title: Evaluation of adherence measures of antiretroviral prophylaxis in HIV exposed infants in the first 6 weeks of life.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for the AIDS Programme of Research in South Africa-CAPRISA, and Women's Health and HIV Research Unit, Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa. desmond@ukzn.ac.za.
authors.forename: Alicia Catherine
authors.initials: AC
authors.lastname: Desmond
authors.affiliation: Center for the AIDS Programme of Research in South Africa-CAPRISA, and Women's Health and HIV Research Unit, Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa. Moodleyd1@ukzn.ac.za.
authors.forename: Dhayendre
authors.initials: D
authors.lastname: Moodley
authors.affiliation: Biostatistics Unit, Medical Research Council, Durban, South Africa. Cconnolly205@gmail.com.
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Conolly
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa. Sandra.castel@uct.ac.za.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Castel
authors.affiliation: Maternal Adolescent and Child Health (MatCH), University of the Witwatersrand, Johannesburg, South Africa. Hcoovadia@match.org.za.
authors.forename: Hoosen M
authors.initials: HM
authors.lastname: Coovadia
mesh_terms: D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000097:blood / Q000627:therapeutic use*; D001942:Breast Feeding / Q000009:adverse effects; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D055118:Medication Adherence; D019829:Nevirapine / Q000097:blood / Q000627:therapeutic use*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D012189:Retrospective Studies; D057566:Self Report; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine