Abd-Elsalam Sherief, Badawi Rehab, Elnawasany Sally, Yousef Mohamed, Mansour Loai, Hawash Nehad, Elkhouly Reham A, Soliman Shaimaa, Selim Amal, Kobtan Abdelrahman, Elfert Asem
Tanta University, Department of Tropical Medicine, Tanta, Egypt.
Menoufia University, Department of Public Health and Community Medicine Tanta, Tanta, Egypt.
Infect Disord Drug Targets. 2019;19(2):179-184. doi: 10.2174/1871526518666180912121835.
BACKGROUND & AIMS: Hepatitis C virus infection is a major public health problem in Egypt with a risk for morbidity and mortality due to chronic liver disease complications. Worldwide, Egypt has the highest prevalence of HCV infection with the overall prevalence of about 14.7%. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus Pegylated Interferon (Peg- IFNa) and Ribavirin (RBV) in Egyptian patients with chronic hepatitis C virus (HCV) infection.
This study was carried out in 1200 patients with chronic hepatitis C virus infection who were eligible for interferon therapy. They were treated with the triple therapy of sofosbuvir 400 mg once daily, Peg-INF subcutaneous injection weekly for 12 weeks in combination with oral weight-based ribavirin. The primary outcome measures were the number of patients with successful eradication of the virus evidenced by the sustained virologic response (SVR) at 12 Weeks. After discontinuation of Therapy (SVR12), the secondary outcome measures were the incidence of adverse effects associated with the tested HCV therapy.
The mean age of the patients was 49.32 ± 6.97 years. 45.9% of them were males and 54.1% were females.70 patients (5.8%) had a history of previous HCV treatment. ''1077 (89.8%)'' of patients achieved successful eradication of virus while ''106 (8.8%)'' were resistant to treatment and ''17 (1.4%)'' stopped treatment. Good predictors of response to the triple therapy were female gender, treatment naive and non-cirrhotic patients.
The triple regimen of Pegylated interferon, sofosbuvir plus ribavirin is safe and effective in the treatment of Egyptian patients with hepatitis C virus and is associated with real-life SVR12 rates of 89.8%.
丙型肝炎病毒感染是埃及一个主要的公共卫生问题，存在因慢性肝病并发症导致发病和死亡的风险。在全球范围内，埃及丙型肝炎病毒感染的患病率最高，总体患病率约为14.7%。本研究的目的是评估索磷布韦（SOF）联合聚乙二醇干扰素（Peg-IFNa）和利巴韦林（RBV）对埃及慢性丙型肝炎病毒（HCV）感染患者的抗病毒疗效、安全性和耐受性。
本研究对1200例符合干扰素治疗条件的慢性丙型肝炎病毒感染患者进行。他们接受索磷布韦400mg每日一次、聚乙二醇干扰素皮下注射每周一次共12周，并联合基于体重的口服利巴韦林的三联疗法。主要结局指标是在12周时通过持续病毒学应答（SVR）证明病毒成功清除的患者数量。治疗中断后（SVR12），次要结局指标是与所测试的丙型肝炎病毒治疗相关的不良反应发生率。
患者的平均年龄为49.32±6.97岁。其中45.9%为男性，54.1%为女性。70例患者（5.8%）有既往丙型肝炎病毒治疗史。1077例（89.8%）患者实现了病毒的成功清除，106例（8.8%）患者对治疗耐药，17例（1.4%）患者停止治疗。三联疗法反应的良好预测因素是女性、初治患者和非肝硬化患者。
聚乙二醇干扰素、索磷布韦联合利巴韦林的三联方案在治疗埃及丙型肝炎病毒患者中安全有效，且与现实生活中89.8%的SVR12率相关。
