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AbbVie Presents New Data for its Investigational Hepatitis C Treatment in Japanese Patients With and Without Cirrhosis | ||
By: PR Newswire Association LLC. - 27 May 2015 | Back to overview list |
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NORTH CHICAGO, Ill., May 26, 2015 /PRNewswire/ -- 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.1 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.1 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.1 In study results related to the secondary endpoint, GT1b HCV patients with compensated cirrhosis achieved 91 percent (n=38/42) SVR12.1 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.1 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.1 The most commonly reported adverse events (>5 percent in any arm) were nasopharyngitis, headache, peripheral edema, nausea, pyrexia and decreased platelet count.1 "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.2 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.3 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. About GIFT-I Study In sub-study 2, 42 GT1b treatment-naïve and IFN (with our without RBV) treatment-experienced patients with compensated cirrhosis received open-label treatment for 12 weeks (Arm C) with SVR12 and assessed as a secondary efficacy endpoint.1 One patient from each arm (n=3/363) experienced on-treatment virologic failure [Arm A, 0.5% (n=1/215); Arm B, 0.9% (n=1/106); Arm C, 2.4% (n=1/42)].1 Across all arms, eight patients (n=8/354) experienced post-treatment relapse [Arm A, 2.4% (n=5/209); Arm B, 1.0% (n=1/105); Arm C, 5.0% (n=2/40)].1 About AbbVie's Investigational Two Direct-Acting Antiviral HCV Treatment AbbVie's chronic HCV treatment combines two direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process. About AbbVie's HCV Clinical Development Program in Japan Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C. Ombitasvir/paritaprevir/ritonavir is an investigational product and its safety and efficacy have not been established in Japan. Additional information about AbbVie's clinical development program in Japan can be found on www.clinicaltrials.gov. About AbbVie Forward-Looking Statements Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Chayama K, et al. Ombitasvir/paritaprevir/ritonavir for Treatment of HCV Genotype 1b in Japanese Patients With or Without Cirrhosis: Results from GIFT-I. Presented at the Annual Meeting of the Japan Society of Hepatology. May 21-23; Kumamoto, Japan
SOURCE AbbVie |
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Copyright 2015 PR Newswire Association LLC. | Back to overview list |