Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)
Source: ClinicalTrials.gov NCT01932762 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12) |
85.2; 75.0; 94.1; 76.9 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days |
86.7; 86.7; 94.7; 78.9; 3.3; 3.3 | — |
| SECONDARY Mean Time to First Achievement of Undetectable HCV RNA During Treatment |
25.2; 26.9; 27.4; 21.3 | — |
| SECONDARY Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint |
42.9; 50.0; 50.0; 53.3; 85.7; 79.2 | — |
| SECONDARY Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint |
96.4; 79.2; 87.5; 93.3; 100.0; 91.7 | — |
| SECONDARY Percentage of Participants Achieving SVR4 |
88.9; 83.3; 94.1; 78.6 | — |
| SECONDARY Percentage of Participants Achieving SVR24 |
84.6; 75.0; 94.1; 76.9 | — |
Eligibility Criteria
Inclusion Criteria
Parts A and B: -Body weight ≥50 kg (111 lbs) and ≤ 125 kg (275 lbs) -Has absence of cirrhosis -Agrees to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential).
Part A only: -Has chronic HCV GT2 infection Part B only: -Has chronic HCV GT2, GT4, GT5, or GT6 infection
Exclusion Criteria
Parts A and B:
-Is not treatment naïve (participant has had previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV) -Is determined to be coinfected with hepatitis B virus (HBsAg positive) or HIV -Has evidence of, or is under evaluation for, hepatocellular carcinoma (HCC) -Has a clinical diagnosis of substance abuse including the following specified drugs within specified timeframes: Alcohol, intravenous drugs, inhalational, psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs (within 1 year of the screening visit), is receiving opiate agonist substitution therapy (within 1 year of screening visit), or excessive historic marijuana use -Has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years -Female participant who is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment, or male participant who is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment -Has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis. -Has uncontrolled diabetes (documented HbA1c >8.5%)
Part A only:
-Has non GT2 HCV infection
Part B only:
-Has HCV infection with a genotype other than GT2, GT4, GT5 or GT6
Data sourced from ClinicalTrials.gov (NCT01932762). 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.