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)
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)
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.
Inclusion Criteria:

 -  Treatment naive

 -  Chronic, compensated HCV GT1 infection

 -  Absence (no medical history or physical findings) of ascites, bleeding esophageal
 varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease,
 or cirrhosis

 -  No evidence of cirrhosis or hepatocellular carcinoma by biopsy or noninvasive testing
 (e.g. FibroScan and/or FibroTest)

 -  Must agree to use two acceptable methods of birth control from at least 2 weeks prior
 to first dose and continue until at least 6 months after last dose of study drug, or
 longer if dictated by local regulations

 Exclusion Criteria:

 -  Non-GT1 HCV infection, including a mixed GT infection (with a non-GT1) or a
 non-typeable genotype.

 -  Documented to be Human Immunodeficiency Virus (HIV) positive or co-infected with
 hepatitis B virus

 -  Hepatocellular carcinoma (HCC) or under evaluation for HCC

 -  Participating in or has participated in a study with an investigational compound or
 device within 30 days of signing informed consent

 -  Diabetic and/or hypertensive with clinically significant ocular examination findings

 -  Current or history of central nervous system trauma, seizure disorder, stroke or
 transient ischemic attack

 -  Chronic pulmonary disease

 -  Current or history of any clinically significant cardiac abnormalities/dysfunction

 -  Active clinical gout within the last year

 -  History of gastric surgery or history of malabsorption disorders

 -  Active or suspected malignancy, or a history of malignancy, within the last 5 years
 (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)

 -  Pregnant, lactating, expecting to conceive or donate eggs, or male participant
 planning to impregnate or provide sperm donation or with a female partner who is
 pregnant

 -  Current moderate or severe depression or history of depression associated with
 hospitalization, electroconvulsive therapy, or severe disruption of daily functions,
 or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric
 disorders

 -  Evidence or history of chronic hepatitis not caused by HCV