Interpreting the iPrEx Trial Results on Daily Oral Truvada for HIV PrEP

PrEP and interpreting the iPrEx trial results James Wilton Biomedical Science of HIV Prevention Project Coordinator December 6 th , 2010

Pre-exposure prophylaxis (PrEP)

What is pre-exposure prophylaxis? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

How would PrEP work? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Potential PrEP strategies Route of drug delivery ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Dosing schedule ,[object Object],[object Object],[object Object],Number of antiretroviral drugs ,[object Object],[object Object],Choice of antiretroviral drug ,[object Object]

What’s being researched? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Concerns ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CAPRISA 004 Study “ Proof-of-concept” for PrEP

CAPRISA Strategy Route of drug delivery ,[object Object],[object Object],[object Object],[object Object],Dosing schedule ,[object Object],[object Object],[object Object],[object Object],Number of antiretroviral drugs ,[object Object],[object Object],Choice of antiretroviral drug ,[object Object],[object Object]

Effectiveness of tenofovir gel ,[object Object],[object Object],[object Object],[object Object],Effectiveness Overall 39% >80% of sex acts 54% 50-80% of sex acts 38% Less than 50% of sex acts 28%

Safety, resistance, and risk behavior ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Oral pre-exposure prophylaxis What do we know?

[object Object],[object Object],[object Object],Study #1 Study #2 Population Heterosexual women (n=~900) Men who have sex with men (n=400) Location(s) Ghana, Nigeria, Cameroon United States Intervention Daily oral tenofovir Daily oral tenofovir Adherence 69% (pill counts) N/A Safety ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],# HIV infections 6 (placebo) vs. 2 (daily tenofovir) 3 (placebo) vs. 3 (delayed arm) vs. 0 (daily tenofovir)

The Pre-Exposure Prophylaxis Initiative (iPrEx) Study

iPrEx Study Basics ,[object Object],[object Object],Locations Brazil, Ecuador, Peru, South Africa, Thailand, United States Population Men who have sex with men (n=2499) Study length July 2007 to October 2010 Study groups ,[object Object],[object Object],[object Object],Comprehensive package of prevention services ,[object Object],[object Object],[object Object],[object Object]

iPrEX Strategy Route of drug delivery ,[object Object],[object Object],[object Object],Dosing schedule ,[object Object],[object Object],[object Object],Number of antiretroviral drugs ,[object Object],[object Object],Choice of antiretroviral drug ,[object Object],[object Object]

Inclusion/exclusion criteria ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Study participant characteristics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Study Measures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Overall effectiveness of daily Truvada ,[object Object],[object Object],[object Object],[object Object],[object Object],Truvada Placebo # Study participants 1251 1248 # HIV infections 36 64

More effective when taken consistently ,[object Object],[object Object],[object Object],[object Object],Effectiveness > 90% adherence 73% > 50% adherence 50% < 50% adherence 32%

Subanalysis of Truvada group ,[object Object],[object Object],[object Object],[object Object],[object Object],Participants who remained HIV-negative Participants who became HIV-positive % with drug in their blood 51% 9%

Safety of daily Truvada ,[object Object],[object Object],[object Object],[object Object],[object Object],Truvada Placebo Elevated serum creatinine levels 2% 1% Moderate nausea (first 4 weeks) 9% 5% Unintentional weight loss (5% or more) 2.2% 1.1%

Risk behavior ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Effect of daily Truvada after infection ,[object Object],[object Object],[object Object],[object Object],[object Object]

What did the trial tell us? ,[object Object],[object Object],[object Object]

What didn’t the trial tell us? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Interpreting the iPrEx Trial Results on Daily Oral Truvada for HIV PrEP

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