Body surface area compared to body weight dosing of valganciclovir is associated with increased toxicity in pediatric solid organ transplantation recipients
Optimal dosing of valganciclovir (VGCV) for cytomegalovirus (CMV) prevention in pediatric solid organ transplantation recipients (SOTR) is controversial. Dosing calculated based on body surface area (BSA) and creatinine clearance is recommended but simplified body weight (BW) dosing is often prescri...
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| Veröffentlicht in: | American journal of transplantation 2023-12, Vol.23 (12), p.1961-1971 |
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| container_title | American journal of transplantation |
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| creator | Demirhan, Salih Munoz, Flor M. Valencia Deray, Kristen G. Bocchini, Claire E. Danziger-Isakov, Lara Blum, Samantha Sharma, Tanvi S. Sherman, Gilad Boguniewicz, Juri Bacon, Samantha Ardura, Monica I. Maron, Gabriela M. Ferrolino, Jose Foca, Marc Herold, Betsy C. |
| description | Optimal dosing of valganciclovir (VGCV) for cytomegalovirus (CMV) prevention in pediatric solid organ transplantation recipients (SOTR) is controversial. Dosing calculated based on body surface area (BSA) and creatinine clearance is recommended but simplified body weight (BW) dosing is often prescribed. We conducted a retrospective 6-center study to compare safety and efficacy of these strategies in the first-year posttransplant There were 100 (24.2%) pediatric SOTR treated with BSA and 312 (75.7%) with BW dosing. CMV DNAemia was documented in 31.0% vs 23.4% (P = .1) at any time during the first year and breakthrough DNAemia in 16% vs 12.2% (P = .3) of pediatric SOTR receiving BSA vs BW dosing, respectively. However, neutropenia (50% vs 29.3%, P |
| doi_str_mv | 10.1016/j.ajt.2023.07.013 |
| format | Article |
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Dosing calculated based on body surface area (BSA) and creatinine clearance is recommended but simplified body weight (BW) dosing is often prescribed. We conducted a retrospective 6-center study to compare safety and efficacy of these strategies in the first-year posttransplant There were 100 (24.2%) pediatric SOTR treated with BSA and 312 (75.7%) with BW dosing. CMV DNAemia was documented in 31.0% vs 23.4% (P = .1) at any time during the first year and breakthrough DNAemia in 16% vs 12.2% (P = .3) of pediatric SOTR receiving BSA vs BW dosing, respectively. However, neutropenia (50% vs 29.3%, P <.001), lymphopenia (51% vs 15.0%, P <.001), and acute kidney injury causing treatment modification (8.0% vs 1.8%, P <.001) were documented more frequently during prophylaxis in pediatric SOTR receiving BSA vs BW dosing. The adjusted odds ratio of VGCV-attributed toxicities comparing BSA and BW dosing was 2.3 (95% confidence interval [CI], 1.4-3.7] for neutropenia, 7.0 (95% CI, 3.9-12.4) for lymphopenia, and 4.6 (95% CI, 2.2-9.3) for premature discontinuation or dose reduction of VGCV, respectively. Results demonstrate that BW dosing is associated with significantly less toxicity without any increase in CMV DNAemia.</description><identifier>ISSN: 1600-6135</identifier><identifier>EISSN: 1600-6143</identifier><identifier>DOI: 10.1016/j.ajt.2023.07.013</identifier><identifier>PMID: 37499799</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Antiviral Agents - therapeutic use ; Body Surface Area ; Body Weight ; Child ; Cytomegalovirus ; Cytomegalovirus Infections - drug therapy ; Cytomegalovirus Infections - etiology ; Cytomegalovirus Infections - prevention & control ; Ganciclovir - therapeutic use ; Humans ; Lymphopenia ; neutropenia ; Neutropenia - drug therapy ; Neutropenia - etiology ; Organ Transplantation - adverse effects ; Retrospective Studies ; solid organ transplantation ; valganciclovir ; Valganciclovir - therapeutic use</subject><ispartof>American journal of transplantation, 2023-12, Vol.23 (12), p.1961-1971</ispartof><rights>2023 American Society of Transplantation & American Society of Transplant Surgeons</rights><rights>Copyright © 2023 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-e352d9facdf05e07de14b458341035be8958aa70ce5ffef046694b846cca3d03</citedby><cites>FETCH-LOGICAL-c353t-e352d9facdf05e07de14b458341035be8958aa70ce5ffef046694b846cca3d03</cites><orcidid>0009-0005-3452-0666 ; 0000-0002-5691-5221 ; 0000-0002-9248-780X ; 0000-0002-1628-8446 ; 0000-0001-9290-6667 ; 0000-0002-0457-7689 ; 0000-0001-5476-0353 ; 0009-0004-8882-6946 ; 0000-0002-2853-2581 ; 0000-0003-4008-5507 ; 0000-0002-5976-6612 ; 0000-0001-5247-5399 ; 0009-0006-3051-2041 ; 0000-0001-9577-8162 ; 0000-0001-9974-0786</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37499799$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Demirhan, Salih</creatorcontrib><creatorcontrib>Munoz, Flor M.</creatorcontrib><creatorcontrib>Valencia Deray, Kristen G.</creatorcontrib><creatorcontrib>Bocchini, Claire E.</creatorcontrib><creatorcontrib>Danziger-Isakov, Lara</creatorcontrib><creatorcontrib>Blum, Samantha</creatorcontrib><creatorcontrib>Sharma, Tanvi S.</creatorcontrib><creatorcontrib>Sherman, Gilad</creatorcontrib><creatorcontrib>Boguniewicz, Juri</creatorcontrib><creatorcontrib>Bacon, Samantha</creatorcontrib><creatorcontrib>Ardura, Monica I.</creatorcontrib><creatorcontrib>Maron, Gabriela M.</creatorcontrib><creatorcontrib>Ferrolino, Jose</creatorcontrib><creatorcontrib>Foca, Marc</creatorcontrib><creatorcontrib>Herold, Betsy C.</creatorcontrib><title>Body surface area compared to body weight dosing of valganciclovir is associated with increased toxicity in pediatric solid organ transplantation recipients</title><title>American journal of transplantation</title><addtitle>Am J Transplant</addtitle><description>Optimal dosing of valganciclovir (VGCV) for cytomegalovirus (CMV) prevention in pediatric solid organ transplantation recipients (SOTR) is controversial. Dosing calculated based on body surface area (BSA) and creatinine clearance is recommended but simplified body weight (BW) dosing is often prescribed. We conducted a retrospective 6-center study to compare safety and efficacy of these strategies in the first-year posttransplant There were 100 (24.2%) pediatric SOTR treated with BSA and 312 (75.7%) with BW dosing. CMV DNAemia was documented in 31.0% vs 23.4% (P = .1) at any time during the first year and breakthrough DNAemia in 16% vs 12.2% (P = .3) of pediatric SOTR receiving BSA vs BW dosing, respectively. However, neutropenia (50% vs 29.3%, P <.001), lymphopenia (51% vs 15.0%, P <.001), and acute kidney injury causing treatment modification (8.0% vs 1.8%, P <.001) were documented more frequently during prophylaxis in pediatric SOTR receiving BSA vs BW dosing. The adjusted odds ratio of VGCV-attributed toxicities comparing BSA and BW dosing was 2.3 (95% confidence interval [CI], 1.4-3.7] for neutropenia, 7.0 (95% CI, 3.9-12.4) for lymphopenia, and 4.6 (95% CI, 2.2-9.3) for premature discontinuation or dose reduction of VGCV, respectively. Results demonstrate that BW dosing is associated with significantly less toxicity without any increase in CMV DNAemia.</description><subject>Antiviral Agents - therapeutic use</subject><subject>Body Surface Area</subject><subject>Body Weight</subject><subject>Child</subject><subject>Cytomegalovirus</subject><subject>Cytomegalovirus Infections - drug therapy</subject><subject>Cytomegalovirus Infections - etiology</subject><subject>Cytomegalovirus Infections - prevention & control</subject><subject>Ganciclovir - therapeutic use</subject><subject>Humans</subject><subject>Lymphopenia</subject><subject>neutropenia</subject><subject>Neutropenia - drug therapy</subject><subject>Neutropenia - etiology</subject><subject>Organ Transplantation - adverse effects</subject><subject>Retrospective Studies</subject><subject>solid organ transplantation</subject><subject>valganciclovir</subject><subject>Valganciclovir - therapeutic use</subject><issn>1600-6135</issn><issn>1600-6143</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1u2zAQhIWiQZMmeYBeCh57sboURf2gpzboHxAgl9wJilw5a8iiyqWd-F36sKXrNMeeuCBnPnB2iuKdhFKCbD5uSrtJZQWVKqEtQapXxYVsAFaNrNXrl1np8-It8wZAtlVXvSnOVVv3fdv3F8XvL8EfBO_iaB0KG9EKF7ZLHrxIQQzH10ek9UMSPjDNaxFGsbfT2s6O3BT2FAWxsMzBkU3Z9UjpQdDsMor_Qp7IUTrkK7Ggz5pITnCYyIsQM0akaGdeJjsnmyjMIqKjhXBOfFWcjXZivH4-L4v7b1_vb36sbu--_7z5fLtySqu0QqUr3-cAfgSN0HqU9VDrTtUSlB6w63VnbQsO9TjiCHXT9PXQ1Y1zVnlQl8WHE3aJ4dcOOZktscMpfwnDjk3VaVBSdqrJUnmSuhiYI45mibS18WAkmGMnZmNyJ-bYiYHW5E6y5_0zfjds0b84_pWQBZ9OAswZ94TRsMv5Xd5W3kUyPtB_8H8AMKmhUw</recordid><startdate>202312</startdate><enddate>202312</enddate><creator>Demirhan, Salih</creator><creator>Munoz, Flor M.</creator><creator>Valencia Deray, Kristen G.</creator><creator>Bocchini, Claire E.</creator><creator>Danziger-Isakov, Lara</creator><creator>Blum, Samantha</creator><creator>Sharma, Tanvi S.</creator><creator>Sherman, Gilad</creator><creator>Boguniewicz, Juri</creator><creator>Bacon, Samantha</creator><creator>Ardura, Monica I.</creator><creator>Maron, Gabriela M.</creator><creator>Ferrolino, Jose</creator><creator>Foca, Marc</creator><creator>Herold, Betsy C.</creator><general>Elsevier Inc</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><orcidid>https://orcid.org/0009-0005-3452-0666</orcidid><orcidid>https://orcid.org/0000-0002-5691-5221</orcidid><orcidid>https://orcid.org/0000-0002-9248-780X</orcidid><orcidid>https://orcid.org/0000-0002-1628-8446</orcidid><orcidid>https://orcid.org/0000-0001-9290-6667</orcidid><orcidid>https://orcid.org/0000-0002-0457-7689</orcidid><orcidid>https://orcid.org/0000-0001-5476-0353</orcidid><orcidid>https://orcid.org/0009-0004-8882-6946</orcidid><orcidid>https://orcid.org/0000-0002-2853-2581</orcidid><orcidid>https://orcid.org/0000-0003-4008-5507</orcidid><orcidid>https://orcid.org/0000-0002-5976-6612</orcidid><orcidid>https://orcid.org/0000-0001-5247-5399</orcidid><orcidid>https://orcid.org/0009-0006-3051-2041</orcidid><orcidid>https://orcid.org/0000-0001-9577-8162</orcidid><orcidid>https://orcid.org/0000-0001-9974-0786</orcidid></search><sort><creationdate>202312</creationdate><title>Body surface area compared to body weight dosing of valganciclovir is associated with increased toxicity in pediatric solid organ transplantation recipients</title><author>Demirhan, Salih ; Munoz, Flor M. ; Valencia Deray, Kristen G. ; Bocchini, Claire E. ; Danziger-Isakov, Lara ; Blum, Samantha ; Sharma, Tanvi S. ; Sherman, Gilad ; Boguniewicz, Juri ; Bacon, Samantha ; Ardura, Monica I. ; Maron, Gabriela M. ; Ferrolino, Jose ; Foca, Marc ; Herold, Betsy C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-e352d9facdf05e07de14b458341035be8958aa70ce5ffef046694b846cca3d03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antiviral Agents - therapeutic use</topic><topic>Body Surface Area</topic><topic>Body Weight</topic><topic>Child</topic><topic>Cytomegalovirus</topic><topic>Cytomegalovirus Infections - drug therapy</topic><topic>Cytomegalovirus Infections - etiology</topic><topic>Cytomegalovirus Infections - prevention & control</topic><topic>Ganciclovir - therapeutic use</topic><topic>Humans</topic><topic>Lymphopenia</topic><topic>neutropenia</topic><topic>Neutropenia - drug therapy</topic><topic>Neutropenia - etiology</topic><topic>Organ Transplantation - adverse effects</topic><topic>Retrospective Studies</topic><topic>solid organ transplantation</topic><topic>valganciclovir</topic><topic>Valganciclovir - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Demirhan, Salih</creatorcontrib><creatorcontrib>Munoz, Flor M.</creatorcontrib><creatorcontrib>Valencia Deray, Kristen G.</creatorcontrib><creatorcontrib>Bocchini, Claire E.</creatorcontrib><creatorcontrib>Danziger-Isakov, Lara</creatorcontrib><creatorcontrib>Blum, Samantha</creatorcontrib><creatorcontrib>Sharma, Tanvi S.</creatorcontrib><creatorcontrib>Sherman, Gilad</creatorcontrib><creatorcontrib>Boguniewicz, Juri</creatorcontrib><creatorcontrib>Bacon, Samantha</creatorcontrib><creatorcontrib>Ardura, Monica I.</creatorcontrib><creatorcontrib>Maron, Gabriela M.</creatorcontrib><creatorcontrib>Ferrolino, Jose</creatorcontrib><creatorcontrib>Foca, Marc</creatorcontrib><creatorcontrib>Herold, Betsy C.</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><jtitle>American journal of transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Demirhan, Salih</au><au>Munoz, Flor M.</au><au>Valencia Deray, Kristen G.</au><au>Bocchini, Claire E.</au><au>Danziger-Isakov, Lara</au><au>Blum, Samantha</au><au>Sharma, Tanvi S.</au><au>Sherman, Gilad</au><au>Boguniewicz, Juri</au><au>Bacon, Samantha</au><au>Ardura, Monica I.</au><au>Maron, Gabriela M.</au><au>Ferrolino, Jose</au><au>Foca, Marc</au><au>Herold, Betsy C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Body surface area compared to body weight dosing of valganciclovir is associated with increased toxicity in pediatric solid organ transplantation recipients</atitle><jtitle>American journal of transplantation</jtitle><addtitle>Am J Transplant</addtitle><date>2023-12</date><risdate>2023</risdate><volume>23</volume><issue>12</issue><spage>1961</spage><epage>1971</epage><pages>1961-1971</pages><issn>1600-6135</issn><eissn>1600-6143</eissn><abstract>Optimal dosing of valganciclovir (VGCV) for cytomegalovirus (CMV) prevention in pediatric solid organ transplantation recipients (SOTR) is controversial. Dosing calculated based on body surface area (BSA) and creatinine clearance is recommended but simplified body weight (BW) dosing is often prescribed. We conducted a retrospective 6-center study to compare safety and efficacy of these strategies in the first-year posttransplant There were 100 (24.2%) pediatric SOTR treated with BSA and 312 (75.7%) with BW dosing. CMV DNAemia was documented in 31.0% vs 23.4% (P = .1) at any time during the first year and breakthrough DNAemia in 16% vs 12.2% (P = .3) of pediatric SOTR receiving BSA vs BW dosing, respectively. However, neutropenia (50% vs 29.3%, P <.001), lymphopenia (51% vs 15.0%, P <.001), and acute kidney injury causing treatment modification (8.0% vs 1.8%, P <.001) were documented more frequently during prophylaxis in pediatric SOTR receiving BSA vs BW dosing. The adjusted odds ratio of VGCV-attributed toxicities comparing BSA and BW dosing was 2.3 (95% confidence interval [CI], 1.4-3.7] for neutropenia, 7.0 (95% CI, 3.9-12.4) for lymphopenia, and 4.6 (95% CI, 2.2-9.3) for premature discontinuation or dose reduction of VGCV, respectively. Results demonstrate that BW dosing is associated with significantly less toxicity without any increase in CMV DNAemia.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>37499799</pmid><doi>10.1016/j.ajt.2023.07.013</doi><tpages>11</tpages><orcidid>https://orcid.org/0009-0005-3452-0666</orcidid><orcidid>https://orcid.org/0000-0002-5691-5221</orcidid><orcidid>https://orcid.org/0000-0002-9248-780X</orcidid><orcidid>https://orcid.org/0000-0002-1628-8446</orcidid><orcidid>https://orcid.org/0000-0001-9290-6667</orcidid><orcidid>https://orcid.org/0000-0002-0457-7689</orcidid><orcidid>https://orcid.org/0000-0001-5476-0353</orcidid><orcidid>https://orcid.org/0009-0004-8882-6946</orcidid><orcidid>https://orcid.org/0000-0002-2853-2581</orcidid><orcidid>https://orcid.org/0000-0003-4008-5507</orcidid><orcidid>https://orcid.org/0000-0002-5976-6612</orcidid><orcidid>https://orcid.org/0000-0001-5247-5399</orcidid><orcidid>https://orcid.org/0009-0006-3051-2041</orcidid><orcidid>https://orcid.org/0000-0001-9577-8162</orcidid><orcidid>https://orcid.org/0000-0001-9974-0786</orcidid></addata></record> |
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| subjects | Antiviral Agents - therapeutic use Body Surface Area Body Weight Child Cytomegalovirus Cytomegalovirus Infections - drug therapy Cytomegalovirus Infections - etiology Cytomegalovirus Infections - prevention & control Ganciclovir - therapeutic use Humans Lymphopenia neutropenia Neutropenia - drug therapy Neutropenia - etiology Organ Transplantation - adverse effects Retrospective Studies solid organ transplantation valganciclovir Valganciclovir - therapeutic use |
| title | Body surface area compared to body weight dosing of valganciclovir is associated with increased toxicity in pediatric solid organ transplantation recipients |
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