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

AbbVie2,118 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,118

Conditions

Hepatitis C

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (156)

Outcomes

Primary Outcomes

Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)

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

Time frame: 12 weeks (i.e. at least 70 days) after the last dose of Glecaprevir plus Pibrentasvir

Secondary Outcomes

Percentage of Participants Taking Concomitant Medications

The percentage of participants taking concomitant medications from the decision to initiate treatment through 12 weeks after the last dose of glecaprevir plus pibrentasvir.

Time frame: Up to approximately 28 weeks

Percentage of Glecaprevir plus Pibrentasvir (GLE/PIB) Doses Taken out of that Prescribed

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).

Time frame: Up to approximately 16 weeks

Changes from Baseline in Estimated Glomerular Filtration Rate (eGFR)

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).

Time frame: Up to 16 weeks

Number of Healthcare Resource Utilization (HCRU)

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.

Time frame: Up to approximately 28 weeks

Percentage of Participants Using Each Treatment Regimen

Data from ClinicalTrials.gov

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Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931

Klagenfurt, Carinthia, Austria

University Hospital St. Polten /ID# 169918

Sankt Pölten, Lower Austria, Austria

Medizinische Universität Graz /ID# 169932

Graz, Styria, Austria

Landeskrankenhaus Hall /ID# 169930

Hall in Tirol, Tyrol, Austria

KH der Elisabethinen Linz GmbH /ID# 169915

Linz, Upper Austria, Austria

Landeskrankenhaus /ID# 169922

Innsbruck, Austria

Wilhelminenspital der Stadt Wien /ID# 169914

Vienna, Austria

Klinikum Wels - Grieskirchen /ID# 169916

Wels, Austria

Uza /Id# 170960

Edegem, Antwerpen, Belgium

UCL Saint-Luc /ID# 170964

Woluwe-Saint-Lambert, Brussels Capital, Belgium

...and 146 more locations