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

AbbVie

Status: Completed

Conditions: Chronic Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT02636608

P15-709

HU15-01 (Other Identifier)

Details and patient eligibility

About

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.

Enrollment: 244 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 chronic hepatitis C (CHC), genotype 1 and 4, receiving combination therapy with the interferon-free paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin (PTV/r+OBV±DSV±RBV) according to standard of care and in line with the current local label.
• If RBV is co-administered with the PTV/r+OBV±DSV±RBV, 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 Subject Information Form and Informed Consent Form prior to inclusion into the study.
• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.
• Patient has been started on PTV/r+OBV±DSV±RBV therapy no more than one (1) month prior to the study enrollment.

Exclusion criteria

• None

Trial design

244 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, was made independently from this observational study and preceded the decision to offer the patient the opportunity to participate in this study.