Phase 2
Completed N=573
A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)
Source: ClinicalTrials.gov NCT01717326 ↗Enrolled (actual)
573
Serious AEs
2.8%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) — 100.0; 95.8; 100.0; 82.8 percentage of participants
Summary
This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) |
100.0; 95.8; 100.0; 82.8; 100.0; 96.8 | — |
| PRIMARY Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days |
88.0; 85.7; 91.7; 90.0; 72.7; 87.1 | — |
| PRIMARY Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) |
21.7; 19.2; 23.4; 27.9; 30.7; 32.0 | — |
| SECONDARY Percentage of Participants Achieving Undetectable HCV RNA at Week 2 |
52.2; 44.0; 41.7; 44.8; 20.0; 16.1 | — |
| SECONDARY Percentage of Participants Achieving Undetectable HCV RNA at Week 4 |
73.9; 91.7; 75.0; 73.3; 83.3; 77.4 | — |
| SECONDARY Percentage of Participants Achieving Undetectable HCV RNA at Week 12 |
100.0; 100.0; 100.0; 100.0; 100.0; 93.3 | — |
| SECONDARY Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2 |
91.3; 92.0; 91.7; 86.2; 73.3; 77.4 | — |
| SECONDARY Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12 |
100.0; 100.0; 100.0; 100.0; 100.0; 93.3 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4) |
100.0; 95.8; 100.0; 93.3; 100.0; 96.8 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24) |
100.0; 95.8; 100.0; 78.6; 100.0; 96.8 | — |
Eligibility Criteria
Inclusion criteria
All participants
- CHC genotype 1 (GT1) virus infection (Parts A, B, and C) or GT3 virus infection (Part D)
- Female participants of childbearing potential or male participant with female partners of childbearing potential, must use two acceptable methods of birth control from ≥2 weeks prior to Day 1 until ≥6 months after last dose of study drug, or longer if dictated by local regulations
Part A - Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis - No evidence of advanced fibrosis, cirrhosis and/or hepatocellular carcinoma by biopsy or noninvasive testing (FibroScan and/or FibroTest)
Parts B, C, and D
- Treatment naïve with or without cirrhosis, or
- Prior treatment failure to Peg-IFN/Ribavirin with or without cirrhosis, or
- Co-infected with human immunodeficiency virus (HIV) without cirrhosis
- Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
- Liver disease staging assessment by liver biopsy or noninvasive testing (FibroScan and/or FibroTest)
Exclusion criteria
All participants
- Non-GT1 HCV infection (Part A, Part B, and Part C) or a non-GT3 HCV infection (Part D) including a mixed GT infection (with a non-GT1 [Part A, Part B, and Part C] or non-GT3 [Part D]) or a non-typeable genotype
- Evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- Currently participating or 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 study
- Diabetic and/or hypertensive with clinically significant ocular examination findings
- History of depression associated with hospitalization for depression, electroconvulsive therapy, or resulting in prolonged absence from work and/or significant disruption of daily functions
- Suicidal or homicidal ideations and/or attempt, or history of severe psychiatric disorders
- Clinical diagnosis of substance abuse
- Current history of seizure disorder, stroke, or transient ischemic attack
- Immunologically mediated disease
- Chronic pulmonary disease
- Clinically significant cardiac abnormalities/dysfunction
- Active clinical gout within the last year
- Hemoglobinopathy or myelodysplastic syndromes
- History of organ transplants including hematopoietic stem cell transplants
- Poor venous access
- Indwelling venous catheter
- History of gastric surgery or malabsorption disorders
- Severe concurrent disease
- Evidence of active or suspected malignancy, or a history of malignancy, ≤5 years before
- Pregnant, lactating, expecting to conceive or donate eggs
- Male participant with pregnant female partner
- Member/family member of the investigational study or sponsor staff directly involved with this study
- Evidence or history of chronic hepatitis not caused by HCV
Part A
- Not treatment-naïve
- Documented to be HIV positive
- Taking or planning to take significant inducers or inhibitors of CYP3A4 substrates or herbal supplements 2 weeks prior to start of study medications
Parts B, C, and D
- Previously received any HCV direct-acting antivirals
- Requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- For participants diagnosed with diabetes mellitus, documented HbA1c >8.5%
Data sourced from ClinicalTrials.gov (NCT01717326). 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.