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High sustained virologic response rate using generic directly acting antivirals in the treatment of chronic hepatitis C virus Egyptian patients

single-center experience

El-Nahaas, Saeed M.a,b; Fouad, Rababa,b; Elsharkawy, Aishaa,b; Khairy, Marwaa,b; Elhossary, Walieda,b; Anwar, Ismaila,b; Abdellatif, Zeinaba,b; Maher, Rabab M.c; Bekheet, Nadera,b; Esmat, Gamala,b

European Journal of Gastroenterology & Hepatology: October 2018 - Volume 30 - Issue 10 - p 1194–1199
doi: 10.1097/MEG.0000000000001228
Original Articles: Hepatology
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Background Hepatitis C virus (HCV) is a major health problem in Egypt, with a high prevalence of genotype 4.

Aim This study aimed to evaluate the safety and efficacy of generic sofosbuvir (SOF) plus generic daclatasvir (DAC) with or without ribavirin in the treatment of Egyptian chronic HCV patients compared with the use of brand drugs.

Materials and methods An observational study that included 234 Egyptian chronic HCV patients was carried out. Patients were classified into two groups: group A (101 patients) received brand SOF 400 mg plus brand DAC 60 mg and group B (134 patients) received generic SOF 400 mg plus generic DAC 60 mg with or without ribavirin for 12 weeks. The end point was a sustained virological response at 12 weeks after treatment.

Results Thirty-eight (37.2%) patients in group A were treatment experienced compared with 12 (9.02%) patients in group B; there were 39 (38%) cirrhotic patients in group A and 22 (16.5%) cirrhotic patients in group B. In group A, 50% of patients received ribavirin, while in group B, 42.1% of patients received ribavirin. All patients were followed up; all of them attended their week 12 post-treatment visit with negative HCV RNA, with achievement of sustained virological response at 12 in 100% of patients receiving generic drugs (group B) and 99% of patients receiving brand drugs (group A). Generic SOF and DAC were well tolerated, with mild adverse events including fatigue and headache.

Conclusion Use of generic SOF and DAC with or without ribavirin is an extremely effective and a well-tolerated treatment for Egyptian chronic HCV patients.

aEndemic Medicine and Hepatogastroentrology Department, Faculty of Medicine

bKasr Al Ainy Viral Hepatitis Centre

cFellow Tropical Medicine, Cairo University, Cairo, Egypt

Correspondence to Saeed M. El-Nahaas, MD, Kasr Al-Aini Street, Cairo 11562, Egypt Tel: +20 100 5159 530; fax: +20 22 368 2030; e-mail: saeednahas@yahoo.com

Received May 3, 2018

Accepted May 24, 2018

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.