amfAR, The Foundation for AIDS Research

FDA Hearing on PrEP Set for May 10

On May 10, an advisory committee to the Federal Drug Administration (FDA) will hold a hearing about the potential use of Truvada, an antiretroviral (ARV) drug already used to treat people living with HIV, to help prevent HIV infection in people who are uninfected. After the hearing, the 12-member panel will recommend whether or not the FDA should approve the use of Truvada for HIV prevention—a practice known as pre-exposure prophylaxis, or PrEP.

Truvada has been available and prescribed to people living with HIV since 2004. During the past two years, several major studies have shown that the ARV, taken consistently by HIV-negative people who are at high risk of contracting HIV, can strongly protect them against infection.

amfAR Deputy Director of Public Policy Owen Ryan appeared on the April29 broadcast of BioCentury This Week, a public affairs show, to discuss why the FDA review of Truvada as PrEP is important and how this could improve our ability to fight the disease globally and in the United States.

amfAR will provide updates after the hearing.