July 17, 2012
HIV Prevention Pill Truvada Approved by FDA
Connie K. Ho for redOrbit.com — Your Universe Online
The U.S. Food and Drug Administration (FDA) recently approved Truvada, which decreases the risk of HIV invention in uninfected individuals who have a high risk of contracting HIV Infection or who are engaged in sexual activities with a partner who is HIV-infected.
"Today´s approval marks an important milestone in our fight against HIV," remarked FDA Commissioner Dr. Margaret A. Hamburg in a prepared statement. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."
According to Med Page Today, the drug was found to lower the rate of infection among males who had sex with other men and among heterosexuals.
The FDA will also strengthen the drug´s boxed warning to alert health care professionals that Truvada for PrEP is only for uninfected individuals who are confirmed to be HIV-negative. Furthermore, the FDA recommends against use for individuals with unknown or positive HIV status as the drug is contraindicated for PrEP in individuals who have those specific traits. In particular, Truvada for PrEP is being approved with a Risk Evaluation and Mitigation Strategy (REMS) to keep risk to uninfected individuals low and to decrease the risk of the production of resistant HIV-1 variants. REMS includes a training and education program that will teach prescribers on how to counsel individuals who are thinking of taking or are taking Truvada for PrEP. It will instruct individuals on the importance of keeping to the recommended dosage regimen and highlighting the risks that are related to HIV infection.
"The REMS for Truvada for the PrEP indication is aimed at educating health care professionals and uninfected individuals to help ensure its safe use for this indication without placing an unnecessary burden on health care professionals and patients," noted Dr. Janet Woodcock, director of the FDA´s Center for Drug Evaluation and Research, in the statement.
Lastly, Truvada´s manufacturer, Gilead Sciences, Inc., has to follow certain conditions set out by the FDA. For one, the company has to collect viral isolates from individuals who contract HIV while taking Truvada to examine whether the isolates will become resistant. As well, they need to record data on pregnancy outcomes for women who become pregnant during the time they are taking Truvada for PrEP. As such, the company has to perform a trial to determine drug adherence and the possibility of adverse events, seroconversion, and resistance development in seroconverters.
“The data clearly demonstrate that Truvada as pre-exposure prophylaxis is effective at reducing the risk of HIV infection acquired through sexual exposure,” explained lead researcher Dr. Connie Celum, a professor of global health and medicine at the University of Washington, in a Boston Globe article. “It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy.”