Gilead Sciences Awaits FDA Decision on Sofosbuvir/Velpatasvir for HCV

Gilead Sciences pic

Gilead Sciences
Image: gilead.com

As vice president of clinical development for Pharmasset, Robert Hindes, MD, played an important role in the development of sofosbuvir, known now as Sovaldi. When the small company was acquired by Gilead Sciences, the nucleoside polymerase inhibitor that Robert Hindes, MD, evaluated in combination with other drugs, continued to be evaluated in clinical trials conducted by Gilead.

In early 2016, the FDA granted priority status to a new drug application (NDA) from Gilead Sciences. This new drug is sofosbuvir/velpatasvir, a combination of a polymerase inhibitor and a next generation NS5A inhibitor. If approved, the fixed-dose combination is expected to be active against all HCV genotypes.

Placebo-controlled trials demonstrated the pan-genotypic activity of the drug, and it expected to be a more effective alternative to Harvoni in patients with non-GT1 HCV. Another recent trial showed 95 percent SVR for patients who have both HCV and HIV.

Sofosbuvir/velpatasvir received the designation of breakthrough therapy from the FDA, meaning the agency recognizes its potential for widespread use and major advances in the treatment of hepatitis C.

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