Phase 3
Completed N=257
Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)
Source: ClinicalTrials.gov NCT02358044 ↗Enrolled (actual)
257
Serious AEs
2.8%
Results posted
Jan 2017
Primary outcomePrimary: Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12) — 99.2; 90.5 percentage of participants — p=<0.001
◆ Published Evidence
Established
54citations · ~5 / year
Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin: A phase III randomized controlled trial.
Summary
This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) [PR] treatment in treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy (assessed by the percentage of participants achieving sustained virologic response 12 weeks after ending study treatment [SVR12]) and safety between the grazoprevir plus elbasvir treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is non-inferior to that in the SOF plus PR treatment arm.
Linked Publications (5)
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Efficacy and safety of elbasvir/grazoprevir and sofosbuvir/pegylated interferon/ribavirin: A phase III randomized controlled trial.
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The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection.
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Efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 4 infection: A pooled analysis.
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Concomitant proton pump inhibitor use does not reduce the efficacy of elbasvir/grazoprevir: A pooled analysis of 1,322 patients with hepatitis C infection.
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Patient-reported outcomes in individuals with hepatitis C virus infection treated with elbasvir/grazoprevir.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12) |
99.2; 90.5 | <0.001 sig |
| PRIMARY Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days |
51.9; 93.7 | — |
| PRIMARY Percentage of Participants Discontinuing Study Treatment Due to an AE |
0.8; 0.8 | — |
| SECONDARY Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days |
0.8; 27.8; 0.0; 2.4; 0.0; 0.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24) |
98.4; 89.7 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4) |
99.2; 92.1 | — |
Eligibility Criteria
Inclusion Criteria
- Weigh ≥40 kg and ≤125 kg
- documented chronic HCV GT1, GT4, or GT6 infection
- cirrhosis/absence of cirrhosis defined by liver biopsy, Fibroscan, or FibroSure®
- either treatment naïve or PR Null Responder, PR Partial Responder, or PR Prior Relapser
- participant and partner both agree to use at least use at least 2 effective methods of contraception from at least 2 weeks prior to Day 1 and continue until up to 6 months after last dose of study drug, or longer if dictated by local regulations
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
- 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 any of the following conditions: immunologically-mediated disease, 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, history of chronic hepatitis not caused by HCV
Data sourced from ClinicalTrials.gov (NCT02358044) and the linked publication. 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.