Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

Study Overview
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Brief Summary
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This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

Official Title
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An Open-label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered With Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT-II)

Conditions
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Hepatitis C Virus

Intervention / Treatment
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* Drug: ABT-450/r/ABT-267
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic HCV-infection prior to study enrollment Screening laboratory result indicating HCV genotype 2 infection Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening Voluntarily sign an informed consent Exclusion Criteria: Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2 Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease Clinically significant laboratory abnormalities Uncontrolled clinically significant disease, disorder or medical illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-450/r/ABT-267 plus RBV for 12 weeks<br>ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks | Drug: ABT-450/r/ABT-267<br>* Tablet; ABT-450 coformulated with ritonavir and ABT-267<br>* Other names: Qurevo;Drug: Ribavirin<br>* Capsule<br>|
| Experimental: ABT-450/r/ABT-267 plus RBV for 16 weeks<br>ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks | Drug: ABT-450/r/ABT-267<br>* Tablet; ABT-450 coformulated with ritonavir and ABT-267<br>* Other names: Qurevo;Drug: Ribavirin<br>* Capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) | The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. | 12 weeks after last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period | On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). | 12 or 16 weeks (end of treatment period) | 
| Percentage of Participants With Post-treatment Relapse | Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. | within 12 weeks after the last dose of study drug | 
| Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations | The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis. | 12 weeks after last dose of study drug | 
| Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations | The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment). | 12 or 16 weeks (end of treatment period) | 
| Percentage of Participants With Post-treatment Relapse Within Different Subpopulations | The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm. | within 12 weeks after the last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japanese, Hepatitis C, Treatment naive, Treatment experienced, Genotype 2, Ombitasvir, Paritaprevir, Ritonavir, Ribavirin, VIEKIRAX Combination Tablets