The FDA has approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF).
The US Food and Drug Administration (FDA) has approved emtricitabine 200 mg and tenofovir alafenamide 25 mg (F/TAF; Descovy) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection through sex, excluding those who have receptive vaginal sex. The approval was granted to Gilead Sciences.
F/TAF is not indicated in individuals at risk of HIV infection from receptive vaginal sex because the effectiveness in this population has not been evaluated.
"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 in the FDA’s statement. "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."
F/TAF was evaluated in a randomized, double-blind multinational trial that included 5387 HIV-negative men and transgender women who have sex with men and were at risk for HIV infection. This trial assessed the safety and efficacy of the product and compared once daily F/TAF to emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg (F/TDF; Truvada).
The participants were followed for 48 to 96 weeks. The primary end point was the rate of HIV infection in each group and the trial concluded that F/TAF was similar to F/TDF in reducing the risk of acquiring HIV. The most common adverse reaction in individuals without HIV who were taking F/TAF in the trial was diarrhea.
“What we were able to determine from this study is that Descovy is non-inferior in its efficacy for PrEP compared to Truvada," Brad Hare, chief of infectious disease at Kaiser-Permanente, San Francisco, and lead presenter of the trial data at CROI 2019, told Contagion®. "We also had some pre-specified secondary end points looking at safety parameters, specifically bone and renal safety using these drugs, and we found a significant difference between the arms that favored the Descovy product over Truvada."
In August, FDA’s Antimicrobial Drugs Advisory Committee recommended F/TAF for PrEP in men and transgender women who have sex with men. The committee voted 16 to 2 to recommend approval for the alternative to F/TDF).
The committee also evaluated pharmacokinetic data on F/TDF and F/TAF for HIV treatment and PrEP in cisgender women, a population that was not studied in the DISCOVER trial. The committee voted 10 to 8 that there was not enough data regarding the efficacy of F/TAF in this population.
There is a boxed warning for individuals who take F/TAF who also have hepatitis B virus (HBV) to be aware of the risk of exacerbations of HBV in those who discontinue products with emtricitabine or tenofovir disproxil fumarate, and which may occur in individuals who discontinue F/TAF for PrEP.
F/TAF for HIV-1 PrEP is also contraindicated in individuals with unknown or positive HIV-1 status. It should only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use.
“Descovy for PrEP should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections,” the FDA said in their statement.
F/TAF was FDA approved in 2016 in combination with other antiretoviral drugs to treat HIV infection in adults and pediatric patients.