The FDA Antimicrobial Drugs Advisory Committee (AMDAC) has voted 16-2 to recommend approval of Gilead Sciences Inc’s combination drug, Descovy, to reduce the risk of sexually acquired HIV infection in those at high risk of acquiring the virus.

The treatment, a combination of emtricitabine and tenofovir alafenamide, is already approved to treat chronic HIV and is now approved as a form of pre-exposure prophylaxis (PrEP) for men and transgender women who have sex with men. That patient population forms the largest component of the PrEP market.1

For patients who take a daily PrEP pill, their estimated level of protection is 99%, according to the results of the iPrEx study that originally found PrEP to be effective.

Even for patients who only take 2 PrEP pills per week, the study found that their estimated level of protection is 76%.2  

The AMDAC reviewed Descovy data from the DISCOVER global Phase 3 clinical study, which evaluated the efficacy and safety of Descovy compared with Truvada. Results from the trial demonstrated the Descovy achieved non-inferiority to Truvada in study participants who were at high risk of HIV acquisition. Statistically significant improvements in renal and bone laboratory parameters were also observed for participants receiving Descovy.

Although not yet approved for PrEP use, Diana Brainard, MD, senior vice president of HIV and emerging viruses at Gilead Sciences, said that the company is optimistic about Descovy receiving approval.

“Descovy represents a potential new therapeutic option for people at risk of sexually acquired HIV-1 infection,” she said in a statement. “If approved for a PrEP indication, Descovy could play a meaningful role in the federal initiative to address the nation’s HIV epidemic.”

References
  1. Gilead Sciences statement on U.S. Food and Drug Administration advisory committee’s recommendation on Descovy for PrEP [news release]. Foster City, CA; August 8, 2019. Gilead Sciences. gilead.com/news-and-press/press-room/press-releases/2019/8/gilead-sciences-statement-on-us-food-and-drug-administration-advisory-committees-recommendation-on-descovy-for-prep. Accessed August 13, 2019.
  2. The Basics. San Francisco AIDS Foundation website. prepfacts.org/prep/the-basics/. Accessed August 13, 2019.