Kamal Sanaa M, Moustafa Khairy N, Chen Jason, Fehr Jutta, Abdel Moneim Azza, Khalifa Khalifa E, El Gohary Leila A, Ramy Amr H, Madwar Mohamed A, Rasenack Jens, Afdhal Nezam H
Department of Gastroenterology and Liver Disease Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02115, USA.
Hepatology. 2006 May;43(5):923-31. doi: 10.1002/hep.21197.
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 microg/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.
急性丙型肝炎病毒感染的自发缓解无法预测，该病在大多数情况下会慢性进展。为评估聚乙二醇干扰素α-2b分别治疗8周、12周或24周对急性丙型肝炎病毒感染患者的疗效和安全性，共纳入161例急性丙型肝炎病毒感染患者。其中，30例患者拒绝治疗，但作为非随机对照组留在研究中。在131例同意治疗的患者中，29例自发缓解，其余102例患者被随机分配接受聚乙二醇干扰素α-2b（1.5μg/kg）治疗，其中8周治疗组（A组；n = 34）、12周治疗组（B组；n = 34）和24周治疗组（C组；n = 34）。主要终点为持续病毒学应答。采用意向性分析评估疗效和安全性终点。A组、B组和C组分别有23/34（67.6%）、28/34（82.4%）和31/34（91.2%）的患者实现了持续病毒学应答；所有患者在治疗结束后48周时丙型肝炎病毒RNA均检测不到。2、3和4型基因型患者接受8周或12周治疗有效，而1型基因型患者需要24周治疗。与24周治疗方案相比，8周和12周治疗方案的不良事件较少。总之，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获得较高的持续病毒学应答率，从而预防慢性丙型肝炎的发生。应根据基因型和第4周时的快速病毒学应答进一步优化治疗疗程。
