FDA Committee Recommends Approval of Descovy for HIV PrEP Indication

Officials with the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) have recommended approval of emitricitabine 200 mg and tenofovir alafenamide 25 mg tablets (Descovy, Gilead) for pre-exposure prophylaxis (PrEP) in men and transgender women who have sex with men, according to a press release.

Descovy was initially approved in April 2016 for the treatment of HIV in adults and pediatric patients weighing at least 35 kg in combination with other antiretroviral agents. The committee ultimately voted 16 to 2 to recommend the treatment for the PrEP indication.

The decision was based on a review of data from the DISCOVER phase 3 clinical study, which evaluated the safety and efficacy of Descovy compared with Truvada in men and transgender women who have sex with men and are at high-risk of sexually-acquired HIV. Based on the data, Descovy achieved non-inferiority to Truvada in participants who were at substantial and sustained risk of HIV. Descovy also showed less toxicity in the kidneys and bones compared with Truvada, according to the study.

In addition, the committee also reviewed Descovy for the potential use as PrEP in cis-gender women, a population that was not part of the DISCOVER study. However, the committee voted 10 to 8 that there were no adequate data to support the efficacy for Descovy as PrEP in cis-women.

“We appreciate the advisory committee’s thoughtful review and discussion of the data during today’s meeting and look forward to collaborating with FDA to make this potential new prevention option available to people at risk of HIV in the United States,” Diana Brainard, MD, senior vice president, HIV and Emerging Viruses, Gilead Sciences, said in a statement. “Descovy represents a potential new therapeutic option for people at risk of sexually acquired HIV-1 infection. If approved for a PrEP indication, Descovy could play a meaningful role in the federal initiative to address the nation’s HIV epidemic.”

Many patient advocacy groups have expressed concern as to whether Descovy for PrEP will be worth the cost, especially as Teva is set to launch a generic version of Truvada in 2020, Reuters reported. According to article, many of the groups have stated that Gilead has not proven that Descovy provides enough of a benefit to justify its use beyond those at risk of kidney or bone density problems.

However, the study data indicate that Descovy may provide an advantage for some because the treatment remains in the body longer than Truvada. According to pharmacokinetic data from separate studies, Descovy users who stopped the drug after 14 to 28 days still maintained tenofovir diphosphate concentrations in peripheral blood mononuclear cells above a 90% effective concentration for at least 60% longer than Truvada users.

Still, both advocacy groups and insurers indicated that the benefit may not be significant enough to warrant choosing Descovy over a cheaper generic regimen, especially since cost is currently a substantial barrier to PrEP access, according to Reuters.

References

Gilead Sciences Statement on US Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP [news release]. Gilead. https://www.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 8, 2019.

Beasley D. Patient groups push back against Gilead’s pricey HIV prevention treatment. Reuters. Published August 7, 2019. https://www.reuters.com/article/us-gilead-hiv-focus/patient-groups-push-back-against-gileads-pricey-hiv-prevention-treatment-idUSKCN1UX113. Accessed August 8, 2019.

Gilead Presents New Findings on Profile of Descovy for Potential Use as HIV Pre-exposure Prophylaxis Compared With Truvada [news release]. Gilead. https://www.gilead.com/news-and-press/press-room/press-releases/2019/7/gilead-presents-new-findings-on-profile-of-descovy-for-potential-use-as-hiv-pre-exposure-prophylaxis-compared-with-truvada. Accessed August 8, 2019.