A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)

Launched by MERCK SHARP & DOHME LLC · Oct 26, 2012

Keywords

ClinConnect Summary

Part A is being done in treatment-naïve (TN), genotype 1 (GT1), interferon eligible, non-cirrhotic (N-C) participants with chronic hepatitis C (CHC). Participants will be assigned randomly to 1 of 2 treatment arms in which they will receive grazoprevir 100 mg once daily (QD) + elbasvir 20 mg or 50 mg QD and twice daily (BID) RBV, or to a treatment arm in which they will receive grazoprevir 100 mg QD + elbasvir 50 mg QD without RBV. Treatment will last 12 weeks.

In Part B, participants with hepatitis C virus (HCV) GT1 and HCV ribonucleic acid (RNA) levels of ≥10,000 IU/mL will be randomly a...

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • All participants
• • CHC genotype 1 (GT1) virus infection (Parts A, B, and C) or GT3 virus infection (Part D)
• • Female participants of childbearing potential or male participant with female partners of childbearing potential, must use two acceptable methods of birth control from ≥2 weeks prior to Day 1 until ≥6 months after last dose of study drug, or longer if dictated by local regulations
• • Part A - 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 advanced fibrosis, cirrhosis and/or hepatocellular carcinoma by biopsy or noninvasive testing (FibroScan and/or FibroTest)
• • Parts B, C, and D
• • Treatment naïve with or without cirrhosis, or
• • Prior treatment failure to Peg-IFN/Ribavirin with or without cirrhosis, or
• • Co-infected with human immunodeficiency virus (HIV) without cirrhosis
• • Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
• • Liver disease staging assessment by liver biopsy or noninvasive testing (FibroScan and/or FibroTest)
• Exclusion criteria:
• • All participants
• • Non-GT1 HCV infection (Part A, Part B, and Part C) or a non-GT3 HCV infection (Part D) including a mixed GT infection (with a non-GT1 \[Part A, Part B, and Part C\] or non-GT3 \[Part D\]) or a non-typeable genotype
• • Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
• • Currently participating or participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study
• • Diabetic and/or hypertensive with clinically significant ocular examination findings
• • History of depression associated with hospitalization for depression, electroconvulsive therapy, or resulting in prolonged absence from work and/or significant disruption of daily functions
• • Suicidal or homicidal ideations and/or attempt, or history of severe psychiatric disorders
• • Clinical diagnosis of substance abuse
• • Current history of seizure disorder, stroke, or transient ischemic attack
• • Immunologically mediated disease
• • Chronic pulmonary disease
• • Clinically significant cardiac abnormalities/dysfunction
• • Active clinical gout within the last year
• • Hemoglobinopathy or myelodysplastic syndromes
• • History of organ transplants including hematopoietic stem cell transplants
• • Poor venous access
• • Indwelling venous catheter
• • History of gastric surgery or malabsorption disorders
• • Severe concurrent disease
• • Evidence of active or suspected malignancy, or a history of malignancy, ≤5 years before
• • Pregnant, lactating, expecting to conceive or donate eggs
• • Male participant with pregnant female partner
• • Member/family member of the investigational study or sponsor staff directly involved with this study
• • Evidence or history of chronic hepatitis not caused by HCV
• • Part A
• • Not treatment-naïve
• • Documented to be HIV positive
• • Taking or planning to take significant inducers or inhibitors of CYP3A4 substrates or herbal supplements 2 weeks prior to start of study medications
• • Parts B, C, and D
• • Previously received any HCV direct-acting antivirals
• • Requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
• • For participants diagnosed with diabetes mellitus, documented HbA1c \>8.5%