A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post–liver transplantation hepatitis B prophylaxis
Prior to effective prophylaxis, liver transplantation for hepatitis B virus (HBV)‐related disease was frequently complicated by recurrence, which could be severe and rapidly progressive. Combination hepatitis B immunoglobulin (HBIG) and lamivudine prophylaxis reduces this rate of recurrence to
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| Veröffentlicht in: | Hepatology (Baltimore, Md.) Md.), 2008-11, Vol.48 (5), p.1460-1466 |
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| container_title | Hepatology (Baltimore, Md.) |
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| creator | Angus, Peter W. Patterson, Scott J. Strasser, Simone I. McCaughan, Geoffrey W. Gane, Edward |
| description | Prior to effective prophylaxis, liver transplantation for hepatitis B virus (HBV)‐related disease was frequently complicated by recurrence, which could be severe and rapidly progressive. Combination hepatitis B immunoglobulin (HBIG) and lamivudine prophylaxis reduces this rate of recurrence to |
| doi_str_mv | 10.1002/hep.22524 |
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Combination hepatitis B immunoglobulin (HBIG) and lamivudine prophylaxis reduces this rate of recurrence to <5% at 5 years; however, HBIG administration is costly and inconvenient. We conducted a multicenter randomized study of adefovir dipivoxil substitution for low‐dose intramuscular (IM) HBIG in patients without HBV recurrence at least 12 months posttransplantation for HBV‐related disease. Thirty‐four patients were randomized, 16 to adefovir (1 patient withdrew consent at 3 months and is not considered in the results) and 18 to continue HBIG. All continued lamivudine. Groups were well matched by age, sex, and time since transplantation (median, 4.5 years), and background virological risk for HBV recurrence (30% of patients in the adefovir group, 24% in the HBIG group having detectable HBV DNA at transplantation). All patients were alive at study completion without recurrence. One patient in the adefovir group became hepatitis B surface antigen–positive at 5 months but was persistently HBV DNA undetectable via polymerase chain reaction (sensitivity 14 IU/mL) over the following 20 months. Median creatinine was not significantly changed over the course of the study in either group. One patient in the adefovir group with a background of diabetic and hypertensive nephropathy (baseline creatinine 150 μmol/L) developed increased creatinine leading to dose reduction and ultimately cessation of adefovir at 15 months. Yearly cost of combination adefovir/lamivudine prophylaxis was $8,290 versus $13,718 IM HBIG/lamivudine. Conclusion: Compared with combination HBIG plus lamivudine prophylaxis, combination adefovir plus lamivudine provides equivalent protection against recurrent HBV infection but with better tolerability and less cost. (HEPATOLOGY 2008.)</description><identifier>ISSN: 0270-9139</identifier><identifier>EISSN: 1527-3350</identifier><identifier>DOI: 10.1002/hep.22524</identifier><identifier>PMID: 18925641</identifier><identifier>CODEN: HPTLD9</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Adenine - analogs & derivatives ; Adenine - therapeutic use ; Adult ; Aged ; Antiviral Agents - therapeutic use ; Biological and medical sciences ; DNA, Viral - blood ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Hepatitis B - immunology ; Hepatitis B - prevention & control ; Human viral diseases ; Humans ; Immunization, Passive ; Immunoglobulins - therapeutic use ; Infectious diseases ; Lamivudine - therapeutic use ; Liver Transplantation - adverse effects ; Liver, biliary tract, pancreas, portal circulation, spleen ; Liver. Biliary tract. Portal circulation. Exocrine pancreas ; Male ; Medical sciences ; Middle Aged ; Organophosphonates - therapeutic use ; Patient Selection ; Postoperative Complications - prevention & control ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Surgery of the digestive system ; Viral diseases ; Viral hepatitis ; Viral Load</subject><ispartof>Hepatology (Baltimore, Md.), 2008-11, Vol.48 (5), p.1460-1466</ispartof><rights>Copyright © 2008 American Association for the Study of Liver Diseases</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3534-8ee70ebab758340cfafd10598bb370c21fdd558f144df48708e462b12fedb1ce3</citedby><cites>FETCH-LOGICAL-c3534-8ee70ebab758340cfafd10598bb370c21fdd558f144df48708e462b12fedb1ce3</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.22524$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fhep.22524$$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=20830639$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18925641$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Angus, Peter W.</creatorcontrib><creatorcontrib>Patterson, Scott J.</creatorcontrib><creatorcontrib>Strasser, Simone I.</creatorcontrib><creatorcontrib>McCaughan, Geoffrey W.</creatorcontrib><creatorcontrib>Gane, Edward</creatorcontrib><title>A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post–liver transplantation hepatitis B prophylaxis</title><title>Hepatology (Baltimore, Md.)</title><addtitle>Hepatology</addtitle><description>Prior to effective prophylaxis, liver transplantation for hepatitis B virus (HBV)‐related disease was frequently complicated by recurrence, which could be severe and rapidly progressive. Combination hepatitis B immunoglobulin (HBIG) and lamivudine prophylaxis reduces this rate of recurrence to <5% at 5 years; however, HBIG administration is costly and inconvenient. We conducted a multicenter randomized study of adefovir dipivoxil substitution for low‐dose intramuscular (IM) HBIG in patients without HBV recurrence at least 12 months posttransplantation for HBV‐related disease. Thirty‐four patients were randomized, 16 to adefovir (1 patient withdrew consent at 3 months and is not considered in the results) and 18 to continue HBIG. All continued lamivudine. Groups were well matched by age, sex, and time since transplantation (median, 4.5 years), and background virological risk for HBV recurrence (30% of patients in the adefovir group, 24% in the HBIG group having detectable HBV DNA at transplantation). All patients were alive at study completion without recurrence. One patient in the adefovir group became hepatitis B surface antigen–positive at 5 months but was persistently HBV DNA undetectable via polymerase chain reaction (sensitivity 14 IU/mL) over the following 20 months. Median creatinine was not significantly changed over the course of the study in either group. One patient in the adefovir group with a background of diabetic and hypertensive nephropathy (baseline creatinine 150 μmol/L) developed increased creatinine leading to dose reduction and ultimately cessation of adefovir at 15 months. Yearly cost of combination adefovir/lamivudine prophylaxis was $8,290 versus $13,718 IM HBIG/lamivudine. Conclusion: Compared with combination HBIG plus lamivudine prophylaxis, combination adefovir plus lamivudine provides equivalent protection against recurrent HBV infection but with better tolerability and less cost. (HEPATOLOGY 2008.)</description><subject>Adenine - analogs & derivatives</subject><subject>Adenine - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Antiviral Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>DNA, Viral - blood</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Hepatitis B - immunology</subject><subject>Hepatitis B - prevention & control</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunization, Passive</subject><subject>Immunoglobulins - therapeutic use</subject><subject>Infectious diseases</subject><subject>Lamivudine - therapeutic use</subject><subject>Liver Transplantation - adverse effects</subject><subject>Liver, biliary tract, pancreas, portal circulation, spleen</subject><subject>Liver. Biliary tract. Portal circulation. Exocrine pancreas</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Organophosphonates - therapeutic use</subject><subject>Patient Selection</subject><subject>Postoperative Complications - prevention & control</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Surgery of the digestive system</subject><subject>Viral diseases</subject><subject>Viral hepatitis</subject><subject>Viral Load</subject><issn>0270-9139</issn><issn>1527-3350</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kM9u1DAQxi0EokvhwAsgX6jEIa3_ZeMc26p0K1WCA5wjxx5rBzlxiJNtlxOPgMQb8iR4yQpOnGY089P3zXyEvObsnDMmLrYwnAtRCvWErHgpqkLKkj0lKyYqVtRc1ifkRUpfGGO1Evo5OeG6FuVa8RX5cUlH07vY4TdwNE2z29PoqXHg4w5H6nDAXXzEQLGnQzAWDuvN1d3tYWBj12JvJow9fcBpS4PpcDc77IGaRIeYpl_ffwbcwUin7JOyQj8tfD46NxMmekWHMQ7bfTCPmF6SZ96EBK-O9ZR8fn_z6XpT3H-4vbu-vC-sLKUqNEDFoDVtVWqpmPXGO87KWretrJgV3DtXltpzpZxXumIa1Fq0XHhwLbcgT8nZopu9v86QpqbDZCHkAyHOqVnXlVJcyQy-W0A7xpRG8M0wYmfGfcNZc4i_yZ80f-LP7Juj6Nx24P6Rx7wz8PYImGRN8DkTi-kvJ5iWbC3rzF0s3AMG2P_fsdncfFysfwPnBaAb</recordid><startdate>200811</startdate><enddate>200811</enddate><creator>Angus, Peter W.</creator><creator>Patterson, Scott J.</creator><creator>Strasser, Simone I.</creator><creator>McCaughan, Geoffrey W.</creator><creator>Gane, Edward</creator><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley</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>7X8</scope></search><sort><creationdate>200811</creationdate><title>A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post–liver transplantation hepatitis B prophylaxis</title><author>Angus, Peter W. ; Patterson, Scott J. ; Strasser, Simone I. ; McCaughan, Geoffrey W. ; Gane, Edward</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3534-8ee70ebab758340cfafd10598bb370c21fdd558f144df48708e462b12fedb1ce3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adenine - analogs & derivatives</topic><topic>Adenine - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Antiviral Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>DNA, Viral - blood</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Hepatitis B - immunology</topic><topic>Hepatitis B - prevention & control</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunization, Passive</topic><topic>Immunoglobulins - therapeutic use</topic><topic>Infectious diseases</topic><topic>Lamivudine - therapeutic use</topic><topic>Liver Transplantation - adverse effects</topic><topic>Liver, biliary tract, pancreas, portal circulation, spleen</topic><topic>Liver. Biliary tract. Portal circulation. Exocrine pancreas</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Organophosphonates - therapeutic use</topic><topic>Patient Selection</topic><topic>Postoperative Complications - prevention & control</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Surgery of the digestive system</topic><topic>Viral diseases</topic><topic>Viral hepatitis</topic><topic>Viral Load</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Angus, Peter W.</creatorcontrib><creatorcontrib>Patterson, Scott J.</creatorcontrib><creatorcontrib>Strasser, Simone I.</creatorcontrib><creatorcontrib>McCaughan, Geoffrey W.</creatorcontrib><creatorcontrib>Gane, Edward</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>MEDLINE - Academic</collection><jtitle>Hepatology (Baltimore, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Angus, Peter W.</au><au>Patterson, Scott J.</au><au>Strasser, Simone I.</au><au>McCaughan, Geoffrey W.</au><au>Gane, Edward</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post–liver transplantation hepatitis B prophylaxis</atitle><jtitle>Hepatology (Baltimore, Md.)</jtitle><addtitle>Hepatology</addtitle><date>2008-11</date><risdate>2008</risdate><volume>48</volume><issue>5</issue><spage>1460</spage><epage>1466</epage><pages>1460-1466</pages><issn>0270-9139</issn><eissn>1527-3350</eissn><coden>HPTLD9</coden><abstract>Prior to effective prophylaxis, liver transplantation for hepatitis B virus (HBV)‐related disease was frequently complicated by recurrence, which could be severe and rapidly progressive. Combination hepatitis B immunoglobulin (HBIG) and lamivudine prophylaxis reduces this rate of recurrence to <5% at 5 years; however, HBIG administration is costly and inconvenient. We conducted a multicenter randomized study of adefovir dipivoxil substitution for low‐dose intramuscular (IM) HBIG in patients without HBV recurrence at least 12 months posttransplantation for HBV‐related disease. Thirty‐four patients were randomized, 16 to adefovir (1 patient withdrew consent at 3 months and is not considered in the results) and 18 to continue HBIG. All continued lamivudine. Groups were well matched by age, sex, and time since transplantation (median, 4.5 years), and background virological risk for HBV recurrence (30% of patients in the adefovir group, 24% in the HBIG group having detectable HBV DNA at transplantation). All patients were alive at study completion without recurrence. One patient in the adefovir group became hepatitis B surface antigen–positive at 5 months but was persistently HBV DNA undetectable via polymerase chain reaction (sensitivity 14 IU/mL) over the following 20 months. Median creatinine was not significantly changed over the course of the study in either group. One patient in the adefovir group with a background of diabetic and hypertensive nephropathy (baseline creatinine 150 μmol/L) developed increased creatinine leading to dose reduction and ultimately cessation of adefovir at 15 months. Yearly cost of combination adefovir/lamivudine prophylaxis was $8,290 versus $13,718 IM HBIG/lamivudine. Conclusion: Compared with combination HBIG plus lamivudine prophylaxis, combination adefovir plus lamivudine provides equivalent protection against recurrent HBV infection but with better tolerability and less cost. (HEPATOLOGY 2008.)</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>18925641</pmid><doi>10.1002/hep.22524</doi><tpages>7</tpages></addata></record> |
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| subjects | Adenine - analogs & derivatives Adenine - therapeutic use Adult Aged Antiviral Agents - therapeutic use Biological and medical sciences DNA, Viral - blood Female Gastroenterology. Liver. Pancreas. Abdomen Hepatitis B - immunology Hepatitis B - prevention & control Human viral diseases Humans Immunization, Passive Immunoglobulins - therapeutic use Infectious diseases Lamivudine - therapeutic use Liver Transplantation - adverse effects Liver, biliary tract, pancreas, portal circulation, spleen Liver. Biliary tract. Portal circulation. Exocrine pancreas Male Medical sciences Middle Aged Organophosphonates - therapeutic use Patient Selection Postoperative Complications - prevention & control Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the digestive system Viral diseases Viral hepatitis Viral Load |
| title | A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post–liver transplantation hepatitis B prophylaxis |
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