Gilead files NDA for TAF-based single tablet regimen to treat HIV

The NDA supports the use of the regimen among adult and adolescent treatment-naïve HIV individuals, virologically suppressed patients who switch regimens and those with renal impairment.

The company said that if approved by the FDA, E/C/F/TAF would be its first single tablet regimen to contain TAF, an investigational, new prodrug of tenofovir, the active agent in its Viread (tenofovir disoproxil fumarate).

TAF is a more targeted form of tenofovir than Viread that has showed high antiviral efficacy at a dose that is ten times lower, as well as an improved renal and bone safety profile.

Gilead Sciences Research and Development executive vice-president and chief scientific officer Norbert Bischofberger said: "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.

"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 application for E/C/F/TAF is based on a 48-week data from two pivotal Phase III trials (Studies 104 and 111), in which the regimen met its primary objective of non-inferiority compared to the company’s Stribild (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) among treatment-naïve patients.

The company intends to submit a regulatory application for E/C/F/TAF in the European Union (EU) by the end of 2014.