Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Completed

• Conditions: Hepatitis C

• Registration Number: NCT03303599
• Lead Sponsor: AbbVie

Brief Summary

The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.

This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-06
• Study Start: 2017-11-13
• Primary Completion: 2020-01-24
• Study Completion: 2020-01-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2118

Inclusion Criteria

• Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.
• Participants may be enrolled up to 4 weeks after treatment initiation
• Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria

None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)	12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir	SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification 12 weeks after the last dose of Glecaprevir plus Pibrentasvir

Secondary Outcome Measures

Name	Time	Method
Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)	Up to 16 weeks	Among participants with renal impairment, changes from baseline during treatment in estimated glomerular filtration rate (eGFR determined by Modification of Diet in Renal Disease \[MDRD\] equation).
Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed	Up to approximately 16 weeks	The percentage of GLE/PIB doses taken by participant in relation to the prescribed target dose (number of pills taken out of the number of pills that should have been taken).
Percentage of Participants with Co-morbidities	Baseline (Day 1)	The percentage of participants with co-morbidities at baseline.
Number of Healthcare Resource Utilization (HCRU)	Up to approximately 28 weeks	Health Care Resource Utilization (HCRU) for a participant will be the total number of visits/touchpoints (face to face or phone call) with an Health Care Provider (HCP) or designee in relation to their HCV infection during the study.
Percentage of Participants Taking Concomitant Medications	Up to approximately 28 weeks	The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.
Percentage of Participants Using Each Treatment Regimen	Up to 16 weeks	Percentage of participants using each treatment regimen (intended treatment duration of 8, 12, or 16 weeks)

Trial Locations

Locations (156)

Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931; 🇦🇹 Klagenfurt Am Woerthersee, Kaernten, Austria

University Hospital St. Polten /ID# 169918; 🇦🇹 St. Pölten, Niederoesterreich, Austria

KH der Elisabethinen Linz GmbH /ID# 169915; 🇦🇹 Linz, Oberoesterreich, Austria

Medizinische Universität Graz /ID# 169932; 🇦🇹 Graz, Steiermark, Austria

Landeskrankenhaus Hall /ID# 169930; 🇦🇹 Hall in Tirol, Tirol, Austria

Landeskrankenhaus /ID# 169922; 🇦🇹 Innsbruck, Austria

Klinikum Wels - Grieskirchen /ID# 169916; 🇦🇹 Wels, Austria

Wilhelminenspital der Stadt Wien /ID# 169914; 🇦🇹 Wien, Austria

Uza /Id# 170960; 🇧🇪 Edegem, Antwerpen, Belgium

UCL Saint-Luc /ID# 170964; 🇧🇪 Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium

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