Hepatitis C
Conditions
Brief summary
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.
Interventions
DRUGAsunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
Observational study - No Intervention \[(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)\]
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Durability of Sustained viral response [SVR] (time to loss of virologic response) | 24 or 48-week Intervals | 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) |
Secondary
| Measure | 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 |
Countries
Argentina, Australia, Brazil, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Outcome results
None listed