Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation (EVEREST)

AbbVie

Status: Completed

Conditions: Chronic Hepatitis C (CHC)

Study type: Observational

Funder types: Industry

Identifiers

NCT03868163

P19-454

Details and patient eligibility

About

This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
• May be enrolled up to 4 weeks after treatment initiation.
• Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion criteria

• None.

Trial design

161 participants in 1 patient group

Glecaprevir plus Pibrentasvir

Description:

Participants in this observational study will receive treatment with glecaprevir and pibrentasvir for up to 16 weeks for treatment of chronic hepatis C (CHC) genotypes 1, 2, 3, 4, 5, or 6. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice, international guidelines and/or label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.