvada Updated Monograph
CONTRAINDICATIONS
 Do not use TRUVADA for pre-exposure prophylaxis in
individuals with unknown ...
Truvada Updated MonographWARNINGS AND PRECAUTIONS
New onset or worsening renal impairment: including ARF and Fanconi synd...
Truvada Updated Monograph
ADVERSE REACTIONS
 In HIV1 infected patients, the most common adverse
reactions (incidence grea...
Truvada Updated Monograph
 Comprehensive Management to Reduce the Risk of
Acquiring HIV-1
 Use TRUVADA for pre-exposure ...
Marks G. AIDS. 2006;20:1447-1450.
MORE
CDC Interim Guidance for MSM
MMWR Jan 2011
Before initiating PrEP
Determine eligibility
Document negative HIV antibody t...
CDC Interim Guidance for MSM
MMWR Jan 2011
Beginning PrEP medication regimen
 Prescribe 1 tablet of Truvada* (TDF [300 mg...
CDC Interim Guidance for MSM
MMWR Jan 2011
Follow-up while PrEP medication is being taken
 Every 2--3 months, perform an ...
CDC Interim Guidance for MSM
MMWR Jan 2011
On discontinuing PrEP (at patient request, for
safety concerns, or if HIV infec...
CDC Interim Guidance-
Heterosexuals MMWR Aug 10 2012
Before initiating PrEP
 Determine eligibility
 Determine if women a...
CDC Interim Guidance-
Heterosexuals MMWR Aug 10 2012
Beginning PrEP medication regimen
 For women, ensure that pregnancy ...
CDC Interim Guidance-
Heterosexuals MMWR Aug 10 2012
Follow-up while PrEP medication is being taken
 At each follow-up vi...
CDC Interim Guidance-
Heterosexuals MMWR Aug 10 2012
 On discontinuing PrEP (at patient request, for
safety concerns, or ...
People Living With HIV
(1,039,000-1,185,000)
New Sexual infections/Year
(~32,000)
Percent
Marks G. AIDS. 2006;20:1447-1450...
Protocol Co-Chairs:
Sheldon Morris M.D., M.P.H.
David J. Moore, Ph.D.
PrEP Algorithm
Identify individuals
with substantial,
ongoing risk for HIV
acquisition
1. Medical History
2. Elicit any ac...
PrEP Study
Double-Blind
Multisite Study
(UCLA, USC, UCSD)
High risk HIV-negative men who
have sex with men
(n=400)
Randomi...
Why Text Reminders Might Work
Well, I’m always aware of the
importance of taking my meds but
time gets lost and at the end...
iTAB Intervention
 Texting reminders developed and chosen by participant that
will be received daily
 If possible, parti...
• Man or transgender M to F who has sex with men
• Age 18 years or older.
• Subjects must have substantial ongoing risk of...
Conclusions
 PrEP works…Woohoo.
 Prescribing PrEP should be done with care:
 For those with substantial ongoing risk an...
CCTG 595: TAPIR study
enrollment starting January 2013
Potential subjects can call AVRC:
619-543-3196
Questions
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  1. 1. The UC San Diego AntiViral Research Center sponsors weekly presentations by infectious disease clinicians, physicians and researchers. The goal of these presentations is to provide the most current research, clinical practices and trends in HIV, HBV, HCV, TB and other infectious diseases of global significance. The slides from the AIDS Clinical Rounds presentation that you are about to view are intended for the educational purposes of our audience. They may not be used for other purposes without the presenter’s express permission. AIDS CLINICAL ROUNDS
  2. 2. Introduction  Antiretroviral medication for HIV prevention are an attractive additional to existing interventions:  Behavioral interventions  HIV positive  HIV negative  HIV testing and counseling  STD screening and treatment  Partner notification  IVDU reduction – methadone, needle exchange  PMTC  Male circumcision
  3. 3. Outline of Recent Advances  Introduction  Update on data on PrEP HIV negatives  Efficacy in men and women  Pharmacology  Adverse events  Future directions  PrEP use guidance
  4. 4. People Living With HIV (1,039,000-1,185,000) New Sexual infections/Year (~32,000) Percent Marks G. AIDS. 2006;20:1447-1450. Efficacy of ART for Reduced Transmission Grant R, NEJM 2010; Grant R, IAS 2011 (Rome); Baeten J, IAS 2011 (Rome); Thigpen M, IAS 2011 (Rome); FHI Press Release April 18, 2011. Study Study Design Population/ Outcomes Reduction in Transmissions Attia 2009 Meta-analysis 5021 heterosexual couples 461 transmissions 92% Partners in Prevention African Prospective Observational 3381 heterosexual couples 103 transmissions 92% HPTN 052 Multisite RCT 1763 couples 28 transmissions 96%
  5. 5. Viral Suppression among HIV infected in United States Smith PLoS 2012 Marks G. AIDS. 2006;20:1447-1450.
  6. 6. 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 Status New infections Aware (ART) Aware (no ART) Unaware Awareness of HIV Serostatus: Estimates of Transmission ~31% ~36% ~54% ~44% Marks G. AIDS. 2006;20:1447-1450. ~25% ~10%?? New Infections/Year (~32,000) People Living With HIV Intervene with ART and PrEP Intervene with HIV testing and PrEP
  7. 7. Update on PrEP PrEP Elf
  8. 8. Past and Current PrEP Trials (July 2011) Available at: www.avac.org.
  9. 9. People Living With HIV (1,039,000-1,185,000) New Sexual infections/Year (~32,000) Percent Marks G. AIDS. 2006;20:1447-1450. Efficacy of Daily Oral FTC/TDF PrEP Celum 2012Rome); Thigpen M, IAS 2011 (Rome); FHI Press Release April 18, 2011. Trial Pop. Efficacy 95% CI iPrEx (completed) 2499 MSM 44% 15 to 63% Partners PrEP (ongoing, placebo arm stopped) Men Women 83% 62% 49 to 94% 19 to 82% TDF2 (stopped early due to large loss to FU) Men Women 80% 49% 25 to 97% -22 to 81% FemPREP (stopped early due to futility) Women 6% - Not Significant - Only 26% had detectable TDF VOICE (ongoing) Women TDF alone arm stopped due to futility, continue TDF gel and TDF/FTC
  10. 10. Poynten 2012 Percent Important New PrEP Studies Trial Population Study HPTN 067 Heterosexual women and MSM TDF/FTC daily vs. twice a week and one PEP dose vs. event-driven FNARAVHPIRE G MSM On demand coital TDF/FTC vs. placebo ATN 082 Young MSM TDF/FTC vs. placebo vs. no pill with behavioral intervention HPTN 069 MSM MVC vs. MVC/TDF vs. MVC/FTC vs. TDF/FTC
  11. 11. iPrEx Study Results: Cumulative Probability of HIV Infection 0 12 24 36 48 60 72 84 96 108 120 132 Weeks Placebo (n=1248) Emtricitabine/ Tenofovir DF (n=1251) P=0.005 CumulativeProbability ofHIVInfection Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  12. 12. Partner PrEP Study Double-Blind Randomization 1:1 Adapted from Baeten J. et al. IAS 2011; Rome. Oral #MOAX0106 Modified Intention-to-Treat Analysis TDF FTC/TDF P HIV incidence (per 100 PY) 0.74 0.53 0.23 HIV protection (vs. placebo) p-value 67% (44-81%) <0.0001 75% (55-87%) <0.0001 Partners PrEP 0.03 0.02 0.01 0 CumulativeHIVAcquisition Months since start TDF FTC/TDF Placebo Number at Risk TDF 1573 1560 1546 1443 1292 1176 966 827 638 406 185 58 5 FTC/TDF 1567 1555 1544 1432 1303 1181 968 825 640 414 187 58 6 Placebo 1568 1557 1541 1431 1294 1164 970 829 637 405 203 62 6 0 3 6 12 159 18 21 24 27 30 33 360 3 6 12 159 18 21 24 27 30 33 36 0.04
  13. 13. People Living With HIV (1,039,000-1,185,000) New Sexual infections/Year (~32,000) Percent Marks G. AIDS. 2006;20:1447-1450. Efficacy of Daily Oral FTC/TDF PrEP Grant R, NEJM 2010; Grant R, IAS 2011 (Rome); Baeten J, IAS 2011 (Rome); Thigpen M, IAS 2011 (Rome); FHI Press Release April 18, 2011.
  14. 14. Phamacology of PrEP TDF dosing in HIV-uninfected individuals  Oral dosing results in 20+ higher plasma levels compared to topical gel but 10 fold less local concentrations  Oral TDF results in 100x greater TFV-DP in rectal tissue compared to vaginal tissue. 20x greater in local CD4 cells. No diff. at 2 weeks.  Oral TDF has a 49-64 hours terminal half life in plasma. 100-112 hours in CD4 cells. FTC dosing  Oral FTC results in 10x greater FTC-TP in vaginal tissue compared to rectal tissue.  Oral FTC has a 8-10 hours terminal half life in plasma. 29-56 hours in PBMCs. Hendrix 2012
  15. 15. Adverse Events with PrEP TDF/FTC  Nausea, back pain, weight loss>5% (iPREX)  1% drop in bone density (iPREX)  Resistance  iPREX had 2 on drug had M184V/I that was not detectable at 6 months by ultrasensitive testing  Partners in PrEP 1 M184V and 1 K65R  Renal toxicity from TDF was not observed higher (2% vs. 1%, p=0.08) in iPREX.  Risk Compensation? Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  16. 16. Sexual Behavior in PnP Celum IAS 2011 Marks G. AIDS. 2006;20:1447-1450.
  17. 17. Sexual Behavior in iPREX Liu IAS 2011 Marks G. AIDS. 2006;20:1447-1450.
  18. 18. Summary of PrEP  TDF/FTC oral appears superior to topical  TDF/FTC oral may be superior to TDF alone  TDF/FTC oral is seems most effective among MSM compared to heterosexual women  This could be related to tissue penetration  TDF/FTC is relatively safe for HIV-uninfected  Tissue penetration and long half life may be the key factor for future development of new PrEP Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  19. 19. Marks G. AIDS. 2006;20:1447-1450.
  20. 20. Truvada Updated Monograph INDICATIONS AND USAGE of TRUVADA  TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.  TRUVADA is indicated in combination with safer sex practices for pre- exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  21. 21. Truvada Updated Monograph WARNINGS  LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED HIV-1 INFECTION  TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use. Drug- resistant HIV-1 variants have been identified with the use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  22. 22. Truvada Updated Monograph  Many HIV-1 tests, such as rapid tests, detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection.  Prior to initiating PrEP indication, evaluate seronegative individuals for current or recent signs or symptoms consistent with acute viral infections (e.g., fever, fatigue, myalgia, skin rash, etc.) and ask about potential exposure events (e.g., unprotected, or condom broke during sex with an HIV-1 infected partner) that may have occurred within the last month.  If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  23. 23. Truvada Updated Monograph CONTRAINDICATIONS  Do not use TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-infected patients only in combination with other antiretroviral agents. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  24. 24. Truvada Updated MonographWARNINGS AND PRECAUTIONS New onset or worsening renal impairment: including ARF and Fanconi syndrome. Assess creatinine clearance (CrCl) before initiating. Monitor CrCl and serum phosphorus in patients at risk. Avoid with use of nephrotoxic drugs. Do not use TRUVADA for a PrEP indication with creatinine clearance below 60 mL/min. Decreases in bone mineral density (BMD): Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. Comprehensive management to reduce the risk of acquiring HIV-1: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule. Management to reduce the risk of acquiring HIV-1 drug resistance:  Prior to initiating for PrEP - if clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm negative HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. While using TRUVADA for PrEP - HIV-1 screening tests should be repeated at least every 3 months.
  25. 25. Truvada Updated Monograph ADVERSE REACTIONS  In HIV1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.  In HIV-1 uninfected individuals in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA subjects and more frequently than by placebo subjects were headache, abdominal pain and weight decreased.
  26. 26. Truvada Updated Monograph  Comprehensive Management to Reduce the Risk of Acquiring HIV-1  Use TRUVADA for pre-exposure prophylaxis only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because TRUVADA is not always effective in preventing the acquisition of HIV-1  Counsel uninfected individuals about safer sex practices that include consistent and correct use of condoms, knowledge of their HIV-1 status and that of their partner(s), and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (such as syphilis and gonorrhea).  ␣ Inform uninfected individuals about and support their efforts in reducing sexual risk behavior.
  27. 27. Marks G. AIDS. 2006;20:1447-1450. MORE
  28. 28. CDC Interim Guidance for MSM MMWR Jan 2011 Before initiating PrEP Determine eligibility Document negative HIV antibody test(s) immediately before starting PrEP medication. Test for acute HIV infection if patient has symptoms consistent with acute HIV infection. Confirm that patient is at substantial, ongoing, high risk for acquiring HIV infection. Confirm that calculated creatinine clearance is ≥60 mL per minute (via Cockcroft-Gault formula). Other recommended actions Screen for hepatitis B infection; vaccinate against hepatitis B if susceptible, or treat if active infection exists, regardless of decision about prescribing PrEP. Screen and treat as needed for STIs. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  29. 29. CDC Interim Guidance for MSM MMWR Jan 2011 Beginning PrEP medication regimen  Prescribe 1 tablet of Truvada* (TDF [300 mg] plus FTC [200 mg]) daily.  In general, prescribe no more than a 90-day supply, renewable only after HIV testing confirms that patient remains HIV-uninfected.  If active hepatitis B infection is diagnosed, consider using TDF/FTC for both treatment of active hepatitis B infection and HIV prevention.  Provide risk-reduction and PrEP medication adherence counseling and condoms. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  30. 30. CDC Interim Guidance for MSM MMWR Jan 2011 Follow-up while PrEP medication is being taken  Every 2--3 months, perform an HIV antibody test; document negative result.  Evaluate and support PrEP medication adherence at each follow- up visit, more often if inconsistent adherence is identified.  Every 2--3 months, assess risk behaviors and provide risk- reduction counseling and condoms. Assess STI symptoms and, if present, test and treat for STI as needed.  Every 6 months, test for STI even if patient is asymptomatic, and treat as needed.  3 months after initiation, then yearly while on PrEP medication, check blood urea nitrogen and serum creatinine. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  31. 31. CDC Interim Guidance for MSM MMWR Jan 2011 On discontinuing PrEP (at patient request, for safety concerns, or if HIV infection is acquired)  Perform HIV test(s) to confirm whether HIV infection has occurred.  If HIV positive, order and document results of resistance testing and establish linkage to HIV care.  If HIV negative, establish linkage to risk-reduction support services as indicated.  If active hepatitis B is diagnosed at initiation of PrEP, consider appropriate medication for continued treatment of hepatitis B. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  32. 32. CDC Interim Guidance- Heterosexuals MMWR Aug 10 2012 Before initiating PrEP  Determine eligibility  Determine if women are planning to become pregnant, are currently pregnant, or are breastfeeding.  Confirm that patient is at ongoing, very high risk for acquiring HIV infection.  If any sexual partner is known to be HIV-infected, determine whether receiving antiretroviral therapy; assist with linkage to care if not in care or not receiving antiretroviral therapy. Other recommended actions  Disclose to women that safety for infants exposed during pregnancy is not fully assessed but no harm has been reported.  Do not prescribe PrEP to women who are breastfeeding. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  33. 33. CDC Interim Guidance- Heterosexuals MMWR Aug 10 2012 Beginning PrEP medication regimen  For women, ensure that pregnancy test is negative or, if pregnant, that the patient has been informed about use during pregnancy. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  34. 34. CDC Interim Guidance- Heterosexuals MMWR Aug 10 2012 Follow-up while PrEP medication is being taken  At each follow-up visit for women, conduct a pregnancy test and document results; if pregnant, discuss continued use of PrEP with patient and prenatal-care provider. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  35. 35. CDC Interim Guidance- Heterosexuals MMWR Aug 10 2012  On discontinuing PrEP (at patient request, for safety concerns, or if HIV infection is acquired  Inform prenatal provider of PrEP use in early pregnancy and coordinate care to maintain HIV prevention during pregnancy and breastfeeding. Grant RM, et al. N Engl J Med. 2010;363:2587-2599.
  36. 36. People Living With HIV (1,039,000-1,185,000) New Sexual infections/Year (~32,000) Percent Marks G. AIDS. 2006;20:1447-1450. Some Possible PrEP Providers • Implementation of PreP will be challenging due to the multiple needs of an effective program • Innovative programs that combine previously unlinked services may be needed Grant R, et al. 51st ICAAC; Chicago, IL; September 17-20, 2011; Abst. H2-1007. *Prevalence of HIV among seronegative partners of HIV+ pts is unknown Access to Seronegatives High HIV Incidence Longitudinal Care Familiar with ART Testing Centers + +/- +/- - STD Clinics + + - - Community Clinics + +/- + - HIV Clinics Partners of HIV+ Patients ?* + + Prevention CBOs + + +/- - Treatment CBOs - - +/- +
  37. 37. Protocol Co-Chairs: Sheldon Morris M.D., M.P.H. David J. Moore, Ph.D.
  38. 38. PrEP Algorithm Identify individuals with substantial, ongoing risk for HIV acquisition 1. Medical History 2. Elicit any acute HIV symptoms 3. Required lab testing: Confirm HIV status HBV status Creatinine clearance Pregnancy test for women 4. Provide risk reduction counseling and STD testing as needed 1. Provide adherence counseling 2. Prescribe no more than 3 months 1. Test for HIV at least every 3 mo. 2. Offer STD screening as needed every 6 mo. 3. Provide ongoing risk reduction 4. Check creatinine at month 3 and then yearly 5. Preg. Test for women every 3 months
  39. 39. PrEP Study Double-Blind Multisite Study (UCLA, USC, UCSD) High risk HIV-negative men who have sex with men (n=400) Randomization 1:1 Truvada (n=200) Study Outcomes •HIV seroconversion •Risk behavior and STIs •Adherence (self report and FTC levels) •Drug resistance Both receive comprehensive web based risk reduction counseling, STD testing, HIV testing Drug resistance, HIV RNA level, immunologic response, and CD4 cell count assessed in people who become HIV positive during the study. Grant RM, et al. N Engl J Med. 2010;363:2587-2599. Minimum Follow- Up 1 year Truvada + iTAB (n=200) Intervention ousing texting reminders (iTAB)
  40. 40. Why Text Reminders Might Work Well, I’m always aware of the importance of taking my meds but time gets lost and at the end of the week or end of the month, you realize you still have a lot of pills left! ” “
  41. 41. iTAB Intervention  Texting reminders developed and chosen by participant that will be received daily  If possible, participants use their own cell phone; otherwise receive study phone  All participant go through process of reminder generation
  42. 42. • Man or transgender M to F who has sex with men • Age 18 years or older. • Subjects must have substantial ongoing risk of acquisition of HIV as evident by one or more of the following: • Has at least one HIV infected sexual partner for ≥4 weeks (i.e. serodiscordant couple). • No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last 3 months • No condom use during anal sex with ≥1 male partner and STI diagnosis during the last 3 months Inclusion Criteria
  43. 43. Conclusions  PrEP works…Woohoo.  Prescribing PrEP should be done with care:  For those with substantial ongoing risk and no medical contraindication (i.e. renal disease)  CONFIRM HIV negative status  Routine adherence counseling, HIV testing, STD testing and risk reduction counseling
  44. 44. CCTG 595: TAPIR study enrollment starting January 2013 Potential subjects can call AVRC: 619-543-3196
  45. 45. Questions

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