Overview

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

Status:
Active, not recruiting
Trial end date:
0000-00-00
Target enrollment:
158
Participant gender:
Both
Summary
This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of Paritaprevir (PTV)/ritonavir (r) - Ombitasvir (OBV), ± Dasabuvir (DSV), ± Ribavirin in chronic hepatitis C (CHC) participants in a real life setting across clinical practice populations.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
Ribavirin
Last Updated:
2016-10-03
Criteria
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 CHC,
genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ±
RBV according to standard of care and in line with the current 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 informed consent prior to inclusion into the
study

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

Exclusion Criteria:

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