Background

The efficacy of adding ribavirin (RBV) to direct antivirals (DAAs) in HCV treatment is still debatable, with allegations of insecure profiles.

Objectives

To evaluate safety and efficacy of RBV in the era of DAAs in chronic HCV Egyptian patients.

Methods

In this cohort retrospective study, data of 847 HCV patients treated with different regimens of DAAs with or without RBV were recruited between June 2017 and September 2018. Cases were categorized into five groups: non-cirrhotic (318), compensated (196), decompensated liver cirrhosis (53), post liver transplantation (30), and 250 treatment experienced patients. All patients’ demographics and laboratory characteristics were evaluated at baseline, week_{4, 12, 24} of treatment. Ribavirin was prescribed or banned outside international guideline recommendations of HCV treatment in cases assembled from the private sector.Results: No statistically significant difference between RBV and non-RBV treated patients was documented regarding SVR₁₂ (97.2%, 97.8%) respectively in the whole cohort (p 0.509). On grouping, adding RBV was only significant in the treatment experienced patients (96.8%, 85% in RBV and non-RBV regimens respectively) (p 0.001). Adding RBV to DAA regimens was generally associated with modest adverse events particularly anemia (8.5%), and hepatic decompensation (jaundice and ascites) (0.3%). Bilirubin, INR, and platelet counts all were found to be the most independent predictors of SVR achievement by multivariate analysis (p ≤ 0.05).Conclusion: RBV may still have an augmenting role in treatment experienced patients; permitting effectual shortening of therapy particularly in patients with cirrhosis, with modest side and adverse consequences.

中文翻译：

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利巴韦林在慢性丙型肝炎的直接作用抗病毒治疗时代中的作用。

背景

HCV治疗中将利巴韦林（RBV）添加到直接抗病毒药物（DAA）中的功效尚有争议，存在不安全特征的指控。

目标

为了评估埃及慢性HCV患者在DAA时代RBV的安全性和有效性。

方法

在这项队列回顾性研究中，于2017年6月至2018年9月期间收集了847例接受不同DAA方案或不采用RBV方案治疗的HCV患者的数据。病例分为五组：非肝硬化（318），补偿（196），失代偿肝硬化（53），肝移植后（30）和250名有治疗经验的患者。在治疗的第₄周_，第12、24周评估所有患者的人口统计学和实验室特征。利巴韦林在国际准则建议的HCV治疗以外的私人机构开处方或被禁止。结果：关于SVR _12的记录，RBV和非RBV治疗的患者之间无统计学意义的差异在整个队列中分别为（97.2％，97.8％）（p 0.509）。分组后，仅在有治疗经验的患者中添加RBV显着（RBV和非RBV方案分别为96.8％，85％）（p 0.001）。在DAA方案中添加RBV通常与中等程度的不良事件有关，特别是贫血（8.5％）和肝代偿失调（黄疸和腹水）（0.3％）。通过多变量分析发现，胆红素，INR和血小板计数均是SVR实现最独立的预测因素（p≤0.05）。结论：RBV在经验丰富的患者中可能仍具有增强作用; 允许有效地缩短治疗时间，特别是对于肝硬化患者，其副作用和不良后果不大。