The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France (OPALE)

AbbVie

Status: Completed

Conditions: Chronic Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT02618928

P15-405

Details and patient eligibility

About

This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.

Enrollment: 735 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4
• Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label
• RBV prescribed in line with the current local label

Exclusion criteria

• Participant is not participating or intending to participate in a concurrent interventional therapeutic trial

Trial design

735 participants in 1 patient group

Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin

Description:

Participants in this observational study received treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir ± ribavirin (RBV) for 8, 12, or 24 weeks for the treatment of chronic hepatitis C (CHC), according to hepatitis C virus (HCV) genotype/subtype and stage of liver disease. The prescription of treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, and was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.