The U.S. Food and Drug Administration Tuesday approved Gilead’s Vosevi as a second-line treatment for chronic hepatitis C virus (HCV) in adults with specific genotypes who have had previous treatment.

Vosevi (compound: Sofosbuvir/Velpatasvir/Voxilaprevir) is a single-tablet used to treat hepatitis C infection in adults with genotypes 1-6 previously treated with Sovaldi, another Gilead drug, or other NS5A-inhibitors. It is also used as a second-line treatment for patients who have not responded to other sofosbuvir-containing drugs without an NS5A-inhibitor.

Clinical studies proved the safety and efficacy of the drug in two Phase 3 clinical trials (POLARIS-1, POLARIS-4) which evaluated the drug for 12 weeks in about 750 HCV-infected patients without cirrhosis or with mild cirrhosis.

“Treatment with Vosevi resulted in high cure rates in clinical studies of patients previously not cured with several widely prescribed DAA regimens. This will provide physicians with an important new therapeutic option that could offer hope for their hardest-to-treat patients,” said Ira Jacobson, principal investigator in the Vosevi clinical trials.

The FDA noted that patients should undergo screening for hepatitis B infection since Vosevi may increase the risk of hepatitis B virus reactivation.

Hepatitis C is a viral disease that inflames the liver. It is spread through the blood or body fluids and often displays few symptoms. The disease affects around 3.5 million people in the United States.

The Ministry of Health and Welfare has also classified HCV as a “Group 3 Infectious Diseases” last month, due to public exposure of the disease through clinics recycling disposable syringes.

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” said Gilead President and CEO John F. Milligan. “The approval of Vosevi completes our portfolio by fulfilling the unmet need for an effective regimen for patients not cured, despite prior treatment with certain DAA regimens.”

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