AbbVie (NYSE: ABBV) released top-line Phase 3 results for its investigational, all-oral, ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan. The primary endpoint of the GIFT-I study was achieved, demonstrating a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic adult GT1b Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load.
"AbbVie is committed to advancing HCV care with the goal of evaluating our treatment in a broad range of patients around the world," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "The GIFT-I results are encouraging and support moving forward with our Japan development program, with a local regulatory submission anticipated in the first quarter of 2015."
In Japan, up to two million people are currently living with hepatitis C. Genotype 1b is the most common sub-genotype, affecting nearly half of the people infected with HCV.
In the GIFT-I study, the primary efficacy population comprised a sub-group of treatment-naive GT1b chronic HCV infected patient population. This sub-group consisted of treatment-naive patients without cirrhosis who were eligible for therapy with IFN with or without RBV, had a high viral load (> 100,000 IU/mL) and received at least one dose of the double-blind active study drug. The primary endpoint was assessed at 12 weeks post treatment (SVR12).
In patients without cirrhosis, the most commonly reported adverse events in the treatment arm were nasopharyngitis (16.7 percent OBV/PTV/r vs. 13.2 percent placebo), headache (8.8 percent OBV/PTV/r vs. 9.4 percent placebo), and oedema peripheral (5.1 percent OBV/PTV/r vs. 0 percent placebo). Two patients without cirrhosis (0.9 percent) discontinued treatment due to adverse events.
Within the primary efficacy patient population, there were no on-treatment virologic failures and 2.8 percent of patients (n=3/109) experienced relapse.
AbbVie will disclose detailed GIFT-I study results at future scientific congresses and in publications.