随机试验比较剂量减少和生长因子补充治疗用于接受聚乙二醇干扰素和利巴韦林治疗的 HIV/丙型肝炎病毒患者的血液学副作用管理。
Randomized trial comparing dose reduction and growth factor supplementation for management of hematological side effects in HIV/hepatitis C virus patients receiving pegylated-interferon and ribavirin.
机构信息
Center for the Study of Hepatitis C, Division of Gastroenterology and Hepatology, Department of Medicine, Weill Cornell Medical College, New York, NY 10065, USA.
出版信息
J Acquir Immune Defic Syndr. 2011 Nov 1;58(3):261-8. doi: 10.1097/QAI.0b013e3182324af9.
BACKGROUND
Pegylated-interferon (PEG-IFN) and ribavirin (RBV), current standard treatment for hepatitis C virus (HCV) infection, are frequently associated with neutropenia and anemia, leading to high treatment discontinuation rates in HIV/HCV-coinfected patients. Our objective was to compare the effectiveness of intervening with hematologic growth factors versus dose reductions of standard HCV therapy for the management of treatment-induced hematologic disorders.
METHODS
Ninety-two HIV/HCV-coinfected, therapy-naive subjects received PEG-IFN alfa-2b 1.5 μg·kg⁻¹·wk⁻¹ and RBV 13 ± 2 mg·kg⁻¹·d⁻¹ for up to 48 weeks. Before treatment initiation, subjects were randomized to subsequently receive growth factors, recombinant human erythropoietin (rHuEPO) and/or granulocyte colony-stimulating factor, or dose reduction (RBV and/or PEG-IFN) for anemia and neutropenia management, respectively. We analyzed the ability of each management strategy to control anemia and neutropenia and the percentage of subjects who achieved a successful treatment outcome according to the different management strategies.
RESULTS
During treatment, 43 subjects developed anemia (human erythropoietin, n = 24; dose reduction, n = 19), whereas 25 subjects developed neutropenia (granulocyte colony-stimulating factor, n = 10; dose reduction, n = 15). After the intervention, the increase in both hemoglobin and absolute neutrophil counts did not differ between the 2 side effect management strategies. Sustained response percentages were similar comparing anemic and neutropenic subjects regardless of management strategy (anemia: recombinant human erythropoietin, 29% versus dose reduction, 21%, P = 0.92; neutropenia: granulocyte colony-stimulating factor, 40% versus dose reduction, 20%, P = 0.46).
CONCLUSIONS
Growth factor supplementation and dose reduction do not seem to differ as management strategies for anemia and neutropenia in HIV/HCV-coinfected individuals treated with PEG-IFN/RBV.
背景
聚乙二醇干扰素（PEG-IFN）和利巴韦林（RBV）是目前治疗丙型肝炎病毒（HCV）感染的标准治疗方法，但常与中性粒细胞减少和贫血相关，导致 HIV/HCV 合并感染患者的治疗中断率较高。我们的目的是比较干预血液生长因子与降低标准 HCV 治疗剂量，以管理治疗诱导的血液学疾病。
方法
92 例 HIV/HCV 合并感染、初治的受试者接受 PEG-IFN alfa-2b 1.5 μg·kg⁻¹·wk⁻¹和 RBV 13 ± 2 mg·kg⁻¹·d⁻¹，疗程最长 48 周。在开始治疗前，受试者随机接受生长因子、重组人红细胞生成素（rHuEPO）和/或粒细胞集落刺激因子，或分别用于贫血和中性粒细胞减少症管理的剂量减少（RBV 和/或 PEG-IFN）。我们分析了每种管理策略控制贫血和中性粒细胞减少症的能力，以及根据不同管理策略达到成功治疗结局的受试者比例。
结果
治疗期间，43 例患者发生贫血（rHuEPO，n = 24；剂量减少，n = 19），25 例患者发生中性粒细胞减少症（粒细胞集落刺激因子，n = 10；剂量减少，n = 15）。干预后，血红蛋白和绝对中性粒细胞计数的增加在两种副作用管理策略之间没有差异。无论管理策略如何，贫血和中性粒细胞减少患者的持续反应率相似（贫血：rHuEPO，29%与剂量减少，21%，P = 0.92；中性粒细胞减少症：粒细胞集落刺激因子，40%与剂量减少，20%，P = 0.46）。
结论
在接受 PEG-IFN/RBV 治疗的 HIV/HCV 合并感染个体中，生长因子补充和剂量减少似乎不能作为贫血和中性粒细胞减少症的管理策略。
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