Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
Study Details
Study Description
Brief Summary
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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HCV Genotypes 1, 2, 3, 4, 5, or 6 participants Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to the current local label. |
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [12 weeks after last dose of drug]
SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level < the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Secondary Outcome Measures
- Percentage of Participants with Post-treatment Relapse [Up to 24 weeks after last dose of drug]
Post-treatment relapse was defined as confirmed HCV RNA >= LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
- Percentage of Participants with On-treatment Virologic Failure [Up to 12 weeks after first dose]
On-treatment virologic failure was defined as HCV RNA levels reach < LLOQ during treatment then increase to >= LLOQ during treatment, or confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment.
- Percentage of Participants Achieving SVR4 [4 weeks after last dose]
SVR4 defined as defined as the HCV RNA level < LLOQ 4 weeks after the last dose of Glecaprevir plus Pibrentasvir.
- Percentage of Participants Achieving SVR8 [8 weeks after last dose of drug]
SVR8 defined as defined as the HCV RNA level < LLOQ 8 weeks after the last dose of Glecaprevir plus Pibrentasvir.
- Percentage of Participants Achieving SVR24 [24 weeks after last dose of drug]
SVR24 defined as the HCV RNA level < LLOQ 24 weeks after the last dose of Glecaprevir plus Pibrentasvir.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.
Exclusion Criteria:
- Patients previously treated with glecaprevir plus pibrentasvir.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Abbvie Japan /ID# 161985 | Tokyo | Japan | 108-6302 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P16-570