FDA OKs Descovy, Second Drug for HIV PrEP

Megan Brooks

October 03, 2019

The US Food and Drug Administration (FDA) has approved a second drug for HIV-1 preexposure prophylaxis (PrEP) as part of ongoing efforts to end the HIV epidemic.

Descovy (Gilead Sciences) is a fixed-dose combination of emtricitabine (200 mg) and tenofovir alafenamide (25 mg). It is indicated to reduce the risk for HIV-1 infection from sex (excluding those who have receptive vaginal sex) in at-risk adults and adolescents weighing at least 35 kg (77 lb).

Descovy is not indicated in individuals at risk for HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated, the FDA said.

In August, a federal advisory panel objected to Gilead Sciences' bid for broad approval of Descovy for PrEP. Panelists chided the company for proceeding despite a lack of data about the drug's effectiveness in women, as reported by Medscape Medical News

The FDA panel voted 16–2 in favor of the view that Descovy had been shown to be safe and effective for PrEP against HIV infection in men and transgender women who have sex with men.

But the FDA panel then split 10–8 on the question of whether available data support approval of a PrEP indication for Descovy for cisgender women. (The term "cisgender" denotes people whose sense of gender corresponds with their birth sex.)

Descovy is already approved in the United States in combination with other antiretroviral drugs to treat HIV-1 infection in adults and pediatric patients.

The safety and efficacy of Descovy for PrEP were evaluated in a randomized, double-blind trial involving 5387 HIV-negative men and transgender women who have sex with men, putting them at risk for HIV-1 infection.

The trial compared once-daily Descovy to Gilead's Truvada, a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate that was approved for PrEP in 2012. Participants were followed for 48 to 96 weeks. The primary endpoint was the rate of HIV-1 infection in each group.

The trial showed that Descovy had efficacy on par with Truvada for reducing the risk of acquiring HIV-1 infection. Diarrhea was the most common adverse effect in individuals without HIV who were taking Descovy for PrEP.

Descovy has a boxed warning for people with hepatitis B virus (HBV) infection to be aware of the risk for exacerbations of HBV in "those who discontinue products with emtricitabine or tenofovir disproxil fumarate, and which may occur in individuals who discontinue Descovy," according to the FDA.

In addition, people with unknown or positive HIV-1 status should not take Descovy, and it should only be prescribed to those confirmed to be HIV-negative immediately before initiating and at least every 3 months during use.

"PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection," said 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 news release announcing approval.

"This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the US Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections," said Murray.

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