A Retrospective, Observational Study on the Effectiveness of Daclatasvir-Containing Regimens in Patients in KSA, UAE and Qatar

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Daclatasvir-Containing Regimens in Patients Treated in Real-Life Setting in Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE) and Qatar

Conditions
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Hepatitis C

Intervention / Treatment
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* Other: Non-Interventional


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria could apply

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 |
| --- | --- |
| daclatasvir patients in KSA, UAE, and Qatar<br>patients treated with daclatasvir-containing regimens in KSA, UAE, and Qatar | Other: Non-Interventional<br>* Non-Interventional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |