Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life

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dc.contributor.authorDesmond, Alicia C
dc.contributor.authorMoodley, Dhayendre
dc.contributor.authorConolly, Catherine A
dc.contributor.authorCastel, Sandra A
dc.contributor.authorCoovadia, Hoosen M
dc.date.accessioned2015-07-30T03:58:19Z
dc.date.available2015-07-30T03:58:19Z
dc.date.issued2015-03-19
dc.date.updated2015-03-31T18:02:13Z
dc.description.abstractAbstract Background Adherence to an antiretroviral regimen is imperative for treatment success in both HIV infected adults and children. Likewise, adherence to antiretroviral prophylaxis is critical in HIV prevention. Studies on pediatric adherence are limited, particularly the prophylactic use of antiretroviral drugs and treatment adherence in very young infants. The HIV Prevention Trials Network (HPTN) 046 study (Clinical Trial Registration NCT00074412) determined the safety and efficacy of an extended regimen of nevirapine suspension in infants born to HIV-1 infected women for the prevention of vertical HIV transmission during breastfeeding. As per protocol, adherence to nevirapine prophylaxis was measured by maternal verbal reports. In addition, the pharmacy assessed the unused returned suspension. The aim of this sub-study was to determine the reliability of maternal verbal reports in measuring adherence to antiretroviral prophylaxis in infants in the first 6 weeks of life and evaluating the unused returned nevirapine as an alternative method of measuring adherence. Methods Maternal verbal reports and pharmacy returns indicative of “missed < 2 doses” were evaluated against a plasma nevirapine concentration of >100 ng/ml in a subgroup of infants at 2, 5 and 6 weeks of age. Plasma nevirapine concentration of >100 ng/ml was used as a marker of adherence (10 times the in vitro IC50 against HIV). Results Adherence was 87.7% (maternal verbal report) and 71.3% (unused returned medication), as compared to 85.6% by plasma nevirapine concentration. Evaluated against plasma nevirapine concentration <100 ng/ml, the sensitivity and specificity of maternal verbal reports to detect a missed dose in the last 3 days were 75% and 78% (p = 0.03) respectively. Overall, among infants who were classified as adherent based on missed doses by maternal verbal reports and unused returned medication, 88.4% and 87.4% of infants attained a nevirapine concentration above 100 ng/ml respectively. Conclusion Maternal verbal reports are a reliable measure of adherence to infant antiretroviral prophylaxis in the first 6 weeks of life and could be useful in assessing adherence to antiretroviral treatment in infants younger than 6 weeks. In the absence of resources or expertise to determine plasma drug concentration, we would recommend random assessments of unused returned medication.
dc.identifier.apacitationDesmond, A. C., Moodley, D., Conolly, C. A., Castel, S. A., & Coovadia, H. M. (2015). Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life. <i>BMC Pediatrics</i>, http://hdl.handle.net/11427/13601en_ZA
dc.identifier.chicagocitationDesmond, Alicia C, Dhayendre Moodley, Catherine A Conolly, Sandra A Castel, and Hoosen M Coovadia "Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life." <i>BMC Pediatrics</i> (2015) http://hdl.handle.net/11427/13601en_ZA
dc.identifier.citationDesmond, A. C., Moodley, D., Conolly, C. A., Castel, S. A., & Coovadia, H. M. (2015). Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life. BMC pediatrics, 15(1), 23.
dc.identifier.ris TY - Journal Article AU - Desmond, Alicia C AU - Moodley, Dhayendre AU - Conolly, Catherine A AU - Castel, Sandra A AU - Coovadia, Hoosen M AB - Abstract Background Adherence to an antiretroviral regimen is imperative for treatment success in both HIV infected adults and children. Likewise, adherence to antiretroviral prophylaxis is critical in HIV prevention. Studies on pediatric adherence are limited, particularly the prophylactic use of antiretroviral drugs and treatment adherence in very young infants. The HIV Prevention Trials Network (HPTN) 046 study (Clinical Trial Registration NCT00074412) determined the safety and efficacy of an extended regimen of nevirapine suspension in infants born to HIV-1 infected women for the prevention of vertical HIV transmission during breastfeeding. As per protocol, adherence to nevirapine prophylaxis was measured by maternal verbal reports. In addition, the pharmacy assessed the unused returned suspension. The aim of this sub-study was to determine the reliability of maternal verbal reports in measuring adherence to antiretroviral prophylaxis in infants in the first 6 weeks of life and evaluating the unused returned nevirapine as an alternative method of measuring adherence. Methods Maternal verbal reports and pharmacy returns indicative of “missed < 2 doses” were evaluated against a plasma nevirapine concentration of >100 ng/ml in a subgroup of infants at 2, 5 and 6 weeks of age. Plasma nevirapine concentration of >100 ng/ml was used as a marker of adherence (10 times the in vitro IC50 against HIV). Results Adherence was 87.7% (maternal verbal report) and 71.3% (unused returned medication), as compared to 85.6% by plasma nevirapine concentration. Evaluated against plasma nevirapine concentration <100 ng/ml, the sensitivity and specificity of maternal verbal reports to detect a missed dose in the last 3 days were 75% and 78% (p = 0.03) respectively. Overall, among infants who were classified as adherent based on missed doses by maternal verbal reports and unused returned medication, 88.4% and 87.4% of infants attained a nevirapine concentration above 100 ng/ml respectively. Conclusion Maternal verbal reports are a reliable measure of adherence to infant antiretroviral prophylaxis in the first 6 weeks of life and could be useful in assessing adherence to antiretroviral treatment in infants younger than 6 weeks. In the absence of resources or expertise to determine plasma drug concentration, we would recommend random assessments of unused returned medication. DA - 2015-03-19 DB - OpenUCT DO - 10.1186/s12887-015-0340-9 DP - University of Cape Town J1 - BMC Pediatrics LK - https://open.uct.ac.za PB - University of Cape Town PY - 2015 T1 - Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life TI - Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life UR - http://hdl.handle.net/11427/13601 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/13601
dc.identifier.urihttp://dx.doi.org/10.1186/s12887-015-0340-9
dc.identifier.vancouvercitationDesmond AC, Moodley D, Conolly CA, Castel SA, Coovadia HM. Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life. BMC Pediatrics. 2015; http://hdl.handle.net/11427/13601.en_ZA
dc.language.rfc3066en
dc.publisher.departmentDivision of Clinical Pharmacologyen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution License*
dc.rights.holderDesmond et al.; licensee BioMed Central.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0*
dc.sourceBMC Pediatricsen_ZA
dc.source.urihttp://www.biomedcentral.com/bmcpediatr/
dc.subject.otherAdherence measuresen_ZA
dc.subject.otherInfantsen_ZA
dc.subject.otherAntiretroviral prophylaxisen_ZA
dc.subject.otherMaternal verbal reporten_ZA
dc.subject.otherPharmacy returnsen_ZA
dc.titleEvaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life
dc.typeJournal Articleen_ZA
uct.type.filetype
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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