Hepatitis C
Conditions
Brief summary
The study will provide safety and efficacy information among patients receiving daclatasvir. It will describe daclatasvir prescribing patterns and provide a clinical profile of patients receiving the treatment in KSA, UAE, and Qatar.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients greater than or equal to 18 years of age * Diagnosed with chronic hepatitis C * Ended treatment with daclatasvir-containing regimen no later than 01-Oct-2015
Exclusion criteria
* Use of a daclatasvir-containing regimen in a clinical trial setting Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12) | 12 weeks after the last dose of study treatment | Patients will be considered to have achieved SVR12 if they have a documented undetectable viral load on or after Week 12 following the end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of SVR12 by Country | 12 weeks after the last dose of study treatment | Defined as the country where treatment with a daclatasvir containing regimen was initiated. Subgroups include Saudi Arabia, UAE, and Qatar. |
| Distribution of SVR12 by Genotype | 12 weeks after the last dose of study treatment | Subgroups genotype 3 and genotype 4 |
| Distribution of SVR12 by HCV-Treatment Experience | 12 weeks after the last dose of study treatment | Subgroups include patients in which prior treatment with IFN and RBV has failed; prior treatment with IFN, RBV and telaprevir or boceprevir has failed; previous treatment with IFN, RBV and simeprevir has failed; previous treatment with sofosbuvir and RBV has failed. |
| Distribution of SVR12 by Treatment Regimen | 12 weeks after the last dose of study treatment | Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin. |
| Distribution of SVR12 by previous liver transplantation | 12 weeks after the last dose of study treatment | Subgroup defined by patients undergoing a liver transplant for any cause prior to the initiation of a daclatasvir containing regimen |
| Incidence of Serious Adverse Events (SAE) | Up to 12 months | Measured by number of patients reporting SAEs |
| Incidence of Adverse Events leading to discontinuation | Up to 12 months | Measured by number of patients reporting AEs that result in treatment discontinuation |
| Distribution of SVR12 by HIV co-infection | 12 weeks after the last dose of study treatment | Subgroup defined as HIV diagnosis prior to the initiation of daclatasvir containing regimen. |
Countries
Saudi Arabia
Outcome results
None listed