FDA approves Harvoni for HCV in adults-Gilead Sciences

The FDA has approved Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), from Gilead Sciencies, as the first once-daily single tablet regimen for the treatment of chronic Hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi in December 2013. Harvoni�s efficacy has been established in patients with chronic Hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-na�ve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.

Harvoni�s approval is supported by data from three Phase III studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-na�ve patients (ION-3), cirrhotic and non-cirrhotic treatment-na�ve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).