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.
Study Type
OBSERVATIONAL
Enrollment
182
Non-Interventional
Local Institution
Doha, Saudi Arabia
Local Institution
Jeddah, Saudi Arabia
Local Institution
Riyadh-11211, Saudi Arabia
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.
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Treatment Regimen
Defined as any daclatasvir containing regimen. Subgroups include: daclatasvir + sofosbuvir; daclatasvir + sofosbuvir + RBV; daclatasvir + simeprevir; daclatasvir + simeprevir + ribavirin.
Time frame: 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.
Time frame: 12 weeks after the last dose of study treatment
Distribution of SVR12 by Genotype
Subgroups genotype 3 and genotype 4
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks after the last dose of study treatment
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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
Time frame: 12 weeks after the last dose of study treatment
Incidence of Serious Adverse Events (SAE)
Measured by number of patients reporting SAEs
Time frame: Up to 12 months
Incidence of Adverse Events leading to discontinuation
Measured by number of patients reporting AEs that result in treatment discontinuation
Time frame: Up to 12 months