The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-05

Study Completion Date

2017-11-29

Brief Summary

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The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir 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 was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real world conditions in Ireland in a clinical practice patient population.

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Detailed Description

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This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Ireland. The prescription of a 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 participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post- treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[SVR12\] and sustained virologic response 24 weeks after the end of treatment \[SVR24\]).

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with HCV genotype 1

Ombitasvir/paritaprevir/ritonavir (two 12.5 mg/75 mg/50 mg co-formulated tablets once daily); ± dasabuvir (tablet; 250 mg twice daily); ± weight-based ribavirin (tablet; 1000 or 1200 mg divided twice a day) up to 24 weeks

Ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

Co-formulated tablet

Dasabuvir

Intervention Type DRUG

Tablet

Ribavirin

Intervention Type DRUG

Tablet

Interventions

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Ombitasvir/paritaprevir/ritonavir

Co-formulated tablet

Intervention Type DRUG

Dasabuvir

Tablet

Intervention Type DRUG

Ribavirin

Tablet

Intervention Type DRUG

Other Intervention Names

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Ombitasvir also known as ABT-267 Paritaprevir also known as ABT-450 ABT-333

Eligibility Criteria

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Inclusion Criteria

* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
* Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial