Phase 3
N=343
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Hepatitis C Virus (HCV)
Bottom Line
View on ClinicalTrials.gov: NCT03089944 ↗Enrolled (actual)
343
Serious AEs
1.8%
Results posted
Jul 2020
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population — 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Glecaprevir/Pibrentasvir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population |
100 | — |
| PRIMARY Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population |
98.2 | — |
| SECONDARY Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population |
99.7 | — |
| SECONDARY Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population |
97.7 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure in the ITT Population |
— | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.3 | — |
| SECONDARY Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population |
98.4 | — |
| SECONDARY Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population |
95.2 | — |
Summary
A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.
Eligibility Criteria
Inclusion Criteria
- Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
- Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
- Treatment-naive to any approved or investigational anti-HCV medication.
- Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.
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.
- Any current or historical clinical evidence of decompensated cirrhosis.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
- History of suspected or confirmed hepatocellular carcinoma.
Data sourced from ClinicalTrials.gov (NCT03089944). 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.