title: Thai HIV-1-infected women do not require a dose increase of lopinavir/ritonavir during the third trimester of pregnancy.
abstract: OBJECTIVE
  To investigate whether Thai HIV-1-infected pregnant women require a dose increase of lopinavir/ritonavir (LPV/r) and to assess the safety and efficacy of the generic tablets during pregnancy.
  
  
  METHODS
  Prospective, single-center pharmacokinetic study.
  
  
  METHODS
  HIV-infected pregnant, antiretroviral therapy-naive or experienced women started HAART containing generic LPV/r 400/100 mg tablets twice daily. The 12-h pharmacokinetic curves were recorded at gestational age 20 weeks (GA20, optional), 33 weeks (GA33) and 12 weeks postpartum (12PP, optional).
  
  
  RESULTS
  Twenty women were included. Median [interquartile range (IQR)] age was 28 (25-33) years and mean (SD) weight at GA33 was 59.9 (4.2) kg. Mean (SD) values for LPV area under the curve(0-12 h), C(max), C(min), and T(half) were 72.9 (19.2) mg/l h, 9.3 (2.2) mg/l, 3.2 (1.3) mg/l and 4.8 (2.4) h, respectively, on GA33 and 98.0 (24.1) mg/l h, 11.7 (2.2) mg/l, 4.7 (2.2) mg/l and 5.9 (2.7) h, respectively on 12PP. Twelve women recorded both GA33 and 12PP curves; mean LPV AUC(0-12) was significantly lower at GA33 [-24.1 (95% confidence interval -44.4 to -3.7) mg/l h]. At GA33, 19 of 20 women had sufficient LPV trough concentrations (>1.0 mg/l) and at 12PP, all had sufficient LPV trough concentrations. None of the women stopped LPV/r before planned discontinuation due to side-effects. At delivery, 19 of 20 women had a viral load below 50 copies/ml. One woman had a viral load of 60 copies/ml, but was undetectable at 12PP.
  
  
  CONCLUSIONS
  Standard dose generic LPV/r (400/100 mg twice daily) in Thai HIV-1-infected pregnant women leads to adequate plasma concentrations during the third trimester. The generic LPV/r tablet is well tolerated and effective for use during pregnancy.
authors.affiliation: The HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand. reshmie.r@hivnat.org
authors.forename: Reshmie A
authors.initials: RA
authors.lastname: Ramautarsing
authors.forename: Jasper
authors.initials: J
authors.lastname: van der Lugt
authors.forename: Meena
authors.initials: M
authors.lastname: Gorowara
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Kerr
authors.forename: David
authors.initials: D
authors.lastname: Burger
authors.forename: Kiat
authors.initials: K
authors.lastname: Ruxrungtham
authors.forename: Praphan
authors.initials: P
authors.lastname: Phanuphak
authors.forename: Surasith
authors.initials: S
authors.lastname: Chaithongwongwatthana
authors.forename: Anchalee
authors.initials: A
authors.lastname: Avihingsanon
authors.forename: Nittaya
authors.initials: N
authors.lastname: Phanuphak
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D061466:Lopinavir; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D011744:Pyrimidinones / Q000008:administration & dosage* / Q000493:pharmacokinetics; D012367:RNA, Viral / Q000187:drug effects*; D019438:Ritonavir / Q000008:administration & dosage* / Q000493:pharmacokinetics; D019562:Viral Load
chemical_list: D011744:Pyrimidinones; D012367:RNA, Viral; D061466:Lopinavir; D019438:Ritonavir