Phase 3
Completed N=489
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
Source: ClinicalTrials.gov NCT02251990 ↗Enrolled (actual)
489
Serious AEs
3.0%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) — 94.2 percentage of participants — p=<0.001
◆ Published Evidence
Established
46citations · ~6 / year
Elbasvir/grazoprevir in Asia-Pacific/Russian participants with chronic hepatitis C virus genotype 1, 4, or 6 infection.
Summary
This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype (GT) 1, 4 or 6 infection. The primary hypothesis is that the percentage of participants receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to the historical reference rate of 73%.
Linked Publications (4)
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Elbasvir/grazoprevir in Asia-Pacific/Russian participants with chronic hepatitis C virus genotype 1, 4, or 6 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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Health-related quality of life in people receiving opioid agonist treatment and treatment for hepatitis C virus infection.
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Efficacy and safety of elbasvir/grazoprevir in treatment-naive Chinese adults with hepatitis C virus infection: A randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) |
94.2 | <0.001 sig |
| PRIMARY Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days |
50.7; 51.2 | — |
| PRIMARY Percentage of Participants That Discontinued From Study Therapy Due to AEs During the DB Treatment Period |
0.3; 0.8 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24) |
94.0 | — |
Eligibility Criteria
Inclusion Criteria
- Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection
- Meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment
- Is abstinent or uses acceptable method(s) of contraception
Exclusion Criteria
- Has evidence of decompensated liver disease
- Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)
- Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- Has a clinically-relevant drug or alcohol abuse within 12 months of screening
- Is pregnant or breast-feeding
- Has any condition or abnormality that might confound the results of the trial or pose an additional risk to the participant
Data sourced from ClinicalTrials.gov (NCT02251990) 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.