First Non-Interferon/Ribavirin Combo Approved for HCV

October 10, 2014

The FDA has approved the first combination to treat chronic hepatitis C (HCV) infection that does not require co-administration with interferon or ribavirin. Harvoni (ledipasvir and sofosbuvir) treats genotype 1 HCV.

The USFood and Drug Administration today approved the first combination pill for hepatitis C virus (HCV) infection that does not require co-administration with either interferon or ribavirin, which has been an impediment to treatment for many patients with comorbid HCV and rheumatic diseases. Harvoni (ledipasvir and sofosbuvir) is also the first that can be used to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Sofosbuvir (Sovaldi) was approved for HCV last December. Harvoni also contains a newly approved direct-acting antiviral called called ledipasvir.

The approval is based on three randomized trials involving 1,518 treatment-naive or -nonresponsive HCV patients testing Harvoni with or without ribavirin. In the first trial, 95% of patients achieved sustained virologic response (SVR) after 8 or 12 weeks of treatment. In the second trial, 99% of patients without cirrhosis were virus-free after 12 weeks. The most common side effects were headache and fatigue.

Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.