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.

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