Background & Aims

Treatment with direct-acting antiviral (DAA) agents can reduce Model for End-Stage Liver Disease and Child-Pugh-Turcotte (CPT) scores in patients with decompensated cirrhosis caused by hepatitis C virus. However, many of these patients still die or require liver transplantation. We collected data on baseline features of patients and aimed to develop a scoring system to predict response to DAA therapy.

Methods

We performed a retrospective analysis of data from 4 trials on the effects of sofosbuvir-based therapy in patients with hepatitis C virus–associated decompensated cirrhosis (502 of CPT class B and 120 of CPT class C). In these trials, patients were given 12 or 24 weeks of treatment with ledipasvir, sofosbuvir, and ribavirin or velpatasvir, sofosbuvir, and/or ribavirin, or 48 weeks of treatment with sofosbuvir and ribavirin. We collected demographic, clinical, treatment response, and laboratory data from patients and tested their associations with patient outcomes at 36 weeks. The primary outcome was factors associated with reduction of CPT score to class A.

Results

The presence of ascites or encephalopathy, serum level of albumin <3.5 g/dL or alanine aminotransferase <60 U/L, and body mass index >25 kg/m² were associated with an increased risk of not achieving a reduction in CPT to class A, independent of sustained viral response to therapy. Serum level of albumin <2.8 g/dL and abnormal level of bilirubin were associated with an increased risk of liver transplantation or death. We developed a scoring system based on 5 baseline factors (body mass index, encephalopathy, ascites, and serum levels of alanine aminotransferase and albumin) associated significantly with patient outcomes, which we called the “BE3A score.” For patients with scores of 4–5, the hazard ratio for reduction of CPT score to class A was 52.3 (95% confidence interval, 15.2–179.7).

Conclusions

We identified 5 baseline factors (body mass index, encephalopathy, ascites, and serum levels of alanine aminotransferase and albumin) associated with a reduction of CPT score to class A in patients with hepatitis C virus–associated decompensated cirrhosis receiving DAA therapy. We developed a predictive score using these factors, called the BE3A score, which can be used as a shared decision-making tool, quantifying the potential benefits of DAA therapy for patients with decompensated cirrhosis.

中文翻译：

---

直接作用抗病毒治疗丙型肝炎病毒感染后代偿性肝硬化改善的基线因素

背景与目标

在由丙型肝炎病毒引起的失代偿性肝硬化患者中，使用直接作用抗病毒药物（DAA）进行治疗可以降低终末期肝病模型和Child-Pugh-Turcotte（CPT）评分。但是，这些患者中许多仍然死亡或需要肝移植。我们收集了有关患者基线特征的数据，旨在开发一个评分系统来预测对DAA治疗的反应。

方法

我们对4项试验的数据进行了回顾性分析，这些研究涉及以sofosbuvir为基础的治疗对丙型肝炎病毒相关的失代偿性肝硬化（CPT类别B为502，CPT类别C为120）的患者的疗效。在这些试验中，患者接受了ledipasvir，sofosbuvir和利巴韦林或velpatasvir，sofosbuvir和/或利巴韦林的12或24周治疗，或sofosbuvir和利巴韦林的48周治疗。我们收集了患者的人口统计学，临床，治疗反应和实验室数据，并在36周时测试了他们与患者预后的关系。主要结局是与CPT评分降低至A级相关的因素。

结果

出现腹水或脑病，血清白蛋白<3.5 g / dL或丙氨酸转氨酶<60 U / L以及体重指数> 25 kg / m ²与未实现CPT降低至等级的风险增加相关A，独立于对治疗的持续病毒反应。血清白蛋白水平<2.8 g / dL和胆红素水平异常与肝移植或死亡的风险增加相关。我们基于与患者预后显着相关的5个基线因素（体重指数，脑病，腹水和血清丙氨酸转氨酶和白蛋白水平）开发了评分系统，我们将其称为“ BE3A评分”。对于得分为4–5的患者，将CPT得分降低至A级的危险比为52.3（95％置信区间，15.2–179.7）。

结论

我们确定了5种基线因素（体重指数，脑病，腹水以及血清丙氨酸转氨酶和白蛋白水平）与接受DAA治疗的丙型肝炎病毒相关失代偿性肝硬化患者的CPT评分降低至A级有关。我们使用这些因素开发了预测得分，称为BE3A得分，可以用作共享的决策工具，量化DAA治疗对失代偿性肝硬化患者的潜在益处。