Phase 2
Completed N=79
Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)
Source: ClinicalTrials.gov NCT02105454 ↗Enrolled (actual)
79
Serious AEs
7.6%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12) — 97.1 Percentage of participants
Summary
In this study, participants with hepatitis C virus (HCV) genotype 1 (GT1) who failed prior direct-acting antiviral (DAA) therapy will receive Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) to evaluate sustained virologic response (SVR) using this drug combination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12) |
97.1 | — |
| PRIMARY Percentage of Participants Experiencing Adverse Events |
79.7 | — |
| PRIMARY Percentage of Participants Discontinuing Study Drug Due to an Adverse Event |
1.3 | — |
| SECONDARY Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy |
88.9; 100.0; 94.4; 100.0; 100.0; 100.0 | — |
Eligibility Criteria
Inclusion criteria
- Documented chronic HCV GT1 infection (with no evidence of non-typable or mixed genotype)
- Absence of cirrhosis, or cirrhosis with these criteria: METAVIR F4, or Fibroscan with result >12.5 kPa, or FibroSure® (Fibrotest®) score of >0.75 + aspartate aminotransferase (AST): platelet ratio index (APRI) of >2- Prior regimen containing an approved DAA (boceprevir, telaprevir, simeprevir, or sofosbuvir), pegylated interferon, and/or RBV
- Participants of reproductive potential must agree to remain truly abstinent or use (or have their partner use) 2 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
Exclusion criteria
- Received any HCV regimen containing a DAA with the exception of boceprevir, telaprevir, simeprevir, or sofosbuvir in combination with pegylated interferon and/or RBV
- Evidence of decompensated liver disease or cirrhosis
- Co-infected with hepatitis B virus or human immunodeficiency virus (HIV)
- 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
- Evidence of hepatocellular carcinoma (HCC) or under evaluation for HCC
- 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
- Clinically-relevant drug or alcohol abuse within 12 months of screening
- Pregnant, 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
- Male participant whose female partner (s) is/are pregnant
- Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
- Poor venous access
- History of gastric surgery (e.g., stapling, bypass) or history of malabsorption disorders (e.g., celiac sprue disease)
- Hemoglobinopathy, including, but not limited to, thalassemia major
- Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- 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 (NCT02105454). 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.