Phase 3
N=40
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
Chronic Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT02115321 ↗Enrolled (actual)
40
Serious AEs
12.5%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12) — 90.0; 100.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Grazoprevir (Drug); Elbasvir (Drug); MK-5172A (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12) |
90.0; 100.0 | — |
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) During Treatment and First 14 Follow-up Days |
25; 8 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to an AE |
0; 0 | — |
| SECONDARY Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores in CP-B Participants |
-0.67; -0.38; -0.34 | — |
| SECONDARY Percentage of Participants With HCV RNA Undetectable at Weeks 2, 4, and 12 |
— | — |
| SECONDARY Percentage of Participants With HCV RNA <LLoQ at Weeks 2, 4, and 12 |
— | — |
| SECONDARY Percentage of Participants Achieving Sustained Viral Response 4 Weeks After Completing Study Therapy (SVR4) |
93.3; 100.0 | — |
| SECONDARY Percentage of Participants Achieving Sustained Viral Response 24 Weeks After Completing Study Therapy (SVR24) |
90.0; 100.0 | — |
Summary
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP) score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the percentage of HCV-infected participants with hepatic insufficiency (the CP-B population) achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will also be given GZR + EBR at the beginning of the study; this will be done for the purpose of collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have hepatic insufficiency.
Eligibility Criteria
Inclusion criteria
- Has documented chronic HCV GT1 infection (for Arm 4 participants may have GT4 or GT6 infection) with no evidence of non-typable or mixed genotype infection
- Has clinical evidence of hepatic cirrhosis with a score on the Child-Pugh scale from 7 to 9 and not anticipated to receive a liver transplant within the next 36 weeks (for Arm 1, Arm 3, and Arm 4)
- Has no evidence of cirrhosis (only for Arm 2 )
- Agrees to remain truly abstinent or use (or have their partner use) an acceptable method of birth control from at least 2 weeks prior to Day 1 and continue until at least 14 days after last dose of study drug, or longer if dictated by local regulations
Exclusion criteria
- Is co-infected with hepatitis B virus or human immunodeficiency virus (HIV)
- Has previously received direct-acting antiviral therapy for HCV
- Has a history of malignancy <=5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or under evaluation for other active or suspected malignancy
- Has cirrhosis and liver imaging results within 4 weeks prior to screening showing evidence of hepatocellular carcinoma (HCC), or is under evaluation for HCC
- Is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
- Has clinically-relevant drug or alcohol abuse within 12 months of screening
- Is pregnant or breast-feeding, or expecting to conceive or donate eggs or sperm from at least 2 weeks prior to Day 1 and continue throughout treatment and follow up, or longer if dictated by local regulations
- Has received organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
- Has poor venous access
- Has a history of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)
- Requires, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- 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
Data sourced from ClinicalTrials.gov (NCT02115321). 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.