Phase 3
Completed N=141
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy
Chronic Hepatitis C · Hepatitis C · HCV · Direct-Acting Antiviral Agent (DAA)-Experienced
Source: ClinicalTrials.gov NCT02446717 ↗
Enrolled (actual)
141
Serious AEs
3.6%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 100; 95.5; 86.4; 88.6 percentage of participants
◆ Published Evidence
Highly cited
201citations · ~22 / year
Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment.
Summary
The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.
Linked Publications (5)
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Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment.
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Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.
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Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.
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Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis.
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Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
100; 95.5; 86.4; 88.6; 91.5 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) |
100.0; 95.5; 95.5; 90.9; 91.5 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.0; 0.0; 4.5; 2.3; 8.5 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.0; 4.8; 0.0; 9.3; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.
- Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse
- Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)
Exclusion Criteria
- History of severe, life-threatening or other significant sensitivity to any drug
- Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
- Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- Co-infection with more than one HCV genotype
Data sourced from ClinicalTrials.gov (NCT02446717) 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.