Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-0003, USA.
Gastroenterology. 2010 Nov;139(5):1602-11, 1611.e1. doi: 10.1053/j.gastro.2010.07.059. Epub 2010 Aug 16.
BACKGROUND & AIMS: Hepatitis C virus (HCV) treatment is frequently complicated by anemia from ribavirin (RBV)-related hemolysis and peginterferon-alfa (PEG-IFN)-related bone marrow suppression. We investigated the relationships among treatment outcomes, anemia, and their management with RBV dose reduction and/or erythropoiesis-stimulating agents (ESAs).
We analyzed data from a trial conducted at 118 United States academic and community centers in treatment-naïve patients with HCV genotype 1. Patients were treated for as many as 48 weeks with 1 of 3 PEG-IFN/RBV regimens. ESAs were permitted for anemic patients (hemoglobin [Hb] <10 g/dL) after RBV dose reduction. Sustained virologic responses (SVR) were assessed based on decreases in Hb, anemia, and ESA use.
While patients received treatment, 3023 had their Hb levels measured at least once. An SVR was associated with the magnitude of Hb decrease: >3 g/dL, 43.7%; ≤3 g/dL, 29.9% (P < .001). Anemia occurred in 865 patients (28.6%); 449 of these (51.9%) used ESAs. In patients with early-onset anemia (≤ 8 weeks of treatment), ESAs were associated with higher SVR rate (45.0% vs 25.9%; P < .001) and reduced discontinuation of treatment because of adverse events (12.6% vs 30.1%, P < .001). ESAs did not affect SVR or discontinuation rates among patients with late-stage anemia.
Among HCV genotype 1-infected patients treated with PEG-IFN/RBV, anemia was associated with higher rates of SVR. The effect of ESAs varied by time to anemia; patients with early-onset anemia had higher rates of SVR with ESA use, whereas no effect was observed in those with late-onset anemia. Prospective trials are needed to assess the role of ESAs in HCV treatment.
丙型肝炎病毒（HCV）的治疗常因利巴韦林（RBV）相关的溶血和聚乙二醇干扰素-α（PEG-IFN）相关的骨髓抑制而导致贫血。我们研究了治疗结果、贫血及其与 RBV 剂量减少和/或红细胞生成刺激剂（ESA）的管理之间的关系。
我们分析了在 118 个美国学术和社区中心进行的一项针对初治 HCV 基因型 1 患者的试验数据。患者接受了多达 48 周的 1 种 PEG-IFN/RBV 方案治疗。在 RBV 剂量减少后，允许贫血患者（血红蛋白[Hb] <10 g/dL）使用 ESA。根据 Hb、贫血和 ESA 使用的减少来评估持续病毒学应答（SVR）。
在患者接受治疗期间，有 3023 名患者至少测量了一次 Hb 水平。SVR 与 Hb 下降幅度相关：>3 g/dL，43.7%；≤3 g/dL，29.9%（P<.001）。865 名患者发生贫血（28.6%）；其中 449 名（51.9%）使用了 ESA。在早期贫血（治疗≤8 周）的患者中，ESA 与更高的 SVR 率（45.0%比 25.9%；P<.001）和因不良事件而减少治疗中断（12.6%比 30.1%，P<.001）相关。ESA 对晚期贫血患者的 SVR 或治疗中断率没有影响。
在接受 PEG-IFN/RBV 治疗的 HCV 基因型 1 感染患者中，贫血与更高的 SVR 率相关。ESA 的作用因贫血发生时间而异；早期贫血患者使用 ESA 可获得更高的 SVR 率，而晚期贫血患者则无此效果。需要前瞻性试验来评估 ESA 在 HCV 治疗中的作用。
