A multicentric, observational, open-design study conducted to evaluate the efficacy and safety of Sofosdac® 400mg/60mg tablets treatment in 100 patients with chronic hepatitis C (HCV)
BEKER laboratories developed the generic drug Sofosdac® 400 mg/60 mg Tablets as fixed dose combination that contains two direct antiviral agents (400 mg Sofosbuvir and 60 mg Daclatasvir) known to be pangenotypic in order to fulfill WHO plan to eradicate HCV by 2030. BEKER conducted an observational clinical trial to evaluate the efficacy and safety of FDC Sofosdac® 400 mg/60 mg treatment in Algerian patients with chronic hepatitis C (HCV).
Study Type
OBSERVATIONAL
Enrollment
99
Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir
Boufarik Public Hospital
Boufarik, Blida Province, Algeria
Khenchla Public Hospital
Khenchla, Khenchla, Algeria
Mustapha Pacha Teaching Hospital
Algiers, Algeria
Oran Teaching Hospital
Oran, Algeria
Detection of RNA HCV 12 weeks after treatment cessation by acceptable quantification assay
A quantification assay is performed to all patients to detect RNA HCV in order to determine the proportion of patients who achieve SVR12 (Sustained Viral Response) defined as: RNA HCV \< LLOQ (Lower Limit of Quantification) 12 weeks after treatment cessation.
Time frame: 12 weeks after treatment cessation
Assessment of reported adverse events
Assessment of observed adverse events / adverse effects and serious adverse events related or not related to Sofosdac® treatment.
Time frame: During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients
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