Efficacy of Locally Manufactured Sofosbuvir and Daclatasvir (Sovodak) in Combination with Ribavirin in Treating Patients with Chronic Hepatitis C and Cirrhosis in Iran – Preliminary Report

Abstract

Background:

Interferon-free treatments for hepatitis C have been recently available. They can cure over 95% of patients within 12 weeks without significant side effects. A combination of daclatasvir and sofosbuvir has been particularly useful as it is effective against all genotypes of hepatitis C virus (HCV). The combination of sofosbuvir and daclatasvir in a single pill has been recently manufactured in Iran (Sovodak®). The current paper is a preliminary report on the first patients treated with Sovodak.

Materials and Methods:

100 patients with cirrhosis due to hepatitis C were included. All genotypes of HCV were eligible. All the patients received treatment with daclatasvir and sofosbuvir (Sovodak) in combination with ribavirin for 12 weeks and were evaluated for effectiveness of the treatment 12 weeks after termination of the treatment (SVR12, sustained virological response at 12 week). The results of the first 50 patients are presented here.

Results:

Of the first 50 patients enrolled in the study, 47 reached the endpoints. Of them, 17 were infected with HCV genotype 3 and showed 100% response to the treatment (17/17). The remaining 30 patients were infected with genotype 1 and 97% responded (29/30) to the treatment. No adverse effects were reported.

Conclusion:

According to international guidelines, the combination of sofosbuvir and daclatasvir is the first line of treatment for all genotypes of HCV infection. For patients with cirrhosis, ribavirin is also added. In our study the efficacy of this combination in patients with cirrhosis was 97% and 100% for genotypes 1 and 3, respectively. Due to its high efficacy and ease of use, we recommend Sovodak for the treatment of all genotypes of HCV in Iran.