A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)

Summary

This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV.

Timeline

Start

2012-12-07

Primary completion

2013-11-25

Completion

2014-01-29

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper The primary endpoint was sustained virologic response (HCV RNA <25 IU/mL 12 weeks after completing therapy [SVR12]). PMID 26353843 ↗

paper SVR12 was achieved by 13 of 24 (54.2%), 21 of 25 (84.0%) and 23 of 26 (88.5%) patients PMID 26353843 ↗

Publications

• Results Lagging M, Brown A, Mantry PS, Ramji A, Weilert F, Vierling JM, Howe A, Gendrano IN 3rd, Hwang P, Zhang B, Wahl J, Robertson M, Mobashery N. Grazoprevir plus peginterferon and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection: a randomized trial. J Viral Hepat. 2016 Feb;23(2):80-8. doi: 10.1111/jvh.12464. Epub 2015 Sep 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GRAZOPREVIR ANHYDROUS	Small molecule	25 mg	Oral
Subject	GRAZOPREVIR ANHYDROUS	Small molecule	50 mg	Oral
Subject	GRAZOPREVIR ANHYDROUS	Small molecule	100 mg	Oral
Background	Pegylated interferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	Subcutaneous
Background	Ribavirin	Small molecule	800 mg	Oral
Background	Ribavirin	Small molecule	1400 mg	Oral

Indications