- A Phase 3 study, GIFT-1, evaluating AbbVie's (NYSE:ABBV) investigational, all-oral, interferon-free, ribavirin-free, two direct-acting (2-DAA) antiviral combination of ombitasvir/paritaprevir/ritonavir for the treatment patients with HCV-1b infection met its primary endpoint demonstrating a high cure rate.
- In a subgroup of treatment-naive, non-cirrhotic adult HCV-1b Japanese patients who were eligible for interferon therapy and had a high viral load, the cure rate was 95% (n=106/112) determined by sustained virologic response 12 weeks after the completion of therapy (SVR12). The cure rate in HCV-1b patients with compensated cirrhosis was 91% (n=38/42).
- In an intent-to-treat analysis, the cure rate was 98% (n=104/106) in HCV-1b patients without cirrhosis. This population included every patient that was randomized to placebo during the test period and then received at least one dose of 2-DAA combo in the open label stage.
- The data were presented at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.
- AbbVie's regulatory application for the 2-DAA candidate is currently under priority review by the Japanese Ministry of Health, Labour and Welfare.
- As many as 2M Japanese are infected with HCV. Up to 70% are infected with genotype 1. About 95% of the HCV-1s are sub-type 1b.
- Previously: AbbVie's 2-DAA HCV-1 candidate gets priority peview in Japan (April 16)
- Related tickers: (NASDAQ:GILD) (NYSE:MRK) (NASDAQ:ENTA)