A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

Study Overview
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Brief Summary
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This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.

Detailed Description
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The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.

Official Title
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An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)

Conditions
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Chronic Hepatitis C Virus (HCV) Infection

Intervention / Treatment
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* Drug: Ombitasvir/Paritaprevir/Ritonavir
* Drug: Dasabuvir
* Drug: Ribavirin (RBV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening) Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening. Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study. Exclusion Criteria: Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody Evidence of current or past Child-Pugh B or C classification Confirmed presence of hepatocellular carcinoma Abnormal laboratory tests Participant who self-reported on average drinking more than 2 drinks per day for current drinkers Previous treatment with a direct acting antiviral agent (DAA) containing regimen History of solid organ transplant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV<br>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks | Drug: Ombitasvir/Paritaprevir/Ritonavir<br>* Tablet; paritaprevir co-formulated with ritonavir and ombitasvir<br>* Other names: Ritonavir also known as norvir;Drug: Dasabuvir<br>* Tablet<br>* Other names: ABT-333;Drug: Ribavirin (RBV)<br>* Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment | Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures. | Post-treatment Day 1 to Post-treatment Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-Treatment Virologic Failure | On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment. | Day 1 through Week 12 | 
| Percentage of Participants With Post-Treatment Relapse | Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment. | Post-treatment Day 1 to Post-treatment Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C, Hepatitis C, Hepatitis C Virus, Hepatitis C Genotype 1b, Interferon-Free