The US Food and Drug Administration’s (FDA’s) Antiviral Drugs Advisory Committee has strongly backed approval of the first-ever drug for the prevention of sexually acquired HIV-1 infection.
In a marathon 12-hour session, the panel recommended approval of a supplemental indication for Truvada (emtricitabine/tenofovir disoproxil fumarate) for preexposure prophylaxis (PrEP) in:
- HIV-uninfected men who have sex with men,
- HIV-uninfected partners in serodiscordant couples, and
- other individuals (such as sex workers) who are at risk of acquiring HIV through sexual activity.
The panel also urged the agency to “put some teeth into” Gilead’s proposed risk evaluation and mitigation strategy (REMS) because of concerns that healthy people taking Truvada for HIV prevention will be harmed if they become infected with HIV and do not change from single-drug PrEP prophylaxis to a 3-drug combination antiretroviral treatment regimen, that continuing single-drug Truvada after HIV infection will lead to development of Truvada-resistant viral strains, and that taking the PrEP regimen increases the risk for adverse effects, particularly kidney damage.
*Join IRMA’s robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at firstname.lastname@example.org. Joining our listserv automatically makes you a member of IRMA – a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.
*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article’s content.