EASL 2014: Abstract O61. EFFICACY AND SAFETY OF MK-5172 AND MK-8742 ± RIBAVIRIN IN HEPATITIS C GENOTYPE 1 INFECTED PATIENTS WITH CIRRHOSIS OR PREVIOUS NULL-REPSONSE: THE C-WORTHY STUDY
E. Lawitz1, C. Hezode2, E. Gane3, E. Tam4, M. Lagging5, L. Balart6, L. Rossaro7, R. Ghalib8, M. Shaughnessy9, P. Hwang9, J. Wahl9, M.N. Robertson9, B. Haber9
1The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, United States, 2Department of Hepatology-Gastroenterology, Henri Mondor Hospital, University of Paris-Est, Creteil, France, 3Auckland Clinical Studies, Grafton, Auckland, New Zealand, 4LAIR Centre, Vancouver, BC, Canada, 5Department of Infectious Disease, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden, 6Gastroenterology & Hepatology, Tulane University Medical Center, New Orleans, LA,7Gastroenterology and Hepatology, University of California, Davis Medical Center, Sacramento, CA, 8Texas Clinical Research Institute, Arlington, TX,9Merck, Whitehouse Station, NJ, United States
Background and aims: The aim of this study was to assess the efficacy, safety and effective treatment duration of MK-5172 (a hepatitis C virus [HCV] NS3/4A protease inhibitor) in combination with MK-8742 (an HCV NS5A replication complex inhibitor) ± ribavirin in patients with HCV genotype (GT)1 infection and poor baseline characteristics of either cirrhosis or prior null response to peginterferon / ribavirin (PEG-RBV NullR).
Results: 254 patients were enrolled (male, 58%; African American, 6%; GT1a, 65%). On-treatment response is presented according to the presence or absence of cirrhosis for patients who are either treatment-naive or PEG-RBV NullR. Overall, 59%-73% of patients had HCV-RNA < 25 IU/mL at TW2, and 94%-100% had HCV-RNA < 25 IU/mL at TW4 (Table). Adverse events reported in >10% of patients were fatigue (29%), headache (29%), and nausea (11%). The trial is on-going: end-of-treatment (EOT) and follow-up week 4 (FU4) response will be presented at the meeting.
Conclusions: MK-5172 plus MK-8742 ± RBV was associated with rapid viral suppression in the first 4 weeks of therapy, despite the treatment-resistant population profile.