FDA Announced Approval of Second HIV-Prevention Drug

The US Food and Drug Administration (FDA) announced on October 3 approval of Descovy^® (emtricitabine 200 mg and tenofovir alafenamide 25 mg) to reduce the risk of HIV-1 infection from sex, excluding vaginal sex, in at-risk adults and adolescents.

The approval makes Descovy the second medication with a pre-exposure prophylaxis (PrEP) indication, the first being Truvada^® (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg) that was approved July 16, 2012. Efficacy data were similar for the 2 drugs.

“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,” Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products, FDA’s Center for Drug Evaluation and Research, Silver Spring, Maryland said in the FDA press release.

This approval comes on the heels of New York City Governor Andrew M. Cuomo’s announcement that New York is set to meet its goal to end the state’s AIDS epidemic by 2020.

Meeting that goal is partly attributed to the increase in the number of PrEP users in the state – nearly 32 000 in 2018 – a 32% increase from 2017.

In addition to PrEP, the FDA recommends Descovy be used as part of a comprehensive treatment plan that includes adherence to daily administration as well as safe sex practices (eg, condoms) to reduce the risk of sexually transmitted diseases.

For patients who take Descovy who also have hepatitis B virus (HBV), there is a boxed warning regarding the risk of HBV exacerbations if they stop taking Descovy or other medications with emtricitabine or tenofovir disproxil fumarate.

Patients must be tested for HIV infection prior to starting Descovy to confirm a negative diagnosis.