A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).

Official Title
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An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)

Conditions
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Hepatitis C Infection, Hepatitis C Virus

Intervention / Treatment
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* Drug: ombitasvir/paritaprevir/ritonavir
* Drug: dasabuvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic HCV infection at Screening. Screening laboratory result indicating HCV genotype 1b infection. Treatment-naïve and non-cirrhotic. Exclusion Criteria: HCV genotype or subtype other than GT1b. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test. Any current or past clinical evidence of cirrhosis. Screening laboratory analyses that shows abnormal results. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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 and Dasabuvir<br>Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks | Drug: ombitasvir/paritaprevir/ritonavir<br>* Tablet<br>* Other names: paritaprevir also known as ABT-450;Drug: dasabuvir<br>* Tablet<br>* Other names: ABT-333;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | 12 weeks after the last actual dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-Treatment Virologic Failure During Treatment Period | On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 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 study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution. | Up to 8 weeks while on treatment | 
| Percentage of Participants With Post-Treatment Relapse12 | Relapse12 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 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution. | Up to 12 weeks after last dose of study drug | 
| Percentage of Female Participants Responding With SVR12 | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | 12 weeks after the last actual dose of study drug | 
| Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12 | SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution. | Baseline and 12 weeks after the last actual dose of study drug | 

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