FDA Approves New PrEP Drug

The FDA has approved Gilead Sciences' emtricitabine 200 mg and tenofovir alafenamide 25 mg combination (Descovy) as a second pre-exposure prophylaxis (PrEP) drug in at-risk adults, and in adolescents weighing at least 75 Ibs, according to the company.

The safety and efficacy of the drug for PrEP use were evaluated in a randomized, double-blind multinational trial in 5387 HIV-negative men and transgender women who have sex with men. The trial compared the once-daily combination to Gilead's emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets (Truvada), and participants were followed between 48 and 96 weeks.

The trial showed that Gilead's emtricitabine and tenofovir alafenamide combination was similar to the company's emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg combination in reducing the risk of acquiring HIV-1 infection. Among the 2694 patients who were at risk of HIV-1 infection and received emtricitabine and tenofovir alafenamide, 7 HIV-1 infections were reported. Among the 2693 patients who received emtricitabine and tenofovir disoproxil fumarate, 15 HIV-1 infections were reported. The most common adverse reaction was diarrhea.

In addition, statistically significant advantages were observed in all 6 prespecified secondary endpoints for both renal and bone laboratory parameters in patients receiving emtricitabine and tenofovir alafenamide compared with emtricitabine and tenofovir disoproxil fumarate.

“Today, because of landmark biomedical and scientific research advances, there are unprecedented opportunities to significantly reduce new HIV infections,” said Edwin DeJesus, MD, FACP, FISDA, Medical Director, Orlando Immunology Center, in a statement.

The newly approved drug is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated. It does not prevent other sexually transmitted infections or cure HIV infections or AIDS.

REFERENCE

Gilead.com. (2019). U.S. Food and Drug Administration Approves Descovy for HIV Pre-Exposure Prophylaxis (PrEP). [online] Available at: https://www.gilead.com/news-and-press/press-room/press-releases/2019/10/us-food-and-drug-administration-approves-descovy-for-hiv-preexposure-prophylaxis-prep [Accessed 3 Oct. 2019].