Peginterferon alfa-2b and Ribavirin: Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy
Peginterferon alfa-2b and Ribavirin: Effective in Patients With Hepatitis C Who Failed Interferon alfa/Ribavirin Therapy
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DOI：
10.1053/j.gastro.2009.01.039
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发表时间：
2009-05-01
期刊：
影响因子：
29.4
通讯作者：
Albrecht, Janice
中科院分区：
文献类型：
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作者：
Poynard, Thierry;Colombo, Massimo;Albrecht, Janice
背景和目标：聚乙二醇干扰素α和利巴韦林联合治疗约60%的丙型肝炎病毒（HCV）感染患者可产生持续病毒学应答（SVR）。对于复发或对治疗无反应的患者，需要替代选择。研究方法：这项前瞻性、国际性、多中心、开放标签研究评估了聚乙二醇干扰素α-2b（1.5 μ g/kg/wk）联合利巴韦林（800-1400 mg/d）治疗2333例既往干扰素α/利巴韦林治疗失败的慢性HCV感染伴显著纤维化/肝硬化患者的疗效和安全性。在治疗第12周（TW）检测不到HCV-RNA的患者接受48周治疗;在TW 12检测到HCV-RNA的患者可以在TW 18进入维持研究; 188例在TW 12检测到HCV-RNA低/可检测的患者应研究者的要求继续治疗。结果：总体而言，22%的患者达到了SVR（56%的患者在TW 12时检测不到HCV-RNA，12%的患者在TW 12时检测到HCV-RNA低/可检测）。无论既往是否接受过治疗，复发者（38%）的SVR均优于无应答者（14%），既往接受过α-干扰素/利巴韦林治疗的患者（25%）的SVR均优于聚乙二醇干扰素α-利巴韦林（17%）。在TW 12检测不到HCV-RNA的患者中，预测应答的因素是基因型（分别为2/3 vs 1;比值比[OR] 2.4; P < .0001）、纤维化评分（F2 vs F4; OR，2.2; F3 vs F4; OR，1.7; P < .0001）和基线病毒载量（600，000 IU/mL; OR，1.4; P = .0223）。这些因素加上既往治疗和反应是SVR的总体预测因素。纤维化组之间的安全性相似。结论：聚乙二醇干扰素α-2b联合利巴韦林治疗干扰素α/利巴韦林治疗失败的患者是有效和安全的。基因型、基线病毒载量和纤维化分期是缓解的预测因素。
Background & Aims: Treatment with peginterferon alfa and ribavirin produces a sustained virologic response (SVR) in approximately 60% of hepatitis C virus (HCV)-infected patients. Alternate options are needed for patients who relapse or do not respond to therapy. Methods: This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 mu g/kg/wk) plus weight-based ribavirin (800-1400 mg/day) in 2333 chronic HCV-infected patients with significant fibrosis/cirrhosis whose previous interferon alfa/ribavirin therapy failed. Patients with undetectable HCV-RNA at treatment week (TW) 12 received 48 weeks of therapy; patients with detectable HCV-RNA at TW12 could enter maintenance studies at TW18; 188 patients with low/detectable HCV-RNA at TW12 continued therapy at the investigator's request. Results: Overall, 22% of the patients attained SVR (56% with undetectable HCV-RNA and 12% with low/detectable HCV-RNA at TW12). SVR was better in relapsers (38%) than nonresponders (14%), regardless of previous treatment, and in patients previously treated with interferon-alfa/ribavirin (25%) than peginterferon alfa-ribavirin (17%). Predictors of response in patients with undetectable HCV-RNA at TW12 were genotype (2/3 vs 1, respectively; odds ratio [OR] 2.4; P < .0001), fibrosis score (F2 vs F4; OR, 2.2; F3 vs F4; OR, 1.7; P < .0001), and baseline viral load (600,000 IU/mL; OR, 1.4; P = .0223). These factors plus previous treatment and response were overall predictors of SVR. Safety was similar among fibrosis groups. Conclusions: Peginterferon alfa-2b plus weight-based ribavirin is effective and safe in patients who failed interferon alfa/ribavirin therapy. Genotype, baseline viral load, and fibrosis stage were predictors of response.