The U.S. Food and Drug Administration today approved Gilead’s drug Descovy to be used as PrEP, a daily HIV prevention regimen that when taken properly makes it virtually impossible to contract the virus from someone living with the virus.
This makes Descovy the second drug approved by the FDA to be used as PrEP, following the approval of Truvada — also manufactured by Gilead — in 2012. HIV organizations have accused Gilead of price gouging when it came to Truvada, but cheaper, generic versions of the drug are expected to become available later this year. Meanwhile, Gilead is hoping to transition Truvada users to Descovy, "which was shown in clinical trials to be less toxic than Truvada to the kidneys and the bones," according to Reuters.
"PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection," Jeffrey Murray, M.D., M.P.H., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a statement on the FDA’s website.
The approval is part of longterm efforts to end the HIV epidemic by 2030. As part of the government’s initiative, "Ending the HIV Epidemic: A Plan for America," the aim is to reduce new diagnoses by 75 percent in the next five years and by 90 percent in the next 10 years.
Descovy was already approved to be used as HIV treatment (in combination with other antiretroviral drugs) in 2016. The drug is a fixed-dose combination containing 200 mg of emtricitabine and 25 mg of tenofovir alafenamide.
The FDA panel voted 16-2 in favor of approving Descovy as PrEP in men who have sex with men (MSM) and transgender women, but later split 10-8 when it came to deciding whether it should be approved for cisgender women because “the effectiveness in this population has not been evaluated,” according to the FDA.
Therefore, while it is approved to be used by MSM and transgender women who have sex with men, it has yet to be approved for transgender men or cisgender women.
The approval came after a trial of participants using Descovy as PrEP was evaluated involving 5,387 HIV-negative men and transgender women who have sex with men. From 48 to 96 weeks, researchers examined participants who took Descovy and compared them to those who took Truvada.
In the end, the trial showed that Descovy and Truvada were equally as effective in preventing HIV contraction.
"This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections," added Murray.