Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, + Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Romania

AbbVie

Status: Completed

Conditions: Chronic Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT02807402

P15-698

Details and patient eligibility

About

This study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) data for the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), + dasabuvir (DSV), +/- ribavirin (RBV) in participants with chronic hepatitis C (CHC) in a real life setting across clinical practice patient populations in Romania.

Enrollment: 522 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Treatment-naïve or -experienced adult male or female patients with confirmed CHC, genotype 1, receiving combination therapy with the interferon-free paritaprevir/ritonavir and ombitasvir with dasabuvir ± RBV according to standard of care and in line with the current local label

If RBV is co-administered with the paritaprevir/ritonavir and ombitasvir with 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 a patient authorization to use and/or disclose his/her anonymized 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

None

Trial design

522 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 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.