Newly Approved Hepatitis C Drug Covers Patients With or Without Cirrhosis

Sofosbuvir/velpatasvir (Epclusa) has been approved by the US Food and Drug Administration (FDA) for a wide range of patients with chronic hepatitis C.

Developed by Gilead Sciences, Inc., Epclusa is indicated for adults with hepatitis C genotype 1 through 6 with or without cirrhosis. The drug is a single oral tablet combination of sofosbuvir 400 mg and velpatasvir 100 mg.

“This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a FDA announcement.

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The approval is based off of safety and efficacy results from three 12-week phase III studies. The clinical trials involved 1,558 patients with hepatitis C either without cirrhosis or with compensated cirrhosis (mild cirrhosis). At the end of study period, blood tests showed that 95% to 99% of patients were cleared of the virus.

Additional research showed that 94% of the 267 patients with decompensated cirrhosis (moderate to severe cirrhosis) who received Epclusa had no virus detection after 12 weeks of treatment. Notably, 87 patients also received ribavirin. Therefore, Epclusa is approved for those with moderate to severe cirrhosis in combination with ribavirin.

The most common side effects of the drug were headache and fatigue. Serious potential issues include symptomatic bradycardia, or serious slowing of heart rate. Special consideration may be needed in patients with a pacemaker.

Sofosbuvir was approved in 2013 and velpatasvir is a new drug. Epclusa is the first and only all-oral, pan-genotypic single tablet for chronic hepatitis C.

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