The FDA has approved Descovy, a fixed-dose combination tablet containing emtricitabine and tenofovir alafenamide, for the treatment of HIV, according to the drug’s manufacturer.
Descovy (emtricitabine/tenofovir alafenamide [F/TAF]; Gilead Sciences) is administered as a single oral tablet taken daily in combination with other antiretroviral agents. The formulation includes 200 mg emtricitabine and 25 mg tenofovir alafenamide, and it is indicated for adults and pediatric patients aged 12 years and older without hepatitis B virus infection and with creatinine clearance of at least 30 mL/min.
F/TAF regimens noninferior to F/TDF regimens
“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,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead Sciences, said in a press release. “With today’s approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF-based portfolio, which is designed to help address the diverse needs of HIV patients worldwide.”
According to the release, the approval is supported by several phase 3 studies demonstrating noninferiority of the F/TAF-based regimen Genvoya (elvitegravir/cobicistat/F/TAF [E/C/F/TAF]; Gilead Sciences) compared with Stribild (E/C/F/tenofovir disoproxil fumarate [E/C/F/TDF]; Gilead Sciences), as well as other F/TDF-based regimens, when administered to HIV patients virally suppressed by F/TDF-based regimens or to patients with no exposure to ART. Tests of renal and bone safety parameters also showed TAF to be favorable over Viread (TDF; Gilead Sciences) and efficacious when administered at a dose less than one-tenth that of TDF.