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

AbbVie

Status: Completed

Conditions: Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT03303599

P17-094

Details and patient eligibility

About

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.

Enrollment: 2,118 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

2,118 participants in 1 patient group

HCV Genotypes 1, 2, 3, 4, 5, or 6 participants

Description:

Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label.