Ahmed Ossama A, Kaisar Hany H, Hawash Nehad, Samir Hossam, Shabana Sherif S T, Hassan A Fouad Mohamed, Rizk Fatma, Abd-Elsalam Sherief
Department of Internal Medicine, Ain Shams University, Faculty of Medicine, Cairo, Egypt.
Tropical Medicine & Infectious Diseases Department, Tanta University, Faculty of Medicine, Tanta, Egypt.
Infect Disord Drug Targets. 2017;17(2):95-100. doi: 10.2174/1871526517666170417143216.
Background & Aims: Sofosbuvir is a powerful drug for the treatment of hepatitis C virus (HCV) infection. In comparison to preceding remedies, sofosbuvirbased regimens provide a higher cure rate, fewer side effects, and much lower duration of treatment. The aim of the work was to assess the efficacy and safety of sofosbuvir plus ribavirin with or without peginterferon-alfa in the treatment of a cohort of Egyptian patients with hepatitis C virus infection.
Two hundred treatment naive patients who were HCV-antibody positive and HCV RNA by PCR positive aged more than 18 years were enrolled in the study and patients were classified into two groups: Group I which included 100 patients who received dual therapy with sofosbuvir plus oral weight based ribavirin for 24 weeks and Group II which included 100 patients on triple therapy with sofosbuvir plus oral weight based ribavirin (as with the dual therapy) and a 180 mcg Peg-INF alpha 2a subcutaneous injection weekly for 12 weeks. The primary end point was a sustained virological response at 12 weeks after end of the treatment determined by quantitative PCR for HCV.
Both patients groups had high sustained virological response that was higher in patients receiving triple than dual therapy (94% vs 83%). The adverse events that occurred in the two groups of patients were more evident in a group of patients receiving triple therapy. The side effects were mainly flu like symptoms.
The triple regimen of Pegylated interferon, sofosbuvir plus ribavirin is safe and effective in the treatment of Egyptian patients with hepatitis C virus as well as sofosbuvir and ribavirin alone wit.
背景与目的:索磷布韦是一种治疗丙型肝炎病毒(HCV)感染的强效药物。与之前的治疗方法相比,基于索磷布韦的治疗方案治愈率更高、副作用更少且治疗时间更短。这项研究的目的是评估索磷布韦联合利巴韦林(联合或不联合聚乙二醇干扰素-α)治疗一组埃及丙型肝炎病毒感染患者的疗效和安全性。
200例年龄超过18岁、HCV抗体阳性且经PCR检测HCV RNA阳性的初治患者纳入本研究,患者分为两组:第一组100例,接受索磷布韦联合基于体重的口服利巴韦林治疗24周;第二组100例,接受三联疗法,即索磷布韦联合基于体重的口服利巴韦林(与二联疗法相同),并每周皮下注射180μg聚乙二醇干扰素-α 2a,共12周。主要终点是治疗结束后12周通过HCV定量PCR测定的持续病毒学应答。
两组患者均有较高的持续病毒学应答,接受三联疗法的患者持续病毒学应答率高于接受二联疗法的患者(94%对83%)。两组患者发生的不良事件在接受三联疗法的患者组中更为明显。副作用主要为流感样症状。
聚乙二醇干扰素、索磷布韦联合利巴韦林的三联疗法以及单独使用索磷布韦和利巴韦林治疗埃及丙型肝炎病毒感染患者均安全有效。