The U.S. Food and Drug Administration (FDA) has approved the first pharmaceutical to treat all six major forms of chronic hepatitis C virus (HCV) infection.
The drug, Epclusa, offers treatment options for a wider range of patients with chronic HCV, Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a release.
In three phase III clinical trials of more than 1,500 subjects without cirrhosis or with mild cirrhosis, 95% to 99% of patients who received Epclusa had no virus detected in the blood 12 weeks after finishing treatment, which led researchers to conclude that the patients' infections had been cured.
Infection with HCV becomes chronic in about 75% to 85% of cases, according to the U.S. Centers for Disease Control and Prevention. Patients with chronic HCV may have complications including bleeding, jaundice, fluid accumulation in the abdomen, infections, and liver cancer.
The pharmaceutical is made and marketed by Gilead.
