The HIV Pandemic 2.6 Million New HIV Infections in 2009 41% in Young People (ages 15-24)
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The HIV Pandemic
2.6 MillionNew HIV Infections in 2009
41% in Young People (ages 15-24)
• MSM and Trans Women• Randomized 1:1 Daily Oral PREP• FTC/TDF vs Placebo• Followed on Drug for:
- HIV seroconversion- Adverse Events (especially renal & liver)- Metabolic Effects (Bone, Fat, Lipids)- HBV Flares among HBsAg+- Risk Behavior & STIs- Adherence- If infected
‣Drug Resistance‣Viral load‣Immune responses & CD4 Count
The iPrEx Study
Grant et al, CROI 2010
Fully enrolled as of December 2009
Lima
IquitosGuayaquil
Sao Paulo
Rio de Janeiro
Boston
San Francisco
Cape Town
Chiang Mai
Sites 11Participants 2,499
New England Journal of Medicine, online Nov 23, 2010
Efficacy (MITT) 44% (15-63%) Through May 1, 2010Durable Through 144 Weeks in the Final Analysis
P = 0.002
Grant et al, CROI 2010
New England Journal of Medicine, online Nov 23, 2010
Drug Levels
• Cases matched to controls by site and time on study
• Drug Detection Correlated with Seronegative Status (OR 12.9, P<0.001)• 92% reduction in
HIV risk• 95% reduction if
controlled for URAI
7Anderson et al, CROI 2010
HIV Infections During PrEP TrialsIn The USA
On PrEP Off PrEP• CDC Safety Study (US sites) 0 6
– Daily Oral TDF vs Placebo– 3 in placebo arm, – 3 in differed arm
• NIH iPrEx (US Sites) 0 3– Daily Oral FTC/TDF vs. Placebo– 2 in placebo arm– 1 in active arm 9 weeks
after stopped due to depression
Grohskopf, IAS Vienna 2010; Grant NEJM 2010
Genotypic Resistance
HIV Status at Enrollment
Infected Uninfected
PlaceboN=8
FTC/TDFN=2
PlaceboN=83
FTC/TDFN=48
65R 0 (0%) 0 (0%) 0 (0%) 0 (0%)
70E 0 (0%) 0 (0%) 0 (0%) 0 (0%)
184I 0 (0%) 1 (50%) 0 (0%) 0 (0%)
184V 1 (13%) 1 (50%) 0 (0%) 0 (0%)
TDF Resistance 0 (0%) 0 (0%) 0 (0%) 0 (0%)
FTC Resistance 1 (13%) 2 (100%) 0 (0%) 0 (0%)
Drug Resistance
Grant et al, CROI 2010
Sexual Partners
Condom Use with High Risk Sex
Grant NEJM 2010
Will pill taking increase if people are given FTC/TDF (without placebo) and know it can be effective?
What will happen to sex practices?
Collect more safety data over longer periods of time
Open Label Extension Aims:
The NIH ADAPT Study (HPTN 067)Alternative Dosing to Augment PrEP Pill Taking
• Intermittent PrEP in:–MSM (N = 180, Bangkok, Thailand)–WSM (N = 180, Cape Town, South Africa)
• Oral FTC/TDF in three dosage groups: –Daily dosing–Time-driven dosing group: FTC/TDF twice weekly with a
post-exposure boost. –Event-driven dosing group: FTC/TDF before and after a
potential exposure to HIV infection.
Conclusions
Oral FTC/TDF PrEP provided additional protection against the acquisition of HIV infection among MSM receiving a
comprehensive package of prevention services.
Detectable drug in blood strongly correlated with the prophylactic effect.
Efficacy was durable through 144 weeks.
Collateral BenefitsAll observed during PrEP in iPrEx
• Found the epidemic with surveillance• Increased HIV testing and counseling• Decreased partners• More condom use• HBV vaccination• STI screening and treatment• Treatment of HIV Infections• Community building• 687 people employed
16
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