Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan.
J Hepatol. 2013 Oct;59(4):667-74. doi: 10.1016/j.jhep.2013.05.017. Epub 2013 May 23.
BACKGROUND & AIMS: Anemia is a common adverse effect of telaprevir (TVR) in combination with pegylated interferon (PegIFN)α and ribavirin (RBV) therapy. It occurs at a higher incidence with the TVR relative to PegIFNα and RBV alone. We herein evaluate the baseline and on-treatment predictors of the development of severe anemia by chronic hepatitis C virus (HCV) patients receiving TVR-based triple therapy.
This prospective, multicenter study consisted of 292 patients (median age: 62 years) infected with HCV genotype 1. All received 12 weeks of TVR in combination with 24 weeks of PegIFNα2b and RBV. The definition of severe anemia during antiviral treatment is hemoglobin (Hb)<85 g/L.
101 (34.6%) patients developed severe anemia during the treatment period. Multivariable logistic regression analysis of possible pretreatment predictors of the development of severe anemia extracted baseline Hb < 135 g/L (Hazard ratio [HR], 2.53; p = 0.0013), estimated glomerular filtration rate <80 ml/min/1.73 m(2) (HR, 1.83; p = 0.0265), and inosine triphosphatase (ITPA) CC genotype (rs1127354) (HR, 2.91; p = 0.0024). For patients with ITPA CC (n = 227), multivariable logistic regression analysis of possible pretreatment and on-treatment predictors of the development of severe anemia extracted Hb level at week 2 (HR, 0.96; p = 0.0085) and the initial four weeks of weight-adjusted TVR (HR, 1.05; p = 0.0281).
Anemia remains a risk for all patients treated with TVR-based triple therapy. However, ITPA polymorphism (rs1127354) is useful for predicting the development of severe anemia and will be helpful in the management of treatment.
替拉瑞韦（TVR）联合聚乙二醇干扰素（PegIFN）α和利巴韦林（RBV）治疗会导致贫血，这是一种常见的不良反应。与 PegIFNα和 RBV 单独使用相比，TVR 更易导致贫血。本研究旨在评估慢性丙型肝炎病毒（HCV）患者接受 TVR 三联疗法时，基线和治疗期间发生严重贫血的预测因素。
这是一项前瞻性、多中心研究，共纳入 292 例（中位年龄：62 岁）感染 HCV 基因 1 型的患者。所有患者均接受 TVR 联合 PegIFNα2b 和 RBV 治疗 12 周，然后继续接受 PegIFNα2b 和 RBV 治疗 24 周。抗病毒治疗期间严重贫血的定义为血红蛋白（Hb）<85 g/L。
101 例（34.6%）患者在治疗期间发生严重贫血。多变量逻辑回归分析可能导致严重贫血的治疗前预测因素，包括基线时 Hb<135 g/L（危险比[HR]，2.53；p=0.0013）、肾小球滤过率<80 ml/min/1.73 m²（HR，1.83；p=0.0265）和肌苷三磷酸酶（ITPA）CC 基因型（rs1127354）（HR，2.91；p=0.0024）。对于 ITPA CC 基因型（n=227）的患者，多变量逻辑回归分析可能导致严重贫血的治疗前和治疗期间的预测因素，包括第 2 周 Hb 水平（HR，0.96；p=0.0085）和体重调整后的 TVR 最初四周（HR，1.05；p=0.0281）。
贫血仍然是所有接受 TVR 三联疗法治疗的患者的风险。然而，ITPA 多态性（rs1127354）有助于预测严重贫血的发生，并有助于治疗管理。
