Why We Oppose FDA Approval of HIV Prevention Pill

• Gilead’s pursuit of FDA approval for Truvada as a pre-exposure prophylaxis (PrEP)—or HIV prevention pill—is largely based on a study of 2,500 gay men, known as the iPrex Trial. The results showed only a 44% effectiveness rate in preventing HIV transmission – a FAILURE by most scientific standards
• In April 2011, a study of Truvada in women, known as the FEM-PrEP Study, was abruptly halted after the trial FAILED to show the drug’s efficacy in preventing HIV transmission
• Late last year, the VOICE Study of 5,029 sexually active, HIV-uninfected women ages 18 to 45 in South Africa, Uganda and Zimbabwe was abruptly halted due to the fact that the research showed that Truvada was NOT effective at preventing HIV transmission

More Information is Needed to Protect Public Health

• A 44% effective rate from the iPrex Trial is simply not enough to warrant approval from the FDA
• The studies so far have not been reflective of the real world. The 44% who received a benefit from Truvada in the iPrex Study were intensively counseled monthly and tested frequently for sexual infections – this is not likely to occur in the real world.
• There could be an increased risk to men as they may falsely believe they are 100% protected and STOP USING CONDOMS. A reduction in condom use will mean increased risk of transmission and the spread of a drug-resistant virus.