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Title: Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis.
Austin Authors: Zeuzem, Stefan;Soriano, Vicente;Asselah, Tarik;Gane, Edward J;Bronowicki, Jean-Pierre;Angus, Peter W ;Lohse, Ansgar W;Stickel, Felix;Müllhaupt, Beat;Roberts, Stuart;Schuchmann, Marcus;Manns, Michael;Bourlière, Marc;Buti, Maria;Stern, Jerry O;Gallivan, John-Paul;Voss, Florian;Sabo, John P;Böcher, Wulf;Mensa, Federico J
Institutional Author: SOUND-C2 Study Group
Affiliation: Austin Health, Heidelberg, Victoria, Australia
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA
Alfred Hospital, Melbourne, Australia
J. W. Goethe University Hospital, Frankfurt, Germany
Hospital Carlos III, Madrid, Spain.
Service d'Hépatologie, Hôpital Beaujon, INSERM UMR S 1149, CRI, Université Paris Diderot, DHU UNITY, Clichy, France.
Auckland Clinical Studies, Auckland, New Zealand.
INSERM 954, Centre Hospitalier Universitaire de Nancy, Vandoeuvre les Nancy, France.
University Hospital Hamburg-Eppendorf, Hamburg, Germany.
University of Bern, Bern, Switzerland.
University Hospital of Zurich, Zurich, Switzerland.
University Hospital Mainz, Mainz, Germany.
Medical School of Hannover, Hannover, Germany.
Hôpital Saint Joseph, Marseille, France.
Hospital Universitario Valle Hebron and Ciberehd del Instituto Carlos III, Barcelona, Spain.
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Issue Date: 15-Dec-2014
Publication information: Antimicrobial Agents and Chemotherapy 2014; 59(2): 1282-91
Abstract: Patients with advanced hepatic fibrosis or cirrhosis with chronic hepatitis C virus (HCV) infection represent an unmet need. The HCV NS3/4A inhibitor, faldaprevir, was evaluated in combination with the nonnucleoside NS5B inhibitor, deleobuvir, with or without ribavirin in treatment-naive patients with HCV genotype 1 infection in the SOUND-C2 study. Here, the efficacy and safety of this interferon-free regimen in a subset of patients with advanced liver fibrosis, including those with compensated cirrhosis, were assessed. Patients (n=362) were randomized to once-daily faldaprevir with either twice-daily (BID) or three-times-daily (TID) deleobuvir for 16 (TID16W), 28 (TID28W and BID28W), or 40 (TID40W) weeks with or without ribavirin (TID28W-NR). Patients were classified according to fibrosis stage (F0 to F2 versus F3 to F4) and the presence of cirrhosis (yes/no). In total, 85 (24%) patients had advanced fibrosis/cirrhosis (F3 to F4) and 33 (9%) had cirrhosis. Within each treatment arm, differences in rates of sustained virologic response 12 weeks after completion of treatment (SVR12) between patients with mild to moderate fibrosis (F0 to F2) versus F3 to F4 did not show a consistent pattern and were not statistically significant (63% versus 47% for TID16W, 53% versus 76% for TID28W, 48% versus 67% for TID40W, 70% versus 67% for BID28W, and 40% versus 36% for TID28W-NR, respectively; P > 0.05 for each arm). The most frequent adverse events in patients with/without cirrhosis were gastrointestinal and skin events, which were mostly mild or moderate in intensity. The degree of liver fibrosis did not appear to affect the probability of achieving SVR12 following treatment with the interferon-free regimen of faldaprevir, deleobuvir, and ribavirin. (This study has been registered at under registration no. NCT01132313.).
Gov't Doc #: 25512403
DOI: 10.1128/AAC.04383-14
Type: Journal Article
Appears in Collections:Journal articles

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