Adequacy of WHO weight-band dosing and fixed-dose combinations for the treatment of TB in children
BACKGROUND: We examined whether the updated WHO weight-band dosing recommendations and fixed-dose combination tablets for the treatment of TB in children achieves recommended calculated dosages and adequate drug plasma exposure.DESIGN/METHODS: Children on first-line TB treatment per WHO guidelines w...
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| Veröffentlicht in: | The international journal of tuberculosis and lung disease 2023-05, Vol.27 (5), p.401-407 |
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| creator | Kwara, A. Yang, H. Martyn-Dickens, C. Enimil, A. Amissah, A. K. Ojewale, O. Dompreh, A. Bosomtwe, D. Sly-Moore, E. Opoku, T. Appiah, A. F. Obeng, R. Asiedu, P. Maranchick, N. Alshaer, M. H. Peloquin, C. A. Antwi, S. |
| description | BACKGROUND: We examined whether the updated WHO weight-band dosing recommendations and fixed-dose combination tablets for the treatment of TB in children achieves recommended calculated dosages and adequate drug plasma exposure.DESIGN/METHODS: Children on first-line
TB treatment per WHO guidelines were enrolled. Blood sampling at pre-dose, 1, 2, 4, 8, and 12 h post-dose after at least 4 weeks of treatment was performed. Drugs concentrations were measured using validated liquid chromatography tandem with mass spectrometry and pharmacokinetic parameters
calculated using noncompartmental analysis. Plasma drug exposure below the lower limit of the 95% confidence interval of the mean for children was considered low and above the upper limit was high.RESULTS: Of 71 participants, 34 (47.9%) had HIV coinfection. The median calculated
dose for isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB) was 10.0 (range 4.3-13.3), 15.0 (range 8.6-20.0), 30.0 (range 21.0-40.0), and 20.4 (range 14.3-26.7) mg/kg, respectively. Overall, most patients had under-exposure for RIF and PZA and
over-exposure for INH and EMB. Drug dose and weight-for-age Z-score were associated with area under the curve from time 0-24 h for all drugs.CONCLUSIONS: Despite adherence to WHO dosing guidelines, low PZA and RIF plasma exposures were frequent in our study population.
Higher than currently recommended dosages of RIF and PZA may be needed in children. |
| doi_str_mv | 10.5588/ijtld.22.0591 |
| format | Article |
| fullrecord | <record><control><sourceid>pubtec_proqu</sourceid><recordid>TN_cdi_proquest_journals_2817790842</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><ingid>iuatld/ijtld/2023/00000027/00000005/art00010</ingid><sourcerecordid>iuatld/ijtld/2023/00000027/00000005/art00010</sourcerecordid><originalsourceid>FETCH-LOGICAL-c456t-641517cda22e321d2df8230d6354ac39774a9b1806785fafb679c18d31a101b13</originalsourceid><addsrcrecordid>eNp1kcFrFDEUhwex2Fo9epWAFy-zzUsmk8yxVm0LhSJUPIZMktnNMpNpk4xa_3qT3a2CYC7v8fj48vi9qnoDeMWYEGdum0azImSFWQfPqhMQwGreEfw895jwmnLojquXMW4xJgDAX1THedZQQvFJ1Z8b-7Ao_YjmAX27ukU_rFtvUt0rb5CZo_NrVNrB_bSmzgOL9Dz1zqvkZh_RMAeUNhalYFWarE_Fc_cBOY_0xo0mWP-qOhrUGO3rQz2tvn7-dHdxVd_cXl5fnN_UumFtqtsGGHBtFCGWEjDEDCKvaFrKGqVpx3mjuh4Ebrlggxr6lncahKGgAEMP9LR6v_feh_lhsTHJyUVtx1F5Oy9REgG4A9EIntF3_6DbeQk-b1cozjssGpKpek_pMMcY7CDvg5tUeJSAZQlf7sKXhMgSfubfHqxLP1nzh35KOwMf90BONUel_v7qFlVMBx8mVOLdI_zQYCZVSLlC0Xz5n0Y_mcrpy-Xld8I92ylxW7QN5dLYQS1jkkkFuf4lY3b-Btw1r5Q</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2817790842</pqid></control><display><type>article</type><title>Adequacy of WHO weight-band dosing and fixed-dose combinations for the treatment of TB in children</title><source>MEDLINE</source><source>PubMed Central</source><source>Alma/SFX Local Collection</source><creator>Kwara, A. ; Yang, H. ; Martyn-Dickens, C. ; Enimil, A. ; Amissah, A. K. ; Ojewale, O. ; Dompreh, A. ; Bosomtwe, D. ; Sly-Moore, E. ; Opoku, T. ; Appiah, A. F. ; Obeng, R. ; Asiedu, P. ; Maranchick, N. ; Alshaer, M. H. ; Peloquin, C. A. ; Antwi, S.</creator><creatorcontrib>Kwara, A. ; Yang, H. ; Martyn-Dickens, C. ; Enimil, A. ; Amissah, A. K. ; Ojewale, O. ; Dompreh, A. ; Bosomtwe, D. ; Sly-Moore, E. ; Opoku, T. ; Appiah, A. F. ; Obeng, R. ; Asiedu, P. ; Maranchick, N. ; Alshaer, M. H. ; Peloquin, C. A. ; Antwi, S.</creatorcontrib><description>BACKGROUND: We examined whether the updated WHO weight-band dosing recommendations and fixed-dose combination tablets for the treatment of TB in children achieves recommended calculated dosages and adequate drug plasma exposure.DESIGN/METHODS: Children on first-line
TB treatment per WHO guidelines were enrolled. Blood sampling at pre-dose, 1, 2, 4, 8, and 12 h post-dose after at least 4 weeks of treatment was performed. Drugs concentrations were measured using validated liquid chromatography tandem with mass spectrometry and pharmacokinetic parameters
calculated using noncompartmental analysis. Plasma drug exposure below the lower limit of the 95% confidence interval of the mean for children was considered low and above the upper limit was high.RESULTS: Of 71 participants, 34 (47.9%) had HIV coinfection. The median calculated
dose for isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB) was 10.0 (range 4.3-13.3), 15.0 (range 8.6-20.0), 30.0 (range 21.0-40.0), and 20.4 (range 14.3-26.7) mg/kg, respectively. Overall, most patients had under-exposure for RIF and PZA and
over-exposure for INH and EMB. Drug dose and weight-for-age Z-score were associated with area under the curve from time 0-24 h for all drugs.CONCLUSIONS: Despite adherence to WHO dosing guidelines, low PZA and RIF plasma exposures were frequent in our study population.
Higher than currently recommended dosages of RIF and PZA may be needed in children.</description><identifier>ISSN: 1027-3719</identifier><identifier>EISSN: 1815-7920</identifier><identifier>DOI: 10.5588/ijtld.22.0591</identifier><identifier>PMID: 37143230</identifier><language>eng</language><publisher>France: International Union Against Tuberculosis and Lung Disease</publisher><subject>Adequacy ; Antitubercular Agents - therapeutic use ; Antituberculosis Drugs ; Child ; Children ; Confidence intervals ; Dosage ; Dosing ; Drug development ; Drug dosages ; Drugs ; Ethambutol ; Exposure ; Guidelines ; HIV ; Human immunodeficiency virus ; Humans ; Isoniazid ; Isoniazid - therapeutic use ; Liquid chromatography ; Mass spectrometry ; Mass spectroscopy ; Mathematical analysis ; Pediatric ; Pharmacokinetics ; Population studies ; Pyrazinamide ; Rifampin ; Rifampin - therapeutic use ; Tuberculosis ; Tuberculosis - complications ; Weight ; World Health Organization</subject><ispartof>The international journal of tuberculosis and lung disease, 2023-05, Vol.27 (5), p.401-407</ispartof><rights>Copyright International Union against Tuberculosis and Lung Disease (IUATLD) 2023</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c456t-641517cda22e321d2df8230d6354ac39774a9b1806785fafb679c18d31a101b13</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37143230$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kwara, A.</creatorcontrib><creatorcontrib>Yang, H.</creatorcontrib><creatorcontrib>Martyn-Dickens, C.</creatorcontrib><creatorcontrib>Enimil, A.</creatorcontrib><creatorcontrib>Amissah, A. K.</creatorcontrib><creatorcontrib>Ojewale, O.</creatorcontrib><creatorcontrib>Dompreh, A.</creatorcontrib><creatorcontrib>Bosomtwe, D.</creatorcontrib><creatorcontrib>Sly-Moore, E.</creatorcontrib><creatorcontrib>Opoku, T.</creatorcontrib><creatorcontrib>Appiah, A. F.</creatorcontrib><creatorcontrib>Obeng, R.</creatorcontrib><creatorcontrib>Asiedu, P.</creatorcontrib><creatorcontrib>Maranchick, N.</creatorcontrib><creatorcontrib>Alshaer, M. H.</creatorcontrib><creatorcontrib>Peloquin, C. A.</creatorcontrib><creatorcontrib>Antwi, S.</creatorcontrib><title>Adequacy of WHO weight-band dosing and fixed-dose combinations for the treatment of TB in children</title><title>The international journal of tuberculosis and lung disease</title><addtitle>Int J Tuberc Lung Dis</addtitle><description>BACKGROUND: We examined whether the updated WHO weight-band dosing recommendations and fixed-dose combination tablets for the treatment of TB in children achieves recommended calculated dosages and adequate drug plasma exposure.DESIGN/METHODS: Children on first-line
TB treatment per WHO guidelines were enrolled. Blood sampling at pre-dose, 1, 2, 4, 8, and 12 h post-dose after at least 4 weeks of treatment was performed. Drugs concentrations were measured using validated liquid chromatography tandem with mass spectrometry and pharmacokinetic parameters
calculated using noncompartmental analysis. Plasma drug exposure below the lower limit of the 95% confidence interval of the mean for children was considered low and above the upper limit was high.RESULTS: Of 71 participants, 34 (47.9%) had HIV coinfection. The median calculated
dose for isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB) was 10.0 (range 4.3-13.3), 15.0 (range 8.6-20.0), 30.0 (range 21.0-40.0), and 20.4 (range 14.3-26.7) mg/kg, respectively. Overall, most patients had under-exposure for RIF and PZA and
over-exposure for INH and EMB. Drug dose and weight-for-age Z-score were associated with area under the curve from time 0-24 h for all drugs.CONCLUSIONS: Despite adherence to WHO dosing guidelines, low PZA and RIF plasma exposures were frequent in our study population.
Higher than currently recommended dosages of RIF and PZA may be needed in children.</description><subject>Adequacy</subject><subject>Antitubercular Agents - therapeutic use</subject><subject>Antituberculosis Drugs</subject><subject>Child</subject><subject>Children</subject><subject>Confidence intervals</subject><subject>Dosage</subject><subject>Dosing</subject><subject>Drug development</subject><subject>Drug dosages</subject><subject>Drugs</subject><subject>Ethambutol</subject><subject>Exposure</subject><subject>Guidelines</subject><subject>HIV</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Isoniazid</subject><subject>Isoniazid - therapeutic use</subject><subject>Liquid chromatography</subject><subject>Mass spectrometry</subject><subject>Mass spectroscopy</subject><subject>Mathematical analysis</subject><subject>Pediatric</subject><subject>Pharmacokinetics</subject><subject>Population studies</subject><subject>Pyrazinamide</subject><subject>Rifampin</subject><subject>Rifampin - therapeutic use</subject><subject>Tuberculosis</subject><subject>Tuberculosis - complications</subject><subject>Weight</subject><subject>World Health Organization</subject><issn>1027-3719</issn><issn>1815-7920</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kcFrFDEUhwex2Fo9epWAFy-zzUsmk8yxVm0LhSJUPIZMktnNMpNpk4xa_3qT3a2CYC7v8fj48vi9qnoDeMWYEGdum0azImSFWQfPqhMQwGreEfw895jwmnLojquXMW4xJgDAX1THedZQQvFJ1Z8b-7Ao_YjmAX27ukU_rFtvUt0rb5CZo_NrVNrB_bSmzgOL9Dz1zqvkZh_RMAeUNhalYFWarE_Fc_cBOY_0xo0mWP-qOhrUGO3rQz2tvn7-dHdxVd_cXl5fnN_UumFtqtsGGHBtFCGWEjDEDCKvaFrKGqVpx3mjuh4Ebrlggxr6lncahKGgAEMP9LR6v_feh_lhsTHJyUVtx1F5Oy9REgG4A9EIntF3_6DbeQk-b1cozjssGpKpek_pMMcY7CDvg5tUeJSAZQlf7sKXhMgSfubfHqxLP1nzh35KOwMf90BONUel_v7qFlVMBx8mVOLdI_zQYCZVSLlC0Xz5n0Y_mcrpy-Xld8I92ylxW7QN5dLYQS1jkkkFuf4lY3b-Btw1r5Q</recordid><startdate>20230501</startdate><enddate>20230501</enddate><creator>Kwara, A.</creator><creator>Yang, H.</creator><creator>Martyn-Dickens, C.</creator><creator>Enimil, A.</creator><creator>Amissah, A. K.</creator><creator>Ojewale, O.</creator><creator>Dompreh, A.</creator><creator>Bosomtwe, D.</creator><creator>Sly-Moore, E.</creator><creator>Opoku, T.</creator><creator>Appiah, A. F.</creator><creator>Obeng, R.</creator><creator>Asiedu, P.</creator><creator>Maranchick, N.</creator><creator>Alshaer, M. H.</creator><creator>Peloquin, C. A.</creator><creator>Antwi, S.</creator><general>International Union Against Tuberculosis and Lung Disease</general><general>International Union against Tuberculosis and Lung Disease (IUATLD)</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>7QL</scope><scope>7U7</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20230501</creationdate><title>Adequacy of WHO weight-band dosing and fixed-dose combinations for the treatment of TB in children</title><author>Kwara, A. ; Yang, H. ; Martyn-Dickens, C. ; Enimil, A. ; Amissah, A. K. ; Ojewale, O. ; Dompreh, A. ; Bosomtwe, D. ; Sly-Moore, E. ; Opoku, T. ; Appiah, A. F. ; Obeng, R. ; Asiedu, P. ; Maranchick, N. ; Alshaer, M. H. ; Peloquin, C. 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A.</creatorcontrib><creatorcontrib>Antwi, S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The international journal of tuberculosis and lung disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kwara, A.</au><au>Yang, H.</au><au>Martyn-Dickens, C.</au><au>Enimil, A.</au><au>Amissah, A. K.</au><au>Ojewale, O.</au><au>Dompreh, A.</au><au>Bosomtwe, D.</au><au>Sly-Moore, E.</au><au>Opoku, T.</au><au>Appiah, A. F.</au><au>Obeng, R.</au><au>Asiedu, P.</au><au>Maranchick, N.</au><au>Alshaer, M. H.</au><au>Peloquin, C. A.</au><au>Antwi, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adequacy of WHO weight-band dosing and fixed-dose combinations for the treatment of TB in children</atitle><jtitle>The international journal of tuberculosis and lung disease</jtitle><addtitle>Int J Tuberc Lung Dis</addtitle><date>2023-05-01</date><risdate>2023</risdate><volume>27</volume><issue>5</issue><spage>401</spage><epage>407</epage><pages>401-407</pages><issn>1027-3719</issn><eissn>1815-7920</eissn><abstract>BACKGROUND: We examined whether the updated WHO weight-band dosing recommendations and fixed-dose combination tablets for the treatment of TB in children achieves recommended calculated dosages and adequate drug plasma exposure.DESIGN/METHODS: Children on first-line
TB treatment per WHO guidelines were enrolled. Blood sampling at pre-dose, 1, 2, 4, 8, and 12 h post-dose after at least 4 weeks of treatment was performed. Drugs concentrations were measured using validated liquid chromatography tandem with mass spectrometry and pharmacokinetic parameters
calculated using noncompartmental analysis. Plasma drug exposure below the lower limit of the 95% confidence interval of the mean for children was considered low and above the upper limit was high.RESULTS: Of 71 participants, 34 (47.9%) had HIV coinfection. The median calculated
dose for isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and ethambutol (EMB) was 10.0 (range 4.3-13.3), 15.0 (range 8.6-20.0), 30.0 (range 21.0-40.0), and 20.4 (range 14.3-26.7) mg/kg, respectively. Overall, most patients had under-exposure for RIF and PZA and
over-exposure for INH and EMB. Drug dose and weight-for-age Z-score were associated with area under the curve from time 0-24 h for all drugs.CONCLUSIONS: Despite adherence to WHO dosing guidelines, low PZA and RIF plasma exposures were frequent in our study population.
Higher than currently recommended dosages of RIF and PZA may be needed in children.</abstract><cop>France</cop><pub>International Union Against Tuberculosis and Lung Disease</pub><pmid>37143230</pmid><doi>10.5588/ijtld.22.0591</doi><tpages>7</tpages></addata></record> |
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| ispartof | The international journal of tuberculosis and lung disease, 2023-05, Vol.27 (5), p.401-407 |
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| subjects | Adequacy Antitubercular Agents - therapeutic use Antituberculosis Drugs Child Children Confidence intervals Dosage Dosing Drug development Drug dosages Drugs Ethambutol Exposure Guidelines HIV Human immunodeficiency virus Humans Isoniazid Isoniazid - therapeutic use Liquid chromatography Mass spectrometry Mass spectroscopy Mathematical analysis Pediatric Pharmacokinetics Population studies Pyrazinamide Rifampin Rifampin - therapeutic use Tuberculosis Tuberculosis - complications Weight World Health Organization |
| title | Adequacy of WHO weight-band dosing and fixed-dose combinations for the treatment of TB in children |
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