Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

Study Overview
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Brief Summary
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The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.

Official Title
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A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Signed Written Informed Consent Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response Completed the required post-treatment follow-up period in previous study Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site Men and women, ages 18 and older Exclusion Criteria: Subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered Subject must not be participating in any other trial, excluding non-interventional trials Prisoners or subjects who are involuntarily incarcerated Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with chronic hepatitis C<br>Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C | Drug: Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)<br>* Observational study - No Intervention [(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of Sustained viral response [SVR] (time to loss of virologic response) | The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA) | 24 or 48-week Intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12 |  | 24 or 48-week intervals | 
| Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality |  | 24 or 48-week intervals |