乙肝e抗原阳性患者完成聚乙二醇干扰素α-2a治疗后，响应持

StephenW

Aliment Pharmacol Ther. 2018 Mar 9. doi: 10.1111/apt.14595. [Epub ahead of print]
Responses are durable for up to 5 years after completion of peginterferon alfa-2a treatment in hepatitis B e antigen-positive patients.
Chuang WL1, Jia J2, Chan HLY3, Han KH4, Tanwandee T5, Tan D6, Chen X2, Gane E7, Piratvisuth T8, Chen L9, Xie Q9, Sung JJ3, Messinger D10, Wat C11, Bakalos G12, Liaw YF13.
Author information

1
    Kaohsiung, Taiwan.
2
    Beijing, China.
3
    Hong Kong SAR, China.
4
    Seoul, Korea.
5
    Bangkok, Thailand.
6
    Changsha, China.
7
    Grafton, New Zealand.
8
    Hat-Yai, Thailand.
9
    Shanghai, China.
10
    Mannheim, Germany.
11
    Welwyn Garden City, UK.
12
    Basel, Switzerland.
13
    Taipei, Taiwan.

Abstract
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.

© 2018 John Wiley & Sons Ltd.

PMID:
    29520872
DOI:
    10.1111/apt.14595

StephenW

Aliment Pharmacol Ther。 2018年3月9日doi：10.1111 / apt.14595。 [电子版提前打印]
乙肝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5年。
Chuang WL1，Jia J2，Chan HLY3，Han KH4，Tanwandee T5，Tan D6，Chen X2，Gane E7，Piratvisuth T8，Chen L9，Xie Q9，Sung JJ3，Messinger D10，Wat C11，Bakalos G12，Liaw YF13。
作者信息

1
    高雄，台湾。
2
    中国北京。
3
    中国香港特别行政区。
4
    韩国首尔。
五
    曼谷，泰国。
6
    长沙，中国。
7
    格拉夫顿，新西兰。
8
    Hat-Yai，泰国。
9
    上海，中国。
10
    德国曼海姆。
11
    韦林花园城市，英国。
12
    瑞士巴塞尔。
13
    台北，台湾。

抽象
背景：

在大型随机NEPTUNE研究中，聚乙二醇干扰素α-2a180μg/周48周可使治疗后24周产生更高的乙型肝炎e抗原（HBeAg）血清转换率（36％），而较低剂量（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。

©2018 John Wiley＆Sons Ltd.

结论：
    29520872
DOI：
    10.1111 / apt.14595