Single-Pill HIV Treatment Makes Its Way to the FDA

Gilead Sciences, Inc., has submitted a new drug application to the FDA for its investigational single-tablet regimen for HIV infection in adult patients.

Gilead Sciences, Inc., has submitted a new drug application to the FDA for its investigational single-tablet regimen for HIV infection in adult patients.

The once-daily, single-pill treatment contains elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF). If approved, it would be Gilead’s first single-tablet HIV regimen to contain TAF, a more targeted form of tenofovir, which is the active agent in the drugmaker’s FDA-approved Stribild and Viread treatments for HIV.

“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,” said Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer for Gilead Sciences, in a press 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 regulatory approval application for E/C/F/TAF is supported by findings from a pair of pivotal phase 3 studies that demonstrated the regimen’s non-inferiority to Stribild in treatment-naïve patients infected with HIV-1. Although both regimens had comparable safety profiles throughout the studies, E/C/F/TAF demonstrated more favorable renal and bone safety indicators.

Gilead’s application for the FDA approval of E/C/F/TAF is also supported by data from phase 3 studies that evaluated the TAF-based regimen among virologically suppressed patients who switched to E/C/F/TAF, as well as among those with renal impairment.

“As individuals with HIV are living longer, there is a need for treatments that are not only highly effective, but also offer an improved safety profile,” Dr. Bischofberger said in a previous statement. “Based on these phase 3 results, we believe that the E/C/F/TAF single tablet regimen has the potential to optimize HIV therapy for a wide range of treatment-naïve patients.”