EASL 2013 聚乙二醇化干扰素α-2a（40KD）HBeAg阳性响应引导治疗

StephenW

Abstract 749
     
EFFICACY AND SAFETY OF PEGINTERFERON ALFA-2A (40KD) IN HBEAG-POSITIVE CHRONIC HEPATITIS B PATIENTS PARTICIPATING IN A RESPONSE-GUIDED THERAPY STUDY: AN INTERIM ANALYSIS AT WEEK 72     Move back Print add this item to your Itinerary
     
J. Hou1*, H. Ma2, J. Sun1, Q. Xie3, Y. Xie4, Y. Sun5, H. Wang6, G. Shi7, M. Wan8, J. Niu9, Q. Ning10, Y. Yu11, Y. Zhao12
1Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangdong Province, 2Liver Research Center, Beijing Friendship Hospital, Beijing, 3Department of Infectious Disease, Shanghai Ruijin Hospital, Shanghai, 4Liver Disease Department, Beijing DiTan Hospital, Beijing, 5Department of Infectious Disease, Tangdu Hospital, The Fourth Military Medical University, Shaanxi Province, 6Liver Disease Department, Peking University People’s Hospital, Beijing, 7Department of Infectious Disease, Huashan Hospital Affiliated to Fudan University, 8Department of Infectious Disease, Shanghai Changhi Hospital, Shanghai, 9Department of Liver, First Hospital of Jilin University, Jilin Province, 10Department of Infectious Disease, Wuhan Tongji Hospital Affiliated Hauzhong Technology University, Tongji Medical College, Hubei Province, 11Department of Infectious Disease, Peking University First Hospital, Beijing, 12Shanghai Roche Pharmaceuticals Co Ltd, Shanghai, China. *[email protected]
Disease, Wuhan Tongji Hospital Affiliated Hauzhong Technology University, Tongji Medical College, Hubei Province, 11Department of Infectious Disease, Peking University First Hospital, Beijing, 12Shanghai Roche Pharmaceuticals Co Ltd, Shanghai, China. *[email protected]

Background/aims: Early on-treatment HBsAg decline is associated with sustained response post-treatment, and HBV DNA levels may improve prediction. This study in HBeAg-positive chronic hepatitis B patients aims to identify how response to peginterferon alfa-2a (Peg-IFNα-2a) can be optimised through treatment extension or combination with nucleos(t)ide analogues using a response-guided treatment strategy. Interim results are reported.
Methods: After 24 weeks of Peg-IFNα-2a treatment, patients categorised as early responders (HBsAg < 1500 IU/mL and HBV DNA < 105 copies/mL) received Peg-IFNα-2a for a further 24 weeks (total 48 weeks; Arm A; N=66). Non-early responders were randomised to Peg-IFNα-2a for 24 (total 48 weeks; Arm B; N=67), 72 (total 96 weeks; Arm C;N=67) or 72 weeks plus adefovir add-on at week 29 for 36 weeks (total 96 weeks; Arm D; N=64). Patients were followed-up for 24 weeks post-treatment. Only patients in Arms A and B have completed follow-up.
Results: The analysis included 264 patients. HBeAg seroconversion at week 48 was achieved by 33.3% of patients in Arm A compared with 13.4%, 14.9% and 9.4% in Arms B, C and D. Addition of adefovir in Arm D resulted in a higher proportion of patients achieving HBV DNA < 2000 IU/mL (57.8%) versus Arms B (25.4%) and C (31.3%). At 24 weeks post-treatment, a higher rate of HBeAg seroconversion was observed in Arm A (48.5%) than B (31.3%), p=0.0435. Median HBsAg decline from baseline to week 72 was greater in Arm A than B, and a similar trend was observed for HBV DNA decline (Figures 1 and 2); treatment is ongoing in Arms C and D. Treatment was well-tolerated; only three patients discontinued treatment due to adverse events (one each in Arms A, B and D).

Summary: Early responders achieved higher rates of HBeAg seroconversion at weeks 48 and 72; HBsAg and HBV DNA declines from baseline to week 72 were also more pronounced. Results from Arms C and D, expected in 2013, will provide information regarding outcomes in non-early responders with treatment modification.

[Figure_1_HBsAg decline]


[Figure_2_HBV DNA decline]


Assigned speakers:

StephenW

背景/目的：早期治疗的HBsAg下降伴有持续应答治疗后，HBV DNA水平可能会提高预测。 HBeAg阳性慢性乙型肝炎患者的这项研究旨在确定如何响应可以通过治疗延长或组合优化与聚乙二醇干扰素α-2a干扰素（PEG-IFNα-2a）的核苷（酸）类似物使用响应指导治疗策略。中期业绩报告。
方法：PEG-IFNα-2a干扰素治疗24周后，病人早期反应者（乙肝表面抗原<1500 IU / mL和HBV DNA <105拷贝/毫升），另有24周（共48周接受PEG-IFNα-2a的分类; A组，N = 66）。非早期应答者被随机分为PEG-IFNα-2a的24（共48周，B组，N = 67），72（共96周; ARM C，N = 67）或阿德福韦72周加周29 36周（共96周;臂D，N = 64）。患者进行随访治疗后24周。只有A和B武器的患者中已经完成了随访。
结果：分析264例。 33.3％的患者在ARM 48周时的HBeAg血清学转换是通过比较，13.4％，14.9％和9.4％的武器B，C和D加入ARM的D阿德福韦导致更高比例的患者达到HBV DNA <为2000 IU / mL（57.8％）与武器乙（25.4％）和C（31.3％）。在治疗后24周，HBeAg血清转换率较高的观察在ARM（48.5％）比B（31.3％），P = 0.0435。位数的HBsAg下降，从基线到72周A组比B大，观察到了类似的趋势（图1和图2）HBV DNA下降;武器C和D治疗耐受性良好的治疗是正在进行中，只有三个病人停止治疗，由于不良事件（每个武器A，B和D）。
摘要：早期应答者达到48周和72周时HBeAg血清学转换率较高，HBsAg和HBV DNA下降，从基线到72周也更加明显。结果从武器C和D，预计在2013年，将提供有关非早期反应治疗修改的结果。