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April 2017 Vol. 5 No.4

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Elsharkawy A
Esmat G

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Merit Research Journal of Medicine and Medical Sciences (ISSN: 2354-323X) Vol. 5(4) pp. 209-213, April, 2017 

Copyright © 2017 Merit Research Journals

Original Research Article

Safety and efficacy of the generic products of sofosbuvir and daclatasvir in treatment of HCV genotype 4 Egyptian patients


Aisha Elsharkawy1, Mohamed Hashem1*, Rabab Fouad1, Mohamed Negm1, Ahmed Cordie1, Mai Ismail Mehrez3 Ossama Mohamed2, Sherif Shabana2, Hany Saad2, Hosam Elbaz2 and Gamal Esmat1


1Endemic medicine and Hepatogastroenterology Department, Faculty of Medicine, Cairo University, Cairo
2Internal Medicine Department, Faculty of Medicine, Ain Shams University, Cairo
3National Hepatology and Tropical Medicine Research Institute

*Corresponding Author’s Email:
Phone no.: +201222335981

Accepted April 10, 2017




Hepatitis C virus (HCV) is a major medical problem in Egypt, with genotype 4 the prevalent genotype. The introduction of the new oral directly acting antiviral drugs (DAAs) in the national treatment program in Egypt since late 2014 was a great achievement. Patients with genotype 4 maybe treated with daily combination of Sofosbuvir/Daclatasvir with or without ribavirin for 12 or 24 weeks. However, little data is available regarding the safety and efficacy of generic products of those DAAs used so the aim of this study was to assess the safety and efficacy of the generic products of sofosbuvir and daclatasvir in treatment of HCV genotype 4 Egyptian patients. Where 139 Egyptian patients chronically infected with HCV genotype 4 were enrolled. They received the generic products of sofosbuvir (Sofolanork, Mash premiere) 400 mg plus daclatasvir (Daklanork, Mash premiere) 60 mg with or without ribavirin for 12 or 24 weeks in Kasr Al Ainy Viral Hepatitis Center and Ain Shams Hospital. Most of the studied patients were males (61.15%), 30 were cirrhotics, 18 patients had a history of previous sofosbuvir based treatment. Treatment was by sofosbuvir plus daclatasvir for 12 weeks in 75 patients and for 24 weeks in 7 patients. Ribavirin was added in 39 patients for 12 weeks and in 18 patients who had previous history of failure to sofosbuvir based therapy for 24 weeks. All patients had SVR12 (100%). A significant improvement occurred in ALT, AST, AFP and Albumin. Moreover, a slight regression in the fibrosis markers was shown through reduction of Fib-4 index. The findings of this study showed that the generic products of the relatively more expensive brand DAAs have almost the same efficacy and safety allowing for the mass treatment of Egyptian patients chronically infected with HCV making the dream of HCV elimination in Egypt achievable.

Keywords: Daclatasvir, Generic, Genotype 4, HCV, Sofosbuvir






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