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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

472 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-03

Study Completion Date

2018-03-26

Brief Summary

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The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Germany in a clinical practice patient population.

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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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Genotype 1a (G1a) Participants

Treatment-naïve or -experienced participants with confirmed chronic hepatitis C (CHC) genotype 1a (G1a, includes all GT1-participants except participants with GT1b or GT1b/4), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) + ribavirin (RBV) according to standard of care and in line with the current local label.

The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

No interventions assigned to this group

Genotype 1b (G1b) Participants

Treatment-naïve or -experienced participants with confirmed CHC genotype 1b (G1b; includes G1b/Genotype 4 \[G4\]), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir with dasabuvir (ABBVIE REGIMEN) according to standard of care and in line with the current local label.

The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes the decision to offer the patient the opportunity to participate in this study.

No interventions assigned to this group

Genotype 4 (G4) Participants

Treatment-naïve or -experienced participants with confirmed CHC genotype 4 (G4; non-G1), receiving combination therapy with the interferon-free paritaprevir/ritonavir - ombitasvir (ABBVIE REGIMEN) + RBV according to standard of care and in line with the current local label.

The prescription of a treatment regimen is at the discretion of the physician in accordance with local clinical practice and label, is made independently from this observational study and precedes 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 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 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 pseudonymized health data prior to inclusion into the study
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial