Phase 3
Completed N=377
A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530
Source: ClinicalTrials.gov NCT02441283 ↗Enrolled (actual)
377
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen — 99.5 percentage of participants
◆ Published Evidence
Emerging
4citations · ~1 / year
Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study.
Summary
This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.
Linked Publications
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Durability of sustained virological response to glecaprevir/pibrentasvir and resistance development: A long-term follow-up study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Maintained a Sustained Virologic Response (SVR) Out of Those Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen |
99.5 | — |
| PRIMARY Percentage of Participants Who Relapsed or Had a New Hepatitis C Virus (HCV) Infection at Any Time up to the Last Follow-up in This Study Among Participants Who Achieved SVR12 in a Prior Study With an ABT-493- and/or ABT-530-containing Regimen |
0.3; 0.3 | — |
| PRIMARY Number of Participants With Persistence of Resistance-Associated Amino Acid Variants Among Those Experiencing Virologic Failure |
1; 1 | — |
| SECONDARY Number of Participants With Medical Events Related to Progression of Liver Disease or Hepatitis C Virus Infection |
7; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Concentration of Interferon Gamma-induced Protein 10 (IP-10) Over Time |
146.884; 147.606; 148.959; 224.400; 133.300; 140.185 | — |
| SECONDARY Mean FibroTest Score Over Time |
0.354; 0.363; 0.353; 0.405; 0.272; 0.321 | — |
| SECONDARY Mean Aspartate Transaminase to Platelet Ratio Index (APRI) Over Time |
0.317; 0.303; 0.298; 0.230; 0.262; 0.275 | — |
| SECONDARY Mean FibroScan Scores Over Time |
13.014; 6.880; 10.780; 7.700; 6.913; 6.757 | — |
Eligibility Criteria
Inclusion Criteria
- Participant is male or female 18 years of age or older
- Participant has received at least one dose of an ABT-493- and/or ABT- 530 containing regimen in a prior AbbVie hepatitis C virus (HCV) Phase 2 or 3 study
- The interval between the last dose of the AbbVie direct-acting antiviral agent (DAA) therapy from the previous clinical study and enrollment in Study M13-576 must be no longer than 2 years for subjects who have not been retreated. Participants who have been treated with a commercially available anti-HCV treatment may be enrolled greater than 2 years after the last dose of the AbbVie DAA therapy from the previous clinical study.
- Participant must voluntarily sign and date the informed consent form approved by an Independent Review Board or Ethics Committee prior to the initiation of any study-specific procedures.
- Participant completed the post-treatment period of an eligible prior study.
Exclusion Criteria
- The investigator considers the participant unsuitable for the study for any reasons (e.g., failure to comply with study procedures in the prior AbbVie clinical study).
- Receipt of any investigational HCV antiviral treatment after receiving ABT-493 and/or ABT-530 in the prior study.
- Participants who experienced non-virologic treatment failure due to premature discontinuation of study drug in prior study of ABT-493/ABT-530.
- Participation in AbbVie's Study M15-942 protocol for re-treatment for virologic failure in the prior Phase 2 or 3 study.
Data sourced from ClinicalTrials.gov (NCT02441283) 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.