Phase 2
Completed N=87
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)
Chronic Hepatitis C (CHC)
Source: ClinicalTrials.gov NCT01710501 ↗
Enrolled (actual)
87
Serious AEs
3.5%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) — 54.2; 84.0; 88.5 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12) |
54.2; 84.0; 88.5 | — |
| PRIMARY Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days |
28; 28; 28 | — |
| PRIMARY Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days |
1; 1; 1 | — |
| SECONDARY Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point |
34.5; 32.0; 55.2; 82.1; 76.9; 89.7 | — |
| SECONDARY Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point |
86.2; 88.0; 96.6; 96.4; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving SVR4 |
76.9; 88.0; 92.3 | — |
| SECONDARY Percentage of Subjects Achieving SVR24 |
54.2; 84.0; 84.6 | — |
| SECONDARY Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response |
9; 5; 3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01710501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.