使用替诺福韦地索普西富马酸盐和聚乙二醇干扰素α-2a的乙

StephenW

Dig Dis Sci. 2018 Aug 22. doi: 10.1007/s10620-018-5251-9. [Epub ahead of print]
Hepatitis B Surface Antigen Loss with Tenofovir Disoproxil Fumarate Plus Peginterferon Alfa-2a: Week 120 Analysis.
Ahn SH1, Marcellin P2, Ma X3, Caruntu FA4, Tak WY5, Elkhashab M6, Chuang WL7, Tabak F8, Mehta R9, Petersen J10, Guyer W1, Jump B11, Chan A11, Subramanian M11, Crans G11, Fung S12, Buti M13, Gaeta GB14, Hui AJ15,16, Papatheodoridis G17, Flisiak R18, Chan HLY19.
Author information

1
    Department of Internal Medicine, Yonsei University College of Medicine, Brain Korea 21 Plus Project for Medical Science, Seoul, Republic of Korea.
2
    Hôpital Beaujon, University Paris-Diderot, Clichy, France. [email protected].
3
    Drexel University College of Medicine, Philadelphia, PA, USA.
4
    National Institute for Infectious Diseases "Matei Bals", Bucharest, Romania.
5
    Kyungpook National University Hospital, Daegu, South Korea.
6
    Toronto Liver Centre, Toronto, Canada.
7
    Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
8
    Cerrahpasa Medical Faculty, University of Istanbul, Istanbul, Turkey.
9
    Liver Clinic, Surat, India.
10
    IFI Institute for Interdisciplinary Medicine, Asklepios Klinik St. George, University of Hamburg, Hamburg, Germany.
11
    Gilead Sciences Inc, Foster City, CA, USA.
12
    Toronto General Hospital, Toronto, Canada.
13
    Hepatology Unit, Hospital Universitari Vall d'Hebron and CIBEREHD del Instituto Carlos III, Barcelona, Spain.
14
    Infectious Diseases and Viral Hepatitis Unit, University of Campania "Luigi Vanvitelli", Naples, Italy.
15
    The Chinese University of Hong Kong, Hong Kong, China.
16
    Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China.
17
    Medical School of National and Kapodistrian University of Athens, General Hospital of Athens "Laiko", Athens, Greece.
18
    Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Białystok, Poland.
19
    Department of Medicine and Therapeutics and Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China. [email protected].

Abstract
BACKGROUND AND AIMS:

Hepatitis B surface antigen (HBsAg) loss is the ideal clinical endpoint but is achieved rarely during oral antiviral treatment. A current unmet need in CHB management is achievement of HBsAg loss with a finite course of oral antiviral therapy, thereby allowing discontinuation of treatment. Significantly higher rates of HBsAg loss at 72 weeks post-treatment have been demonstrated when tenofovir disoproxil fumarate (TDF) was combined with pegylated interferon (PEG-IFN) for 48 weeks compared with either monotherapy. This analysis provides follow-up data at week 120.
METHODS:

In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus PEG-IFN for 48 weeks (group A), TDF plus PEG-IFN for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or PEG-IFN for 48 weeks (group D). Efficacy and safety at week 120 were assessed.
RESULTS:

Rates of HBsAg loss at week 120 were significantly higher in group A (10.4%) than in group B (3.5%), group C (0%), and group D (3.5%). Rates of HBsAg loss and HBsAg seroconversion in group A were significantly higher than rates in group C (P < 0.001 for both) or group D (HBsAg loss: P = 0.002; HBsAg seroconversion: P < 0.001).
CONCLUSIONS:

The results of this analysis confirm the results from earlier time points which demonstrate the increased rate of HBsAg loss in patients treated with a finite course of PEG-IFN plus TDF compared with the rates in patients receiving either monotherapy.
KEYWORDS:

Chronic hepatitis B; HBsAg loss; HBsAg seroconversion; Virological response

PMID:
    30136045
DOI:
    10.1007/s10620-018-5251-9

StephenW

Dig Dis Sci。 2018年8月22日doi：10.1007 / s10620-018-5251-9。 [提前打印]
使用替诺福韦地索普西富马酸盐和聚乙二醇干扰素α-2a的乙型肝炎表面抗原损失：第120周分析。
Ahn SH1，Marcellin P2，Ma X3，Caruntu FA4，Tak WY5，Elkhashab M6，Chuang WL7，Tabak F8，Mehta R9，Petersen J10，Guyer W1，Jump B11，Chan A11，Subramanian M11，Crans G11，Fung S12，Buti M13 ，Gaeta GB14，Hui AJ15,16，Papatheodoridis G17，Flisiak R18，Chan HLY19。
作者信息

1
    延世大学医学院内科，脑韩国21 Plus医学科学项目，韩国首尔。
2
    HôpitalBeaujon，巴黎大学 - 狄德罗大学，克利希，法国。 [email protected]。
3
    美国宾夕法尼亚州费城德雷塞尔大学医学院。
4
    国家传染病研究所“Matei Bals”，罗马尼亚布加勒斯特。
五
    韩国大邱Kyungpook国立大学医院。
6
    多伦多肝脏中心，加拿大多伦多。
7
    台湾高雄市高雄医科大学高雄医科大学附属医院。
8
    土耳其伊斯坦布尔伊斯坦布尔大学Cerrahpasa医学院。
9
    肝脏诊所，苏拉特，印度。
10
    IFI跨学科医学研究所，Asklepios Klinik St. George，德国汉堡汉堡大学。
11
    吉利德科学公司，福斯特城，加利福尼亚州，美国。
12
    多伦多综合医院，加拿大多伦多。
13
    西班牙巴塞罗那Vall d'Hebron大学医学院和CIBEREHD del Instituto Carlos III。
14
    传染病和病毒性肝炎病房，坎帕尼亚大学“Luigi Vanvitelli”，意大利那不勒斯。
15
    香港中文大学，中国香港。
16
    中国香港爱丽丝何妙龄那打素医院。
17
    雅典国立和Kapodistrian大学医学院，雅典总医院“Laiko”，雅典，希腊。
18
    波兰比亚韦斯托克比亚韦斯托克医科大学传染病与肝病学系。
19
    香港中文大学医学与治疗学系和消化疾病研究所，中国香港。 [email protected]。

抽象
背景和目的：

乙型肝炎表面抗原（HBsAg）丢失是理想的临床终点，但在口服抗病毒治疗期间很少实现。 CHB管理中目前未满足的需求是通过有限的口服抗病毒疗法实现HBsAg损失，从而允许停止治疗。与单药治疗相比，替诺福韦地索普西富马酸盐（TDF）与聚乙二醇化干扰素（PEG-IFN）联合治疗48周后，治疗后72周HBsAg消失率显着增高。该分析在第120周提供了后续数据。
方法：

在一项开放标签，主动对照研究中，740名慢性乙型肝炎患者被随机分配接受TDF加PEG-IFN治疗48周（A组），TDF加PEG-IFN治疗16周，随后接受TDF治疗32周（ B组），TDF 120周（C组）或PEG-IFN 48周（D组）。评估第120周的功效和安全性。
结果：

A组120周HBsAg消失率（10.4％）明显高于B组（3.5％），C组（0％）和D组（3.5％）。 A组HBsAg消失率和HBsAg血清转换率明显高于C组（两者均P <0.001）或D组（HBsAg消失：P = 0.002; HBsAg血清转换：P <0.001）。
结论：

该分析的结果证实了早期时间点的结果，该结果表明，与接受单一疗法的患者相比，用有限疗程的PEG-IFN加TDF治疗的患者中HBsAg消失的速率增加。
关键词：

慢性乙型肝炎; HBsAg丢失; HBsAg血清学转换;病毒学反应

结论：
    30136045
DOI：
    10.1007 / s10620-018-5251-9

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