Phase 2
Completed N=143
Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)
Source: ClinicalTrials.gov NCT02133131 ↗Enrolled (actual)
143
Serious AEs
2.8%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12) — 33.3; 89.3; 80.0; 89.5 Percentage of participants
Summary
This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12) |
33.3; 89.3; 80.0; 89.5; 93.3; 100.0 | — |
| PRIMARY Number of Participants Experiencing at Least 1 Adverse Event (AE) |
5; 7; 7; 4; 4; 3 | — |
| PRIMARY Number of Participants Discontinuing Study Therapy Due to an AE |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4) |
— | — |
Eligibility Criteria
Inclusion Criteria
- has HCV RNA ≥10, 000 IU/mL in peripheral blood at the time of screening
- has documented chronic HCV GT1 or GT3 infection
- has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®)
- is treatment naïve to all anti-HCV treatment
Exclusion Criteria
- has evidence of decompensated liver disease
- is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
- has a history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
- has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- has clinically-relevant drug or alcohol abuse within 12 months of screening
- has any of the following conditions: organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- has a history of chronic hepatitis not caused by HCV
Data sourced from ClinicalTrials.gov (NCT02133131). 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.