pre-exposure prophylaxis (prep) 1° prevention of hiv in at-risk … · 2012-07-03 · final...
TRANSCRIPT
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Pre-Exposure Prophylaxis (PrEP)
1° Prevention of HIV in At-Risk Women:
Coming of Age
Aaron Kofman, BA, MD ’14
Eli Y. Adashi, MD, MS, CPE, FACOG
BRIGHT Series June 12, 2012
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Women and the HIV Epidemic
Global Indicators
2010
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Global Indicator1 Datum2
New HIV Infections a Year 1,100,000(41% of Total)
Annual HIV-related Deaths 730,000(41% of Total)
HIV(+) Women Receiving ARVs (% in Need) 53%
1LMICs 2WHO/UNAIDS/UNICEF: GLOBAL HIV/AIDS RESPONSE, 2011
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Global Indicator1 Datum2
Women Living with HIV 17,000,000
Women Living with HIV (% of Total Global Cohort) 50%
Women Living with HIV (% of Total SSA Cohort)3 59%
1LMICs 2WHO/UNAIDS/UNICEF: GLOBAL HIV/AIDS RESPONSE, 20113SSA=Sub-Saharan Africa
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Global Indicator1 Datum2
Young Women Living with HIV3 3,200,000
Young Women Living with HIV (% of Young Global Cohort) 64%
Young Women Living with HIV (% of Young SSA Cohort)4 71%
1LMICs 2WHO/UNAIDS/UNICEF: GLOBAL HIV/AIDS RESPONSE, 20113Young Women=15-24 Years Old4SSA=Sub-Saharan Africa
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Trends: Women & HIV
• New HIV infections are on the decline
• Dying of HIV-related causes is on the decline
• Living with HIV has stabilized at 50% of total
• ART coverage of eligible women has increased to 53%
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PrEP in Women
Addressing Unique Challenges
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• Inability to negotiate safe sex due to gender
inequity and harmful gender norms:
Abusive and violent relationships
Transactional survival sex
Cross-generational (age-disparate) sex
Absent social or economic power
• Unknowns of casual relationships:
Improbability of abstinence & monogamy
Unreliability of condom use & male circumcision
• Increased risk of transmission:
Twice as vulnerable as men
Twice as vulnerable during pregnancy
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PrEP in Women
Going Beyond Prevention
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Prevention Through Empowerment
“…little attention has been given to barriers to HIV
transmission that depend on the woman and are under
her control…including the possibility of a topical
virucide that might block transmission through the
vaginal route.”Am J Public Health 1990;80:460-462
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The History of PrEP
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1990-2007Non-specific Topical Antivirals
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Class Agent
Trials
(#) Outcome
Surfactants
Nonoxynol-9
4 NegativeSAVVY (C31G)
Polymers
Cellulose Sulfate
8 Negative
Carraguard
PRO2000
BufferGel
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1990-2007Non-specific Topical Antivirals
2007-2012Specific Antiretroviral Agents
(Topical & Systemic)
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Tenofovir Disoproxyl Fumarate (TDF)
Emtricitabine (FTC)
Dapivirine (TMC120)
Maraviroc
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The History of PrEP
Early Successes
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Trial Intervention
CAPRISA 004 Peri-coital Vaginal TDF Gel
Partners PrEP Daily Oral TDF or TDF/FTC Tablets
TDF2 Daily Oral TDF/FTC Tablets
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CAPRISA 004
Abdool Karim Q. et al. Science 329: 1168-1174, 2010
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CAPRISA 004
Phase IIb, Two Arm, Double-Blind RPCT
Completed March 2010
Variable Datum
Intervention Pericoital Vaginal TDF Gel (1%)
Pericoital Vaginal Placebo Gel
Participants 889 HIV(-) Heterosexual Women (at high risk) Ages 18 to 40
1° Outcome HIV Seroconversion
Adherence
MeasureReturned Used Applicators
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CAPRISA 004
Phase IIb, Two Arm, Double-Blind RPCT
Completed March 2010
Variable Datum
Intervention Peri-coital Vaginal TDF Gel (1%)
Peri-coital Vaginal Placebo Gel
Participants 889 HIV(-) Heterosexual Women Ages 18 to 40
1° Outcome HIV Seroconversion
ResultsLow (<50%) adherence:
Intermediate (50-80%) adherence:
High (>80%) adherence:
28% protection38% protection54% protection
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Lessons PrEP is accomplishable (proof of concept)
PrEP efficacy is adherence-dependent
39% risk reduction is not good enough
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TDF2
Key Facts: http://www.cdc.gov/hiv/prep/pdf/TDF2factsheet.pdf
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TDF2
Phase IIb, Two Armed, Double-Blind RPCT
Completed July 2011
Metric Datum
InterventionDaily Oral TDF/FTC Tablets
Daily Oral Placebo Tablets
Participants 1219 HIV (-) Heterosexual Women Ages 18 to 39
1° Outcome HIV Seroconversion
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TDF2
Phase IIb, Two Armed, Double-Blind RPCT
Completed July 2011
Metric Datum
InterventionDaily Oral TDF/FTC Tablets
Daily Oral Placebo Tablets
Participants 1219 HIV (-) Heterosexual Women Ages 18 to 39
1° Outcome HIV Seroconversion
Results TDF/FTC afforded 76% protection to women
Adherence Overall Adherence Rate (Residual Pill Count): 84%
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Partners PrEP
Press Release: http://www.avac.org/ht/a/GetDocumentAction/i/35459
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Partners PrEP
Phase III, Three Arm, Double-Blind RPCT
Completed July 2011
Metric Datum
Intervention
Daily Oral TDF Tablets to HIV (-) Partner
Daily Oral TDF/FTC Tablets to HIV (-) Partner
Daily Placebo Tablets to HIV (-) Partner
Participants 4,758 stable heterosexual HIV-discordant couples
1° Outcome Seroconversion of HIV (-) Partner
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Partners PrEP
Phase III, Three Arm, Double-Blind RPCT
Completed July 2011
Metric Datum
Intervention
Daily Oral TDF Tablets to HIV (-) Partner
Daily Oral TDF/FTC Tablets to HIV (-) Partner
Daily Oral Placebo Tablets to HIV (-) Partner
Participants 4,758 Stable Heterosexual HIV-discordant Couples
1° Outcome Seroconversion of HIV (-) Partner
ResultsTDF afforded 68% protection to women partners
TDF/FTC afforded 62% protection to women partners
Adherence Overall Adherence Rate (Residual Pill Count): 97%
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On the Importance of “Couple Trials”The sub-Saharan Example
75% of adults (20–49) are in cohabiting unions
≤50% of cohabiting HIV (+) adults have an HIV (-) partner
Women are as likely as men to be the index partner
Serodiscordant couples are likely HIV status agnostic
New infections are on the rise in serodiscordant couples
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The History of PrEP
Recent Failures
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Trial Intervention
FEM PrEP Daily Oral TDF/FTC Tablets
VOICE Daily Oral TDF Tablets or Vaginal TDF Gel
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FEM-PrEP
Press Release: http://www.cdc.gov/hiv/prep/femprep.htm
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FEM PrEP
Phase III, Two Arm, Double-Blind RPCT
Variable Datum
InterventionDaily Oral TDF/FTC Tablets
Daily Oral Placebo Tablets
Participants 1951 HIV(-) Heterosexual Women (at high risk) Ages 18 to 35
1° Outcome HIV Seroconversion
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FEM PrEP
Phase III, Two Arm, Double-Blind RPCT
Variable Datum
InterventionDaily Oral TDF/FTC Tablets
Daily Oral Placebo Tablets
Participants 1951 HIV(-), Heterosexual, 18 to 35 Year-Old Women
1° Outcome HIV Seroconversion
Results Trial halted 4/18/11 by the IDMC* for futility
Adherence Overall Adherence Rate (Residual Pill Count): 95%
*Independent Data Monitoring Committee
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Why did FEM-PrEP Fail?
The FEM PrEP trial failed, at least in part,
due to poor product adherence.
Post Hoc Analysis
Only 26% of the women in the treatment arm
displayed detectable serum levels of TDF at
the last visit prior to seroconversion.
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Possible Drivers of Poor Adherence
• Youthful perception of invincibility
• Duration of the study (“Study Fatigue”)
• Failure to refill drug supplies (i.e. skipped visits)
• Lingering stigma of HIV
• Presumed assignment to the placebo arm
• Pill sharing between trial participants
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VOICE*
Projected Results: Late 2012
*VOICE=Vaginal and Oral Interventions to Control the Epidemic
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VOICE
Phase IIb, Five Arm, Double-Blind RPCT
Variable Datum
Intervention
Daily Oral TDF Tablets
Daily Oral TDF/FTC Tablets
Daily Vaginal TDF Gel
Daily Placebo Tablets or Placebo Vaginal Gel
Participants 5029 HIV(-) Heterosexual Women Ages 18 to 45
1° Outcome HIV Seroconversion
Results
Oral TDF arm halted by the DSMB* on 9/16/11 for futility
Vaginal TDF arm halted by the DSMB* on 11/17/11 for futility
Post hoc analysis is pending
Oral TDF/FTC arm is ongoing
*Data and Safety Monitoring Board
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Going Forward
Current and Upcoming Phase III PrEP Trials
Results are Expected in 2014
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Trial Intervention
FACTS 001 Peri-coital TDF Vaginal Gel
ASPIRE Long-Acting Dapivirine-Releasing Vaginal Ring
IPM 027 Long-Acting Dapivirine-Releasing Vaginal Ring
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Regulatory Approval
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Truvada® tablets be approved for PrEP in:
Men having sex with men
HIV (-) negative partners in serodiscordant couples
Others at risk due to sexual activity
Tenofovir vaginal gel or oral tablets are not
candidates for approval as PrEP at this time
FDA Advisory Committee: May 10, 2012
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Final ThoughtsThe promise of PrEP for the 1° prevention of HIV in
at-risk women is still best viewed as work in
progress
Regulatory approval is likely to be granted to
Truvada® tablets as PrEP in serodiscordant couples
and in women deemed to be at high risk.
Regulatory approval of the Tenofovir Vaginal gel as
PrEP is contingent on the outcome of FACTS 001
and thus is not anticipated until 2015 at the earliest.
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Final ThoughtsStable serodiscordant couples may be better served
by treatment of the HIV (+) partner (96%
protection) than by PrEP of the HIV (-) partner
(73% protection)
PrEP effectiveness may be well served by:
Favoring multi-agent paradigms capable of targeting
several especially earlier phases of the HIV life cycle
Focusing on user-independent PrEP strategies i.e.
vaginal rings, injectables, implantables, and
transdermal patches
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Conclusions
The effectiveness of long-
acting reversible
contraception (IUD or
Implants) is superior to
that of contraceptive pills,
patch, or ring.
New Engl J Med
366:1998-2007, 2012
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Residual All Important Matters
Impact of PrEP on disease burden
Optimal population target (s)
Implementational costs
Implementational Logistics
Cost-effectiveness
Prioritization by donors/payers
Risk Compensation
Resistance development
Drug safety
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The End