FDA Approves Epclusa for Chronic Hepatitis C

Share this content:
FDA Approves Epclusa for Chronic Hepatitis C
FDA Approves Epclusa for Chronic Hepatitis C

TUESDAY, June 28, 2016 (HealthDay News) -- The combination drug Epclusa has been approved by the U.S. Food and Drug Administration to treat the six major strains of chronic hepatitis C virus.

Epclusa combines sofosbuvir, FDA-approved in 2013, and the new drug velpatasvir. For patients with moderate-to-severe cirrhosis, Epclusa is approved to be used in combination with ribavirin. Epclusa also is approved for use in patients who haven't developed cirrhosis, the agency said Tuesday in a news release.

Epclusa was evaluated in clinical trials involving 1,558 patients. Up to 99 percent of participants given the drug had no virus detected in the blood 12 weeks after treatment, the FDA said. The most common side effects reported were headache and fatigue. The drug's label warns that Epclusa, when used with certain other drugs, including amiodarone, could lead to symptomatic bradycardia.

"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Epclusa is produced and marketed by Gilead Sciences, based in Foster City, Calif.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions

More in Home

Basivertebral Nerve Ablation Beneficial for Chronic Back Pain

Basivertebral Nerve Ablation Beneficial for Chronic Back Pain

Improvement in self-reported outcomes at three months in patients with chronic lumbar back pain

FDA Approves Trulance for Chronic Idiopathic Constipation

FDA Approves Trulance for Chronic Idiopathic Constipation

Drug designed to stimulate secretion of intestinal fluid

ECG Could Be Used As Password for E-Health Record Access

ECG Could Be Used As Password for E-Health ...

Researchers say heartbeat could serve as a secure 'password' for patient's electronic medical history

is free, fast, and customized just for you!

Already a member?

Sign In Now »