EASL 2012: THE EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF BI201335 AND BI207127 IN GENOTYPE 1 HCV PATIENTS WITH CIRRHOSIS - INTERIM ANALYSIS FROM SOUND-C2

Abstract

Title: THE EFFICACY AND SAFETY OF THE INTERFERON-FREE COMBINATION OF BI201335 AND BI207127 IN GENOTYPE 1 HCV PATIENTS WITH CIRRHOSIS - INTERIM ANALYSIS FROM SOUND-C2

Speaker: Vicente Soriano

Author: V. Soriano¹*, E. Gane², P. Angus³, F. Stickel⁴, J.-P. Bronowicki⁵, S. Roberts⁶, M. Manns⁷, S. Zeuzem⁸, L. Dai⁹, W. Boecher¹⁰, J. Stern⁹, F. Mensa⁹

Affiliation: ¹Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain, ²Auckland Clinical Studies, Auckland, New Zealand, ³Austin Health, Liver Trasnplant Unit, Heidelberg, VIC, Australia, ⁴Universitätsklinik für Viszerale Chirurgie und Medizin, Bern, Switzerland, ⁵Hopital de Brabois, Vandoeuvre, France, ⁶Alfred Hospital, Department of Gastroenterology, Melbourne, VIC, Australia, ⁷Medizinische Hochschule Hannover, Hannover, ⁸Klinikum der J. W. Goethe-Universität, Frankfurt am Main, Germany, ⁹Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA, ¹⁰Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany. *vsoriano@dragonet.es

Background: SOUND-C2 is an open-label, randomized, phase IIb study with 5 treatment arms evaluating the efficacy and safety of interferon-free combination regimens of BI201335, an HCV protease inhibitor, and BI207127, a non-nucleoside RNA polymerase inhibitor, +/- ribavirin (R) for 16-40 weeks (W), in HCV GT1 infected treatment naïve (TN) patients. This is an interim sub-analysis of patients with compensated liver cirrhosis enrolled in SOUND-C2.
Methods: 37 patients with biopsy or Fibroscan confirmed cirrhosis were treated in 5 arms (described in Zeuzem et al, Hepatology, 2011, Supp1, LB15). All 37 patients had compensated liver disease, 25 were GT1b and 30 had IL-28b genotype CT/TT. Patients who received the same dose for 16, 28 or 40W (arms A, B and C) were pooled.

Results: Efficacy (ITT) and safety data in patients with cirrhosis (randomization not stratified by cirrhosis):

[Table 1]

Mild skin and gastrointestinal disorders were the most commonly reported AEs.

Conclusions: Interferon-free combination therapy with BI201335, BI207127 and R achieved up to 60% SVR12^† in GT-1a and up to 83% in GT1b patients with compensated liver cirrhosis. The safety and tolerability was more favorable in the BI207127_BID arm than in the BI207127_TID arms. Response rates in cirrhotic and non-cirrhotic patients were similar, but a statistical comparison is not possible due to the limited sample size and imbalances in host and viral factors. Thus, these SVR4/12 rates suggest that this IFN-free regimen may obtain similar SVR rates to those achieved with approved DAAs + PR regimens with shorter treatment duration. These are the first data of an interferon free-regimen in a population with compensated HCV cirrhosis and they support further evaluation of this regimen for chronic HCV GT1 infection, including patients with cirrhosis.

Source