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Factors influencing plasma nevirapine levels: a study in HIV-infected children on generic antiretroviral treatment in India
Nevirapine is an important component of paediatric combination HIV therapy. Adequate drug exposure is necessary in order to achieve long-lasting viral suppression. To study the influence of age, drug dose and formulation type, nutritional status and CYP2B6 516G>T polymorphism on blood concentrati...
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| Published in: | Journal of antimicrobial chemotherapy 2011-06, Vol.66 (6), p.1354-1359 |
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| container_title | Journal of antimicrobial chemotherapy |
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| creator | SWAMINATHAN, Soumya RAMACHANDRAN, Geetha KUMAR AGIBOTHU KUPPARAM, Hemanth MAHALINGAM, Vasantha SOUNDARARAJAN, Lakshmi PERUMAL KANNABIRAN, Bhavani POORANA GANGA DEVI NAVANEETHAPANDIAN SHAH, Ira KARUNAIANANDHAM, Ramesh SIKHAMANI, Rajasekaran |
| description | Nevirapine is an important component of paediatric combination HIV therapy. Adequate drug exposure is necessary in order to achieve long-lasting viral suppression.
To study the influence of age, drug dose and formulation type, nutritional status and CYP2B6 516G>T polymorphism on blood concentrations of nevirapine in children treated with generic antiretroviral drugs.
A multicentre study was conducted at four sites in India. HIV-infected children receiving generic nevirapine-based fixed-dose combinations were recruited. Trough and 2 h nevirapine plasma concentrations were determined by HPLC. Characterization of the CYP2B6 gene polymorphism was performed using direct sequencing. Clinical and nutritional status was recorded. Groups were compared using the Mann-Whitney U-test and multivariable logistic regression analysis was performed to identify factors contributing to low drug levels.
Ninety-four children of median age 78 months were studied; 60% were undernourished or stunted. Stunted children had a significantly lower 2 h nevirapine concentration compared with non-stunted children (P |
| doi_str_mv | 10.1093/jac/dkr075 |
| format | article |
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To study the influence of age, drug dose and formulation type, nutritional status and CYP2B6 516G>T polymorphism on blood concentrations of nevirapine in children treated with generic antiretroviral drugs.
A multicentre study was conducted at four sites in India. HIV-infected children receiving generic nevirapine-based fixed-dose combinations were recruited. Trough and 2 h nevirapine plasma concentrations were determined by HPLC. Characterization of the CYP2B6 gene polymorphism was performed using direct sequencing. Clinical and nutritional status was recorded. Groups were compared using the Mann-Whitney U-test and multivariable logistic regression analysis was performed to identify factors contributing to low drug levels.
Ninety-four children of median age 78 months were studied; 60% were undernourished or stunted. Stunted children had a significantly lower 2 h nevirapine concentration compared with non-stunted children (P < 0.05); there were no significant differences in trough concentrations between different nutritional groups. Nevirapine levels were significantly higher in children with TT compared with GG and GT CYP2B6 genotypes (P < 0.01). Children ≤ 3 years had a 3.2 (95% confidence interval 1.07-9.45) times higher risk of having sub-therapeutic nevirapine concentrations.
Nevirapine blood concentrations are affected by many factors, most notably age ≤ 3 years; a combination of young age, stunting and CYP2B6 GG or GT genotype could potentially result in sub-therapeutic nevirapine concentrations. Dosing recommendations for children should be reviewed in the light of these findings.</description><identifier>ISSN: 0305-7453</identifier><identifier>EISSN: 1460-2091</identifier><identifier>DOI: 10.1093/jac/dkr075</identifier><identifier>PMID: 21393201</identifier><identifier>CODEN: JACHDX</identifier><language>eng</language><publisher>Oxford: Oxford University Press</publisher><subject>Age Factors ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - blood ; Anti-HIV Agents - pharmacokinetics ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiretroviral drugs ; Antiretroviral Therapy, Highly Active - methods ; Aryl Hydrocarbon Hydroxylases - genetics ; Biological and medical sciences ; Child ; Child, Preschool ; Children & youth ; Chromatography, High Pressure Liquid ; Cytochrome P-450 CYP2B6 ; Drug dosages ; Female ; Genotype & phenotype ; HIV ; HIV Infections - drug therapy ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; India ; Infant ; Infectious diseases ; Male ; Medical sciences ; Models, Statistical ; Nevirapine - administration & dosage ; Nevirapine - blood ; Nevirapine - pharmacokinetics ; Original Research ; Oxidoreductases, N-Demethylating - genetics ; Pharmacology. Drug treatments ; Plasma - chemistry ; Polymorphism ; Polymorphism, Genetic ; Regression analysis ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids</subject><ispartof>Journal of antimicrobial chemotherapy, 2011-06, Vol.66 (6), p.1354-1359</ispartof><rights>2015 INIST-CNRS</rights><rights>Copyright Oxford Publishing Limited(England) Jun 2011</rights><rights>The Author 2011. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c466t-5c6d143fd12b0247609951a45d134921cedf548d471fc6109dbc99b7714a69cf3</citedby><cites>FETCH-LOGICAL-c466t-5c6d143fd12b0247609951a45d134921cedf548d471fc6109dbc99b7714a69cf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27923,27924</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24202435$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21393201$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>SWAMINATHAN, Soumya</creatorcontrib><creatorcontrib>RAMACHANDRAN, Geetha</creatorcontrib><creatorcontrib>KUMAR AGIBOTHU KUPPARAM, Hemanth</creatorcontrib><creatorcontrib>MAHALINGAM, Vasantha</creatorcontrib><creatorcontrib>SOUNDARARAJAN, Lakshmi</creatorcontrib><creatorcontrib>PERUMAL KANNABIRAN, Bhavani</creatorcontrib><creatorcontrib>POORANA GANGA DEVI NAVANEETHAPANDIAN</creatorcontrib><creatorcontrib>SHAH, Ira</creatorcontrib><creatorcontrib>KARUNAIANANDHAM, Ramesh</creatorcontrib><creatorcontrib>SIKHAMANI, Rajasekaran</creatorcontrib><title>Factors influencing plasma nevirapine levels: a study in HIV-infected children on generic antiretroviral treatment in India</title><title>Journal of antimicrobial chemotherapy</title><addtitle>J Antimicrob Chemother</addtitle><description>Nevirapine is an important component of paediatric combination HIV therapy. Adequate drug exposure is necessary in order to achieve long-lasting viral suppression.
To study the influence of age, drug dose and formulation type, nutritional status and CYP2B6 516G>T polymorphism on blood concentrations of nevirapine in children treated with generic antiretroviral drugs.
A multicentre study was conducted at four sites in India. HIV-infected children receiving generic nevirapine-based fixed-dose combinations were recruited. Trough and 2 h nevirapine plasma concentrations were determined by HPLC. Characterization of the CYP2B6 gene polymorphism was performed using direct sequencing. Clinical and nutritional status was recorded. Groups were compared using the Mann-Whitney U-test and multivariable logistic regression analysis was performed to identify factors contributing to low drug levels.
Ninety-four children of median age 78 months were studied; 60% were undernourished or stunted. Stunted children had a significantly lower 2 h nevirapine concentration compared with non-stunted children (P < 0.05); there were no significant differences in trough concentrations between different nutritional groups. Nevirapine levels were significantly higher in children with TT compared with GG and GT CYP2B6 genotypes (P < 0.01). Children ≤ 3 years had a 3.2 (95% confidence interval 1.07-9.45) times higher risk of having sub-therapeutic nevirapine concentrations.
Nevirapine blood concentrations are affected by many factors, most notably age ≤ 3 years; a combination of young age, stunting and CYP2B6 GG or GT genotype could potentially result in sub-therapeutic nevirapine concentrations. Dosing recommendations for children should be reviewed in the light of these findings.</description><subject>Age Factors</subject><subject>Anti-HIV Agents - administration & dosage</subject><subject>Anti-HIV Agents - blood</subject><subject>Anti-HIV Agents - pharmacokinetics</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral Therapy, Highly Active - methods</subject><subject>Aryl Hydrocarbon Hydroxylases - genetics</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Children & youth</subject><subject>Chromatography, High Pressure Liquid</subject><subject>Cytochrome P-450 CYP2B6</subject><subject>Drug dosages</subject><subject>Female</subject><subject>Genotype & phenotype</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>Human immunodeficiency virus</subject><subject>Human viral diseases</subject><subject>Humans</subject><subject>Immunodeficiencies</subject><subject>Immunodeficiencies. Immunoglobulinopathies</subject><subject>Immunopathology</subject><subject>India</subject><subject>Infant</subject><subject>Infectious diseases</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Models, Statistical</subject><subject>Nevirapine - administration & dosage</subject><subject>Nevirapine - blood</subject><subject>Nevirapine - pharmacokinetics</subject><subject>Original Research</subject><subject>Oxidoreductases, N-Demethylating - genetics</subject><subject>Pharmacology. Drug treatments</subject><subject>Plasma - chemistry</subject><subject>Polymorphism</subject><subject>Polymorphism, Genetic</subject><subject>Regression analysis</subject><subject>Viral diseases</subject><subject>Viral diseases of the lymphoid tissue and the blood. Aids</subject><issn>0305-7453</issn><issn>1460-2091</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNpdkUuLFDEUhYMoTju68QdIEEQQysmz0nEhyOA4DQNu1G1IJ7d60qZSbZJqGPzzpul2fKyyyHfPPfcchJ5T8pYSzS-21l3475ko-QAtqOhJx4imD9GCcCI7JSQ_Q09K2RJCetkvH6MzRrnmjNAF-nllXZ1ywSENcYbkQtrgXbRltDjBPmS7CwlwhD3E8g5bXOrs7xqNr1ffujYEroLH7jZEnyHhKeENJMjBYZtqyFDzdFCJuGawdYRUD8Or5IN9ih4NNhZ4dnrP0derj18ur7ubz59Wlx9uOif6vnbS9Z4KPnjK1oQJ1ROtJbVCesqFZtSBH6RYeqHo4PqWiF87rddKUWF77QZ-jt4fdXfzegTvmodmyOxyGG2-M5MN5t-fFG7NZtob3tYKrprA65NAnn7MUKoZQ3EQo00wzcVowhqlFGvky__I7TTn1K4zS8Vly5yTBr05Qi5PpWQY7q1QYg6NmtaoOTba4Bd_m79Hf1fYgFcnwBZn45BtK7H84QRrobXVvwDXUava</recordid><startdate>20110601</startdate><enddate>20110601</enddate><creator>SWAMINATHAN, Soumya</creator><creator>RAMACHANDRAN, Geetha</creator><creator>KUMAR AGIBOTHU KUPPARAM, Hemanth</creator><creator>MAHALINGAM, Vasantha</creator><creator>SOUNDARARAJAN, Lakshmi</creator><creator>PERUMAL KANNABIRAN, Bhavani</creator><creator>POORANA GANGA DEVI NAVANEETHAPANDIAN</creator><creator>SHAH, Ira</creator><creator>KARUNAIANANDHAM, Ramesh</creator><creator>SIKHAMANI, Rajasekaran</creator><general>Oxford University Press</general><general>Oxford Publishing Limited (England)</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>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>5PM</scope></search><sort><creationdate>20110601</creationdate><title>Factors influencing plasma nevirapine levels: a study in HIV-infected children on generic antiretroviral treatment in India</title><author>SWAMINATHAN, Soumya ; RAMACHANDRAN, Geetha ; KUMAR AGIBOTHU KUPPARAM, Hemanth ; MAHALINGAM, Vasantha ; SOUNDARARAJAN, Lakshmi ; PERUMAL KANNABIRAN, Bhavani ; POORANA GANGA DEVI NAVANEETHAPANDIAN ; SHAH, Ira ; KARUNAIANANDHAM, Ramesh ; SIKHAMANI, Rajasekaran</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c466t-5c6d143fd12b0247609951a45d134921cedf548d471fc6109dbc99b7714a69cf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Age Factors</topic><topic>Anti-HIV Agents - administration & dosage</topic><topic>Anti-HIV Agents - blood</topic><topic>Anti-HIV Agents - pharmacokinetics</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiretroviral drugs</topic><topic>Antiretroviral Therapy, Highly Active - methods</topic><topic>Aryl Hydrocarbon Hydroxylases - genetics</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Children & youth</topic><topic>Chromatography, High Pressure Liquid</topic><topic>Cytochrome P-450 CYP2B6</topic><topic>Drug dosages</topic><topic>Female</topic><topic>Genotype & phenotype</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>Human immunodeficiency virus</topic><topic>Human viral diseases</topic><topic>Humans</topic><topic>Immunodeficiencies</topic><topic>Immunodeficiencies. Immunoglobulinopathies</topic><topic>Immunopathology</topic><topic>India</topic><topic>Infant</topic><topic>Infectious diseases</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Models, Statistical</topic><topic>Nevirapine - administration & dosage</topic><topic>Nevirapine - blood</topic><topic>Nevirapine - pharmacokinetics</topic><topic>Original Research</topic><topic>Oxidoreductases, N-Demethylating - genetics</topic><topic>Pharmacology. Drug treatments</topic><topic>Plasma - chemistry</topic><topic>Polymorphism</topic><topic>Polymorphism, Genetic</topic><topic>Regression analysis</topic><topic>Viral diseases</topic><topic>Viral diseases of the lymphoid tissue and the blood. Aids</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>SWAMINATHAN, Soumya</creatorcontrib><creatorcontrib>RAMACHANDRAN, Geetha</creatorcontrib><creatorcontrib>KUMAR AGIBOTHU KUPPARAM, Hemanth</creatorcontrib><creatorcontrib>MAHALINGAM, Vasantha</creatorcontrib><creatorcontrib>SOUNDARARAJAN, Lakshmi</creatorcontrib><creatorcontrib>PERUMAL KANNABIRAN, Bhavani</creatorcontrib><creatorcontrib>POORANA GANGA DEVI NAVANEETHAPANDIAN</creatorcontrib><creatorcontrib>SHAH, Ira</creatorcontrib><creatorcontrib>KARUNAIANANDHAM, Ramesh</creatorcontrib><creatorcontrib>SIKHAMANI, Rajasekaran</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>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of antimicrobial chemotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>SWAMINATHAN, Soumya</au><au>RAMACHANDRAN, Geetha</au><au>KUMAR AGIBOTHU KUPPARAM, Hemanth</au><au>MAHALINGAM, Vasantha</au><au>SOUNDARARAJAN, Lakshmi</au><au>PERUMAL KANNABIRAN, Bhavani</au><au>POORANA GANGA DEVI NAVANEETHAPANDIAN</au><au>SHAH, Ira</au><au>KARUNAIANANDHAM, Ramesh</au><au>SIKHAMANI, Rajasekaran</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Factors influencing plasma nevirapine levels: a study in HIV-infected children on generic antiretroviral treatment in India</atitle><jtitle>Journal of antimicrobial chemotherapy</jtitle><addtitle>J Antimicrob Chemother</addtitle><date>2011-06-01</date><risdate>2011</risdate><volume>66</volume><issue>6</issue><spage>1354</spage><epage>1359</epage><pages>1354-1359</pages><issn>0305-7453</issn><eissn>1460-2091</eissn><coden>JACHDX</coden><abstract>Nevirapine is an important component of paediatric combination HIV therapy. Adequate drug exposure is necessary in order to achieve long-lasting viral suppression.
To study the influence of age, drug dose and formulation type, nutritional status and CYP2B6 516G>T polymorphism on blood concentrations of nevirapine in children treated with generic antiretroviral drugs.
A multicentre study was conducted at four sites in India. HIV-infected children receiving generic nevirapine-based fixed-dose combinations were recruited. Trough and 2 h nevirapine plasma concentrations were determined by HPLC. Characterization of the CYP2B6 gene polymorphism was performed using direct sequencing. Clinical and nutritional status was recorded. Groups were compared using the Mann-Whitney U-test and multivariable logistic regression analysis was performed to identify factors contributing to low drug levels.
Ninety-four children of median age 78 months were studied; 60% were undernourished or stunted. Stunted children had a significantly lower 2 h nevirapine concentration compared with non-stunted children (P < 0.05); there were no significant differences in trough concentrations between different nutritional groups. Nevirapine levels were significantly higher in children with TT compared with GG and GT CYP2B6 genotypes (P < 0.01). Children ≤ 3 years had a 3.2 (95% confidence interval 1.07-9.45) times higher risk of having sub-therapeutic nevirapine concentrations.
Nevirapine blood concentrations are affected by many factors, most notably age ≤ 3 years; a combination of young age, stunting and CYP2B6 GG or GT genotype could potentially result in sub-therapeutic nevirapine concentrations. Dosing recommendations for children should be reviewed in the light of these findings.</abstract><cop>Oxford</cop><pub>Oxford University Press</pub><pmid>21393201</pmid><doi>10.1093/jac/dkr075</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0305-7453 |
| ispartof | Journal of antimicrobial chemotherapy, 2011-06, Vol.66 (6), p.1354-1359 |
| issn | 0305-7453 1460-2091 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3143437 |
| source | Oxford Journals Online |
| subjects | Age Factors Anti-HIV Agents - administration & dosage Anti-HIV Agents - blood Anti-HIV Agents - pharmacokinetics Antibiotics. Antiinfectious agents. Antiparasitic agents Antiretroviral drugs Antiretroviral Therapy, Highly Active - methods Aryl Hydrocarbon Hydroxylases - genetics Biological and medical sciences Child Child, Preschool Children & youth Chromatography, High Pressure Liquid Cytochrome P-450 CYP2B6 Drug dosages Female Genotype & phenotype HIV HIV Infections - drug therapy Human immunodeficiency virus Human viral diseases Humans Immunodeficiencies Immunodeficiencies. Immunoglobulinopathies Immunopathology India Infant Infectious diseases Male Medical sciences Models, Statistical Nevirapine - administration & dosage Nevirapine - blood Nevirapine - pharmacokinetics Original Research Oxidoreductases, N-Demethylating - genetics Pharmacology. Drug treatments Plasma - chemistry Polymorphism Polymorphism, Genetic Regression analysis Viral diseases Viral diseases of the lymphoid tissue and the blood. Aids |
| title | Factors influencing plasma nevirapine levels: a study in HIV-infected children on generic antiretroviral treatment in India |
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