Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens
Background & Aims Nucleotides with add‐on interferon treatment (NUC‐IFN) provide significantly higher rates of hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B (CHB). This study aimed to investigate the sustainability of HBsAg loss and the prevention of clinical rela...
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| Veröffentlicht in: | Liver international 2021-07, Vol.41 (7), p.1498-1508 |
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| creator | Pan, Calvin Q. Li, Ming‐Hui Yi, Wei Zhang, Lu Lu, Yao Hao, Hong‐Xiao Wan, Gang Cao, Wei‐Hua Wang, Xing‐Yue Ran, Chong‐Ping Shen, Ge Wu, Shu‐Ling Chang, Min Gao, Yuan‐Jiao Xie, Yao |
| description | Background & Aims
Nucleotides with add‐on interferon treatment (NUC‐IFN) provide significantly higher rates of hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B (CHB). This study aimed to investigate the sustainability of HBsAg loss and the prevention of clinical relapse.
Methods
Patients with CHB who achieved HBsAg loss and HBV DNA levels .05). These outcomes were similar between patients who received entecavir and those who received telbivudine/lamivudine/adefovir before the combination therapy. In NUC‐IFN‐treated patients, fibrosis regression was observed at week 96. Baseline HBsAb negativity was independent predictors of HBsAg sero‐reversion and recurrence of viremia in IFN treated group.
Conclusion
NUC‐IFN and IFN therapies are equally effective in achieving sustained functional cure and fibrosis regression. (ClinicalTrials.gov, Number NCT02336399). |
| doi_str_mv | 10.1111/liv.14801 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2480749223</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2480749223</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3531-e86a6478672c28c3c3d391d46909b7eabdf8157abd19e2364969351d23a4a2eb3</originalsourceid><addsrcrecordid>eNp1kTtPwzAUhS0EoqUw8AeQJRYYCnHsOPYIFYVKFSzAGjnODXXJo9hOK_49LoEOSHi4D-nzke45CJ2S6IqEd12Z9RVhIiJ7aEhYKsY0pmR_N8d0gI6cW0YRkTIhh2hAKRNcpGyI3FPndVsDbks8WZgGHOCV8gYa7_DG-AVewHb3xuFbrDyWHG8A3h1WpQeLy67R3rSNqrDuLPRfZtNHvAbrOoeDdm4atUWwhTdTQ-OO0UGpKgcnP32EXqZ3z5OH8fzpfja5mY81TSgZg-CKhwt4GutYaKppQSUpGJeRzFNQeVEKkqShEwkx5UxySRNSxFQxFUNOR-ii113Z9qMD57PaOA1VpRpoO5fFwbKUyeBPQM__oMu2s-GqQCWMCB6qCNRlT2nbOmehzFbW1Mp-ZiTKtklkIYnsO4nAnv0odnkNxY78tT4A1z2wMRV8_q-UzWevveQX-U2R2w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2541862548</pqid></control><display><type>article</type><title>Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens</title><source>Wiley Online Library Journals Frontfile Complete</source><creator>Pan, Calvin Q. ; Li, Ming‐Hui ; Yi, Wei ; Zhang, Lu ; Lu, Yao ; Hao, Hong‐Xiao ; Wan, Gang ; Cao, Wei‐Hua ; Wang, Xing‐Yue ; Ran, Chong‐Ping ; Shen, Ge ; Wu, Shu‐Ling ; Chang, Min ; Gao, Yuan‐Jiao ; Xie, Yao</creator><creatorcontrib>Pan, Calvin Q. ; Li, Ming‐Hui ; Yi, Wei ; Zhang, Lu ; Lu, Yao ; Hao, Hong‐Xiao ; Wan, Gang ; Cao, Wei‐Hua ; Wang, Xing‐Yue ; Ran, Chong‐Ping ; Shen, Ge ; Wu, Shu‐Ling ; Chang, Min ; Gao, Yuan‐Jiao ; Xie, Yao</creatorcontrib><description>Background & Aims
Nucleotides with add‐on interferon treatment (NUC‐IFN) provide significantly higher rates of hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B (CHB). This study aimed to investigate the sustainability of HBsAg loss and the prevention of clinical relapse.
Methods
Patients with CHB who achieved HBsAg loss and HBV DNA levels <20 IU/ml after IFN or NUC‐IFN therapy were enrolled and followed up for 96 weeks. The primary outcome was HBsAg negativity without viremia at week 96. Secondary outcomes included virological or clinical relapse and predictors of relapse.
Results
420 patients were included in intention‐to‐treat analysis with 290 and 130 in the IFN and NUC‐IFN groups respectively. At week 96, the intention‐to‐treat analysis revealed similar outcomes between groups, including HBsAg seroreversion (24.83% vs. 23.08%, P = .70), viremia (16.90% vs 13.08%, P = .32) and clinical relapse (11.38% vs 10.00%, P = .68); the per‐protocol analyses also showed HBsAg seroreversion, viremia and clinical relapse in IFN group (15.50%, 6.59% and 0.39%) did not differ from those in NUC‐IFN group (15.25%, 4.24% and 0.85%, P > .05). These outcomes were similar between patients who received entecavir and those who received telbivudine/lamivudine/adefovir before the combination therapy. In NUC‐IFN‐treated patients, fibrosis regression was observed at week 96. Baseline HBsAb negativity was independent predictors of HBsAg sero‐reversion and recurrence of viremia in IFN treated group.
Conclusion
NUC‐IFN and IFN therapies are equally effective in achieving sustained functional cure and fibrosis regression. (ClinicalTrials.gov, Number NCT02336399).</description><identifier>ISSN: 1478-3223</identifier><identifier>EISSN: 1478-3231</identifier><identifier>DOI: 10.1111/liv.14801</identifier><identifier>PMID: 33486874</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adefovir ; Antigens ; clinical relapse ; Deoxyribonucleic acid ; DNA ; Fibrosis ; HBsAg seroreversion ; Hepatitis ; Hepatitis B ; hepatitis B flare ; Hepatitis B surface antigen ; Interferon ; Lamivudine ; Nucleotides ; Patients ; Sustainability ; Viremia ; virological relapse</subject><ispartof>Liver international, 2021-07, Vol.41 (7), p.1498-1508</ispartof><rights>2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><rights>2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><rights>2021 John Wiley & Sons A/S</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3531-e86a6478672c28c3c3d391d46909b7eabdf8157abd19e2364969351d23a4a2eb3</citedby><cites>FETCH-LOGICAL-c3531-e86a6478672c28c3c3d391d46909b7eabdf8157abd19e2364969351d23a4a2eb3</cites><orcidid>0000-0003-3233-5473 ; 0000-0003-4241-8205 ; 0000-0003-4108-7037 ; 0000-0002-3644-5306 ; 0000-0002-3723-6688 ; 0000-0002-3422-0082</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fliv.14801$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fliv.14801$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33486874$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pan, Calvin Q.</creatorcontrib><creatorcontrib>Li, Ming‐Hui</creatorcontrib><creatorcontrib>Yi, Wei</creatorcontrib><creatorcontrib>Zhang, Lu</creatorcontrib><creatorcontrib>Lu, Yao</creatorcontrib><creatorcontrib>Hao, Hong‐Xiao</creatorcontrib><creatorcontrib>Wan, Gang</creatorcontrib><creatorcontrib>Cao, Wei‐Hua</creatorcontrib><creatorcontrib>Wang, Xing‐Yue</creatorcontrib><creatorcontrib>Ran, Chong‐Ping</creatorcontrib><creatorcontrib>Shen, Ge</creatorcontrib><creatorcontrib>Wu, Shu‐Ling</creatorcontrib><creatorcontrib>Chang, Min</creatorcontrib><creatorcontrib>Gao, Yuan‐Jiao</creatorcontrib><creatorcontrib>Xie, Yao</creatorcontrib><title>Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens</title><title>Liver international</title><addtitle>Liver Int</addtitle><description>Background & Aims
Nucleotides with add‐on interferon treatment (NUC‐IFN) provide significantly higher rates of hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B (CHB). This study aimed to investigate the sustainability of HBsAg loss and the prevention of clinical relapse.
Methods
Patients with CHB who achieved HBsAg loss and HBV DNA levels <20 IU/ml after IFN or NUC‐IFN therapy were enrolled and followed up for 96 weeks. The primary outcome was HBsAg negativity without viremia at week 96. Secondary outcomes included virological or clinical relapse and predictors of relapse.
Results
420 patients were included in intention‐to‐treat analysis with 290 and 130 in the IFN and NUC‐IFN groups respectively. At week 96, the intention‐to‐treat analysis revealed similar outcomes between groups, including HBsAg seroreversion (24.83% vs. 23.08%, P = .70), viremia (16.90% vs 13.08%, P = .32) and clinical relapse (11.38% vs 10.00%, P = .68); the per‐protocol analyses also showed HBsAg seroreversion, viremia and clinical relapse in IFN group (15.50%, 6.59% and 0.39%) did not differ from those in NUC‐IFN group (15.25%, 4.24% and 0.85%, P > .05). These outcomes were similar between patients who received entecavir and those who received telbivudine/lamivudine/adefovir before the combination therapy. In NUC‐IFN‐treated patients, fibrosis regression was observed at week 96. Baseline HBsAb negativity was independent predictors of HBsAg sero‐reversion and recurrence of viremia in IFN treated group.
Conclusion
NUC‐IFN and IFN therapies are equally effective in achieving sustained functional cure and fibrosis regression. (ClinicalTrials.gov, Number NCT02336399).</description><subject>Adefovir</subject><subject>Antigens</subject><subject>clinical relapse</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>Fibrosis</subject><subject>HBsAg seroreversion</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>hepatitis B flare</subject><subject>Hepatitis B surface antigen</subject><subject>Interferon</subject><subject>Lamivudine</subject><subject>Nucleotides</subject><subject>Patients</subject><subject>Sustainability</subject><subject>Viremia</subject><subject>virological relapse</subject><issn>1478-3223</issn><issn>1478-3231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kTtPwzAUhS0EoqUw8AeQJRYYCnHsOPYIFYVKFSzAGjnODXXJo9hOK_49LoEOSHi4D-nzke45CJ2S6IqEd12Z9RVhIiJ7aEhYKsY0pmR_N8d0gI6cW0YRkTIhh2hAKRNcpGyI3FPndVsDbks8WZgGHOCV8gYa7_DG-AVewHb3xuFbrDyWHG8A3h1WpQeLy67R3rSNqrDuLPRfZtNHvAbrOoeDdm4atUWwhTdTQ-OO0UGpKgcnP32EXqZ3z5OH8fzpfja5mY81TSgZg-CKhwt4GutYaKppQSUpGJeRzFNQeVEKkqShEwkx5UxySRNSxFQxFUNOR-ii113Z9qMD57PaOA1VpRpoO5fFwbKUyeBPQM__oMu2s-GqQCWMCB6qCNRlT2nbOmehzFbW1Mp-ZiTKtklkIYnsO4nAnv0odnkNxY78tT4A1z2wMRV8_q-UzWevveQX-U2R2w</recordid><startdate>202107</startdate><enddate>202107</enddate><creator>Pan, Calvin Q.</creator><creator>Li, Ming‐Hui</creator><creator>Yi, Wei</creator><creator>Zhang, Lu</creator><creator>Lu, Yao</creator><creator>Hao, Hong‐Xiao</creator><creator>Wan, Gang</creator><creator>Cao, Wei‐Hua</creator><creator>Wang, Xing‐Yue</creator><creator>Ran, Chong‐Ping</creator><creator>Shen, Ge</creator><creator>Wu, Shu‐Ling</creator><creator>Chang, Min</creator><creator>Gao, Yuan‐Jiao</creator><creator>Xie, Yao</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-3233-5473</orcidid><orcidid>https://orcid.org/0000-0003-4241-8205</orcidid><orcidid>https://orcid.org/0000-0003-4108-7037</orcidid><orcidid>https://orcid.org/0000-0002-3644-5306</orcidid><orcidid>https://orcid.org/0000-0002-3723-6688</orcidid><orcidid>https://orcid.org/0000-0002-3422-0082</orcidid></search><sort><creationdate>202107</creationdate><title>Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens</title><author>Pan, Calvin Q. ; Li, Ming‐Hui ; Yi, Wei ; Zhang, Lu ; Lu, Yao ; Hao, Hong‐Xiao ; Wan, Gang ; Cao, Wei‐Hua ; Wang, Xing‐Yue ; Ran, Chong‐Ping ; Shen, Ge ; Wu, Shu‐Ling ; Chang, Min ; Gao, Yuan‐Jiao ; Xie, Yao</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3531-e86a6478672c28c3c3d391d46909b7eabdf8157abd19e2364969351d23a4a2eb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adefovir</topic><topic>Antigens</topic><topic>clinical relapse</topic><topic>Deoxyribonucleic acid</topic><topic>DNA</topic><topic>Fibrosis</topic><topic>HBsAg seroreversion</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>hepatitis B flare</topic><topic>Hepatitis B surface antigen</topic><topic>Interferon</topic><topic>Lamivudine</topic><topic>Nucleotides</topic><topic>Patients</topic><topic>Sustainability</topic><topic>Viremia</topic><topic>virological relapse</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pan, Calvin Q.</creatorcontrib><creatorcontrib>Li, Ming‐Hui</creatorcontrib><creatorcontrib>Yi, Wei</creatorcontrib><creatorcontrib>Zhang, Lu</creatorcontrib><creatorcontrib>Lu, Yao</creatorcontrib><creatorcontrib>Hao, Hong‐Xiao</creatorcontrib><creatorcontrib>Wan, Gang</creatorcontrib><creatorcontrib>Cao, Wei‐Hua</creatorcontrib><creatorcontrib>Wang, Xing‐Yue</creatorcontrib><creatorcontrib>Ran, Chong‐Ping</creatorcontrib><creatorcontrib>Shen, Ge</creatorcontrib><creatorcontrib>Wu, Shu‐Ling</creatorcontrib><creatorcontrib>Chang, Min</creatorcontrib><creatorcontrib>Gao, Yuan‐Jiao</creatorcontrib><creatorcontrib>Xie, Yao</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Liver international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pan, Calvin Q.</au><au>Li, Ming‐Hui</au><au>Yi, Wei</au><au>Zhang, Lu</au><au>Lu, Yao</au><au>Hao, Hong‐Xiao</au><au>Wan, Gang</au><au>Cao, Wei‐Hua</au><au>Wang, Xing‐Yue</au><au>Ran, Chong‐Ping</au><au>Shen, Ge</au><au>Wu, Shu‐Ling</au><au>Chang, Min</au><au>Gao, Yuan‐Jiao</au><au>Xie, Yao</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens</atitle><jtitle>Liver international</jtitle><addtitle>Liver Int</addtitle><date>2021-07</date><risdate>2021</risdate><volume>41</volume><issue>7</issue><spage>1498</spage><epage>1508</epage><pages>1498-1508</pages><issn>1478-3223</issn><eissn>1478-3231</eissn><abstract>Background & Aims
Nucleotides with add‐on interferon treatment (NUC‐IFN) provide significantly higher rates of hepatitis B surface antigen (HBsAg) loss in patients with chronic hepatitis B (CHB). This study aimed to investigate the sustainability of HBsAg loss and the prevention of clinical relapse.
Methods
Patients with CHB who achieved HBsAg loss and HBV DNA levels <20 IU/ml after IFN or NUC‐IFN therapy were enrolled and followed up for 96 weeks. The primary outcome was HBsAg negativity without viremia at week 96. Secondary outcomes included virological or clinical relapse and predictors of relapse.
Results
420 patients were included in intention‐to‐treat analysis with 290 and 130 in the IFN and NUC‐IFN groups respectively. At week 96, the intention‐to‐treat analysis revealed similar outcomes between groups, including HBsAg seroreversion (24.83% vs. 23.08%, P = .70), viremia (16.90% vs 13.08%, P = .32) and clinical relapse (11.38% vs 10.00%, P = .68); the per‐protocol analyses also showed HBsAg seroreversion, viremia and clinical relapse in IFN group (15.50%, 6.59% and 0.39%) did not differ from those in NUC‐IFN group (15.25%, 4.24% and 0.85%, P > .05). These outcomes were similar between patients who received entecavir and those who received telbivudine/lamivudine/adefovir before the combination therapy. In NUC‐IFN‐treated patients, fibrosis regression was observed at week 96. Baseline HBsAb negativity was independent predictors of HBsAg sero‐reversion and recurrence of viremia in IFN treated group.
Conclusion
NUC‐IFN and IFN therapies are equally effective in achieving sustained functional cure and fibrosis regression. (ClinicalTrials.gov, Number NCT02336399).</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>33486874</pmid><doi>10.1111/liv.14801</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-3233-5473</orcidid><orcidid>https://orcid.org/0000-0003-4241-8205</orcidid><orcidid>https://orcid.org/0000-0003-4108-7037</orcidid><orcidid>https://orcid.org/0000-0002-3644-5306</orcidid><orcidid>https://orcid.org/0000-0002-3723-6688</orcidid><orcidid>https://orcid.org/0000-0002-3422-0082</orcidid></addata></record> |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Adefovir Antigens clinical relapse Deoxyribonucleic acid DNA Fibrosis HBsAg seroreversion Hepatitis Hepatitis B hepatitis B flare Hepatitis B surface antigen Interferon Lamivudine Nucleotides Patients Sustainability Viremia virological relapse |
| title | Outcome of Chinese patients with hepatitis B at 96 weeks after functional cure with IFN versus combination regimens |
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