Combination HIV Treatment Awaits FDA Action

Gilead Sciences is seeking FDA approval for its fixed-dose emtricitabine/tenofovir alafenamide (F/TAF) treatment for HIV-1 infection in adults and adolescents.

TAF is an investigational nucleotide reverse transcriptase inhibitor demonstrating high antiviral efficacy at a dose less than one-tenth of Gilead’s tenofovir disoproxil fumarate (Viread). It has also shown signs of improved renal and bone parameters compared with Viread in clinical trials.

The recommended dose of F/TAF is 200/25 mg, but if it is used in combination with a protease inhibitor administered with ritonavir or cobicistat, the recommended dose is 200/10 mg. The New Drug Application (NDA) for F/TAF seeks approval for both of these dosage strengths.

The FDA is expected to act on the NDA on November 5, 2015.

“Gilead has a long history of innovating HIV treatments, and with F/TAF, we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment,” said Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer for Gilead, in a press release. “With its high antiviral efficacy and favorable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens.”

This filing marks Gilead's second F/TAF-based NDA, as it submitted one for a single-tablet HIV regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and TAF 10 mg (E/C/F/TAF) in November 2014.

Similar F/TAF-based HIV treatments are currently in development.