Sequential combination therapy with pegylated interferon leads to loss of hepatitis B surface antigen and hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive chronic hepatitis B patients receiving long-term entecavir treatment
Nucleos(t)ide analogues rarely result in a durable off-treatment response in chronic hepatitis B infection, whereas pegylated interferon (Peg-IFN) induces a long-lasting response only in a subset of patients. We assessed the effect of sequential combination therapy with Peg-IFN-α2a and entecavir in...
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| Veröffentlicht in: | Antimicrobial agents and chemotherapy 2015-07, Vol.59 (7), p.4121-4128 |
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| creator | Li, Guo-Jun Yu, Yi-Qi Chen, Shao-Long Fan, Ping Shao, Ling-Yun Chen, Jia-Zhen Li, Chang-Shui Yi, Bin Chen, Wei-Cun Xie, Shu-Yuan Mao, Xiao-Na Zou, He-Hui Zhang, Wen-Hong |
| description | Nucleos(t)ide analogues rarely result in a durable off-treatment response in chronic hepatitis B infection, whereas pegylated interferon (Peg-IFN) induces a long-lasting response only in a subset of patients. We assessed the effect of sequential combination therapy with Peg-IFN-α2a and entecavir in hepatitis B e antigen (HBeAg)-positive patients with prior long-term entecavir therapy and investigated the predictors of response to treatment. HBeAg-positive individuals who did not achieve HBeAg seroconversion during previous long-term entecavir therapy, receiving Peg-IFN-α2a added to ongoing entecavir therapy (sequential combination [S-C] therapy; n = 81) for 48 weeks or remaining on entecavir monotherapy (n = 116), were retrospectively included. A matched pair was created at a 1:1 ratio from each treatment group. The primary endpoint was HBeAg seroconversion at week 48. Subgroup analysis of response prediction was conducted for 81 patients with S-C therapy. More patients in the S-C therapy group achieved HBeAg seroconversion than those in the entecavir group (44% versus 6%; P < 0.0001). An HBeAg level of |
| doi_str_mv | 10.1128/AAC.00249-15 |
| format | Article |
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We assessed the effect of sequential combination therapy with Peg-IFN-α2a and entecavir in hepatitis B e antigen (HBeAg)-positive patients with prior long-term entecavir therapy and investigated the predictors of response to treatment. HBeAg-positive individuals who did not achieve HBeAg seroconversion during previous long-term entecavir therapy, receiving Peg-IFN-α2a added to ongoing entecavir therapy (sequential combination [S-C] therapy; n = 81) for 48 weeks or remaining on entecavir monotherapy (n = 116), were retrospectively included. A matched pair was created at a 1:1 ratio from each treatment group. The primary endpoint was HBeAg seroconversion at week 48. Subgroup analysis of response prediction was conducted for 81 patients with S-C therapy. More patients in the S-C therapy group achieved HBeAg seroconversion than those in the entecavir group (44% versus 6%; P < 0.0001). An HBeAg level of <200 signal-to-cutoff ratio (S/CO) at baseline was a strong predictor for higher HBeAg seroconversion than that achieved when HBeAg was ≥200 S/CO (64.2% versus 17.9%; P < 0.0001). Hepatitis B surface antigen (HBsAg) levels at baseline and the decrease in HBsAg levels predicted HBsAg loss in the S-C therapy group. The combination of baseline HBeAg of <200 S/CO and HBsAg of <1,000 IU/ml and an HBsAg decline at week 12 of ≥0.5 log10 IU/ml provided the highest rate of HBeAg seroconversion (92.31%) and HBsAg loss (83.3%) at week 48. Patients receiving sequential combination therapy have a higher rate of HBeAg seroconversion and are more likely to experience HBsAg clearance than do those continuing entecavir monotherapy. Sequential combination therapy can be guided by baseline HBsAg/HBeAg levels and on-treatment HBsAg dynamics.</description><identifier>ISSN: 0066-4804</identifier><identifier>EISSN: 1098-6596</identifier><identifier>DOI: 10.1128/AAC.00249-15</identifier><identifier>PMID: 25941216</identifier><language>eng</language><publisher>United States: American Society for Microbiology</publisher><subject>Adult ; Antiviral Agents ; Antiviral Agents - therapeutic use ; Area Under Curve ; Endpoint Determination ; Female ; Guanine ; Guanine - analogs & derivatives ; Guanine - therapeutic use ; Hepatitis B e Antigens ; Hepatitis B e Antigens - immunology ; Hepatitis B Surface Antigens ; Hepatitis B Surface Antigens - immunology ; Hepatitis B virus ; Hepatitis B, Chronic ; Hepatitis B, Chronic - drug therapy ; Hepatitis B, Chronic - immunology ; Hepatitis B, Chronic - virology ; Humans ; Interferon-alpha ; Interferon-alpha - therapeutic use ; Male ; Middle Aged ; Polyethylene Glycols ; Polyethylene Glycols - therapeutic use ; Predictive Value of Tests ; Recombinant Proteins - therapeutic use ; Retrospective Studies ; Seroconversion ; Treatment Outcome ; Young Adult</subject><ispartof>Antimicrobial agents and chemotherapy, 2015-07, Vol.59 (7), p.4121-4128</ispartof><rights>Copyright © 2015, American Society for Microbiology. All Rights Reserved.</rights><rights>Copyright © 2015, American Society for Microbiology. All Rights Reserved. 2015 American Society for Microbiology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a494t-20b3f60a0682b0f6c7c1dfd209c42693640f264226d22dda8f3e0e32ffded6b83</citedby><cites>FETCH-LOGICAL-a494t-20b3f60a0682b0f6c7c1dfd209c42693640f264226d22dda8f3e0e32ffded6b83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4468690/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4468690/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,724,777,781,882,27905,27906,53772,53774</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25941216$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Guo-Jun</creatorcontrib><creatorcontrib>Yu, Yi-Qi</creatorcontrib><creatorcontrib>Chen, Shao-Long</creatorcontrib><creatorcontrib>Fan, Ping</creatorcontrib><creatorcontrib>Shao, Ling-Yun</creatorcontrib><creatorcontrib>Chen, Jia-Zhen</creatorcontrib><creatorcontrib>Li, Chang-Shui</creatorcontrib><creatorcontrib>Yi, Bin</creatorcontrib><creatorcontrib>Chen, Wei-Cun</creatorcontrib><creatorcontrib>Xie, Shu-Yuan</creatorcontrib><creatorcontrib>Mao, Xiao-Na</creatorcontrib><creatorcontrib>Zou, He-Hui</creatorcontrib><creatorcontrib>Zhang, Wen-Hong</creatorcontrib><title>Sequential combination therapy with pegylated interferon leads to loss of hepatitis B surface antigen and hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive chronic hepatitis B patients receiving long-term entecavir treatment</title><title>Antimicrobial agents and chemotherapy</title><addtitle>Antimicrob Agents Chemother</addtitle><addtitle>Antimicrob Agents Chemother</addtitle><description>Nucleos(t)ide analogues rarely result in a durable off-treatment response in chronic hepatitis B infection, whereas pegylated interferon (Peg-IFN) induces a long-lasting response only in a subset of patients. We assessed the effect of sequential combination therapy with Peg-IFN-α2a and entecavir in hepatitis B e antigen (HBeAg)-positive patients with prior long-term entecavir therapy and investigated the predictors of response to treatment. HBeAg-positive individuals who did not achieve HBeAg seroconversion during previous long-term entecavir therapy, receiving Peg-IFN-α2a added to ongoing entecavir therapy (sequential combination [S-C] therapy; n = 81) for 48 weeks or remaining on entecavir monotherapy (n = 116), were retrospectively included. A matched pair was created at a 1:1 ratio from each treatment group. The primary endpoint was HBeAg seroconversion at week 48. Subgroup analysis of response prediction was conducted for 81 patients with S-C therapy. More patients in the S-C therapy group achieved HBeAg seroconversion than those in the entecavir group (44% versus 6%; P < 0.0001). An HBeAg level of <200 signal-to-cutoff ratio (S/CO) at baseline was a strong predictor for higher HBeAg seroconversion than that achieved when HBeAg was ≥200 S/CO (64.2% versus 17.9%; P < 0.0001). Hepatitis B surface antigen (HBsAg) levels at baseline and the decrease in HBsAg levels predicted HBsAg loss in the S-C therapy group. The combination of baseline HBeAg of <200 S/CO and HBsAg of <1,000 IU/ml and an HBsAg decline at week 12 of ≥0.5 log10 IU/ml provided the highest rate of HBeAg seroconversion (92.31%) and HBsAg loss (83.3%) at week 48. Patients receiving sequential combination therapy have a higher rate of HBeAg seroconversion and are more likely to experience HBsAg clearance than do those continuing entecavir monotherapy. Sequential combination therapy can be guided by baseline HBsAg/HBeAg levels and on-treatment HBsAg dynamics.</description><subject>Adult</subject><subject>Antiviral Agents</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Area Under Curve</subject><subject>Endpoint Determination</subject><subject>Female</subject><subject>Guanine</subject><subject>Guanine - analogs & derivatives</subject><subject>Guanine - therapeutic use</subject><subject>Hepatitis B e Antigens</subject><subject>Hepatitis B e Antigens - immunology</subject><subject>Hepatitis B Surface Antigens</subject><subject>Hepatitis B Surface Antigens - immunology</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B, Chronic</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Hepatitis B, Chronic - immunology</subject><subject>Hepatitis B, Chronic - virology</subject><subject>Humans</subject><subject>Interferon-alpha</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Polyethylene Glycols</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Predictive Value of Tests</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Retrospective Studies</subject><subject>Seroconversion</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0066-4804</issn><issn>1098-6596</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUsFu1DAQjRCILoUbZ-RjK5FiO46bXJC2K6BIlTgAZ8uxx1lXiR1sZ6v9aP4Bp1sKe0D4Mh69N2-ePVMUrwm-IIQ279brzQXGlLUlqZ8UK4LbpuR1y58WK4w5L1mD2UnxIsZbnPO6xc-LE1q3jFDCV8XPr_BjBpesHJDyY2edTNY7lLYQ5LRHdzZt0QT9fpAJNLIuQTAQMmMAqSNKHg0-RuQN2sKUa5ON6ArFORipAMms3IPLUR_hf5Cz6ytY9-coZlHl3Q5CXPpbh-6BcvIx1-wAqW3uatWRzHLL5iMKoMDurOuzG9eX2eSIMgBK7mxAKYBMY85fFs-MHCK8eoinxfePH75trsubL58-b9Y3pWQtSyXFXWU4lpg3tMOGq0tFtNEUt4pR3lacYUM5o5RrSrWWjakAQ0WN0aB511SnxfuD7jR3I2iVWwc5iCnYUYa98NKKY8TZrej9TjDGG97iLHD2IBB8nk9MYrRRwTBIB36OglxiwtpqOf-l8qbBuKr5YuvtgapCnlkA8-iIYLEsk8jLJO6XSZA6088PdBlHKm79HFz-tH9x3_z94kfh35tW_QIGzNhg</recordid><startdate>20150701</startdate><enddate>20150701</enddate><creator>Li, Guo-Jun</creator><creator>Yu, Yi-Qi</creator><creator>Chen, Shao-Long</creator><creator>Fan, Ping</creator><creator>Shao, Ling-Yun</creator><creator>Chen, Jia-Zhen</creator><creator>Li, Chang-Shui</creator><creator>Yi, Bin</creator><creator>Chen, Wei-Cun</creator><creator>Xie, Shu-Yuan</creator><creator>Mao, Xiao-Na</creator><creator>Zou, He-Hui</creator><creator>Zhang, Wen-Hong</creator><general>American Society for Microbiology</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><scope>7T7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20150701</creationdate><title>Sequential combination therapy with pegylated interferon leads to loss of hepatitis B surface antigen and hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive chronic hepatitis B patients receiving long-term entecavir treatment</title><author>Li, Guo-Jun ; Yu, Yi-Qi ; Chen, Shao-Long ; Fan, Ping ; Shao, Ling-Yun ; Chen, Jia-Zhen ; Li, Chang-Shui ; Yi, Bin ; Chen, Wei-Cun ; Xie, Shu-Yuan ; Mao, Xiao-Na ; Zou, He-Hui ; Zhang, Wen-Hong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a494t-20b3f60a0682b0f6c7c1dfd209c42693640f264226d22dda8f3e0e32ffded6b83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Antiviral Agents</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Area Under Curve</topic><topic>Endpoint Determination</topic><topic>Female</topic><topic>Guanine</topic><topic>Guanine - analogs & derivatives</topic><topic>Guanine - therapeutic use</topic><topic>Hepatitis B e Antigens</topic><topic>Hepatitis B e Antigens - immunology</topic><topic>Hepatitis B Surface Antigens</topic><topic>Hepatitis B Surface Antigens - immunology</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B, Chronic</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Hepatitis B, Chronic - immunology</topic><topic>Hepatitis B, Chronic - virology</topic><topic>Humans</topic><topic>Interferon-alpha</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Polyethylene Glycols</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Predictive Value of Tests</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Retrospective Studies</topic><topic>Seroconversion</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Li, Guo-Jun</creatorcontrib><creatorcontrib>Yu, Yi-Qi</creatorcontrib><creatorcontrib>Chen, Shao-Long</creatorcontrib><creatorcontrib>Fan, Ping</creatorcontrib><creatorcontrib>Shao, Ling-Yun</creatorcontrib><creatorcontrib>Chen, Jia-Zhen</creatorcontrib><creatorcontrib>Li, Chang-Shui</creatorcontrib><creatorcontrib>Yi, Bin</creatorcontrib><creatorcontrib>Chen, Wei-Cun</creatorcontrib><creatorcontrib>Xie, Shu-Yuan</creatorcontrib><creatorcontrib>Mao, Xiao-Na</creatorcontrib><creatorcontrib>Zou, He-Hui</creatorcontrib><creatorcontrib>Zhang, Wen-Hong</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><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Antimicrobial agents and chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Li, Guo-Jun</au><au>Yu, Yi-Qi</au><au>Chen, Shao-Long</au><au>Fan, Ping</au><au>Shao, Ling-Yun</au><au>Chen, Jia-Zhen</au><au>Li, Chang-Shui</au><au>Yi, Bin</au><au>Chen, Wei-Cun</au><au>Xie, Shu-Yuan</au><au>Mao, Xiao-Na</au><au>Zou, He-Hui</au><au>Zhang, Wen-Hong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sequential combination therapy with pegylated interferon leads to loss of hepatitis B surface antigen and hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive chronic hepatitis B patients receiving long-term entecavir treatment</atitle><jtitle>Antimicrobial agents and chemotherapy</jtitle><stitle>Antimicrob Agents Chemother</stitle><addtitle>Antimicrob Agents Chemother</addtitle><date>2015-07-01</date><risdate>2015</risdate><volume>59</volume><issue>7</issue><spage>4121</spage><epage>4128</epage><pages>4121-4128</pages><issn>0066-4804</issn><eissn>1098-6596</eissn><abstract>Nucleos(t)ide analogues rarely result in a durable off-treatment response in chronic hepatitis B infection, whereas pegylated interferon (Peg-IFN) induces a long-lasting response only in a subset of patients. We assessed the effect of sequential combination therapy with Peg-IFN-α2a and entecavir in hepatitis B e antigen (HBeAg)-positive patients with prior long-term entecavir therapy and investigated the predictors of response to treatment. HBeAg-positive individuals who did not achieve HBeAg seroconversion during previous long-term entecavir therapy, receiving Peg-IFN-α2a added to ongoing entecavir therapy (sequential combination [S-C] therapy; n = 81) for 48 weeks or remaining on entecavir monotherapy (n = 116), were retrospectively included. A matched pair was created at a 1:1 ratio from each treatment group. The primary endpoint was HBeAg seroconversion at week 48. Subgroup analysis of response prediction was conducted for 81 patients with S-C therapy. More patients in the S-C therapy group achieved HBeAg seroconversion than those in the entecavir group (44% versus 6%; P < 0.0001). An HBeAg level of <200 signal-to-cutoff ratio (S/CO) at baseline was a strong predictor for higher HBeAg seroconversion than that achieved when HBeAg was ≥200 S/CO (64.2% versus 17.9%; P < 0.0001). Hepatitis B surface antigen (HBsAg) levels at baseline and the decrease in HBsAg levels predicted HBsAg loss in the S-C therapy group. The combination of baseline HBeAg of <200 S/CO and HBsAg of <1,000 IU/ml and an HBsAg decline at week 12 of ≥0.5 log10 IU/ml provided the highest rate of HBeAg seroconversion (92.31%) and HBsAg loss (83.3%) at week 48. Patients receiving sequential combination therapy have a higher rate of HBeAg seroconversion and are more likely to experience HBsAg clearance than do those continuing entecavir monotherapy. Sequential combination therapy can be guided by baseline HBsAg/HBeAg levels and on-treatment HBsAg dynamics.</abstract><cop>United States</cop><pub>American Society for Microbiology</pub><pmid>25941216</pmid><doi>10.1128/AAC.00249-15</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Antimicrobial agents and chemotherapy, 2015-07, Vol.59 (7), p.4121-4128 |
| issn | 0066-4804 1098-6596 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4468690 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | Adult Antiviral Agents Antiviral Agents - therapeutic use Area Under Curve Endpoint Determination Female Guanine Guanine - analogs & derivatives Guanine - therapeutic use Hepatitis B e Antigens Hepatitis B e Antigens - immunology Hepatitis B Surface Antigens Hepatitis B Surface Antigens - immunology Hepatitis B virus Hepatitis B, Chronic Hepatitis B, Chronic - drug therapy Hepatitis B, Chronic - immunology Hepatitis B, Chronic - virology Humans Interferon-alpha Interferon-alpha - therapeutic use Male Middle Aged Polyethylene Glycols Polyethylene Glycols - therapeutic use Predictive Value of Tests Recombinant Proteins - therapeutic use Retrospective Studies Seroconversion Treatment Outcome Young Adult |
| title | Sequential combination therapy with pegylated interferon leads to loss of hepatitis B surface antigen and hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive chronic hepatitis B patients receiving long-term entecavir treatment |
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