Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation (HCV RWE)

AbbVie

Status: Completed

Conditions: Genotype 1; Chronic Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT02669940

P15-743

Details and patient eligibility

About

This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.

Enrollment: 158 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients are eligible for observation in this cohort if the following applies:

• Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label
• If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, 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 informed consent prior to inclusion into the study

Exclusion criteria

• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Trial design

158 participants in 1 patient group

Participants With Chronic Hepatitis C Genotype 1

Description:

Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.