Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)

AbbVie

Status: Completed

Conditions: Chronic Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT02615145

P15-398

Details and patient eligibility

About

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.

Enrollment: 472 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naïve or -experienced patients with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with local label.
• If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
• Patients must voluntarily sign and date a patient authorization to use and/or disclose his/her pseudonymized health data prior to inclusion into the study
• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Exclusion criteria

• Adolescents; people not treated according to label

Trial design

472 participants in 3 patient groups

Genotype 1a (G1a) Participants

Description:

Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Genotype 1b (G1b) Participants

Description:

Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 \[G4\]), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

Genotype 4 (G4) Participants

Description:

Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label. The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.