El-Nahaas Saeed M, Fouad Rabab, Elsharkawy Aisha, Khairy Marwa, Elhossary Walied, Anwar Ismail, Abdellatif Zeinab, Maher Rabab M, Bekheet Nader, Esmat Gamal
Endemic Medicine and Hepatogastroentrology Department, Faculty of Medicine.
Kasr Al Ainy Viral Hepatitis Centre.
Eur J Gastroenterol Hepatol. 2018 Oct;30(10):1194-1199. doi: 10.1097/MEG.0000000000001228.
Hepatitis C virus (HCV) is a major health problem in Egypt, with a high prevalence of genotype 4.
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.
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.
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.
Use of generic SOF and DAC with or without ribavirin is an extremely effective and a well-tolerated treatment for Egyptian chronic HCV patients.
丙型肝炎病毒（HCV）是埃及的一个主要健康问题，基因型4的患病率很高。
本研究旨在评估通用型索磷布韦（SOF）加通用型达卡他韦（DAC）联合或不联合利巴韦林治疗埃及慢性HCV患者的安全性和有效性，并与使用品牌药物进行比较。
开展了一项观察性研究，纳入234例埃及慢性HCV患者。患者分为两组：A组（101例患者）接受品牌SOF 400mg加品牌DAC 60mg，B组（134例患者）接受通用型SOF 400mg加通用型DAC 60mg联合或不联合利巴韦林治疗12周。终点是治疗后12周的持续病毒学应答。
A组有38例（37.2%）患者有治疗史，而B组有12例（9.02%）患者有治疗史；A组有39例（38%）肝硬化患者，B组有22例（16.5%）肝硬化患者。A组50%的患者接受了利巴韦林治疗，而B组42.1%的患者接受了利巴韦林治疗。所有患者均接受随访；他们全部在治疗后第12周就诊时HCV RNA呈阴性，接受通用药物治疗的患者（B组）100%在12周时实现了持续病毒学应答，接受品牌药物治疗的患者（A组）99%实现了持续病毒学应答。通用型SOF和DAC耐受性良好，不良事件轻微，包括疲劳和头痛。
通用型SOF和DAC联合或不联合利巴韦林治疗埃及慢性HCV患者是一种极其有效且耐受性良好的治疗方法。
