AbbVie (NYSE: ABBV) presented new results from the Phase 3 GIFT-I study of its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan. GIFT-I evaluated genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected Japanese patients, with and without cirrhosis, who were either treatment-naïve or IFN (with or without RBV) treatment-experienced. The primary endpoint was achieved, demonstrating 95 percent (n=106/112) SVR12 in a sub-group of treatment-naïve, non-cirrhotic, adult GT1b HCV infected Japanese patients who were eligible for therapy with IFN and had a high viral load. In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR12.
In an additional intent-to-treat (ITT) analysis, SVR12 was achieved in 98 percent (n=104/106) of the GT1b HCV infected patients without cirrhosis (Arm B) who were randomized to initially receive double-blind placebo for 12 weeks, followed by open-label treatment with ombitasvir/paritaprevir/ritonavir. The ITT population included every patient that was randomized to placebo and received at least one dose of active, open-label study drug.
"It is critical to address the burden of hepatitis C in Japan, with GT1b being the most prevalent sub-type of the disease in the country," said Kazuaki Chayama, M.D., Ph.D, professor and head of the Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University. "GIFT-I shows the potential of this treatment to achieve high SVR rates for Japanese patients with GT1b hepatitis C, including those with compensated cirrhosis."
Across all study arms, three patients (n=3/363) discontinued treatment due to adverse events. The most commonly reported adverse events (>5 percent in any arm) were nasopharyngitis, headache, peripheral edema, nausea, pyrexia and decreased platelet count.
"We are pleased to present full results from GIFT-I, which provide further insight into our hepatitis C treatment currently under priority review by the Japanese health authorities," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "We know physicians weigh the risks and benefits of HCV treatments for their patients as they look for an option that offers a potential cure. These data will help guide clinicians in their decision making and support AbbVie's goal of bringing an interferon- and ribavirin-free treatment to people living with genotype 1 hepatitis C in Japan."
In Japan, approximately 1.5 to 2 million people are living with HCV. Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the GT1b sub-type. AbbVie studied its two direct-acting antiviral treatment regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b.
AbbVie's investigational, two direct-acting antiviral treatment consists of ombitasvir/paritaprevir/ritonavir and is currently under priority review by the Japanese Ministry of Health, Labour and Welfare.