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Enanta Announces SVR12 results of 95% from AbbVie's GIFT-1 Study in Non-cirrhotic, Japanese Patients with Genotype 1b Hepatitis C Virus1Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today that new data from AbbVie's phase 3 GIFT-I study, its investigational, all-oral, interferon (IFN)- and ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir, was presented 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 Interferon (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. In an additional intent-to-treat (ITT (News - Alert)) 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. 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 In Japan, approximately 1.5 to 2 million people are living with HCV.2 60 to 70 percent of Japanese HCV patients are infected with Genotype 1, 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. Paritaprevir is Enanta's lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the two direct-acting antivirals (2-DAA) in AbbVie's treatment regimen currently under priority review by the Japanese Ministry of Health, Labour and Welfare. AbbVie has previously announced that it expects regulatory approval of the 2-DAA treatment regimen in Japan in the second half of 2015. Upon commercialization regulatory approval in Japan, Enanta will be entitled to a $30 million milestone payment from AbbVie. In addition, Enanta will be eligible to receive annually tiered royalties, ranging from the low double digits up to twenty percent, on AbbVie's aggregate net sales of all paritaprevir-containing regimens, including 45% of AbbVie's worldwide net sales of any 2-DAA regimen. Paritaprevir is included in AbbVie's HCV treatment regimens approved in the U.S. in late 2014and in the E.U. in early 2015.
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
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Forward Looking Statements Disclaimer 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 2 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html 3 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html
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