Duration of peginterferon therapy in acute hepatitis C: A randomized trial
Duration of peginterferon therapy in acute hepatitis C: A randomized trial
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DOI：
10.1002/hep.21197
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发表时间：
2006-05-01
期刊：
影响因子：
13.5
通讯作者：
Afdhal, NH
中科院分区：
文献类型：
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作者：
Kamal, SM;Moustafa, KN;Afdhal, NH
急性丙型肝炎病毒感染的自发消退是无法预测的，在大多数情况下，疾病会发生慢性演变。为了评估聚乙二醇干扰素α -2b在急性丙型肝炎病毒感染患者中应用8周、12周或24周的有效性和安全性，共有161例患者被确定为急性丙型肝炎病毒感染。其中，30名患者拒绝治疗，但作为非随机对照组保留在研究中。在131名同意治疗的患者中，29名患者自发消退，剩下102名患者随机分配给聚乙二醇干扰素α -2b （1-5 μ g/ kg）治疗8周（A组，n = 34）， 12周（B组，n = 34）和24周（C组，n = 34）。主要终点是持续的病毒学反应。疗效和安全性终点采用意向治疗分析。A组、B组和C组分别有23/34（67.6%）、28/34（82.4%）和31/34（91.2%）的患者实现了持续的病毒学应答；治疗结束48周后，所有患者的丙型肝炎病毒RNA均检测不到。基因型2、3和4治疗8或12周有效，而基因型1需要治疗24周。与24周的治疗方案相比，8周和12周的治疗方案的不良事件较少。综上所述，聚乙二醇干扰素α -2b可有效诱导急性丙型肝炎病毒感染患者较高的持续病毒学应答率，从而预防慢性丙型肝炎的发展。应根据基因型和第4周的快速病毒学应答进一步优化治疗时间。
Spontaneous resolution of acute hepatitis C virus infection cannot be predicted, and chronic evolution of the disease occurs in a majority of cases. To assess the efficacy and safety of peginterferon alpha-2b administered for 8, 12, or 24 weeks in patients with acute hepatitis C virus infection a total of 161 patients were identified with acute hepatitis C virus infection. Of these, 30 patients refused treatment but were retained in the study as a nonrandomized comparison group. Of the 131 patients who consented to treatment, 29 patients spontaneously resolved, leaving 102 patients randomly assigned to peginterferon alpha-2b (1-5 mu g/ kg) for 8 weeks (group A; n = 34), 12 weeks (group B; n = 34), and 24 weeks (group C; n = 34). The primary end point was sustained virologic response. An intent-to-treat analysis was used for efficacy and safety end points. Sustained virologic response was achieved in 23/34 (67.6%), 28/34 (82.4%), and 31/34 (91.2%) of patients in groups A, B, and C, respectively; all had undetectable hepatitis C virus RNA 48 weeks after the end of therapy. Treatment for 8 or 12 weeks was effective in genotypes 2, 3, and 4, whereas genotype 1 required 24 weeks of therapy. The 8- and 12-week regimens were associated with fewer adverse events compared with the 24-week regimen. In conclusion, peginterferon alpha-2b effectively induces high sustained virologic response rates in patients with acute hepatitis C virus infection, thus preventing development of chronic hepatitis C. Duration of treatment should be further optimized based on genotype and rapid virologic response at week 4.