PegIFN alpha-2a reduces relapse in HBeAg-negative patients after nucleo(s)tide analogue cessation: A randomized-controlled trial
Nucleo(s)tide analogue (NUC) cessation can lead to hepatitis B surface antigen (HBsAg) clearance but also a high rate of virological relapse. However, the effect of pegylated interferon alpha-2a (PegIFN-α-2a) on virological relapse after NUC cessation is unknown. Therefore, this study aimed to evalu...
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| creator | Li, Fahong Qu, Lihong Liu, Yanhong Wu, Xiaoping Qi, Xun Wang, Jinyu Zhu, Haoxiang Yang, Feifei Shen, Zhongliang Guo, Yifei Zhang, Yongmei Yu, Jie Mao, Richeng Zhang, Qiran Zhang, Fengdi Chen, Liang Huang, Yuxian Zhang, Xinxin Li, Qingxing Zhang, Wenhong Zhang, Jiming |
| description | Nucleo(s)tide analogue (NUC) cessation can lead to hepatitis B surface antigen (HBsAg) clearance but also a high rate of virological relapse. However, the effect of pegylated interferon alpha-2a (PegIFN-α-2a) on virological relapse after NUC cessation is unknown. Therefore, this study aimed to evaluate the effect of switching from NUC to PegIFN-α-2a treatment for 48 weeks on virological relapse up to week 96.
In this multicenter randomized-controlled clinical trial, 180 non-cirrhotic patients with HBeAg-negative chronic hepatitis B on continuous NUC therapy for ≥2.5 years, with HBV DNA levels |
| doi_str_mv | 10.1016/j.jhep.2024.07.019 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3087562598</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0168827824024267</els_id><sourcerecordid>3087562598</sourcerecordid><originalsourceid>FETCH-LOGICAL-c1523-94701d969164ec462ed54103eaf04cfbbc7f9ec14eda63b9171308231191f95d3</originalsourceid><addsrcrecordid>eNp9kDtvFDEUhS1ERJbAH6BALkMxw_VjHkY0m4iQSFFCAbXlte9svPKOB3smElT56Xi1gZLqNN85uvcj5B2DmgFrP-7q3QNONQcua-hqYOoFWbEWoIJWspdkVaC-6nnXn5LXOe8AQICSr8ipUCU7KVbk6Rtub67uqAnTg6m4oQndYjGXDGbKSP1Iry9wva1G3JrZPyKdSuA4Z2qGGRMdFxswnucPs3dIzWhC3C5Iy0YuYBw_0TVNZnRx73-jq2wc5xRDQEfn5E14Q04GEzK-fc4z8uPqy_fL6-r2_uvN5fq2sqzhoirnAnOqVayVaGXL0TWSgUAzgLTDZmO7QaFlEp1pxUaxjgnouWBMsUE1TpyR8-PulOLPBfOs9z5bDMGMGJesC901LW9UX1B-RG2KOScc9JT83qRfmoE-mNc7fTCvD-Y1dLqYL6X3z_vLZo_uX-Wv6gJ8PgJYvnz0mHS2xaNF5xPaWbvo_7f_BzjDlRw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3087562598</pqid></control><display><type>article</type><title>PegIFN alpha-2a reduces relapse in HBeAg-negative patients after nucleo(s)tide analogue cessation: A randomized-controlled trial</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Li, Fahong ; Qu, Lihong ; Liu, Yanhong ; Wu, Xiaoping ; Qi, Xun ; Wang, Jinyu ; Zhu, Haoxiang ; Yang, Feifei ; Shen, Zhongliang ; Guo, Yifei ; Zhang, Yongmei ; Yu, Jie ; Mao, Richeng ; Zhang, Qiran ; Zhang, Fengdi ; Chen, Liang ; Huang, Yuxian ; Zhang, Xinxin ; Li, Qingxing ; Zhang, Wenhong ; Zhang, Jiming</creator><creatorcontrib>Li, Fahong ; Qu, Lihong ; Liu, Yanhong ; Wu, Xiaoping ; Qi, Xun ; Wang, Jinyu ; Zhu, Haoxiang ; Yang, Feifei ; Shen, Zhongliang ; Guo, Yifei ; Zhang, Yongmei ; Yu, Jie ; Mao, Richeng ; Zhang, Qiran ; Zhang, Fengdi ; Chen, Liang ; Huang, Yuxian ; Zhang, Xinxin ; Li, Qingxing ; Zhang, Wenhong ; Zhang, Jiming</creatorcontrib><description>Nucleo(s)tide analogue (NUC) cessation can lead to hepatitis B surface antigen (HBsAg) clearance but also a high rate of virological relapse. However, the effect of pegylated interferon alpha-2a (PegIFN-α-2a) on virological relapse after NUC cessation is unknown. Therefore, this study aimed to evaluate the effect of switching from NUC to PegIFN-α-2a treatment for 48 weeks on virological relapse up to week 96.
In this multicenter randomized-controlled clinical trial, 180 non-cirrhotic patients with HBeAg-negative chronic hepatitis B on continuous NUC therapy for ≥2.5 years, with HBV DNA levels <60 IU/ml, were randomized to discontinue NUC therapy (n = 90) or receive 48 weeks of PegIFN-α-2a treatment (n = 90). Patients were followed up for up to 96 weeks. The primary endpoint was the virological relapse rate up to week 96.
Intention-to-treat analysis revealed patients in the interferon monotherapy group had significantly lower cumulative virological relapse rates than the NUC cessation group until week 96 (20.8% vs. 53.6%, p <0.0001). Consistently, a significantly lower proportion of patients in the interferon monotherapy group had virological relapse than those in the NUC cessation group at 48 weeks off treatment (17.8% vs. 36.7%, p = 0.007). The virological relapse rate positively correlated with HBsAg levels in the NUC cessation group. The interferon monotherapy group had a lower cumulative clinical relapse rate (7.8% vs. 20.9%, p = 0.008) and a higher HBsAg loss rate (21.5% vs. 9.0%, p = 0.03) than the NUC cessation group.
Switching from NUC to PegIFN-α-2a treatment for 48 weeks significantly reduces virological relapse rates and leads to higher HBsAg loss rates than NUC treatment cessation alone in patients with HBeAg-negative chronic hepatitis B.
Nucleo(s)tide analogue (NUC) cessation can lead to HBsAg clearance but also a high rate of virological relapse, but an optimized scheme to reduce the virological relapse rate after NUC withdrawal is yet to be reported. This randomized-controlled trial investigated the effect of switching from NUC to PegIFN-α-2a treatment for 48 weeks on virological relapse up to week 96 in patients with HBeAg-negative chronic hepatitis B. The interferon monotherapy group had a significantly lower cumulative virological relapse rate (20.8% vs. 53.6%, p <0.0001) and higher HBsAg loss rate (21.5% vs. 9.0%, p = 0.03) than the NUC cessation group up to week 96. This provides an optimized strategy for NUC cessation in HBeAg-negative patients.
NCT02594293.
[Display omitted]
•Switching to PegIFN-α reduces virological relapse and increases HBsAg loss after NUC cessation in HBeAg(-) patients.•HBeAg(-) patients with HBsAg <10 IU/ml have a high likelihood of HBsAg clearance when switching from NUCs to PegIFN-α.•Discontinuation is not appropriate in patients with HBsAg >1,000 IU/ml due to high relapse rate and poor HBsAg clearance.•It is safe to switch from NUCs to PegIFN-α in HBeAg(-) patients without significant fibrosis or cirrhosis.</description><identifier>ISSN: 0168-8278</identifier><identifier>ISSN: 1600-0641</identifier><identifier>EISSN: 1600-0641</identifier><identifier>DOI: 10.1016/j.jhep.2024.07.019</identifier><identifier>PMID: 39094743</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adult ; Antiviral Agents - therapeutic use ; chronic hepatitis B ; DNA, Viral - blood ; Female ; HBeAg-negative ; Hepatitis B e Antigens - blood ; Hepatitis B Surface Antigens - blood ; Hepatitis B virus - drug effects ; Hepatitis B virus - genetics ; Hepatitis B, Chronic - drug therapy ; Hepatitis B, Chronic - virology ; Humans ; interferon alpha-2a ; Interferon-alpha - administration & dosage ; Interferon-alpha - therapeutic use ; Male ; Middle Aged ; Polyethylene Glycols - administration & dosage ; Polyethylene Glycols - therapeutic use ; randomized controlled trial ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - therapeutic use ; Recurrence ; relapse ; treatment cessation ; Treatment Outcome</subject><ispartof>Journal of hepatology, 2025-02, Vol.82 (2), p.211-221</ispartof><rights>2024 European Association for the Study of the Liver</rights><rights>Copyright © 2024 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c1523-94701d969164ec462ed54103eaf04cfbbc7f9ec14eda63b9171308231191f95d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0168827824024267$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39094743$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Fahong</creatorcontrib><creatorcontrib>Qu, Lihong</creatorcontrib><creatorcontrib>Liu, Yanhong</creatorcontrib><creatorcontrib>Wu, Xiaoping</creatorcontrib><creatorcontrib>Qi, Xun</creatorcontrib><creatorcontrib>Wang, Jinyu</creatorcontrib><creatorcontrib>Zhu, Haoxiang</creatorcontrib><creatorcontrib>Yang, Feifei</creatorcontrib><creatorcontrib>Shen, Zhongliang</creatorcontrib><creatorcontrib>Guo, Yifei</creatorcontrib><creatorcontrib>Zhang, Yongmei</creatorcontrib><creatorcontrib>Yu, Jie</creatorcontrib><creatorcontrib>Mao, Richeng</creatorcontrib><creatorcontrib>Zhang, Qiran</creatorcontrib><creatorcontrib>Zhang, Fengdi</creatorcontrib><creatorcontrib>Chen, Liang</creatorcontrib><creatorcontrib>Huang, Yuxian</creatorcontrib><creatorcontrib>Zhang, Xinxin</creatorcontrib><creatorcontrib>Li, Qingxing</creatorcontrib><creatorcontrib>Zhang, Wenhong</creatorcontrib><creatorcontrib>Zhang, Jiming</creatorcontrib><title>PegIFN alpha-2a reduces relapse in HBeAg-negative patients after nucleo(s)tide analogue cessation: A randomized-controlled trial</title><title>Journal of hepatology</title><addtitle>J Hepatol</addtitle><description>Nucleo(s)tide analogue (NUC) cessation can lead to hepatitis B surface antigen (HBsAg) clearance but also a high rate of virological relapse. However, the effect of pegylated interferon alpha-2a (PegIFN-α-2a) on virological relapse after NUC cessation is unknown. Therefore, this study aimed to evaluate the effect of switching from NUC to PegIFN-α-2a treatment for 48 weeks on virological relapse up to week 96.
In this multicenter randomized-controlled clinical trial, 180 non-cirrhotic patients with HBeAg-negative chronic hepatitis B on continuous NUC therapy for ≥2.5 years, with HBV DNA levels <60 IU/ml, were randomized to discontinue NUC therapy (n = 90) or receive 48 weeks of PegIFN-α-2a treatment (n = 90). Patients were followed up for up to 96 weeks. The primary endpoint was the virological relapse rate up to week 96.
Intention-to-treat analysis revealed patients in the interferon monotherapy group had significantly lower cumulative virological relapse rates than the NUC cessation group until week 96 (20.8% vs. 53.6%, p <0.0001). Consistently, a significantly lower proportion of patients in the interferon monotherapy group had virological relapse than those in the NUC cessation group at 48 weeks off treatment (17.8% vs. 36.7%, p = 0.007). The virological relapse rate positively correlated with HBsAg levels in the NUC cessation group. The interferon monotherapy group had a lower cumulative clinical relapse rate (7.8% vs. 20.9%, p = 0.008) and a higher HBsAg loss rate (21.5% vs. 9.0%, p = 0.03) than the NUC cessation group.
Switching from NUC to PegIFN-α-2a treatment for 48 weeks significantly reduces virological relapse rates and leads to higher HBsAg loss rates than NUC treatment cessation alone in patients with HBeAg-negative chronic hepatitis B.
Nucleo(s)tide analogue (NUC) cessation can lead to HBsAg clearance but also a high rate of virological relapse, but an optimized scheme to reduce the virological relapse rate after NUC withdrawal is yet to be reported. This randomized-controlled trial investigated the effect of switching from NUC to PegIFN-α-2a treatment for 48 weeks on virological relapse up to week 96 in patients with HBeAg-negative chronic hepatitis B. The interferon monotherapy group had a significantly lower cumulative virological relapse rate (20.8% vs. 53.6%, p <0.0001) and higher HBsAg loss rate (21.5% vs. 9.0%, p = 0.03) than the NUC cessation group up to week 96. This provides an optimized strategy for NUC cessation in HBeAg-negative patients.
NCT02594293.
[Display omitted]
•Switching to PegIFN-α reduces virological relapse and increases HBsAg loss after NUC cessation in HBeAg(-) patients.•HBeAg(-) patients with HBsAg <10 IU/ml have a high likelihood of HBsAg clearance when switching from NUCs to PegIFN-α.•Discontinuation is not appropriate in patients with HBsAg >1,000 IU/ml due to high relapse rate and poor HBsAg clearance.•It is safe to switch from NUCs to PegIFN-α in HBeAg(-) patients without significant fibrosis or cirrhosis.</description><subject>Adult</subject><subject>Antiviral Agents - therapeutic use</subject><subject>chronic hepatitis B</subject><subject>DNA, Viral - blood</subject><subject>Female</subject><subject>HBeAg-negative</subject><subject>Hepatitis B e Antigens - blood</subject><subject>Hepatitis B Surface Antigens - blood</subject><subject>Hepatitis B virus - drug effects</subject><subject>Hepatitis B virus - genetics</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Hepatitis B, Chronic - virology</subject><subject>Humans</subject><subject>interferon alpha-2a</subject><subject>Interferon-alpha - administration & dosage</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Polyethylene Glycols - administration & dosage</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>randomized controlled trial</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Recurrence</subject><subject>relapse</subject><subject>treatment cessation</subject><subject>Treatment Outcome</subject><issn>0168-8278</issn><issn>1600-0641</issn><issn>1600-0641</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2025</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kDtvFDEUhS1ERJbAH6BALkMxw_VjHkY0m4iQSFFCAbXlte9svPKOB3smElT56Xi1gZLqNN85uvcj5B2DmgFrP-7q3QNONQcua-hqYOoFWbEWoIJWspdkVaC-6nnXn5LXOe8AQICSr8ipUCU7KVbk6Rtub67uqAnTg6m4oQndYjGXDGbKSP1Iry9wva1G3JrZPyKdSuA4Z2qGGRMdFxswnucPs3dIzWhC3C5Iy0YuYBw_0TVNZnRx73-jq2wc5xRDQEfn5E14Q04GEzK-fc4z8uPqy_fL6-r2_uvN5fq2sqzhoirnAnOqVayVaGXL0TWSgUAzgLTDZmO7QaFlEp1pxUaxjgnouWBMsUE1TpyR8-PulOLPBfOs9z5bDMGMGJesC901LW9UX1B-RG2KOScc9JT83qRfmoE-mNc7fTCvD-Y1dLqYL6X3z_vLZo_uX-Wv6gJ8PgJYvnz0mHS2xaNF5xPaWbvo_7f_BzjDlRw</recordid><startdate>202502</startdate><enddate>202502</enddate><creator>Li, Fahong</creator><creator>Qu, Lihong</creator><creator>Liu, Yanhong</creator><creator>Wu, Xiaoping</creator><creator>Qi, Xun</creator><creator>Wang, Jinyu</creator><creator>Zhu, Haoxiang</creator><creator>Yang, Feifei</creator><creator>Shen, Zhongliang</creator><creator>Guo, Yifei</creator><creator>Zhang, Yongmei</creator><creator>Yu, Jie</creator><creator>Mao, Richeng</creator><creator>Zhang, Qiran</creator><creator>Zhang, Fengdi</creator><creator>Chen, Liang</creator><creator>Huang, Yuxian</creator><creator>Zhang, Xinxin</creator><creator>Li, Qingxing</creator><creator>Zhang, Wenhong</creator><creator>Zhang, Jiming</creator><general>Elsevier B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202502</creationdate><title>PegIFN alpha-2a reduces relapse in HBeAg-negative patients after nucleo(s)tide analogue cessation: A randomized-controlled trial</title><author>Li, Fahong ; Qu, Lihong ; Liu, Yanhong ; Wu, Xiaoping ; Qi, Xun ; Wang, Jinyu ; Zhu, Haoxiang ; Yang, Feifei ; Shen, Zhongliang ; Guo, Yifei ; Zhang, Yongmei ; Yu, Jie ; Mao, Richeng ; Zhang, Qiran ; Zhang, Fengdi ; Chen, Liang ; Huang, Yuxian ; Zhang, Xinxin ; Li, Qingxing ; Zhang, Wenhong ; Zhang, Jiming</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c1523-94701d969164ec462ed54103eaf04cfbbc7f9ec14eda63b9171308231191f95d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2025</creationdate><topic>Adult</topic><topic>Antiviral Agents - therapeutic use</topic><topic>chronic hepatitis B</topic><topic>DNA, Viral - blood</topic><topic>Female</topic><topic>HBeAg-negative</topic><topic>Hepatitis B e Antigens - blood</topic><topic>Hepatitis B Surface Antigens - blood</topic><topic>Hepatitis B virus - drug effects</topic><topic>Hepatitis B virus - genetics</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Hepatitis B, Chronic - virology</topic><topic>Humans</topic><topic>interferon alpha-2a</topic><topic>Interferon-alpha - administration & dosage</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Polyethylene Glycols - administration & dosage</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>randomized controlled trial</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Recurrence</topic><topic>relapse</topic><topic>treatment cessation</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Li, Fahong</creatorcontrib><creatorcontrib>Qu, Lihong</creatorcontrib><creatorcontrib>Liu, Yanhong</creatorcontrib><creatorcontrib>Wu, Xiaoping</creatorcontrib><creatorcontrib>Qi, Xun</creatorcontrib><creatorcontrib>Wang, Jinyu</creatorcontrib><creatorcontrib>Zhu, Haoxiang</creatorcontrib><creatorcontrib>Yang, Feifei</creatorcontrib><creatorcontrib>Shen, Zhongliang</creatorcontrib><creatorcontrib>Guo, Yifei</creatorcontrib><creatorcontrib>Zhang, Yongmei</creatorcontrib><creatorcontrib>Yu, Jie</creatorcontrib><creatorcontrib>Mao, Richeng</creatorcontrib><creatorcontrib>Zhang, Qiran</creatorcontrib><creatorcontrib>Zhang, Fengdi</creatorcontrib><creatorcontrib>Chen, Liang</creatorcontrib><creatorcontrib>Huang, Yuxian</creatorcontrib><creatorcontrib>Zhang, Xinxin</creatorcontrib><creatorcontrib>Li, Qingxing</creatorcontrib><creatorcontrib>Zhang, Wenhong</creatorcontrib><creatorcontrib>Zhang, Jiming</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Li, Fahong</au><au>Qu, Lihong</au><au>Liu, Yanhong</au><au>Wu, Xiaoping</au><au>Qi, Xun</au><au>Wang, Jinyu</au><au>Zhu, Haoxiang</au><au>Yang, Feifei</au><au>Shen, Zhongliang</au><au>Guo, Yifei</au><au>Zhang, Yongmei</au><au>Yu, Jie</au><au>Mao, Richeng</au><au>Zhang, Qiran</au><au>Zhang, Fengdi</au><au>Chen, Liang</au><au>Huang, Yuxian</au><au>Zhang, Xinxin</au><au>Li, Qingxing</au><au>Zhang, Wenhong</au><au>Zhang, Jiming</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>PegIFN alpha-2a reduces relapse in HBeAg-negative patients after nucleo(s)tide analogue cessation: A randomized-controlled trial</atitle><jtitle>Journal of hepatology</jtitle><addtitle>J Hepatol</addtitle><date>2025-02</date><risdate>2025</risdate><volume>82</volume><issue>2</issue><spage>211</spage><epage>221</epage><pages>211-221</pages><issn>0168-8278</issn><issn>1600-0641</issn><eissn>1600-0641</eissn><abstract>Nucleo(s)tide analogue (NUC) cessation can lead to hepatitis B surface antigen (HBsAg) clearance but also a high rate of virological relapse. However, the effect of pegylated interferon alpha-2a (PegIFN-α-2a) on virological relapse after NUC cessation is unknown. Therefore, this study aimed to evaluate the effect of switching from NUC to PegIFN-α-2a treatment for 48 weeks on virological relapse up to week 96.
In this multicenter randomized-controlled clinical trial, 180 non-cirrhotic patients with HBeAg-negative chronic hepatitis B on continuous NUC therapy for ≥2.5 years, with HBV DNA levels <60 IU/ml, were randomized to discontinue NUC therapy (n = 90) or receive 48 weeks of PegIFN-α-2a treatment (n = 90). Patients were followed up for up to 96 weeks. The primary endpoint was the virological relapse rate up to week 96.
Intention-to-treat analysis revealed patients in the interferon monotherapy group had significantly lower cumulative virological relapse rates than the NUC cessation group until week 96 (20.8% vs. 53.6%, p <0.0001). Consistently, a significantly lower proportion of patients in the interferon monotherapy group had virological relapse than those in the NUC cessation group at 48 weeks off treatment (17.8% vs. 36.7%, p = 0.007). The virological relapse rate positively correlated with HBsAg levels in the NUC cessation group. The interferon monotherapy group had a lower cumulative clinical relapse rate (7.8% vs. 20.9%, p = 0.008) and a higher HBsAg loss rate (21.5% vs. 9.0%, p = 0.03) than the NUC cessation group.
Switching from NUC to PegIFN-α-2a treatment for 48 weeks significantly reduces virological relapse rates and leads to higher HBsAg loss rates than NUC treatment cessation alone in patients with HBeAg-negative chronic hepatitis B.
Nucleo(s)tide analogue (NUC) cessation can lead to HBsAg clearance but also a high rate of virological relapse, but an optimized scheme to reduce the virological relapse rate after NUC withdrawal is yet to be reported. This randomized-controlled trial investigated the effect of switching from NUC to PegIFN-α-2a treatment for 48 weeks on virological relapse up to week 96 in patients with HBeAg-negative chronic hepatitis B. The interferon monotherapy group had a significantly lower cumulative virological relapse rate (20.8% vs. 53.6%, p <0.0001) and higher HBsAg loss rate (21.5% vs. 9.0%, p = 0.03) than the NUC cessation group up to week 96. This provides an optimized strategy for NUC cessation in HBeAg-negative patients.
NCT02594293.
[Display omitted]
•Switching to PegIFN-α reduces virological relapse and increases HBsAg loss after NUC cessation in HBeAg(-) patients.•HBeAg(-) patients with HBsAg <10 IU/ml have a high likelihood of HBsAg clearance when switching from NUCs to PegIFN-α.•Discontinuation is not appropriate in patients with HBsAg >1,000 IU/ml due to high relapse rate and poor HBsAg clearance.•It is safe to switch from NUCs to PegIFN-α in HBeAg(-) patients without significant fibrosis or cirrhosis.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>39094743</pmid><doi>10.1016/j.jhep.2024.07.019</doi><tpages>11</tpages></addata></record> |
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| ispartof | Journal of hepatology, 2025-02, Vol.82 (2), p.211-221 |
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| subjects | Adult Antiviral Agents - therapeutic use chronic hepatitis B DNA, Viral - blood Female HBeAg-negative Hepatitis B e Antigens - blood Hepatitis B Surface Antigens - blood Hepatitis B virus - drug effects Hepatitis B virus - genetics Hepatitis B, Chronic - drug therapy Hepatitis B, Chronic - virology Humans interferon alpha-2a Interferon-alpha - administration & dosage Interferon-alpha - therapeutic use Male Middle Aged Polyethylene Glycols - administration & dosage Polyethylene Glycols - therapeutic use randomized controlled trial Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use Recurrence relapse treatment cessation Treatment Outcome |
| title | PegIFN alpha-2a reduces relapse in HBeAg-negative patients after nucleo(s)tide analogue cessation: A randomized-controlled trial |
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