FDA Approves Gilead's Descovy for the Treatment of HIV

The treatment is a fixed-dose combination of emtricitabine 200 mg and tenofovir alafenamide 25 mg.

The FDA has approved Gilead Science’s Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. This is Gilead’s third TAF-based HIV treatment to receive approval.

According to Gilead, Descovy is indicated “in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older,” and should not be used as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences, said “As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care. As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.”

The FDA approved Descovy for the treatment of HIV based on safety and efficacy data from two 48-week phase 3 studies in which treatment-naïve adult patients received treatment with either elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) or elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (E/C/F/TDF). In the studies, the F/TAF regimen met its primary objective of non-inferiority compared to F/TDF.

Data from a third study, which evaluated the F/TAF-based regimen among virologically suppressed adult patients who switched from F/TDF-based regimens, was also considered during the approval process. In that study, “the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens.”

The Descovy labeling will include a boxed warning “regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.”