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Sofosbuvir/Daclatasvir treatment is effective and safe in achieving a high sustained virologic response rate (95.8%) for patients with chronic hepatitis C, spanning 12 to 24 weeks without Ribavirin.
In a multicentric, observational, open-label study, the use of a generic fixed-dose combination of Sofosbuvir (400 mg) and Daclatasvir (60 mg) exhibited a good safety and efficacy profile for treating Algerian people suffering from chronic hepatitis C. The objective of the study was to evaluate the effectiveness and safety of a fixed-dose combination containing two direct antiviral agents (orally administered once daily) for chronic hepatitis C management.
The study encompassed 100 patients, covering all hepatitis C genotypes, who underwent a treatment duration of either 12 or 24 weeks, without the use of Ribavirin. The major endpoint was the percentage of subjects who achieved a sustained virologic response (SVR) 12 weeks following treatment completion. Additionally, the study also examined the treatment's safety profile and the occurrence of any adverse events as secondary outcomes.
The full analysis set consisted of 99 volunteers, with a mean age of 51.4 ± 14.4 years and a male-to-female ratio of 0.86. Among the patients, there were various hepatitis C virus (HCV) genotypes: 1b (n = 47), 2 (n = 17), 1a (n = 3), 2a/2c (n = 2), 3 (n = 2), and 4 (n = 1), while genotype information was missing for 27 subjects. The majority of individuals were treatment-naive and noncirrhotic (n = 70), receiving a 12-week intervention, whereas 19 individuals had cirrhosis, with 68.42% (n = 13) classified as Child-Pugh A and 5 people had prior treatment experience, all of whom received a 24-week intervention.
The efficacy analysis was conducted on 95 subjects, revealing that 91 patients achieved an SVR12, resulting in a response rate of 95.8%. There were 6 reported adverse events, all of which were manageable and minor. When treating Algerian HCV patients without Ribavirin for 12 or 24 weeks, Sofosbuvir/Daclatasvir was found to be promising. The results of this study warranted further trials to explore the safety and efficiency of this combination in treating special populations.
Journal of Clinical Pharmacy and Therapeutics
Efficacy of Sofosbuvir/Daclatasvir in a Single Tablet for Treating Chronic Viral Hepatitis C
Nabil Debzi et al.
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