聚乙二醇化干扰素单药治疗与恩替卡韦和聚乙二醇化干扰素

StephenW

Chin Med J (Engl). 2018 Jul 20;131(14):1645-1651. doi: 10.4103/0366-6999.235880.
Efficacy of Pegylated Interferon Monotherapy versus Sequential Therapy of Entecavir and Pegylated Interferon in Hepatitis B e Antigen-Positive Hepatitis B Patients: A Randomized, Multicenter, Phase IIIb Open-Label Study (POTENT Study).
Jun DW1, Ahn SB2, Kim TY3, Sohn JH3, Kim SG4, Lee SW5, Kim BH6, Kim DJ7, Kim JK8, Kim HS9, Hwang SG10, Choi WC11, Tak WY12, Lee HJ13, Yoon KT14, Yun BC15, Lee SW16, Baik SK17, Park SH18, Park JW19, Park SJ20, Lee JS21.
Author information

1
    Department of Internal Medicine, Hanyang University Seoul Hospital, Hanyang University, Seoul 04763, Korea.
2
    Department of Internal Medicine, Nowon Eulji Hospital, Eulji University, Seoul 01830, Korea.
3
    Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University, Guri 11923, Korea.
4
    Department of Internal Medicine, SoonChunHyang University Bucheon Hospital, SoonChunHyang University, Bucheon 14584, Korea.
5
    Department of Internal Medicine, SoonChunHyang University Cheonan Hospital, SoonChunHyang University, Cheonan 31151, Korea.
6
    Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul 02453, Korea.
7
    Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University, Chuncheon 24252, Korea.
8
    Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University, Seoul 05355, Korea.
9
    Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University, Seoul 06273, Korea.
10
    Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam 13496, Korea.
11
    Department of Internal Medicine, Sanggye Paik Hospital, Inje University, Seoul 01757, Korea.
12
    Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University, Daegu 41944, Korea.
13
    Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University, Daegu 42415, Korea.
14
    Department of Internal Medicine, Pusan National University Yangsan Hospital, Pusan National University, Yangsan 50612, Korea.
15
    Department of Internal Medicine, Kosin University Gospel Hospital, Kosin University, Pusan 49267, Korea.
16
    Department of Internal Medicine, Dong A University Medical Center, Dong A University, Pusan 49201, Korea.
17
    Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University, Wonju 26426, Korea.
18
    Department of Internal Medicine, Haeundae Paik Hospital, Inje University, Pusan 48108, Korea.
19
    Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University, Anyang 14068, Korea.
20
    Department of Clinical Pharmacy, Graduate School of Clinical Pharmacy, Sungkyunkwan University, Suwon 16419, Korea.
21
    Clinical Research Center, Asan Medical Center, Seoul 05505, Korea.

Abstract
Background:

Until now, various types of combined therapy with nucleotide analogs and pegylated interferon (Peg-INF) in patients with hepatitis B patients have been tried. However, studies regarding the benefits of de novo combination, late-add on, and sequential treatment are very limited. The objective of the current study was to identify the efficacy of sequential treatment of Peg-INF after short-term antiviral treatment.
Methods:

Between June 2010 and June 2015, hepatitis B e antigen (HBeAg)-positive patients (n = 162) received Peg-IFN for 48 weeks (mono-treatment group, n = 81) and entecavir (ETV) for 12 weeks with a 48-week course of Peg-IFN starting at week 5 of ETV therapy (sequential treatment group, n = 81). The primary endpoint was HBeAg seroconversion at the end of follow-up period after the 24-week treatment. The primary endpoint was analyzed using Chi-square test, Fisher's exact test, and regression analysis.
Results:

HBeAg seroconversion rate (18.2% vs. 18.2%, t = 0.03, P = 1.000) and seroclearance rate (19.7% vs. 19.7%, t = 0.03, P = 1.000) were same in both mono-treatment and sequential treatment groups. The rate of alanine aminotransferase (ALT) normalization (45.5% vs. 54.5%, t = 1.12, P = 0.296) and serum hepatitis B virus (HBV)-DNA <2000 U/L (28.8% vs. 28.8%, t = 0.10, P = 1.000) was not different in sequential and mono-treatment groups at 24 weeks of Peg-INF. Viral response rate (HBeAg seroconversion and serum HBV-DNA <2000 U/L) was not different in the two groups (12.1% vs. 16.7%, t = 1.83, P = 0.457). Baseline HBV-DNA level (7 log10U/ml vs. 7.5 log10U/ml, t = 1.70, P = 0.019) and hepatitis B surface antigen titer (3.6 log10U/ml vs. 4.0 log10U/ml, t = 2.19, P = 0.020) were lower and predictors of responder in mono-treatment and sequential treatment groups, respectively.
Conclusions:

The current study shows no differences in HBeAg seroconversion rate, ALT normalization, and HBV-DNA levels between mono-therapy and sequential therapy regimens.
Trial Registration:

ClinicalTrials.gov, NCT01220596; https://clinicaltrials.gov/ct2/s ... 1220596&rank=1.
KEYWORDS:

Entecavir; Hepatitis B; Peginterferon Alfa-2a

PMID:
    29998882
DOI:
    10.4103/0366-6999.235880

StephenW

Chin Med J（Engl）。 2018年7月20日; 131（14）：1645-1651。 doi：10.4103 / 0366-6999.235880。
聚乙二醇化干扰素单药治疗与恩替卡韦和聚乙二醇化干扰素在乙型肝炎e抗原阳性乙型肝炎患者中的顺序治疗的疗效：随机，多中心，IIIb期开放标记研究（POTENT研究）。
Jun DW1，Ahn SB2，Kim TY3，Sohn JH3，Kim SG4，Lee SW5，Kim BH6，Kim DJ7，Kim JK8，Kim HS9，Hwang SG10，Choi WC11，Tak WY12，Lee HJ13，Yoon KT14，Yun BC15，Lee SW16 ，Baik SK17，Park SH18，Park JW19，Park SJ20，Lee JS21。
作者信息

1
    汉阳大学首尔医院内科，汉阳大学，首尔04763
2
    Eulji大学Nowon Eulji医院内科，首尔01830，韩国。
3
    汉阳大学汉城大学内里医院内科，韩国古里11923。
4
    SoonChunHyang大学富川大学内科，顺天大学，韩国富川市14584。
五
    SoonChunHyang大学天安医院内科，顺天大学，韩国天安31151
6
    韩国庆熙大学庆熙大学医院内科，首尔02453
7
    韩国春川市春川大学春川市中心医院内科24252。
8
    韩国汉城大学康东圣心医院内科，韩国首尔05355
9
    延世大学江南Severance医院内科，首尔06273，韩国。
10
    CHA大学CHA盆唐医疗中心内科，韩国城南13496。
11
    韩国首尔仁济大学Sanggye Paik医院内科，首尔01757
12
    Kyungpook国立大学Kyungpook国立大学医院内科，大邱41944，韩国。
13
    Yeungnam大学医学中心内科，大邱42415，韩国。
14
    釜山国立大学内蒙古自治区釜山国立大学内山医学院，梁山50612，韩国。
15
    Kosin大学Kosin大学福音医院内科，韩国釜山49267
16
    东亚大学东亚大学医学中心内科，韩国釜山49201
17
    延世大学原州Severance基督教医院内科，韩国原州26426
18
    Inje大学海云台白医院内科，韩国釜山48108
19
    哈利姆大学圣心大学医学院内科，安阳14068，韩国。
20
    成均馆大学研究生院临床药学系，韩国水原16419
21
    韩国首尔牙山医疗中心临床研究中心，05505

抽象
背景：

迄今为止，已经尝试了在乙型肝炎患者中使用核苷酸类似物和聚乙二醇化干扰素（Peg-INF）的各种类型的联合治疗。然而，关于从头组合，晚期添加和顺序治疗的益处的研究非常有限。本研究的目的是确定短期抗病毒治疗后顺序治疗Peg-INF的疗效。
方法：

2010年6月至2015年6月期间，乙型肝炎e抗原（HBeAg）阳性患者（n = 162）接受Peg-IFN治疗48周（单一治疗组，n = 81）和恩替卡韦（ETV）治疗12周，48例 - 在ETV治疗的第5周开始的Peg-IFN的每周疗程（顺序治疗组，n = 81）。主要终点是在24周治疗后的随访期结束时的HBeAg血清学转换。使用卡方检验，Fisher精确检验和回归分析分析主要终点。
结果：

单一治疗组和序贯治疗组的HBeAg血清转换率（18.2％对18.2％，t = 0.03，P = 1.000）和血清清除率（19.7％对19.7％，t = 0.03，P = 1.000）相同。丙氨酸氨基转移酶（ALT）正常化率（45.5％对54.5％，t = 1.12，P = 0.296）和血清乙型肝炎病毒（HBV）-DNA <2000 U / L（28.8％对28.8％，t =在Pg-INF的24周时，顺序和单一治疗组中0.10，P = 1.000）没有差异。病毒应答率（HBeAg血清转换和血清HBV-DNA <2000 U / L）在两组中没有差异（12.1％对16.7％，t = 1.83，P = 0.457）。基线HBV-DNA水平（7 log10U / ml对7.5 log10U / ml，t = 1.70，P = 0.019）和乙型肝炎表面抗原滴度（3.6 log10U / ml对4.0 log10U / ml，t = 2.19，P = 0.020 ）分别是单一治疗组和序贯治疗组中应答者的较低和预测因子。
结论：

目前的研究表明，单药治疗和序贯治疗方案之间HBeAg血清转换率，ALT正常化和HBV-DNA水平无差异。
试用注册：

ClinicalTrials.gov，NCT01220596; HTTP

齐欢畅

马克

newchinabok

咱觉得“中”

qq2019

这类研究不少的。

搞来搞去，指南里都概括了。