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Gilead Seeks Approval for Treatment of Genotypes 1-6

Gilead Sciences announced it submitted an application for review to the Food and Drug Administration (FDA) for a new hepatitis C treatment, which would treat all genotypes. The once per day treatment is a combination of Sovaldi (sofosbuvir) and velpatasvir, an investigational NS5A inhibitor.

In Phase III trials, 1,015 patients with genotypes 1-6 (98% of those who participated) reached sustained virologic response (SVR) after 12 weeks of treatment. The study also included 267 patients with decompensated cirrhosis. Of those who took the treatment with ribavirin for 12 weeks, 94% reached SVR. While those who received the treatment for 12 or 24 weeks without ribavirin, only 83% and 84% achieved SVR, respectively. The treatment has received the FDA’s breakthrough therapy designation.

Sovaldi was approved in December 2013 as one of the first hepatitis C treatments where patients did not experience as many painful side effects that were commonly associated with interferon treatments.

Gilead hopes the treatment will help eliminate the need of testing for genotype. It plans to release the treatment to the market next year, if everything goes according to plan. Along with Harvoni and Technivie, this would mean Gilead would have three hepatitis C treatments available in the United States. In the European Union, Gilead said it plans to submit an application for approval by the end of the year.1,2

For more information regarding Gilead’s announcement, visit the company’s press release.

  1. Garde D. Gilead tees up another hep C combo for FDA review. Fierce Biotech. Published October 29, 2015. Accessed October 29, 2015.
  2. Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C. Gilead Sciences. Published October 28, 2015. Accessed October 29, 2015.