Long-term entecavir or tenofovir disoproxil fumarate therapy in treatment-naïve chronic hepatitis B patients in the real-world setting
Summary The aim of this study was to determine the long‐term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) on the natural course of disease in chronic hepatitis B patients (CHB) with/without cirrhosis in clinical practice. A total of 355 treatment‐naïve CHB patients were enroll...
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| Veröffentlicht in: | Journal of viral hepatitis 2015-05, Vol.22 (5), p.504-510 |
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| container_title | Journal of viral hepatitis |
| container_volume | 22 |
| creator | Idilman, R. Gunsar, F. Koruk, M. Keskin, O. Meral, C. E. Gulsen, M. Elhan, A. H. Akarca, U. S. Yurdaydin, C. |
| description | Summary
The aim of this study was to determine the long‐term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) on the natural course of disease in chronic hepatitis B patients (CHB) with/without cirrhosis in clinical practice. A total of 355 treatment‐naïve CHB patients were enrolled into the study. The primary outcome measure was viral suppression as defined by serum HBV DNA level |
| doi_str_mv | 10.1111/jvh.12358 |
| format | Article |
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The aim of this study was to determine the long‐term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) on the natural course of disease in chronic hepatitis B patients (CHB) with/without cirrhosis in clinical practice. A total of 355 treatment‐naïve CHB patients were enrolled into the study. The primary outcome measure was viral suppression as defined by serum HBV DNA level <20 IU/mL. A secondary outcome measure was to determine the development of Hepatocellular carcinoma (HCC). Virological and biochemical responses were similar between the two treatment groups over time. The presence of cirrhosis and hepatitis B e antigen (HBeAg) positivity did not appear to impact viral suppression. The cumulative probability of HBeAg loss was 41% at 4 years of therapy. Hepatitis B surface antigen (HBsAg) loss occurred in four patients. Model for End‐Stage Liver Disease score was significantly improved from baseline to week 48 and 96 under antiviral therapy (P = 0.013, P = 0.01). HCC was diagnosed in 17 patients (4.8%). The cumulative probability of the development of HCC was 3.3% at 1 year and 7.3% at 4 years of therapy. The development of HCC was independently associated with older age (P = 0.031) and the presence of cirrhosis (P = 0.004). Serum creatinine levels and creatinine clearance remained stable over time. ETV and TDF effectively maintained virological and biochemical responses in long‐term follow‐up of CHB patients with/without cirrhosis. HCC may still develop, although at a lower rate, and is more likely to develop in patients with cirrhosis, especially in older patients.</description><identifier>ISSN: 1352-0504</identifier><identifier>EISSN: 1365-2893</identifier><identifier>DOI: 10.1111/jvh.12358</identifier><identifier>PMID: 25431108</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adult ; Antiviral Agents - therapeutic use ; Carcinoma, Hepatocellular - epidemiology ; chronic hepatitis B ; Creatinine - blood ; DNA, Viral - blood ; entecavir ; Female ; Guanine - analogs & derivatives ; Guanine - therapeutic use ; Hepatitis B e Antigens - blood ; Hepatitis B virus - isolation & purification ; Hepatitis B, Chronic - complications ; Hepatitis B, Chronic - drug therapy ; hepatocellular carcinoma ; Humans ; Incidence ; Liver Neoplasms - epidemiology ; Male ; Metabolic Clearance Rate ; Middle Aged ; Prospective Studies ; Retrospective Studies ; Tenofovir - therapeutic use ; tenofovir disoproxil fumarate ; Treatment Outcome ; Viral Load</subject><ispartof>Journal of viral hepatitis, 2015-05, Vol.22 (5), p.504-510</ispartof><rights>2014 John Wiley & Sons Ltd</rights><rights>2014 John Wiley & Sons Ltd.</rights><rights>Copyright © 2015 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4268-471f0e3304aab46f30574fb3ebabf5ac4943029f33d6b909f48afa59181e12a83</citedby><cites>FETCH-LOGICAL-c4268-471f0e3304aab46f30574fb3ebabf5ac4943029f33d6b909f48afa59181e12a83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjvh.12358$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjvh.12358$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25431108$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Idilman, R.</creatorcontrib><creatorcontrib>Gunsar, F.</creatorcontrib><creatorcontrib>Koruk, M.</creatorcontrib><creatorcontrib>Keskin, O.</creatorcontrib><creatorcontrib>Meral, C. E.</creatorcontrib><creatorcontrib>Gulsen, M.</creatorcontrib><creatorcontrib>Elhan, A. H.</creatorcontrib><creatorcontrib>Akarca, U. S.</creatorcontrib><creatorcontrib>Yurdaydin, C.</creatorcontrib><title>Long-term entecavir or tenofovir disoproxil fumarate therapy in treatment-naïve chronic hepatitis B patients in the real-world setting</title><title>Journal of viral hepatitis</title><addtitle>J Viral Hepat</addtitle><description>Summary
The aim of this study was to determine the long‐term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) on the natural course of disease in chronic hepatitis B patients (CHB) with/without cirrhosis in clinical practice. A total of 355 treatment‐naïve CHB patients were enrolled into the study. The primary outcome measure was viral suppression as defined by serum HBV DNA level <20 IU/mL. A secondary outcome measure was to determine the development of Hepatocellular carcinoma (HCC). Virological and biochemical responses were similar between the two treatment groups over time. The presence of cirrhosis and hepatitis B e antigen (HBeAg) positivity did not appear to impact viral suppression. The cumulative probability of HBeAg loss was 41% at 4 years of therapy. Hepatitis B surface antigen (HBsAg) loss occurred in four patients. Model for End‐Stage Liver Disease score was significantly improved from baseline to week 48 and 96 under antiviral therapy (P = 0.013, P = 0.01). HCC was diagnosed in 17 patients (4.8%). The cumulative probability of the development of HCC was 3.3% at 1 year and 7.3% at 4 years of therapy. The development of HCC was independently associated with older age (P = 0.031) and the presence of cirrhosis (P = 0.004). Serum creatinine levels and creatinine clearance remained stable over time. ETV and TDF effectively maintained virological and biochemical responses in long‐term follow‐up of CHB patients with/without cirrhosis. HCC may still develop, although at a lower rate, and is more likely to develop in patients with cirrhosis, especially in older patients.</description><subject>Adult</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Carcinoma, Hepatocellular - epidemiology</subject><subject>chronic hepatitis B</subject><subject>Creatinine - blood</subject><subject>DNA, Viral - blood</subject><subject>entecavir</subject><subject>Female</subject><subject>Guanine - analogs & derivatives</subject><subject>Guanine - therapeutic use</subject><subject>Hepatitis B e Antigens - blood</subject><subject>Hepatitis B virus - isolation & purification</subject><subject>Hepatitis B, Chronic - complications</subject><subject>Hepatitis B, Chronic - drug therapy</subject><subject>hepatocellular carcinoma</subject><subject>Humans</subject><subject>Incidence</subject><subject>Liver Neoplasms - epidemiology</subject><subject>Male</subject><subject>Metabolic Clearance Rate</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Retrospective Studies</subject><subject>Tenofovir - therapeutic use</subject><subject>tenofovir disoproxil fumarate</subject><subject>Treatment Outcome</subject><subject>Viral Load</subject><issn>1352-0504</issn><issn>1365-2893</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kctu1DAUhi1ERS-w4AWQJTZ0kdbXXJZ0BB3QtEgIytJyMseNhyQebGfaeQIeh4fgxXA6bRdI9cbH0vf9sv0j9JqSE5rW6WrTnlDGZfkMHVCey4yVFX8-zZJlRBKxjw5DWBFCOZP0BdpnUnBKSXmAfi_ccJ1F8D2GIUKjN9Zj53GEwRk3HZY2uLV3t7bDZuy11xFwbMHr9RbbAUcPOvbJzQb9988GcNN6N9gGt7DW0UYb8BmepoSEO6EFnJwuu3G-W-IAMdrh-iXaM7oL8Op-P0LfP374Nptniy_nn2bvF1kjWF5moqCGAOdEaF2L3HAiC2FqDrWujdSNqAQnrDKcL_O6IpURpTZaVrSkQJku-RF6t8tNT_o1Qoiqt6GBrtMDuDEomheUMVLQPKFv_0NXbvRDut1EEVKUnIlEHe-oxrsQPBi19jZ901ZRoqZ2VGpH3bWT2Df3iWPdw_KRfKgjAac74MZ2sH06SX2-mj9EZjvDhgi3j4b2P1Ve8EKqH5fn6ut8ls85u1IX_B_r8aqv</recordid><startdate>201505</startdate><enddate>201505</enddate><creator>Idilman, R.</creator><creator>Gunsar, F.</creator><creator>Koruk, M.</creator><creator>Keskin, O.</creator><creator>Meral, C. E.</creator><creator>Gulsen, M.</creator><creator>Elhan, A. H.</creator><creator>Akarca, U. S.</creator><creator>Yurdaydin, C.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</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>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope></search><sort><creationdate>201505</creationdate><title>Long-term entecavir or tenofovir disoproxil fumarate therapy in treatment-naïve chronic hepatitis B patients in the real-world setting</title><author>Idilman, R. ; Gunsar, F. ; Koruk, M. ; Keskin, O. ; Meral, C. E. ; Gulsen, M. ; Elhan, A. H. ; Akarca, U. S. ; Yurdaydin, C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4268-471f0e3304aab46f30574fb3ebabf5ac4943029f33d6b909f48afa59181e12a83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Carcinoma, Hepatocellular - epidemiology</topic><topic>chronic hepatitis B</topic><topic>Creatinine - blood</topic><topic>DNA, Viral - blood</topic><topic>entecavir</topic><topic>Female</topic><topic>Guanine - analogs & derivatives</topic><topic>Guanine - therapeutic use</topic><topic>Hepatitis B e Antigens - blood</topic><topic>Hepatitis B virus - isolation & purification</topic><topic>Hepatitis B, Chronic - complications</topic><topic>Hepatitis B, Chronic - drug therapy</topic><topic>hepatocellular carcinoma</topic><topic>Humans</topic><topic>Incidence</topic><topic>Liver Neoplasms - epidemiology</topic><topic>Male</topic><topic>Metabolic Clearance Rate</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Retrospective Studies</topic><topic>Tenofovir - therapeutic use</topic><topic>tenofovir disoproxil fumarate</topic><topic>Treatment Outcome</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Idilman, R.</creatorcontrib><creatorcontrib>Gunsar, F.</creatorcontrib><creatorcontrib>Koruk, M.</creatorcontrib><creatorcontrib>Keskin, O.</creatorcontrib><creatorcontrib>Meral, C. E.</creatorcontrib><creatorcontrib>Gulsen, M.</creatorcontrib><creatorcontrib>Elhan, A. H.</creatorcontrib><creatorcontrib>Akarca, U. S.</creatorcontrib><creatorcontrib>Yurdaydin, C.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</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>Journal of viral hepatitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Idilman, R.</au><au>Gunsar, F.</au><au>Koruk, M.</au><au>Keskin, O.</au><au>Meral, C. E.</au><au>Gulsen, M.</au><au>Elhan, A. H.</au><au>Akarca, U. S.</au><au>Yurdaydin, C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Long-term entecavir or tenofovir disoproxil fumarate therapy in treatment-naïve chronic hepatitis B patients in the real-world setting</atitle><jtitle>Journal of viral hepatitis</jtitle><addtitle>J Viral Hepat</addtitle><date>2015-05</date><risdate>2015</risdate><volume>22</volume><issue>5</issue><spage>504</spage><epage>510</epage><pages>504-510</pages><issn>1352-0504</issn><eissn>1365-2893</eissn><abstract>Summary
The aim of this study was to determine the long‐term efficacy of entecavir (ETV) and tenofovir disoproxil fumarate (TDF) on the natural course of disease in chronic hepatitis B patients (CHB) with/without cirrhosis in clinical practice. A total of 355 treatment‐naïve CHB patients were enrolled into the study. The primary outcome measure was viral suppression as defined by serum HBV DNA level <20 IU/mL. A secondary outcome measure was to determine the development of Hepatocellular carcinoma (HCC). Virological and biochemical responses were similar between the two treatment groups over time. The presence of cirrhosis and hepatitis B e antigen (HBeAg) positivity did not appear to impact viral suppression. The cumulative probability of HBeAg loss was 41% at 4 years of therapy. Hepatitis B surface antigen (HBsAg) loss occurred in four patients. Model for End‐Stage Liver Disease score was significantly improved from baseline to week 48 and 96 under antiviral therapy (P = 0.013, P = 0.01). HCC was diagnosed in 17 patients (4.8%). The cumulative probability of the development of HCC was 3.3% at 1 year and 7.3% at 4 years of therapy. The development of HCC was independently associated with older age (P = 0.031) and the presence of cirrhosis (P = 0.004). Serum creatinine levels and creatinine clearance remained stable over time. ETV and TDF effectively maintained virological and biochemical responses in long‐term follow‐up of CHB patients with/without cirrhosis. HCC may still develop, although at a lower rate, and is more likely to develop in patients with cirrhosis, especially in older patients.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>25431108</pmid><doi>10.1111/jvh.12358</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Antiviral Agents - therapeutic use Carcinoma, Hepatocellular - epidemiology chronic hepatitis B Creatinine - blood DNA, Viral - blood entecavir Female Guanine - analogs & derivatives Guanine - therapeutic use Hepatitis B e Antigens - blood Hepatitis B virus - isolation & purification Hepatitis B, Chronic - complications Hepatitis B, Chronic - drug therapy hepatocellular carcinoma Humans Incidence Liver Neoplasms - epidemiology Male Metabolic Clearance Rate Middle Aged Prospective Studies Retrospective Studies Tenofovir - therapeutic use tenofovir disoproxil fumarate Treatment Outcome Viral Load |
| title | Long-term entecavir or tenofovir disoproxil fumarate therapy in treatment-naïve chronic hepatitis B patients in the real-world setting |
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