Department of Tropical Medicine, Faculty of Medicine, Fayoum University, Fayoum 63511, Egypt.
Department of Endemic Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.
Curr Drug Saf. 2023;18(2):207-213. doi: 10.2174/1574886317666220510184749.
Chronic infection with HCV is progressive worldwide health problem and the core reason for liver cirrhosis, portal hypertension, or hepatocellular carcinoma. HCV-G4 represents the most common threat to transplantation of the liver in Egypt. New interferon-free regimens have been started consuming direct-acting antiviral oral tablets for HCV cure.
In the current study, comparing the safety and efficacy of DAAs combination regimens including sofosbuvir with daclatasvir or sofosbuvir with simeprevir plus ribavirin for naïve cirrhotic Egyptian patients infected with HCV-G4 was our main goal.
We recruited 150 naïve cirrhotic HCV patients from the Tropical patients' clinic at Fayoum General Hospital. They were classified randomly into two groups, group one (n=75 patients) were administrated Sofosbuvir plus simeprevir (400 mg and 150 mg once daily respectively ) for twelve weeks, and group two (n=75 patients) were administrated Sofosbuvir plus Daclatasvir (400 mg and 60 mg once daily respectively) with ribavirin (1-1.2 gm daily weight-based) for twelve weeks. Clinical follow-up, laboratory investigations, and viral PCR were measured to detect treatment efficacy, safety, and any adverse events.
Sustained virological response rates (SVR12) were 92%and 90.7% in the first and second groups, respectively. The major unfavorable events were fatigue, arthralgia, and weight loss without statistically meaningful differences between study groups. However, anemia and headache were significantly widespread in the second group (P=0.0161 and 0.0495, respectively). We observed four patients with photosensitivity in group I and not observed in the second group.
The current study revealed that DAAs are safe and effective in the cure of naïve cirrhotic patients chronically infected by HCV-G4 with better results in those treated with sofosbuvir plus simeprevir regimen.
慢性 HCV 感染是全球范围内的一个健康问题，也是导致肝硬化、门静脉高压或肝细胞癌的核心原因。HCV-G4 是埃及肝移植的核心威胁。新的无干扰素方案已开始使用直接作用抗病毒口服片剂来治愈 HCV。
本研究旨在比较包含索非布韦的 DAA 联合方案与包含达卡他韦或索非布韦与西美瑞韦联合利巴韦林的方案对埃及初治肝硬化 HCV-G4 感染患者的安全性和疗效。
我们从法尤姆综合医院热带病诊所招募了 150 名初治肝硬化 HCV 患者。他们被随机分为两组，一组（n=75 例）接受索非布韦联合西美瑞韦（分别为 400mg 和 150mg 每日一次）治疗 12 周，另一组（n=75 例）接受索非布韦联合达卡他韦（分别为 400mg 和 60mg 每日一次）联合利巴韦林（基于体重 1-1.2gm 每日）治疗 12 周。临床随访、实验室检查和病毒 PCR 用于检测治疗效果、安全性和任何不良事件。
第一组和第二组的持续病毒学应答率（SVR12）分别为 92%和 90.7%。主要不良事件为疲劳、关节痛和体重减轻，但两组间无统计学意义差异。然而，贫血和头痛在第二组中更为常见（P=0.0161 和 0.0495）。我们观察到第一组中有 4 例患者出现光敏性，而第二组中没有观察到。
本研究表明，DAA 方案在治疗初治肝硬化 HCV-G4 感染患者方面是安全有效的，其中索非布韦联合西美瑞韦方案的疗效更好。
