APASL2013乙肝表面抗原水平预测干扰素α-2a干扰素（40KD）AS

StephenW

HBsAg Level Predicts Sustained Response in Peginterferon Alfa-2a (40KD)-treated HBeAg-positive Patients: Initial Post-treatment Results from the 'Real-life' S-collate Cohort
Heiner Wedemeyer1, Qing Xie2, Teerha Piratvisuth3, Seung Woon Paik4, Yongping Chen5, Yao Xie6, XiaoPing Chen7, Loredana Regep8, Diethelm Messinger9, Patrick Marcellin10
1Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, Hannover, Germany, 2Department of Infectious Diseases, Shanghai Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China, 3Department of Internal Medicine, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand, 4Division of Gastroenterology, Samsung Medical Center, Sungkyunkwan University Kangbook Samsung Hospital, Seoul, Republic of Korea, 5Infection Department, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, 6Beijing DiTan Hospital, Beijing, 7Guangdong Provincial People’s Hospital, Guangdong, China, 8F. Hoffmann-La Roche, Basel, 9IST GmbH, Mannheim, Germany, 10Service d’Hépatologie and INSERM CRB3/U773, University Paris-Diderot, Paris, France
Background: S-Collate is a multinational, prospective, observational cohort study investigating on-treatment predictors of hepatitis B surface antigen (HBsAg) clearance in peginterferon alfa-2a (Peg-IFNα-2a) (40KD)-treated chronic hepatitis B patients. Of 1802 patients treated with Peg-IFNα-2a, 866 were hepatitis B e antigen (HBeAg)-positive. The first post-treatment (6 months) outcomes in HBeAg-positive patients are reported. Methods: Patients treated with Peg-IFNα-2a for a maximum of 1 year were included (N=655). Response rates were calculated using available measurements at end of treatment or 6 months post-treatment. Results: Mean age was 31.3 years, 74% were Asian and 68% male. The majority of patients (94%) had no previous treatment with interferon/antiviral agents. Six months post-treatment, HBeAg loss + hepatitis B virus (HBV) DNA < 2000 IU/mL (combined endpoint) and HBV DNA < 80 IU/mL was achieved in 23% and 22% of patients, respectively (table). HBsAg < 1000 IU/mL was achieved in 31% of patients. HBsAg ≤20 000 IU/mL at week 24 was associated with higher rates of the combined endpoint post-treatment than >20 000 IU/mL (26% vs 8%); HBsAg < 1500 IU/mL at week 24 was associated with the highest rate of the combined endpoint (45%). Rates of adverse and serious adverse events were similar to previous studies, with 7% of treatment withdrawals due to adverse events. Conclusions: Peg-IFNα-2a was efficacious and well-tolerated in a 'real-life' cohort of HBeAg-positive patients treated for up to 1 year, supporting findings from the Phase III/NEPTUNE studies. On-treatment measurements of HBsAg predicted the likelihood of achieving the combined endpoint post-treatment. [HBeAg-positive table]

StephenW

背景：S-分页是一家跨国公司，前瞻性，观察性队列研究，调查乙肝表面抗原（HBsAg）的间隙聚乙二醇干扰素α-2a干扰素（PEG-IFNα-2a）的处理（40KD）慢性乙肝患者治疗的预测。与PEG-IFNα-2a干扰素治疗的1802例患者中，866例乙肝e抗原（HBeAg）阳性。 HBeAg阳性患者第一次治疗后（6个月）结果的报告。
方法：用PEG-IFNα-2a干扰素治疗的患者最多1年（N = 655）。应答率分别为治疗或治疗后6个月结束时使用可用的测量计算。
结果：平均年龄为31.3岁，74％为亚洲人和68％的男性。多数患者（94％）以前没有与干扰素/抗病毒药物治疗。 6个月的治疗后，HBeAg消失+ B型肝炎病毒（HBV）DNA <2000 IU /毫升（联合终点）和HBV DNA <80 IU / mL的达到了23％和22％的患者，分别为（表）。取得了31％的患者乙肝表面抗原<1000 IU / mL的。乙肝表面抗原≤20 000 IU / mL的24周相关与联合终点后处理率较高比> 20 000 IU /毫升（26％比8％），乙肝表面抗原<1500 IU / mL的24周与率最高（45％）的联合终点。不良率和严重不良事件类似于以前的研究，由于不良事件的处理提款的7％。
结论：PEG-IFNα-2a的疗效和耐受性良好的治疗HBeAg阳性患者长达1年的“现实生活”的队列，支持从第一阶段III /海王星研究结果。处理测量HBsAg的预测实现的联合终点后处理的可能性。
[HBeAg阳性表]