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- W2797222819 abstract "Background: The pangenotypic direct-acting antivirals (DAAs) glecaprevir and pibrentasvir, comprisethe interteron (IFN)- and ribavirin (RBV)-free regimen G/P. In seven phase 2/3 clinical lrials, G/Pachieved SVR12 rates of 92-100% across all six major HCV genotypes (GTs). Here we present anintegrated analysis from these studies on lhe efficacy of 8 and 12 weeks of G/P treatment in noncirrholicpatienls with GT1-6 infection. Methods: Data were pooled from the phase 2 SURVEYOR-I and-11, and phase 3 EXPEDITION-4 and ENDURANCE 1 ,2,3 and 4 sludies. Patients with chronic HCV GTt,2,3,4,5 or 6 infection without cirrhosis received G/P without RBV for either 8 or 12 weeks. Patientswere either treatment-naive or treatmenl-experienced with IFN-based or sofosbuvir (SOF)-basedregimens. Patients experienced wilh a DAA other than SOF were excluded. Efficacy was evaluated asthe rate of sustained virologic response (HCV RNA <lower limit of quantification) 12 weeks after lheend of treatment (SVR12). Safety was assessed in all patients. Results: In total, 1981 patients withoutcirrhosis were enrolled and 1975 received study drug. Select baseline characteristics are shown inTable 1. SVR12 rates by treatmenl duration and genotype, excluding 22 patients that were treated fort6 weeks, are shown in Figure 1. In lhe intent-to-treat population (ITT), 191111953 (98%) patientsachieved SVR12, with similar rales of 97% and 98% in patients lreated for 8 and 12 weeks,respectively. Across all genotypes, lhere were 4 breakthroughs (0.2%), 14 relapses (0.7%) and 11discontinualions (0.6%). G/P was well-tolerated; discontinualions due to adverse events, DAA-relaledserious adverse events and grade 3 or higher laboratory abnormalities were rare.Conclusions: The GIP regimen yielded high SVR12rates across all genotypes, regardless of priortreatment experience or treatment duration. The resultsfrom lhis integrated analysis suggest that the G/Pregimen could provide an effective 8-week IFN- andRBV-Iree treatment option for patients with HCV GT1-6infection without cirrhosis." @default.
- W2797222819 created "2018-04-24" @default.
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- W2797222819 date "2017-09-14" @default.
- W2797222819 modified "2023-10-17" @default.
- W2797222819 title "High SVR Rates with 8 and 12 Weeks of Pangenotypic GlecapreviriPibrentasvir: PH2Integrated Efficacy and Safety Analysis of Genotype 1-6 Patients without Cirrhosis" @default.
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