Early on‐treatment prediction of response to peginterferon alfa‐2a for HBeAg‐negative chronic hepatitis B using HBsAg and HBV DNA levels
Peginterferon alfa‐2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B (CHB). This study investigated the role of early on‐treatment serum hepatitis B surface antigen (HBsAg) levels in the prediction of SR in HBeAg‐negativ...
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| Veröffentlicht in: | Hepatology (Baltimore, Md.) Md.), 2010-08, Vol.52 (2), p.454-461 |
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| creator | Rijckborst, Vincent Hansen, Bettina E. Cakaloglu, Yilmaz Ferenci, Peter Tabak, Fehmi Akdogan, Meral Simon, Krzysztof Akarca, Ulus S. Flisiak, Robert Verhey, Elke Van Vuuren, Anneke J. Boucher, Charles A. B. ter Borg, Martijn J. Janssen, Harry L. A. |
| description | Peginterferon alfa‐2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B (CHB). This study investigated the role of early on‐treatment serum hepatitis B surface antigen (HBsAg) levels in the prediction of SR in HBeAg‐negative patients receiving peginterferon alfa‐2a. HBsAg (Architect from Abbott) was quantified at the baseline and during treatment (weeks 4, 8, 12, 24, 36, and 48) and follow‐up (weeks 60 and 72) in the sera from 107 patients who participated in an international multicenter trial (peginterferon alfa‐2a, n = 53, versus peginterferon alfa‐2a and ribavirin, n = 54). Overall, 24 patients (22%) achieved SR [serum hepatitis B virus (HBV) DNA level < 10,000 copies/mL and normal alanine aminotransferase levels at week 72]. Baseline characteristics were comparable between sustained responders and nonresponders. From week 8 onward, serum HBsAg levels markedly decreased in sustained responders, whereas only a modest decline was observed in nonresponders. However, HBsAg declines alone were of limited value in the prediction of SR [area under the receiver operating characteristic curve (AUC) at weeks 4, 8, and 12 = 0.59, 0.56, and 0.69, respectively]. Combining the declines in HBsAg and HBV DNA allowed the best prediction of SR (AUC at week 12 = 0.74). None of the 20 patients (20% of the study population) in whom a decrease in serum HBsAg levels was absent and whose HBV DNA levels declined less than 2 log copies/mL exhibited an SR (negative predictive value = 100%). Conclusion: At week 12 of peginterferon alfa‐2a treatment for HBeAg‐negative CHB, a solid stopping rule was established with a combination of declines in serum HBV DNA and HBsAg levels from the baseline. Quantitative serum HBsAg in combination with HBV DNA enables on‐treatment adjustments of peginterferon therapy for HBeAg‐negative CHB. (HEPATOLOGY 2010) |
| doi_str_mv | 10.1002/hep.23722 |
| format | Article |
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B. ; ter Borg, Martijn J. ; Janssen, Harry L. A.</creator><creatorcontrib>Rijckborst, Vincent ; Hansen, Bettina E. ; Cakaloglu, Yilmaz ; Ferenci, Peter ; Tabak, Fehmi ; Akdogan, Meral ; Simon, Krzysztof ; Akarca, Ulus S. ; Flisiak, Robert ; Verhey, Elke ; Van Vuuren, Anneke J. ; Boucher, Charles A. B. ; ter Borg, Martijn J. ; Janssen, Harry L. A.</creatorcontrib><description>Peginterferon alfa‐2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B (CHB). This study investigated the role of early on‐treatment serum hepatitis B surface antigen (HBsAg) levels in the prediction of SR in HBeAg‐negative patients receiving peginterferon alfa‐2a. HBsAg (Architect from Abbott) was quantified at the baseline and during treatment (weeks 4, 8, 12, 24, 36, and 48) and follow‐up (weeks 60 and 72) in the sera from 107 patients who participated in an international multicenter trial (peginterferon alfa‐2a, n = 53, versus peginterferon alfa‐2a and ribavirin, n = 54). Overall, 24 patients (22%) achieved SR [serum hepatitis B virus (HBV) DNA level < 10,000 copies/mL and normal alanine aminotransferase levels at week 72]. Baseline characteristics were comparable between sustained responders and nonresponders. From week 8 onward, serum HBsAg levels markedly decreased in sustained responders, whereas only a modest decline was observed in nonresponders. However, HBsAg declines alone were of limited value in the prediction of SR [area under the receiver operating characteristic curve (AUC) at weeks 4, 8, and 12 = 0.59, 0.56, and 0.69, respectively]. Combining the declines in HBsAg and HBV DNA allowed the best prediction of SR (AUC at week 12 = 0.74). None of the 20 patients (20% of the study population) in whom a decrease in serum HBsAg levels was absent and whose HBV DNA levels declined less than 2 log copies/mL exhibited an SR (negative predictive value = 100%). Conclusion: At week 12 of peginterferon alfa‐2a treatment for HBeAg‐negative CHB, a solid stopping rule was established with a combination of declines in serum HBV DNA and HBsAg levels from the baseline. Quantitative serum HBsAg in combination with HBV DNA enables on‐treatment adjustments of peginterferon therapy for HBeAg‐negative CHB. (HEPATOLOGY 2010)</description><identifier>ISSN: 0270-9139</identifier><identifier>EISSN: 1527-3350</identifier><identifier>DOI: 10.1002/hep.23722</identifier><identifier>PMID: 20683945</identifier><identifier>CODEN: HPTLD9</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Adult ; Antigens ; Antiviral Agents - therapeutic use ; Biological and medical sciences ; Deoxyribonucleic acid ; DNA ; DNA, Viral - blood ; Double-Blind Method ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Hepatitis ; Hepatitis B ; Hepatitis B e Antigens ; Hepatitis B Surface Antigens - blood ; Hepatitis B virus ; Hepatitis B virus - genetics ; Hepatitis B, Chronic - blood ; Hepatitis B, Chronic - drug therapy ; Hepatology ; Human viral diseases ; Humans ; Immunomodulators ; Infectious diseases ; Interferon ; Interferon-alpha - therapeutic use ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Pharmacology. Drug treatments ; Polyethylene Glycols - therapeutic use ; Predictive Value of Tests ; Recombinant Proteins ; Remission Induction ; Retrospective Studies ; Time Factors ; Viral diseases ; Viral hepatitis</subject><ispartof>Hepatology (Baltimore, Md.), 2010-08, Vol.52 (2), p.454-461</ispartof><rights>Copyright © 2010 American Association for the Study of Liver Diseases</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5162-1fa118c3e48346dfe6ae6a0efbef7bc21e7c3cf5edfdf7a6a857db3c614cd1c13</citedby><cites>FETCH-LOGICAL-c5162-1fa118c3e48346dfe6ae6a0efbef7bc21e7c3cf5edfdf7a6a857db3c614cd1c13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fhep.23722$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fhep.23722$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23099335$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20683945$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rijckborst, Vincent</creatorcontrib><creatorcontrib>Hansen, Bettina E.</creatorcontrib><creatorcontrib>Cakaloglu, Yilmaz</creatorcontrib><creatorcontrib>Ferenci, Peter</creatorcontrib><creatorcontrib>Tabak, Fehmi</creatorcontrib><creatorcontrib>Akdogan, Meral</creatorcontrib><creatorcontrib>Simon, Krzysztof</creatorcontrib><creatorcontrib>Akarca, Ulus S.</creatorcontrib><creatorcontrib>Flisiak, Robert</creatorcontrib><creatorcontrib>Verhey, Elke</creatorcontrib><creatorcontrib>Van Vuuren, Anneke J.</creatorcontrib><creatorcontrib>Boucher, Charles A. B.</creatorcontrib><creatorcontrib>ter Borg, Martijn J.</creatorcontrib><creatorcontrib>Janssen, Harry L. A.</creatorcontrib><title>Early on‐treatment prediction of response to peginterferon alfa‐2a for HBeAg‐negative chronic hepatitis B using HBsAg and HBV DNA levels</title><title>Hepatology (Baltimore, Md.)</title><addtitle>Hepatology</addtitle><description>Peginterferon alfa‐2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B (CHB). This study investigated the role of early on‐treatment serum hepatitis B surface antigen (HBsAg) levels in the prediction of SR in HBeAg‐negative patients receiving peginterferon alfa‐2a. HBsAg (Architect from Abbott) was quantified at the baseline and during treatment (weeks 4, 8, 12, 24, 36, and 48) and follow‐up (weeks 60 and 72) in the sera from 107 patients who participated in an international multicenter trial (peginterferon alfa‐2a, n = 53, versus peginterferon alfa‐2a and ribavirin, n = 54). Overall, 24 patients (22%) achieved SR [serum hepatitis B virus (HBV) DNA level < 10,000 copies/mL and normal alanine aminotransferase levels at week 72]. Baseline characteristics were comparable between sustained responders and nonresponders. From week 8 onward, serum HBsAg levels markedly decreased in sustained responders, whereas only a modest decline was observed in nonresponders. However, HBsAg declines alone were of limited value in the prediction of SR [area under the receiver operating characteristic curve (AUC) at weeks 4, 8, and 12 = 0.59, 0.56, and 0.69, respectively]. Combining the declines in HBsAg and HBV DNA allowed the best prediction of SR (AUC at week 12 = 0.74). None of the 20 patients (20% of the study population) in whom a decrease in serum HBsAg levels was absent and whose HBV DNA levels declined less than 2 log copies/mL exhibited an SR (negative predictive value = 100%). Conclusion: At week 12 of peginterferon alfa‐2a treatment for HBeAg‐negative CHB, a solid stopping rule was established with a combination of declines in serum HBV DNA and HBsAg levels from the baseline. Quantitative serum HBsAg in combination with HBV DNA enables on‐treatment adjustments of peginterferon therapy for HBeAg‐negative CHB. (HEPATOLOGY 2010)</description><subject>Adult</subject><subject>Antigens</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>DNA, Viral - blood</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Hepatitis</subject><subject>Hepatitis B</subject><subject>Hepatitis B e Antigens</subject><subject>Hepatitis B Surface Antigens - blood</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B virus - genetics</subject><subject>Hepatitis B, Chronic - blood</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>Hepatology</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunomodulators</subject><subject>Infectious diseases</subject><subject>Interferon</subject><subject>Interferon-alpha - therapeutic use</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Polyethylene Glycols - therapeutic use</subject><subject>Predictive Value of Tests</subject><subject>Recombinant Proteins</subject><subject>Remission Induction</subject><subject>Retrospective Studies</subject><subject>Time Factors</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><issn>0270-9139</issn><issn>1527-3350</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90ttu0zAYAGALgVgpXPACyBJCwEU2HxI7uey2QpEm4AK4jVznd-YptTM7HerdngDxjDwJP7SAhASS5ePn429CHnN2zBkTJ5cwHguphbhDZrwSupCyYnfJjAnNiobL5og8yPmKMdaUor5PjgRTtWzKaka-LE0adjSGb7dfpwRm2kCY6Jig83byMdDoaII8xpCBTpGO0PswQXKQcNAMzuBEYaiLia5OYdFjM0BvJn8D1F4i8pbi-bBj8pme0m32oUeaFz01ocPaJ3r-dkEHuIEhPyT3nBkyPDqUc_Lx1fLD2aq4ePf6zdniorAVV6LgznBeWwllLUvVOVAGEwO3BqfXVnDQVlpXQec6p40ydaW7tbSKl7bjlss5eb5fd0zxegt5ajc-WxgGEyBuc6vLupF1jdmcvPiv5ForpbRqKqRP_6JXcZsC3gOVUrXgNVeoXu6VTTHnBK4dk9-YtGs5a3-Es8Xnan-GE-2Tw4rb9Qa63_JX_BA8OwCTLUYjmWB9_uMkaxr8DOhO9u6zH2D37x3b1fL9fuvvZuW6IQ</recordid><startdate>201008</startdate><enddate>201008</enddate><creator>Rijckborst, Vincent</creator><creator>Hansen, Bettina E.</creator><creator>Cakaloglu, Yilmaz</creator><creator>Ferenci, Peter</creator><creator>Tabak, Fehmi</creator><creator>Akdogan, Meral</creator><creator>Simon, Krzysztof</creator><creator>Akarca, Ulus S.</creator><creator>Flisiak, Robert</creator><creator>Verhey, Elke</creator><creator>Van Vuuren, Anneke J.</creator><creator>Boucher, Charles A. B.</creator><creator>ter Borg, Martijn J.</creator><creator>Janssen, Harry L. A.</creator><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley</general><general>Wolters Kluwer Health, Inc</general><scope>IQODW</scope><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>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201008</creationdate><title>Early on‐treatment prediction of response to peginterferon alfa‐2a for HBeAg‐negative chronic hepatitis B using HBsAg and HBV DNA levels</title><author>Rijckborst, Vincent ; Hansen, Bettina E. ; Cakaloglu, Yilmaz ; Ferenci, Peter ; Tabak, Fehmi ; Akdogan, Meral ; Simon, Krzysztof ; Akarca, Ulus S. ; Flisiak, Robert ; Verhey, Elke ; Van Vuuren, Anneke J. ; Boucher, Charles A. 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Abdomen</topic><topic>Hepatitis</topic><topic>Hepatitis B</topic><topic>Hepatitis B e Antigens</topic><topic>Hepatitis B Surface Antigens - blood</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B virus - genetics</topic><topic>Hepatitis B, Chronic - blood</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>Hepatology</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunomodulators</topic><topic>Infectious diseases</topic><topic>Interferon</topic><topic>Interferon-alpha - therapeutic use</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Polyethylene Glycols - therapeutic use</topic><topic>Predictive Value of Tests</topic><topic>Recombinant Proteins</topic><topic>Remission Induction</topic><topic>Retrospective Studies</topic><topic>Time Factors</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rijckborst, Vincent</creatorcontrib><creatorcontrib>Hansen, Bettina E.</creatorcontrib><creatorcontrib>Cakaloglu, Yilmaz</creatorcontrib><creatorcontrib>Ferenci, Peter</creatorcontrib><creatorcontrib>Tabak, Fehmi</creatorcontrib><creatorcontrib>Akdogan, Meral</creatorcontrib><creatorcontrib>Simon, Krzysztof</creatorcontrib><creatorcontrib>Akarca, Ulus S.</creatorcontrib><creatorcontrib>Flisiak, Robert</creatorcontrib><creatorcontrib>Verhey, Elke</creatorcontrib><creatorcontrib>Van Vuuren, Anneke J.</creatorcontrib><creatorcontrib>Boucher, Charles A. 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A.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Hepatology (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rijckborst, Vincent</au><au>Hansen, Bettina E.</au><au>Cakaloglu, Yilmaz</au><au>Ferenci, Peter</au><au>Tabak, Fehmi</au><au>Akdogan, Meral</au><au>Simon, Krzysztof</au><au>Akarca, Ulus S.</au><au>Flisiak, Robert</au><au>Verhey, Elke</au><au>Van Vuuren, Anneke J.</au><au>Boucher, Charles A. B.</au><au>ter Borg, Martijn J.</au><au>Janssen, Harry L. A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Early on‐treatment prediction of response to peginterferon alfa‐2a for HBeAg‐negative chronic hepatitis B using HBsAg and HBV DNA levels</atitle><jtitle>Hepatology (Baltimore, Md.)</jtitle><addtitle>Hepatology</addtitle><date>2010-08</date><risdate>2010</risdate><volume>52</volume><issue>2</issue><spage>454</spage><epage>461</epage><pages>454-461</pages><issn>0270-9139</issn><eissn>1527-3350</eissn><coden>HPTLD9</coden><abstract>Peginterferon alfa‐2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg)–negative chronic hepatitis B (CHB). This study investigated the role of early on‐treatment serum hepatitis B surface antigen (HBsAg) levels in the prediction of SR in HBeAg‐negative patients receiving peginterferon alfa‐2a. HBsAg (Architect from Abbott) was quantified at the baseline and during treatment (weeks 4, 8, 12, 24, 36, and 48) and follow‐up (weeks 60 and 72) in the sera from 107 patients who participated in an international multicenter trial (peginterferon alfa‐2a, n = 53, versus peginterferon alfa‐2a and ribavirin, n = 54). Overall, 24 patients (22%) achieved SR [serum hepatitis B virus (HBV) DNA level < 10,000 copies/mL and normal alanine aminotransferase levels at week 72]. Baseline characteristics were comparable between sustained responders and nonresponders. From week 8 onward, serum HBsAg levels markedly decreased in sustained responders, whereas only a modest decline was observed in nonresponders. However, HBsAg declines alone were of limited value in the prediction of SR [area under the receiver operating characteristic curve (AUC) at weeks 4, 8, and 12 = 0.59, 0.56, and 0.69, respectively]. Combining the declines in HBsAg and HBV DNA allowed the best prediction of SR (AUC at week 12 = 0.74). None of the 20 patients (20% of the study population) in whom a decrease in serum HBsAg levels was absent and whose HBV DNA levels declined less than 2 log copies/mL exhibited an SR (negative predictive value = 100%). Conclusion: At week 12 of peginterferon alfa‐2a treatment for HBeAg‐negative CHB, a solid stopping rule was established with a combination of declines in serum HBV DNA and HBsAg levels from the baseline. Quantitative serum HBsAg in combination with HBV DNA enables on‐treatment adjustments of peginterferon therapy for HBeAg‐negative CHB. (HEPATOLOGY 2010)</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>20683945</pmid><doi>10.1002/hep.23722</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Antigens Antiviral Agents - therapeutic use Biological and medical sciences Deoxyribonucleic acid DNA DNA, Viral - blood Double-Blind Method Female Gastroenterology. Liver. Pancreas. Abdomen Hepatitis Hepatitis B Hepatitis B e Antigens Hepatitis B Surface Antigens - blood Hepatitis B virus Hepatitis B virus - genetics Hepatitis B, Chronic - blood Hepatitis B, Chronic - drug therapy Hepatology Human viral diseases Humans Immunomodulators Infectious diseases Interferon Interferon-alpha - therapeutic use Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Pharmacology. Drug treatments Polyethylene Glycols - therapeutic use Predictive Value of Tests Recombinant Proteins Remission Induction Retrospective Studies Time Factors Viral diseases Viral hepatitis |
| title | Early on‐treatment prediction of response to peginterferon alfa‐2a for HBeAg‐negative chronic hepatitis B using HBsAg and HBV DNA levels |
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