Gilead submits new drug application for single-tablet HIV treatment

Gilead Sciences announced that it has submitted a new drug application to the FDA for its investigational tenofovir alafenamide-based regimen for the treatment of adults with HIV-1 infection, according to a news release.

The once-daily, single-tablet regimen contains elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg. TAF is a novel prodrug of tenofovir, the active agent in tenofovir disoproxil fumarate (Viread, Gilead), a nucleoside reverse transcriptase inhibitor used in combination with other HIV medications. It has shown high antiviral efficacy at a dose 10 times lower than tenofovir disoproxil fumarate and has an improved renal and bone safety profile, according to the drugmaker.

“This TAF-based regimen has the potential to provide a range of HIV patients with a highly effective and well-tolerated new treatment option with a favorable safety profile,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead Sciences, said in the release. “Gilead remains focused on advancing next-generation therapies that have the potential to improve HIV treatment over the long term, and TAF will be the cornerstone of future Gilead single-tablet regimens.”

The new drug application is supported by data from two phase 3 studies, which demonstrated noninferiority of the TAF-based regimen to one containing elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead) in treatment-naive patients. In the studies, the TAF-based regimen showed improved renal and bone safety. The filing also is supported by other phase 3 studies of virologically suppressed patients with HIV who switched to the investigational treatment and patients with renal impairment.

The company plans to file a regulatory application for the TAF-based regimen in the European Union by the end of the year.