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The combination of MK-5172, peginterferon, and ribavirin is effective in treatment-naive patients with hepatitis C virus genotype 1 infection without cirrhosis.

Author(s): Manns MP(1), Vierling JM(2), Bacon BR(3), Bruno S(4), Shibolet O(5), Baruch Y(6), Marcellin P(7), Caro L(8), Howe AY(8), Fandozzi C(8), Gress J(8), Gilbert CL(8), Shaw PM(8), Cooreman MP(8), Robertson MN(8), Hwang P(8), Dutko FJ(8), Wahl J(8), Mobashery N(8).

Affiliation(s): Author information: (1)Hannover Medical School, Hannover, Germany; German Center for Infection Research (DZIF), Hannover-Braunschweig, Germany. Electronic address: manns.michael@mh-hannover.de. (2)Baylor College of Medicine, Houston, Texas. (3)Saint Louis University, Saint Louis, Missouri. (4)A. O. Fatebenefratelli and Oftalmico, Milan, Italy. (5)Liver Unit, Department of Gastroenterology, Tel-Aviv Medical Center, Tel-Aviv, Israel. (6)Liver Unit, Rambam Health Care Campus, Haifa, Israel. (7)University Paris-Diderot, Clichy, France. (8)Merck & Co, Inc, Whitehouse Station, New Jersey.

Publication date & source: 2014, Gastroenterology. , 147(2):366-76

BACKGROUND & AIMS: MK-5172 is an inhibitor of the hepatitis C virus (HCV) nonstructural protein 3/4A protease; MK-5172 is taken once daily and has a higher potency and barrier to resistance than licensed protease inhibitors. We investigated the efficacy and tolerability of MK-5172 with peginterferon and ribavirin (PR) in treatment-naive patients with chronic HCV genotype 1 infection without cirrhosis. METHODS: We performed a multicenter, double-blind, randomized, active-controlled, dose-ranging, response-guided therapy study. A total of 332 patients received MK-5172 (100, 200, 400, or 800 mg) once daily for 12 weeks in combination with PR. Patients in the MK-5172 groups received PR for an additional 12 or 36 weeks, based on response at week 4. Patients in the control group (n = 66) received a combination of boceprevir and PR, dosed in accordance with boceprevir's US product circular. RESULTS: At 24 weeks after the end of therapy, sustained virologic responses were achieved in 89%, 93%, 91%, and 86% of the patients in the groups given the combination of PR and MK-5172 (100, 200, 400, or 800 mg), respectively, vs 61% of controls. In the MK-5172 group receiving 100 mg, 91% of patients had undetectable levels of HCV RNA at week 4 and qualified for the short duration of therapy. The combination of MK-5172 and PR generally was well tolerated. Transient increases in transaminase levels were noted in the MK-5172 groups given 400 and 800 mg, at higher frequencies than in the MK-5172 groups given 100 or 200 mg, or control groups. CONCLUSIONS: Once-daily MK-5172 (100 mg) with PR for 24 or 48 weeks was highly effective and well tolerated among treatment-naive patients with HCV genotype 1 infection without cirrhosis. Studies are underway to evaluate interferon-free MK-5172-based regimens. ClinicalTrials.gov number: NCT01353911.

Page last updated: 2014-11-30

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