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索磷布韦联合利巴韦林在真实临床实践中治疗基因4型丙型肝炎病毒肝硬化患者的疗效和安全性

Efficacy and safety of sofosbuvir plus ribavirin for treatment of cirrhotic patients with genotype 4 hepatitis C virus in real-life clinical practice.

作者信息

Abd-Elsalam Sherief, Sharaf-Eldin Mohamed, Soliman Shaimaa, Elfert Asem, Badawi Rehab, Ahmad Youssef K

机构信息

Department of Tropical Medicine, Faculty of Medicine, Tanta University, El Geish Street, Tanta, Gharbia Governorate, Egypt.

Department of Public Health and Community Medicine, Menoufia University, Menoufia, Egypt.

出版信息

Arch Virol. 2018 Jan;163(1):51-56. doi: 10.1007/s00705-017-3573-0. Epub 2017 Oct 5.

DOI:10.1007/s00705-017-3573-0
PMID:28983675
Abstract

Egypt has the highest hepatitis C virus (HCV) prevalence in the world. Sofosbuvir is a new highly effective drug for treatment of HCV infection. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to fourfold reduced duration of therapy. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin in Egyptian patients with liver cirrhosis due to chronic HCV infection. We studied 2400 cirrhotic Egyptian patients with chronic HCV infection who were treated with dual therapy with sofosbuvir and ribavirin for 24 weeks. Efficacy was determined by assessment of serum HCV RNA. Any adverse events during treatment were recorded. Two thousand four hundred cirrhotic Egyptian patients with chronic HCV infection treated with sofosbuvir and ribavirin for 24 weeks were enrolled in the study. The mean age of the studied group (± SD) was 53.9 ± 6.5 years, 1549 (64.54%) were males, all were cirrhotic patients, 3.41% were treatment-experienced, the baseline mean HCV RNA concentration was 4.33 × 10 IU/mL, and 94.37% of the patients had completed the full course of therapy. The overall SVR12 rate was 71.2%. The most common adverse events were fatigue, myalgia, headache, insomnia, and anemia. One hundred thirty-five (5.63%) patients stopped treatment permanently due to the appearance of complications that prevented continuation of treatment. The sofosbuvir and ribavirin combination is safe and effective in treatment of HCV patients with liver cirrhosis. However, further studies are needed to establish the optimal treatment regimen for those cases.

摘要

埃及是世界上丙型肝炎病毒(HCV)感染率最高的国家。索磷布韦是一种用于治疗HCV感染的新型高效药物。与以往的治疗方法相比,基于索磷布韦的治疗方案治愈率更高、副作用更少,治疗疗程缩短了两到四倍。本研究的目的是评估索磷布韦联合利巴韦林对埃及慢性HCV感染所致肝硬化患者的抗病毒疗效、安全性和耐受性。我们研究了2400例慢性HCV感染的埃及肝硬化患者,他们接受了索磷布韦和利巴韦林的联合治疗,疗程为24周。通过评估血清HCV RNA来确定疗效。记录治疗期间的任何不良事件。2400例慢性HCV感染的埃及肝硬化患者接受了索磷布韦和利巴韦林治疗24周,并纳入本研究。研究组的平均年龄(±标准差)为53.9±6.5岁,男性1549例(64.54%),均为肝硬化患者,3.41%有治疗史,基线平均HCV RNA浓度为4.33×10 IU/mL,94.37%的患者完成了整个疗程。总体SVR12率为71.2%。最常见的不良事件是疲劳、肌痛、头痛、失眠和贫血。135例(5.63%)患者因出现并发症而无法继续治疗,最终永久停药。索磷布韦和利巴韦林联合治疗对HCV肝硬化患者是安全有效的。然而,需要进一步研究以确定这些病例的最佳治疗方案。

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