在II期和III期研究的长期随访HBeAg阳性和HBeAg阴性慢性乙型肝

StephenW

Hepatol Res. 2015 Dec 15. doi: 10.1111/hepr.12638. [Epub ahead of print]
Long-term follow-up of peginterferon-α-2a treatment of HBeAg-positive and HBeAg-negative chronic hepatitis B patients in phase II and III studies.Okanoue T1, Shima T1, Hasebe C2, Karino Y3, Imazeki F4, Kumada T5, Minami M6, Imai Y7, Yoshihara H8, Mita E9, Morikawa T10, Nishiguchi S11, Kawakami Y12, Nomura H13, Sakisaka S14, Kurosaki M15, Yatsuhashi H16, Oketani M17, Kohno H18, Masumoto A19, Ikeda K20, Kumada H20.
Author information

• 1Center of Gastroenterology & Hepatology, Saiseikai Suita Hospital, Suita, Osaka, 564-0013, Japan.
• 2Department of Gastroenterology, Asahikawa Red Cross Hospital, Asahikawa, 070-8530, Japan.
• 3Department of Hepatology, Sapporo Kohseiren Hospital, Sapporo, 060-0033, Japan.
• 4Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, 503-8502, Japan.
• 5Department of Gastroenterology and Nephrology, Chiba University, Chiba, 260-8670, Japan.
• 6Department of Gastroenterology, Kyoto Prefectural University of Medicine, Kyoto, 602-8566, Japan.
• 7Department of Gastroenterology, Ikeda Municipal Hospital, Ikeda, 563-8510, Japan.
• 8Department of Gastroenterology, Osaka Rousai Hospital, Sakai, 591-8025, Japan.
• 9Department of Gastroenterology, National Hospital Organization Osaka Medical Center, Osaka, 540-0006, Japan.
• 10Department of Hepatology, Akashi Municipal Hospital, Akashi, 673-8501, Japan.
• 11Division of Hepatobiliary and Pancreatic Medicine, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, 663-8501, Japan.
• 12Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, 734-8551, Japan.
• 13Hepatology Center, Shin-Kokura Hospital, Kitakyushu, 803-8505, Japan.
• 14Department of Gastroenterolgy, Fukuoka University, Fukuoka, 814-0180, Japan.
• 15Department of Gastroenterology, Musashino Red Cross Hospital, Musashino, 180-0023, Japan.
• 16Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, 856-8562, Japan.
• 17Department of Gastroenterology and Life Style-Relate Disease, Kagoshima University, Kagoshima, 890-8520, Japan.
• 18Department of Gastroenterology, National Hospital Organization, Kure Medical Center and Chugoku Cancer Center, Kure, 737-0023, Japan.
• 19Department of Hepatology, Aso Iizuka Hospital, Iizuka, 820-8505, Japan.
• 20Ikeda K, Kumada H: Department of Hepatology, Toranomon Hospital, Tokyo, 105-8470, Japan.
  


AbstractBACKGROUND: We analyzed the 5-year post-treatment response to peginterferon α-2a (PEG-IFN-α-2a) in hepatitis B e antigen (HBeAg)-positive and negative chronic hepatitis B patients.
METHODS: One hundred thirty-seven chronic hepatitis B (CHB) patients receiving 90 µg or 180 µg of PEG-IFN-α-2a for 24 or 48 weeks in phase II or III studies were enrolled in the study, including 100 HBeAg-positive patients and 37 HBeAg-negative patients; 121 patients (88.4%) had genotype C.
RESULTS: Of the 137 patients, 94 received additional antiviral therapy because of viral reactivation and 43 did not receive any additional antiviral treatment during follow-up, while. Five years upon PEG-IFN-α-2a treatment, 32 patients (23.4%) who did not receive any additional antiviral agent after PEG-IFN-α-2a therapy achieved a good response (normal serum alanine aminotransferase, low-level HBV DNA, and HBeAg-negativity). Female gender and low HBV DNA levels by the end of treatment were independently associated with favorable 5-year post-treatment responses. Forty-eight weeks administration of PEG-IFN-α-2a showed a better response (26.4%) than 24 weeks administration (18.0%). Six patients (4.3%), four males and two females, cleared hepatitis B surface antigen (HBsAg) during the 5-year follow-up period CONCLUSIONS: The 48-week administration of PEG-IFN-α-2a achieved better biochemical and virological responses than the 24-week administration, particularly in younger females. The 5-year post-treatment response rate was 23.4%; however, more than two-thirds of the patients received additional antiviral therapy because of viral reactivation after PEG-IFN-α-2a treatment. HBsAg clearance was noted in six patients (4.3%). PEG-IFN-α-2a is effective in young female patients. This article is protected by copyright. All rights reserved.
This article is protected by copyright. All rights reserved.


KEYWORDS: Chronic hepatitis B; peginterferon; response; seroconversion

PMID:26670363 [PubMed - as supplied by publisher]  


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StephenW

肝脏病水库。 2015年15月DOI：10.1111 / hepr.12638。 [打印EPUB提前]
在II期和III期研究的长期随访HBeAg阳性和HBeAg阴性慢性乙型肝炎患者的聚乙二醇干扰素 - 化α-2a治疗。
Okanoue T1，石马T1，长谷部C2，Karino Y3，Imazeki F4，熊田T5，南M6，今井Y7，吉原H8，美达E9，森川T10，西口S11，川Y12，野村H13，Sakisaka S14，黑崎M15，八桥H16 ，Oketani M17，河野H18，升本A19，池田K20，熊田H20。
作者信息

    1Center肠胃病学和肝脏病，济生会吹田医院，吹田，大阪，564-0013，日本。
    消化内科教研室，旭川红十字医院，旭川，070-8530，日本。
    3Department肝病，札幌Kohseiren医院，札幌，060-0033，日本。
    4Department胃肠病学和肝病，大垣市立医院，大垣，503-8502，日本。
    5Department消化内科和肾内科，千叶大学，千叶，260-8670，日本。
    6Department消化内科，医学京都府立大学，京都，602-8566，日本。
    7Department消化内科，池田市市立医院池田，5​​63-8510，日本。
    8Department消化内科，大阪Rousai医院，酒井，591-8025，日本。
    9Department消化内科，国立医院机构大阪医疗中心，大阪，540-0006，日本。
    10Department肝病，明石市立医院，明石，673-8501，日本。
    11区肝胆胰医学，内科，医学学院兵库县西宫，663-8501，日本。
    12Department胃肠病学和代谢，广岛大学，广岛，734-8551，日本。
    13Hepatology中心，信小仓医院，北九州，803-8505，日本。
    14Department Gastroenterolgy，福冈大学，福冈，814-0180，日本。
    15Department消化内科，武藏野红十字医院，武藏野，180-0023，日本。
    16Clinical研究中心，全国医院组织长崎医疗中心，长崎，856-8562，日本。
    消化17Department和生活方式，相关疾病，鹿儿岛大学，鹿儿岛，890-8520，日本。
    18Department消化，国立医院机构吴医疗中心和中国地方癌症中心，吴，737-0023，日本。
    19Department肝病，麻生饭冢医院，饭冢，820-8505，日本。
    20Ikeda K，熊田H：肝病，虎之门医院，东京，105-8470，日本部。

抽象
背景：

我们分析了5年治疗后的反应聚乙二醇干扰素α-2a干扰素（PEG-IFN-α-2a）中乙型肝炎e抗原（HBeAg）阳性和阴性的慢性乙肝患者。
方法：

一百37慢性乙型肝炎（CHB）患者接受90微克或180 PEG-IFN-α-2a的24或48周微克II期或III研究，参加了研究，其中包括100例HBeAg阳性患者和37 HBeAg阴性的患者; 121例（88.4％）的基因型C.
结果：

在137例患者中，94收到，因为病毒复发额外的抗病毒治疗，43没有接受随访过程中的任何其他抗病毒治疗，同时。在PEG-IFN-α-2a的治疗，32例（23.4％）谁没有收到任何额外抗病毒剂后，PEG-IFN-α-2a的治疗取得了良好的反响（正常血清谷丙转氨酶，低层次的HBV DNA五年和e抗原阴性）。女性性别和低HBV DNA水平由治疗结束独立与有利的5年后处理反应有关。四十八周给药1 PEG-IFN-α-2a的显示，超过24周管理（18.0％），更好的反应（26.4％）。六例（4.3％），四男二女，清除乙肝表面抗原（HBsAg），在5年的随访期间结论：PEG-IFN-α-2a的48个星期的管理取得了较好的生化和病毒学比24周给药的反应，尤其是在年轻女性。 5年后的治疗有效率为23.4％;然而，超过三分之二的患者接受，因为后的PEG-IFN-α-2a的治疗病毒的再活化附加抗病毒治疗。 HBsAg清除中指出例（4.3％）。 PEG-IFN-α-2a是有效的年轻女性患者。这篇文章是受版权保护的。版权所有。

这篇文章是受版权保护的。版权所有。
关键词：

慢性乙型肝炎;聚乙二醇干扰素;响应;血清转换

结论：
    26670363
    [考研 - 由发行商提供]