Hepatitis C
Conditions
Brief summary
The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)
Interventions
OTHERNon-interventional
Non-interventional
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
* Males or females 18 years of age or older at initiation of prior DCV-based therapy * Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks * Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies
Exclusion criteria
\- N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hepatic disease progression events | up to 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability of virologic response | up to 5 years | assessed by response in subjects previously treated with DCV-based therapy who achieved sustained virologic response at 12 or 24 weeks(SVR12/24) after the end of treatment |
| Change in liver stiffness | baseline up to 5 years | measured using elastography values |
| Number of subjects with HCV sequence variants | baseline up to 5 years | presence of HCV sequence variants over time in subjects who failed to prior Daclatasvir(DCV)-based therapy |
| Distribution of HCV retreatment patterns | baseline up to 5 years | distribution of HCV retreatment patterns including number of subjects receiving retreatment, retreatment regimen, retreatment duration and retreatment results |
Countries
China
Outcome results
None listed