Phase 3
Completed N=84
A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection
Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT02966795 ↗
Enrolled (actual)
84
Serious AEs
5.9%
Results posted
Jul 2019
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) — 95.7; 98.4 percentage of participants
◆ Published Evidence
Established
60citations · ~9 / year
Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial.
Summary
A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.
Linked Publications (2)
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Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5,6): an open-label, multicentre, phase 3b trial.
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Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12) |
95.7; 98.4 | — |
| SECONDARY Percentage of Participants With On-treatment HCV Virologic Failure |
0.0; 1.6 | — |
| SECONDARY Percentage of Participants With Relapse |
4.3; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Screening laboratory result indicating hepatitis C virus (HCV) GT5 or 6 infection.
- Participant has a positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/mL at Screening Visit.
- Participant must be HCV treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-HCV medication) or treatment-experienced (i.e., has failed prior interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN therapy). Prior HCV treatment with any other approved or investigational medications is not allowed. Previous HCV treatment must have been completed greater than or equal to 2 months prior to screening.
- Participant must be documented as having no cirrhosis or compensated cirrhosis.
Exclusion Criteria
- Female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug.
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
- Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
- History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.
Data sourced from ClinicalTrials.gov (NCT02966795) 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.