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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| daclatasvir patients in KSA, UAE, and Qatar | patients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants achieving sustained virological response 12 weeks post-treatment (SVR12) | 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. | 12 weeks after the last dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of SVR12 by Treatment Regimen | Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin. | 12 weeks after the last dose of study treatment |
| Distribution of SVR12 by Country |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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The study will enroll all patients initiating a new daclatasvir-containing HCV treatment, regardless of treatment history and previous treatment response from availability of the drug on country markets up to 01-Oct-2015.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Doha | Saudi Arabia | ||||
| Local Institution |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Defined as the country where treatment with a daclatasvir containing regimen was initiated. Subgroups include Saudi Arabia, UAE, and Qatar. |
| 12 weeks after the last dose of study treatment |
| Distribution of SVR12 by Genotype | Subgroups genotype 3 and genotype 4 | 12 weeks after the last dose of study treatment |
| Distribution of SVR12 by HCV-Treatment Experience | 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. | 12 weeks after the last dose of study treatment |
| Distribution of SVR12 by HIV co-infection | Subgroup defined as HIV diagnosis prior to the initiation of daclatasvir containing regimen. | 12 weeks after the last dose of study treatment |
| Distribution of SVR12 by previous liver transplantation | Subgroup defined by patients undergoing a liver transplant for any cause prior to the initiation of a daclatasvir containing regimen | 12 weeks after the last dose of study treatment |
| Incidence of Serious Adverse Events (SAE) | Measured by number of patients reporting SAEs | Up to 12 months |
| Incidence of Adverse Events leading to discontinuation | Measured by number of patients reporting AEs that result in treatment discontinuation | Up to 12 months |
| Jeddah |
| 23325 |
| Saudi Arabia |
| Local Institution | Riyadh-11211 | 11211 | Saudi Arabia |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |