在乙型肝炎e抗原阳性患者完成聚乙二醇干扰素α-2a治疗后，

StephenW

Responses are durable for up to 5 years after completion of peginterferon alfa‐2a treatment in hepatitis B e antigen‐positive patients
W.‐L. Chuang
J. Jia
H. L. Y. Chan
K.‐H. Han
T. Tanwandee
D. Tan
X. Chen
E. Gane
T. Piratvisuth
L. Chen
Q. Xie
J. J.‐Y. Sung
D. Messinger
C. Wat
G. Bakalos
Y. F. Liaw
First published: 9 March 2018
https://doi.org/10.1111/apt.14595

The Handling Editor for this article was Professor Roy Pounder, and it was accepted for publica ... More

The authors’ complete affiliations are listed in Appendix 1.
Read the full text


Summary
Background

In the large randomised NEPTUNE study, peginterferon alfa‐2a 180 μg/wk for 48 weeks produced higher hepatitis B e antigen (HBeAg) seroconversion rates 24 weeks post‐treatment (36%) than a lower dose (90 μg/wk) and/or shorter duration (24 weeks) (range 14%‐26%).
Aim

To determine seroconversion rates 5 years after completion of treatment in NEPTUNE.
Methods

HBeAg‐positive patients who completed 24 weeks’ follow‐up in NEPTUNE (with peginterferon alfa‐2a 90 μg/wk × 24 weeks [group 1]; 180 μg/wk × 24 weeks [2]; 90 μg/wk × 48 weeks [3] or 180 μg/wk × 48 weeks [4]) were followed up.
Results

Three hundred and eighty three of the 544 patients in the original study were enrolled in the long‐term follow‐up study. Many patients (196 overall; more in groups 1‐3 than 4) received nucleos(t)ide analogues or immunomodulators during follow‐up, and more patients had missing data at year 5 in groups 2 and 4 (48 weeks, 50/112) than in groups 1 and 3 (24 weeks, 23/103), which confounds the planned per‐protocol analysis. HBeAg seroconversion rates in groups 1, 2, 3 and 4 at year 5 were 47.5%, 50.7%, 52.2% and 67.1%, respectively, (odds ratio for group 4 versus 1‐3: 2.02; 95% CI 1.21, 3.38), using multiple imputation methods for missing measurements.
Conclusion

Seroconversion rates are durable for up to 5 years after completion of peginterferon alfa‐2a therapy and, consistent with NEPTUNE, the results suggest that the licensed regimen (180 μg × 48 weeks) is more efficacious for HBeAg‐positive patients than a lower dose and/or shorter treatment duration.

StephenW

在乙型肝炎e抗原阳性患者完成聚乙二醇干扰素α-2a治疗后，响应持续长达5年
W.-L.庄
J. Jia
H.L.Y.Chan
K.-H。韩
T. Tanwandee
D. Tan
X.陈
E.甘恩
T. Piratvisuth
L. Chen
谢先生
J. J.-Y.宋
D. Messinger
C. Wat
G. Bakalos
Y. F. Liaw
首次发表：2018年3月9日
https://doi.org/10.1111/apt.14595

这篇文章的处理编辑是Roy Pounder教授，并且被公开接受了......更多

附录1列出了作者完整的从属关系。
阅读全文


概要
背景

在大型随机NEPTUNE研究中，聚乙二醇干扰素α-2a 180μg/周48周可使治疗后24周的HBeAg血清转换率（36％）高于较低剂量（90μg/周）和/或持续时间较短（24周）（范围14％-26％）。
目标

确定NEPTUNE治疗结束5年后的血清转化率。
方法

HBeAg阳性患者在NEPTUNE（聚乙二醇干扰素α-2a90μg/周×24周[组1];180μg/周×24周[2];90μg/周×48周）中完成24周随访[3]或180微克/周×48周[4]）随访。
结果

原始研究中544名患者中的三百八十三名参加了长期随访研究。在随访期间，许多患者（总体上196名;更多1-3组比4）在接受随访期间接受了核苷（酸）类似物或免疫调节剂，并且更多患者在第2组和第4组（48周，50/112 ）比组1和3（24周，23/103），这混淆了计划的每个协议分析。第5，第1,2,3和4组HBeAg血清转换率分别为47.5％，50.7％，52.2％和67.1％（第4组比较比1-3：2.02; 95％CI 1.21,3.38） ，使用多种插补方法进行缺失测量。
结论

在完成聚乙二醇干扰素α-2a治疗后，血清转化率持续达5年，与NEPTUNE相一致，结果表明许可方案（180μg×48周）对于HBeAg阳性患者比低剂量更有效， /或更短的治疗持续时间。

StephenW

https://onlinelibrary.wiley.com/doi/full/10.1111/apt.14595