FDA Approves Fixed Dose HIV Drug Combination

The FDA has approved the 2-drug fixed dose combination tablet Descovy for the treatment of HIV.

Descovy contains 2 HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), emtricitabine (FTC), and tenofovir alafenamide (TAF). However, it is not a complete regimen and must be used in combination with other antiretroviral agents.

The approval was based on a relative bioavailability trial that showed FTC and TAF exposures were similar between Descovy and Genvoya (elvitegravir/cobicistat/FTC/TAF).

A single Descovy table contains 200 mg of FTC and 25 mg of TAF that’s equivalent to 28 mg of tenofovir alafenamide fumarate.

TAF exposures for FTC/TAF 200 mg/25 mg when used with boosted protease inhibitors will be higher than Genvoya, but exposures of the metabolite, tenofovir with remain significantly lower than the previously approved tenofovir disoproxil fumarate (TDF).

The approval was 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). The results showed the F/TAF regimen met its primary objective of non-inferiority compared to F/TDF.

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

“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care,” said Norbert Bischofberger, PhD, executive vice president of Research and Development and chief scientific officer at Gilead Sciences. 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.”