FDA Approves New HIV PrEP Drug

A new drug for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection through sex, excluding those who have receptive vaginal sex will soon be available.

The US Food and Drug Administration (FDA) has approved Gilead Sciences for emtricitabine 200 mg and tenofovir alafenamide 25 mg (f/TAF; Descovy) for men who have sex with men and transgender women to reduce the risk of HIV.

F/TAF is not indicated for individuals at risk of HIV infection from receptive vaginal sex because the effectiveness in this population has not yet been evaluated.

“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 the US Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”

The investigators evaluated the treatment 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.

The 48-96-week 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 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, the FDA’s Antimicrobial Drugs Advisory Committee recommended F/TAF for PrEP in men and transgender women who have sex with men.

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.

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.

F/TAF was FDA approved in 2016 in combination with other antiretoviral drugs to treat HIV infection in adults and pediatric patients.

This article was originally published in Contagion® Live.