Kamal Sanaa M, Fouly Amr E, Kamel Refaat R, Hockenjos Bridgette, Al Tawil Ahmed, Khalifa Khalifa E, He Qi, Koziel Margaret J, El Naggar Khairy M, Rasenack Jens, Afdhal Nezam H
Division of Gastroenterology and Liver Disease Center, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Gastroenterology. 2006 Mar;130(3):632-8. doi: 10.1053/j.gastro.2006.01.034.
BACKGROUND & AIMS: Pegylated interferon therapy has not been adequately evaluated in acute hepatitis C virus (HCV) infection. This randomized trial assessed the efficacy, safety, and timing of pegylated interferon alfa-2b for treatment of acute hepatitis C.
One hundred seventy-five patients acutely infected with HCV were screened. Patients whose infection did not spontaneously resolve by week 8 were randomized to once weekly peginterferon alfa-2b monotherapy (1.5 microg/kg per week) started at weeks 8, 12, or 20 for a duration of 12 weeks. The primary endpoint was undetectable HCV RNA 24 weeks after the end of treatment (sustained virologic response [SVR]). All patients were followed for 48 weeks after cessation of therapy.
One hundred twenty-nine subjects started treatment at week 8 (group A, n = 43), week 12 (group B, n = 43), or week 20 (group C, n = 43). By using an intent-to-treat analysis, the overall SVR rate was 87%. The SVR rates were 95%, 92%, and 76% with treatment onset at 8, 12, and 20 weeks, respectively. Overall, SVR rates were better for patients infected with genotypes 2, 3, and 4 than those infected with genotype 1. Earlier initiation of therapy improved SVR rates for patients infected with genotype 1 with high viral load. Peginterferon alfa-2b was well tolerated. Subjects with SVR maintained undetectable HCV RNA 48 weeks after therapy.
Peginterferon alfa-2b monotherapy in acute hepatitis C induces high sustained virologic response rates, prevents chronic evolution, and is well tolerated. Initiation of treatment at week 8 or 12 results in higher sustained virologic rates than initiation at week 20.
聚乙二醇化干扰素疗法在急性丙型肝炎病毒（HCV）感染中的疗效尚未得到充分评估。本随机试验评估了聚乙二醇化干扰素α-2b治疗急性丙型肝炎的疗效、安全性及治疗时机。
对175例急性感染HCV的患者进行筛查。感染在第8周时未自发缓解的患者被随机分为三组，分别在第8周、第12周或第20周开始接受每周一次的聚乙二醇化干扰素α-2b单药治疗（1.5μg/kg/周），疗程为12周。主要终点为治疗结束后24周时HCV RNA检测不到（持续病毒学应答[SVR]）。所有患者在治疗停止后随访48周。
129名受试者在第8周（A组，n = 43）、第12周（B组，n = 43）或第20周（C组，n = 43）开始治疗。采用意向性分析，总体SVR率为87%。治疗开始于第8周、第12周和第20周时的SVR率分别为95%、92%和76%。总体而言，感染2、3和4型的患者的SVR率高于感染1型的患者。对于高病毒载量的1型感染患者，更早开始治疗可提高SVR率。聚乙二醇化干扰素α-2b耐受性良好。达到SVR的受试者在治疗后48周HCV RNA仍检测不到。
聚乙二醇化干扰素α-2b单药治疗急性丙型肝炎可诱导较高的持续病毒学应答率，预防慢性化，且耐受性良好。在第8周或第12周开始治疗比在第20周开始治疗能获得更高的持续病毒学应答率。
