title: Pharmacokinetics of nevirapine, stavudine and lamivudine in Indian HIV-infected children receiving generic fixed dose combinations.
abstract: OBJECTIVE
  To determine the trough and two hour plasma levels of nevirapine, stavudine, and lamivudine when administered in fixed dose combinations (FDC).
  
  
  METHODS
  Cross sectional.
  
  
  METHODS
  Tertiary care hospital in Northern India.
  
  
  METHODS
  79 HIV-infected children receiving antiretroviral therapy with FDCs for more than month.
  
  
  METHODS
  Two-point sampling (0 and 2 hours after the morning dose).
  
  
  METHODS
  Plasma concentrations of all three drugs were simultaneously assayed by liquid chromatography/mass spectroscopy.
  
  
  RESULTS
  Majority (77%) of children were receiving fixed dose combination of stavudine, lamivudine, nevirapine in the ratio of 6:30:50 mg. The median (IQR) trough and 2-hour plasma levels (µg/mL) of nevirapine, stavudine and lamivudine were 5.2 (4.0, 6.3) and 7.9 (6.0, 9.7); 0.1 (0.06, 0.16) and 1.1 (0.59, 1.6); 0.1 (0.02, 0.2) and 2.5 (1.4, 3.1), respectively. Very few children had sub-therapeutic plasma drug levels of stavudine (2.5%), lamivudine (7.6%) and nevirapine (10%). Inadequate viral suppression at 6 months follow up was significantly associated with initial high viral load, low CD4 percentage at the time of enrolment in study, and lower doses of lamivudine and stavudine.
  
  
  CONCLUSIONS
  The currently available generic pediatric fixed dose antiretroviral combinations in India provide adequate drug exposure in majority of children.
authors.affiliation: Departments of Pediatrics, *Ocular Pharmacology and #Microbiology, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Dr Rakesh Lodha, Additional Professor, Department of Pediatrics, AIIMS, New Delhi, India. rlodha1661@gmail.com.
authors.forename: Aparna
authors.initials: A
authors.lastname: Mukherjee
authors.forename: Mohit
authors.initials: M
authors.lastname: Singla
authors.forename: T
authors.initials: T
authors.lastname: Velpandian
authors.forename: Anju
authors.initials: A
authors.lastname: Sirohiwal
authors.forename: M
authors.initials: M
authors.lastname: Vajpayee
authors.forename: Ravinder
authors.initials: R
authors.lastname: Singh
authors.forename: S K
authors.initials: SK
authors.lastname: Kabra
authors.forename: Rakesh
authors.initials: R
authors.lastname: Lodha
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D007223:Infant; D019259:Lamivudine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D008297:Male; D019829:Nevirapine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D018119:Stavudine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D016568:Drugs, Generic; D019259:Lamivudine; D019829:Nevirapine; D018119:Stavudine