AbbVie recently presented new outcomes from the Phase 3 GIFT-I study of its all-oral, investigational, interferon (IFN)- and ribavirin (RBV)-free, 2-direct-acting antiviral treatment, ombitasvir/paritaprevir/ritonavir. The presentation took place at the Annual Meeting of the Japan Society of Hepatology in Kumamoto, Japan.
AbbVie is a worldwide research-based biopharmaceutical company formed after separation from Abbott Laboratories in 2013. The company has a clinical advancement program in Japan to assess chronic HCV infected patients.
GIFT-I evaluated Japanese patients with the genotype 1b (GT1b) and infected with chronic hepatitis C virus (HCV), without and with cirrhosis, who were either treatment-naïve or IFN (with or without RBV) treatment-experienced. The main goal was achieved, since it demonstrated that 95 percent in a non-cirrhotic and treatment-naïve group and adult GT1b HCV-infected had a high viral load. Results concerning the secondary endpoint, GT1b HCV cirrhotic patients demonstrated 91 percent.
“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. 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,” noted Kazuaki Chayama from Hiroshima University.
Only 3 patients discontinued the treatments because of adverse side effects; headache, nausea, nasopharyngitis, peripheral edema, 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. 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,” explained Scott Brun, the vice president of AbbVie.
There are between 1.5 and 2 million of Japanese living with HCV, and genotype 1 is frequent among them (60 to 70 percent). AbbVie assessed its 2-direct-acting antiviral treatment regimen without RBV in a Japanese population and assessed the high prevalence of GT1b (95 percent of those with the genotype 1 are also GT1b).