High SVR Rates with 8 and 12 Weeks of Pangenotypic GlecapreviriPibrentasvir: PH2 Integrated Efficacy and Safety Analysis of Genotype 1-6 Patients without Cirrhosis

Puoti, M; Foster, G; Wang, S; Mutimer, D; Gane, E; Moreno, C; Tsung Chang, T; Lee, SS; Marinho, R; Dufour, Jean-François; Pol, S; Hezode, C; Gordon, SC; Strasser, SI; Thuluvath, PJ; Liu, R; Pilot-Matias, T; Mensa, F (14 September 2017). High SVR Rates with 8 and 12 Weeks of Pangenotypic GlecapreviriPibrentasvir: PH2 Integrated Efficacy and Safety Analysis of Genotype 1-6 Patients without Cirrhosis. Swiss medical weekly, 147(Suppl 225), p. 20. EMH Schweizerischer Ärzteverlag

Background: The pangenotypic direct-acting antivirals (DAAs) glecaprevir and pibrentasvir, comprise the interteron (IFN)- and ribavirin (RBV)-free regimen G/P. In seven phase 2/3 clinical lrials, G/P achieved SVR12 rates of 92-100% across all six major HCV genotypes (GTs). Here we present an integrated analysis from these studies on lhe efficacy of 8 and 12 weeks of G/P treatment in noncirrholic patienls 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 GT t,2,3,4,5 or 6 infection without cirrhosis received G/P without RBV for either 8 or 12 weeks. Patients were either treatment-naive or treatmenl-experienced with IFN-based or sofosbuvir (SOF)-based regimens. Patients experienced wilh a DAA other than SOF were excluded. Efficacy was evaluated as the rate of sustained virologic response (HCV RNA <lower limit of quantification) 12 weeks after lhe end of treatment (SVR12). Safety was assessed in all patients. Results: In total, 1981 patients without cirrhosis were enrolled and 1975 received study drug. Select baseline characteristics are shown in Table 1. SVR12 rates by treatmenl duration and genotype, excluding 22 patients that were treated for t6 weeks, are shown in Figure 1. In lhe intent-to-treat population (ITT), 191111953 (98%) patients achieved 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 11 discontinualions (0.6%). G/P was well-tolerated; discontinualions due to adverse events, DAA-relaled serious adverse events and grade 3 or higher laboratory abnormalities were rare. Conclusions: The GIP regimen yielded high SVR12 rates across all genotypes, regardless of prior treatment experience or treatment duration. The results from lhis integrated analysis suggest that the G/P regimen could provide an effective 8-week IFN- and RBV-Iree treatment option for patients with HCV GT1-6 infection without cirrhosis.

Item Type:

Conference or Workshop Item (Poster)

Division/Institute:

04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Hepatology
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Hepatologie

UniBE Contributor:

Dufour, Jean-François

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1424-7860

Publisher:

EMH Schweizerischer Ärzteverlag

Language:

English

Submitter:

Thi Thao Anh Pham

Date Deposited:

16 Jan 2018 15:52

Last Modified:

16 Jan 2018 15:52

URI:

https://boris.unibe.ch/id/eprint/107120

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