Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir, Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

394 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-26

Study Completion Date

2017-03-29

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Paritaprevir/Ritonavir + Ombitasvir ± Dasabuvir ± Ribavirin

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Treatment-naïve or -experienced adult male or female 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 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 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