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The Food and Drug Administration’s (FDA) Antimicrobial Drug Advisory Committee has voted in favor (16 to 2) of approval of Descovy (emtricitabine, tenofovir alafenamide [F/TAF]; Gilead) for use in HIV-1 pre-exposure prophylaxis (PrEP) in men and transgender women who have sex with men.
The recommendation was based on data from the phase 3 DISCOVER trial which showed that Descovy was noninferior to Truvada (emtricitabine and tenofovir disoproxil fumarate; Gilead) for PrEP in reducing the risk of HIV-1 infection in at-risk men and transgender women. In addition, the study showed statistically significant improvements in renal and bone laboratory parameters in patients receiving Descovy compared with those on Truvada.
With regard to cisgender women, the panel voted 10 to 8 that the pharmacokinetic data did not support the use of Descovy in this patient population. In meeting documents, the committee stated that “In the absence of clinical efficacy data with Descovy in cisgender women, evidence of adequate drug concentrations in cervicovaginal tissues with F/TAF dosing is considered necessary to allow for extrapolation of Truvada efficacy in support of a female Descovy PrEP indication.”
Descovy is currently approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients weighing at least 35kg. It is also indicated, in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 25kg and less than 35kg.
Although not bound by the committees’ recommendations, the FDA does take them into consideration when making decisions on approval.
“Descovy represents a potential new therapeutic option for people at risk of sexually acquired HIV-1 infection,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “If approved for a PrEP indication, Descovy could play a meaningful role in the federal initiative to address the nation’s HIV epidemic.”
For more information visit fda.gov.
