Phase 3
Completed N=506
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
Chronic Hepatitis C · Hepatitis C · Genotype 3 Hepatitis C Virus
Source: ClinicalTrials.gov NCT02640157 ↗
Enrolled (actual)
506
Serious AEs
2.0%
Results posted
Sep 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B — 95.3; 96.5 percentage of participants
◆ Published Evidence
Established
38citations · ~5 / year
Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies.
Summary
The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.
Linked Publications (5)
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Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies.
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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): Noninferiority of Arm A to Arm B |
95.3; 96.5 | — |
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A |
95.3; 94.9 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B |
95.3; 96.5 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.4; 0; 0.6 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
1.4; 0.9; 3.3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.
- Screening laboratory result indicating HCV GT3 infection.
- Chronic HCV infection, defined as one of the following:
- Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening; or
- A liver biopsy consistent with chronic HCV infection; or
- Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.
- Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).
- Documented as noncirrhotic.
Exclusion Criteria
- Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was 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 have precluded 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 Ab (HIV Ab).
- Hepatitis C virus genotyping performed during screening indicated co-infection with more than one HCV genotype.
- Any cause of liver disease other than chronic HCV infection.
- Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.
- History of severe, life-threatening, or other significant sensitivity to any excipients of the study drug.
- Previous use of any anti-HCV treatment.
Data sourced from ClinicalTrials.gov (NCT02640157) 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.