The FDA has approved Gilead’s second HIV prevention pill, Descovy, for at-risk adults and adolescents weighing at least 35 kg, excluding those who are at risk of HIV due to vaginal sex because the efficacy of Descovy has not been assessed in this population.
Most people at high risk for HIV will now have another option to prevent infection following the FDA’s approval of Gilead’s Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg).
The approval, which comes 2 months after an FDA panel recommended use of the pill for pre-exposure prophylaxis (PrEP) in men and transgender women, covers at-risk adults and adolescents weighing at least 35 kg, excluding those who are at risk of HIV due to vaginal sex because the efficacy of Descovy has not been assessed in this population.
Until now, Truvada (emtricitabine/tenofovir disoproxil fumarate), which is also sold by Gilead, has remained the only PrEP pill on the market since its approval for HIV prevention in 2012.
“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and [HHS] to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”
The safety and efficacy of Descovy was demonstrated during the multiyear global DISCOVER trial of more than 5300 men and transgender women who have sex with men and were at risk of HIV infection. Comparing Descovy with Truvada over 48 to 96 weeks, researchers found that Descovy produced comparable risk reduction to Truvada. Among the 2694 participants who received Descovy, there were 7 HIV infections, compared with 15 infections among the 2693 patients taking Truvada.
The most common adverse reaction observed in the patients was diarrhea.
“Today, because of landmark biomedical and scientific research advances, there are unprecedented opportunities to significantly reduce new HIV infections,” said Edwin DeJesus, MD, FACP, FIDSA, Medical Director, Orlando Immunology Center, in a statement. “Descovy for PrEP offers healthcare providers and appropriate people at risk for HIV an additional biomedical prevention option with a demonstrated improvement in bone and renal safety parameters as compared to Truvada.”
Descovy, which was approved in April 2016 for the treatment of HIV, comes with a Boxed Warning based on the risk of posttreatment acute exacerbation of hepatitis B. The label also includes a Boxed Warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV infection.