Sirolimus exposure and the occurrence of cytomegalovirus DNAemia after allogeneic hematopoietic stem cell transplantation
Sirolimus appears to protect against cytomegalovirus (CMV) in organ transplant recipients. The effect of this drug in allogeneic hematopoietic stem cell transplantation recipients remains unexplored. By means of multivariate continuous‐time Markov model analyses, we identified 3 independent covariat...
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| Veröffentlicht in: | American journal of transplantation 2018-12, Vol.18 (12), p.2885-2894 |
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| creator | Piñana, José Luis Perez‐Pitarch, Alejandro Guglieri‐Lopez, Beatriz Giménez, Estela Hernandez‐Boluda, Juan Carlos Terol, María José Ferriols‐Lisart, Rafael Solano, Carlos Navarro, David |
| description | Sirolimus appears to protect against cytomegalovirus (CMV) in organ transplant recipients. The effect of this drug in allogeneic hematopoietic stem cell transplantation recipients remains unexplored. By means of multivariate continuous‐time Markov model analyses, we identified 3 independent covariates that significantly impacted the risk of CMV DNAemia: recipient/donor CMV serostatus, tacrolimus exposure, and sirolimus exposure. CMV‐seropositive recipients with CMV‐seronegative donors had a significantly higher probability of having detectable CMV DNAemia. Increasing the tacrolimus trough concentration from 0 to 16 ng/mL increased the probability of patients having detectable CMV DNAemia by 40% (from 40% to 80%), whereas this probability decreased by 25% (from 40% to 15%) when trough concentrations of sirolimus increased from 0 to 16 ng/mL. Sensitivity analysis showed that sirolimus exposure between 0 and 6 ng/mL has no or negligible effect on CMV DNAemia, but levels >8 ng/mL significantly decreased the number of detectable CMV DNAemia cases (the risk ratios decreased from 0.68 to 0.21 when whole blood sirolimus concentrations changed from 8 to 18 ng/mL, P |
| doi_str_mv | 10.1111/ajt.14754 |
| format | Article |
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Through multivariate continuous‐time Markov model analyses, this study shows that allogeneic stem cell transplant recipients have fewer detectable cytomegalovirus DNAemia events as sirolimus exposure increases, with the effect more evident when sirolimus levels are over 8 ng/mL.</description><identifier>ISSN: 1600-6135</identifier><identifier>EISSN: 1600-6143</identifier><identifier>DOI: 10.1111/ajt.14754</identifier><identifier>PMID: 29603596</identifier><language>eng</language><publisher>United States: Elsevier Limited</publisher><subject>Adult ; Aged ; antibiotic: antiviral ; Antibiotics ; Antiviral drugs ; basic (laboratory) research/science ; Bone marrow ; bone marrow/hematopoietic stem cell transplantation ; clinical research/practice ; Cytomegalovirus ; Cytomegalovirus - drug effects ; Cytomegalovirus - genetics ; Cytomegalovirus - isolation & purification ; Cytomegalovirus Infections - drug therapy ; Cytomegalovirus Infections - epidemiology ; Cytomegalovirus Infections - microbiology ; DNA, Viral - genetics ; Female ; Follow-Up Studies ; Hematopoietic Stem Cell Transplantation - adverse effects ; Hematopoietic stem cells ; Humans ; immunosuppressant—calcineurin inhibitor: tacrolimus ; immunosuppressant—mechanistic target of rapamycin: sirolimus ; Immunosuppressive Agents - therapeutic use ; Incidence ; infection and infectious agents—viral: cytomegalovirus (CMV) ; infectious disease ; Male ; Middle Aged ; Pharmacodynamics ; Pharmacokinetics ; pharmacokinetics/pharmacodynamics ; pharmacology ; Prognosis ; Rapamycin ; Risk Factors ; Sensitivity analysis ; Sirolimus - therapeutic use ; Spain - epidemiology ; Stem cell transplantation ; Stem cells ; Tacrolimus ; Transplant Recipients ; Transplantation, Homologous ; Transplants & implants ; Viremia - drug therapy ; Viremia - epidemiology ; Viremia - microbiology</subject><ispartof>American journal of transplantation, 2018-12, Vol.18 (12), p.2885-2894</ispartof><rights>2018 The American Society of Transplantation and the American Society of Transplant Surgeons</rights><rights>2018 The American Society of Transplantation and the American Society of Transplant Surgeons.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3884-49c55e2f67a1f8165972fed2458cce5434a8c66686008d740aad43b2cf2e7d5f3</citedby><cites>FETCH-LOGICAL-c3884-49c55e2f67a1f8165972fed2458cce5434a8c66686008d740aad43b2cf2e7d5f3</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%2Fajt.14754$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fajt.14754$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29603596$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Piñana, José Luis</creatorcontrib><creatorcontrib>Perez‐Pitarch, Alejandro</creatorcontrib><creatorcontrib>Guglieri‐Lopez, Beatriz</creatorcontrib><creatorcontrib>Giménez, Estela</creatorcontrib><creatorcontrib>Hernandez‐Boluda, Juan Carlos</creatorcontrib><creatorcontrib>Terol, María José</creatorcontrib><creatorcontrib>Ferriols‐Lisart, Rafael</creatorcontrib><creatorcontrib>Solano, Carlos</creatorcontrib><creatorcontrib>Navarro, David</creatorcontrib><title>Sirolimus exposure and the occurrence of cytomegalovirus DNAemia after allogeneic hematopoietic stem cell transplantation</title><title>American journal of transplantation</title><addtitle>Am J Transplant</addtitle><description>Sirolimus appears to protect against cytomegalovirus (CMV) in organ transplant recipients. The effect of this drug in allogeneic hematopoietic stem cell transplantation recipients remains unexplored. By means of multivariate continuous‐time Markov model analyses, we identified 3 independent covariates that significantly impacted the risk of CMV DNAemia: recipient/donor CMV serostatus, tacrolimus exposure, and sirolimus exposure. CMV‐seropositive recipients with CMV‐seronegative donors had a significantly higher probability of having detectable CMV DNAemia. Increasing the tacrolimus trough concentration from 0 to 16 ng/mL increased the probability of patients having detectable CMV DNAemia by 40% (from 40% to 80%), whereas this probability decreased by 25% (from 40% to 15%) when trough concentrations of sirolimus increased from 0 to 16 ng/mL. Sensitivity analysis showed that sirolimus exposure between 0 and 6 ng/mL has no or negligible effect on CMV DNAemia, but levels >8 ng/mL significantly decreased the number of detectable CMV DNAemia cases (the risk ratios decreased from 0.68 to 0.21 when whole blood sirolimus concentrations changed from 8 to 18 ng/mL, P < .01). In conclusion, we used a pharmacometric statistical tool to provide the first clinical evidence that fewer CMV DNAemia events become detectable as sirolimus exposure increases.
Through multivariate continuous‐time Markov model analyses, this study shows that allogeneic stem cell transplant recipients have fewer detectable cytomegalovirus DNAemia events as sirolimus exposure increases, with the effect more evident when sirolimus levels are over 8 ng/mL.</description><subject>Adult</subject><subject>Aged</subject><subject>antibiotic: antiviral</subject><subject>Antibiotics</subject><subject>Antiviral drugs</subject><subject>basic (laboratory) research/science</subject><subject>Bone marrow</subject><subject>bone marrow/hematopoietic stem cell transplantation</subject><subject>clinical research/practice</subject><subject>Cytomegalovirus</subject><subject>Cytomegalovirus - drug effects</subject><subject>Cytomegalovirus - genetics</subject><subject>Cytomegalovirus - isolation & purification</subject><subject>Cytomegalovirus Infections - drug therapy</subject><subject>Cytomegalovirus Infections - epidemiology</subject><subject>Cytomegalovirus Infections - microbiology</subject><subject>DNA, Viral - genetics</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hematopoietic Stem Cell Transplantation - adverse effects</subject><subject>Hematopoietic stem cells</subject><subject>Humans</subject><subject>immunosuppressant—calcineurin inhibitor: tacrolimus</subject><subject>immunosuppressant—mechanistic target of rapamycin: sirolimus</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Incidence</subject><subject>infection and infectious agents—viral: cytomegalovirus (CMV)</subject><subject>infectious disease</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pharmacodynamics</subject><subject>Pharmacokinetics</subject><subject>pharmacokinetics/pharmacodynamics</subject><subject>pharmacology</subject><subject>Prognosis</subject><subject>Rapamycin</subject><subject>Risk Factors</subject><subject>Sensitivity analysis</subject><subject>Sirolimus - therapeutic use</subject><subject>Spain - epidemiology</subject><subject>Stem cell transplantation</subject><subject>Stem cells</subject><subject>Tacrolimus</subject><subject>Transplant Recipients</subject><subject>Transplantation, Homologous</subject><subject>Transplants & implants</subject><subject>Viremia - drug therapy</subject><subject>Viremia - epidemiology</subject><subject>Viremia - microbiology</subject><issn>1600-6135</issn><issn>1600-6143</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kLtOxDAQRS0E4l3wA8gSFcVC_Iy3XPFGCAqgjowzBq-cONgOsH-PYYGOaWZGOjqjuQjtkeqIlDrW83xEeC34CtoksqomknC2-jczsYG2UppXFampoutog05lxcRUbqLFvYvBu25MGD6GkMYIWPctzi-AgzFjjNCbMlpsFjl08Kx9eHOx4Ke3M-icxtpmiFh7H56hB2fwC3Q6hyE4yGVLGTpswHuco-7T4HWfdXah30FrVvsEuz99Gz2enz2cXE5u7i6uTmY3E8OU4hM-NUIAtbLWxCoixbSmFlrKhTIGBGdcKyOlVOVX1da80rrl7IkaS6FuhWXb6GDpHWJ4HSHlZh7G2JeTDSWsFkRKpgp1uKRMDClFsM0QXafjoiFV8xVyU0JuvkMu7P6PcXzqoP0jf1MtwPESeHceFv-bmtn1w1L5CWMJiGk</recordid><startdate>201812</startdate><enddate>201812</enddate><creator>Piñana, José Luis</creator><creator>Perez‐Pitarch, Alejandro</creator><creator>Guglieri‐Lopez, Beatriz</creator><creator>Giménez, Estela</creator><creator>Hernandez‐Boluda, Juan Carlos</creator><creator>Terol, María José</creator><creator>Ferriols‐Lisart, Rafael</creator><creator>Solano, Carlos</creator><creator>Navarro, David</creator><general>Elsevier Limited</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>7QP</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>201812</creationdate><title>Sirolimus exposure and the occurrence of cytomegalovirus DNAemia after allogeneic hematopoietic stem cell transplantation</title><author>Piñana, José Luis ; Perez‐Pitarch, Alejandro ; Guglieri‐Lopez, Beatriz ; Giménez, Estela ; Hernandez‐Boluda, Juan Carlos ; Terol, María José ; Ferriols‐Lisart, Rafael ; Solano, Carlos ; Navarro, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3884-49c55e2f67a1f8165972fed2458cce5434a8c66686008d740aad43b2cf2e7d5f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Adult</topic><topic>Aged</topic><topic>antibiotic: antiviral</topic><topic>Antibiotics</topic><topic>Antiviral drugs</topic><topic>basic (laboratory) research/science</topic><topic>Bone marrow</topic><topic>bone marrow/hematopoietic stem cell transplantation</topic><topic>clinical research/practice</topic><topic>Cytomegalovirus</topic><topic>Cytomegalovirus - drug effects</topic><topic>Cytomegalovirus - genetics</topic><topic>Cytomegalovirus - isolation & purification</topic><topic>Cytomegalovirus Infections - drug therapy</topic><topic>Cytomegalovirus Infections - epidemiology</topic><topic>Cytomegalovirus Infections - microbiology</topic><topic>DNA, Viral - genetics</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hematopoietic Stem Cell Transplantation - adverse effects</topic><topic>Hematopoietic stem cells</topic><topic>Humans</topic><topic>immunosuppressant—calcineurin inhibitor: tacrolimus</topic><topic>immunosuppressant—mechanistic target of rapamycin: sirolimus</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Incidence</topic><topic>infection and infectious agents—viral: cytomegalovirus (CMV)</topic><topic>infectious disease</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pharmacodynamics</topic><topic>Pharmacokinetics</topic><topic>pharmacokinetics/pharmacodynamics</topic><topic>pharmacology</topic><topic>Prognosis</topic><topic>Rapamycin</topic><topic>Risk Factors</topic><topic>Sensitivity analysis</topic><topic>Sirolimus - therapeutic use</topic><topic>Spain - epidemiology</topic><topic>Stem cell transplantation</topic><topic>Stem cells</topic><topic>Tacrolimus</topic><topic>Transplant Recipients</topic><topic>Transplantation, Homologous</topic><topic>Transplants & implants</topic><topic>Viremia - drug therapy</topic><topic>Viremia - epidemiology</topic><topic>Viremia - microbiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Piñana, José Luis</creatorcontrib><creatorcontrib>Perez‐Pitarch, Alejandro</creatorcontrib><creatorcontrib>Guglieri‐Lopez, Beatriz</creatorcontrib><creatorcontrib>Giménez, Estela</creatorcontrib><creatorcontrib>Hernandez‐Boluda, Juan Carlos</creatorcontrib><creatorcontrib>Terol, María José</creatorcontrib><creatorcontrib>Ferriols‐Lisart, Rafael</creatorcontrib><creatorcontrib>Solano, Carlos</creatorcontrib><creatorcontrib>Navarro, David</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>American journal of transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Piñana, José Luis</au><au>Perez‐Pitarch, Alejandro</au><au>Guglieri‐Lopez, Beatriz</au><au>Giménez, Estela</au><au>Hernandez‐Boluda, Juan Carlos</au><au>Terol, María José</au><au>Ferriols‐Lisart, Rafael</au><au>Solano, Carlos</au><au>Navarro, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sirolimus exposure and the occurrence of cytomegalovirus DNAemia after allogeneic hematopoietic stem cell transplantation</atitle><jtitle>American journal of transplantation</jtitle><addtitle>Am J Transplant</addtitle><date>2018-12</date><risdate>2018</risdate><volume>18</volume><issue>12</issue><spage>2885</spage><epage>2894</epage><pages>2885-2894</pages><issn>1600-6135</issn><eissn>1600-6143</eissn><abstract>Sirolimus appears to protect against cytomegalovirus (CMV) in organ transplant recipients. The effect of this drug in allogeneic hematopoietic stem cell transplantation recipients remains unexplored. By means of multivariate continuous‐time Markov model analyses, we identified 3 independent covariates that significantly impacted the risk of CMV DNAemia: recipient/donor CMV serostatus, tacrolimus exposure, and sirolimus exposure. CMV‐seropositive recipients with CMV‐seronegative donors had a significantly higher probability of having detectable CMV DNAemia. Increasing the tacrolimus trough concentration from 0 to 16 ng/mL increased the probability of patients having detectable CMV DNAemia by 40% (from 40% to 80%), whereas this probability decreased by 25% (from 40% to 15%) when trough concentrations of sirolimus increased from 0 to 16 ng/mL. Sensitivity analysis showed that sirolimus exposure between 0 and 6 ng/mL has no or negligible effect on CMV DNAemia, but levels >8 ng/mL significantly decreased the number of detectable CMV DNAemia cases (the risk ratios decreased from 0.68 to 0.21 when whole blood sirolimus concentrations changed from 8 to 18 ng/mL, P < .01). In conclusion, we used a pharmacometric statistical tool to provide the first clinical evidence that fewer CMV DNAemia events become detectable as sirolimus exposure increases.
Through multivariate continuous‐time Markov model analyses, this study shows that allogeneic stem cell transplant recipients have fewer detectable cytomegalovirus DNAemia events as sirolimus exposure increases, with the effect more evident when sirolimus levels are over 8 ng/mL.</abstract><cop>United States</cop><pub>Elsevier Limited</pub><pmid>29603596</pmid><doi>10.1111/ajt.14754</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Aged antibiotic: antiviral Antibiotics Antiviral drugs basic (laboratory) research/science Bone marrow bone marrow/hematopoietic stem cell transplantation clinical research/practice Cytomegalovirus Cytomegalovirus - drug effects Cytomegalovirus - genetics Cytomegalovirus - isolation & purification Cytomegalovirus Infections - drug therapy Cytomegalovirus Infections - epidemiology Cytomegalovirus Infections - microbiology DNA, Viral - genetics Female Follow-Up Studies Hematopoietic Stem Cell Transplantation - adverse effects Hematopoietic stem cells Humans immunosuppressant—calcineurin inhibitor: tacrolimus immunosuppressant—mechanistic target of rapamycin: sirolimus Immunosuppressive Agents - therapeutic use Incidence infection and infectious agents—viral: cytomegalovirus (CMV) infectious disease Male Middle Aged Pharmacodynamics Pharmacokinetics pharmacokinetics/pharmacodynamics pharmacology Prognosis Rapamycin Risk Factors Sensitivity analysis Sirolimus - therapeutic use Spain - epidemiology Stem cell transplantation Stem cells Tacrolimus Transplant Recipients Transplantation, Homologous Transplants & implants Viremia - drug therapy Viremia - epidemiology Viremia - microbiology |
| title | Sirolimus exposure and the occurrence of cytomegalovirus DNAemia after allogeneic hematopoietic stem cell transplantation |
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