The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects

Study Overview
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Brief Summary
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This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment of chronic hepatitis C.

Official Title
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A Follow-up Study to Assess the Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

Conditions
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Hepatitis C Virus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants treated in Study M12-536 or M13-004 with the 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow-up, regardless of SVR achievement. Participants who agree to sign the informed consent Exclusion Criteria: Participants treated with a direct-acting antiviral agent (DAA) immediately after Study M12-536 or M13-004.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Participants who were treated with 2D regimen (ombitasvir/ paritaprevir/ ritonavir) and completed 48 weeks of follow up from the prior Phase 2 or 3 studies conducted in Japan. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C virus ribonucleic acid (HCV RNA) levels | HCV RNA levels in plasma | 60 months after completion of the 2D treatment in M12-536 or M13-004 study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Paritaprevir in Non-structural Viral Protein 3 (NS3) |  | For approximately 5 years | 
| Number of Participants With Resistance-Associated Variants and Phenotypic Resistance to Ombitasvir in Non-structural Viral Protein 5A (NS5A) |  | For approximately 5 years | 
| Percentage of participants with hepatocellular carcinoma |  | Up to 60 month after completion of the 2D treatment in M12-536 or M13-004 | 
| Number of participants with serious adverse events (SAEs) | All serious adverse events will be monitored during the observation period. | Up to 60 month after completion of the 2D treatment in M132-536 or M13-004 study | 
| Hepatitis C virus ribonucleic acid (HCV RNA) levels | HCV RNA levels in plasma | 18, 24, 30, 36, 42, 48, 52 months after completion of the 2D treatment in M12-536 or M13-004 study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Follow-up, Observation, Japanese