- The FDA has approved Descovy, the second PrEP drug for HIV prevention.
- In a clinical trial, the drug showed promise in reducing the risk of contracting HIV-1 from sexual activity.
- Descovy’s effectiveness on HIV prevention for women who have vaginal sex hasn’t been proven yet.
There’s a new drug that can lower your risk for contracting HIV-1 from sex.
However, there’s one big caveat: The drug hasn’t yet been proven to prevent transmission in women who have vaginal sex.
The Food and Drug Administration (FDA)
Developed by Gilead Sciences, Descovy is a compound of antiviral medications called emtricitabine and tenofovir alafenamide.
The FDA approved the drug for use among adults and adolescents who weigh at least 77 pounds and have known risk factors for HIV-1 infection but aren’t yet exposed to the virus.
The drug doesn’t prevent other sexually transmitted infections or cure HIV.
The FDA also states that the drug shouldn’t be given to people who already have HIV.
People with hepatitis B have reported worsening conditions if they begin and then discontinue use of other drugs in the same class as Descovy.
Dr. Jeffrey Murray, MPH, deputy director of the division of antiviral products in the FDA’s Center for Drug Evaluation and Research, stated that pre-exposure prophylaxis (PrEP) drugs such as Descovy have proven to be “highly effective” in preventing HIV transmission.
“This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections,” Murray said in a press release.
The FDA approved the drug in expedited fashion based on data from DISCOVER, a multiyear, global phase III registrational clinical trial that compared Descovy with Truvada, another HIV-prevention drug made by Gilead Sciences.
Daniel O’Day, chairman and CEO of Gilead Sciences, said in a press release that Descovy’s efficacy is similar to that of Truvada, but with improvements in renal- and bone-related side effects that “can be an important consideration, as people at risk increasingly use PrEP for longer periods of time.”
“Descovy has not been proven to be a better, safer, more effective kind of PrEP,” noted a fact sheet on the DISCOVER clinical trial prepared by AVAC: Global Advocacy for HIV Prevention.
“Truvada was a game changer. Descovy is just a new player in the game,” Seth Kalichman, PhD, an HIV prevention researcher and professor of community psychology at the University of Connecticut, told Healthline.
Nonetheless, he said, “The approval of a second pairing of drugs for HIV PrEP is a major advance.”
The clinical trial included more than 5,300 adult cisgender men who have sex with men as well as transgender women who have sex with men. Both groups are considered to have known risk factors for HIV.
The drug wasn’t approved for those engaged in receptive vaginal sex “because effectiveness in this population has not been evaluated,” according to the press release from Gilead Sciences.
“No cisgender women were enrolled, so there is no information available about [Descovy] efficacy or safety for cis women,” Dr. Christopher Hall, vice president of medical affairs at the San Francisco AIDS Foundation, wrote in a blog post after the findings were presented at the March 2019 Conference on Retroviruses and Opportunistic Infections.
“Truvada remains a safe and effective PrEP strategy for cis women or trans men who have vaginal or front-hole intercourse,” Hall added.
Researchers found that of 2,694 participants who received Descovy, only seven developed HIV-1 infections, while 15 infections were reported among the 2,693 participants who received Truvada.
All participants were screened for HIV at 48 weeks. Half were rescreened at 96 weeks.
Kalichman says that while the availability of Descovy adds another HIV prevention tool, “perhaps as important as anything, the approval opens the door to innovation in marketing, messaging, and reaching those in greatest need.”
The adoption of PrEP drugs has been poor, notes Kalichman, with less than 500,000 people receiving PrEP worldwide — about half of them in the United States.
“Hopefully, with competition for the PrEP market, there will be increased public sector resources, smarter marketing, and improved messaging,” he said.