Peginterferon alfa-2a (40KD) plus ribavirin in chronic hepatitis C patients who failed previous interferon therapy
Peginterferon alfa-2a (40KD) plus ribavirin in chronic hepatitis C patients who failed previous interferon therapy
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DOI：
10.1136/gut.2005.083113
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发表时间：
2006-11-01
期刊：
影响因子：
24.5
通讯作者：
Lee, S. S.
中科院分区：
文献类型：
--
作者：
Sherman, M.;Yoshida, E. M.;Lee, S. S.
背景：慢性丙型肝炎复发或对干扰素治疗无效的患者的管理是肝病学家面临的一个重要问题。目的：我们通过开展一项多中心开放标签研究，评估聚乙二醇干扰素α -2a （40KD）联合利巴韦林在该人群中的有效性和安全性。患者：分析了以往常规干扰素或常规干扰素/利巴韦林联合治疗后无应答或复发的血清丙型肝炎病毒（HCV） RNA检测成人的数据。方法：根据研究人员的决定，患者接受聚乙二醇干扰素α -2a (40KD) 180 mg/周加利巴韦林800 mg/天的治疗，持续24或48周。该研究是在基因1型患者的最佳利巴韦林剂量（1000/1200 mg/天）已知之前构思的。主要终点是持续病毒学应答（SVR），定义为随访24周后未检测到HCV RNA （< 50 IU/ml）。分析的目的是治疗。结果：共纳入312例患者（无应答者212例，复发者100例）。其中28例患者治疗24周，284例患者治疗48周。无应答者和复发者的基线特征相似，但更多的无应答者有基因型1感染（87% vs 69%）。无应答者的总SVR为23%(48/212)，复发者为41%（41/100）。按基因型分析数据时，基因型1的SVR为24%(61/253)，基因型2/3的SVR为47%（28/59）。结论：在一个大的患者队列中，这些结果表明，通过聚乙二醇干扰素α -2a （40KD）加利巴韦林治疗，有可能治愈一部分以前无反应和复发的患者。
Background: The management of patients with chronic hepatitis C who have relapsed or failed to respond to interferon based therapies is an important issue facing hepatologists.Aims: We evaluated the efficacy and safety of peginterferon alfa-2a ( 40KD) plus ribavirin in this population by conducting a multicentre open label study.Patients: Data from adults with detectable serum hepatitis C virus ( HCV) RNA who had not responded or had relapsed after previous conventional interferon or conventional interferon/ribavirin combination therapy were analysed.Methods: Patients were retreated with peginterferon alfa-2a ( 40KD) 180 mg/week plus ribavirin 800 mg/day for 24 or 48 weeks at the investigators' discretion. The study was conceived before the optimal dose of ribavirin ( 1000/1200 mg/day) for patients with genotype 1 was known. The primary endpoint was sustained virological response ( SVR), defined as undetectable HCV RNA (< 50 IU/ml) after 24 weeks of follow up. The analysis was conducted by intention to treat.Results: A total of 312 patients ( 212 non-responders, 100 relapsers) were included. Of these, 28 patients were treated for 24 weeks and 284 for 48 weeks. Baseline characteristics between non-responders and relapsers were similar although more non-responders had genotype 1 infection ( 87% v 69%). Overall SVR rates were 23% ( 48/212) for non-responders and 41% ( 41/100) for relapsers. When data were analysed by genotype, SVR rates were 24% ( 61/253) in genotype 1 and 47% ( 28/59) in genotype 2/3.Conclusions: These results in a large patient cohort demonstrate that it is possible to cure a proportion of previous non-responders and relapsers by retreating with peginterferon alfa-2a ( 40KD) plus ribavirin.