Frequency, Severity and Impact of Pegylated Interferon Alpha–Associated Flares in Hepatitis D Infection

IF 2.5 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Svenja Hardtke, Cihan Yurdaydin, Florin A. Caruntu, Manuela G. Curescu, Kendal Yalcin, Ulus S. Akarca, Selim Gürel, Stefan Zeuzem, Andreas Erhardt, Stefan Lüth, George V. Papatheodoridis, Kerstin Port, Michael P. Manns, Markus Cornberg, Julia Kahlhöfer, Heiner Wedemeyer
{"title":"Frequency, Severity and Impact of Pegylated Interferon Alpha–Associated Flares in Hepatitis D Infection","authors":"Svenja Hardtke,&nbsp;Cihan Yurdaydin,&nbsp;Florin A. Caruntu,&nbsp;Manuela G. Curescu,&nbsp;Kendal Yalcin,&nbsp;Ulus S. Akarca,&nbsp;Selim Gürel,&nbsp;Stefan Zeuzem,&nbsp;Andreas Erhardt,&nbsp;Stefan Lüth,&nbsp;George V. Papatheodoridis,&nbsp;Kerstin Port,&nbsp;Michael P. Manns,&nbsp;Markus Cornberg,&nbsp;Julia Kahlhöfer,&nbsp;Heiner Wedemeyer","doi":"10.1111/jvh.70022","DOIUrl":null,"url":null,"abstract":"<p>We analysed the frequency, severity and impact of hepatitis flares in a large Phase 2 study investigating pegylated interferon-alfa-2a (PEG-IFNa) for the treatment of hepatitis D. In the HIDIT-II study, 120 patients were treated for 96 weeks with PEG-IFNa (180 μg weekly) in combination with tenofovir disoproxil fumarate (TDF, 300 mg once daily) or placebo. Hepatitis flares were defined as ALT increases above 10 times the upper limit of normal or increases of more than 2.5-fold above baseline or nadir values. ALT flares occurred in 28 patients (23%) during treatment (&lt; 96) and in 14 patients post-treatment until follow-up Week 24. There were no differences in the flare frequency between the two treatment arms (12 PEG-IFNa + placebo vs. 16 PEG-IFNa + TDF). The frequency of ALT increases did not differ between cirrhotic and noncirrhotic patients. None of the patients with cirrhosis experienced liver decompensation during or after a flare. Fifty-four per cent of the patients with ALT flare experienced a decrease in HDV RNA (&gt; 1 log10 cop/ml) during subsequent study visits. Mean ALT levels early during treatment were higher in patients with HBsAg loss at follow-up Week 24. More than a third of hepatitis D patients undergoing PEG-IFNa therapy may experience ALT flares during or after treatment. ALT flares in this study posed no obvious safety risk to patients and should not lead to premature withdrawal from treatment. If ALT flares may be beneficial in single patients requires further investigation.</p><p>Clinical Trial Registration: NCT00932971, EudraCT 2008–005560-13.</p>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"32 4","pages":""},"PeriodicalIF":2.5000,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jvh.70022","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Viral Hepatitis","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/jvh.70022","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

We analysed the frequency, severity and impact of hepatitis flares in a large Phase 2 study investigating pegylated interferon-alfa-2a (PEG-IFNa) for the treatment of hepatitis D. In the HIDIT-II study, 120 patients were treated for 96 weeks with PEG-IFNa (180 μg weekly) in combination with tenofovir disoproxil fumarate (TDF, 300 mg once daily) or placebo. Hepatitis flares were defined as ALT increases above 10 times the upper limit of normal or increases of more than 2.5-fold above baseline or nadir values. ALT flares occurred in 28 patients (23%) during treatment (< 96) and in 14 patients post-treatment until follow-up Week 24. There were no differences in the flare frequency between the two treatment arms (12 PEG-IFNa + placebo vs. 16 PEG-IFNa + TDF). The frequency of ALT increases did not differ between cirrhotic and noncirrhotic patients. None of the patients with cirrhosis experienced liver decompensation during or after a flare. Fifty-four per cent of the patients with ALT flare experienced a decrease in HDV RNA (> 1 log10 cop/ml) during subsequent study visits. Mean ALT levels early during treatment were higher in patients with HBsAg loss at follow-up Week 24. More than a third of hepatitis D patients undergoing PEG-IFNa therapy may experience ALT flares during or after treatment. ALT flares in this study posed no obvious safety risk to patients and should not lead to premature withdrawal from treatment. If ALT flares may be beneficial in single patients requires further investigation.

Clinical Trial Registration: NCT00932971, EudraCT 2008–005560-13.

Abstract Image

求助全文
约1分钟内获得全文 求助全文
来源期刊
Journal of Viral Hepatitis
Journal of Viral Hepatitis 医学-病毒学
CiteScore
6.00
自引率
8.00%
发文量
138
审稿时长
1.5 months
期刊介绍: The Journal of Viral Hepatitis publishes reviews, original work (full papers) and short, rapid communications in the area of viral hepatitis. It solicits these articles from epidemiologists, clinicians, pathologists, virologists and specialists in transfusion medicine working in the field, thereby bringing together in a single journal the important issues in this expanding speciality. The Journal of Viral Hepatitis is a monthly journal, publishing reviews, original work (full papers) and short rapid communications in the area of viral hepatitis. It brings together in a single journal important issues in this rapidly expanding speciality including articles from: virologists; epidemiologists; clinicians; pathologists; specialists in transfusion medicine.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信