title: PHARMACOKINETIC EXPOSURE AND VIROLOGIC RESPONSE IN HIV-1 INFECTED PREGNANT WOMEN TREATED WITH LOPINAVIR/RITONAVIR: AIDS CLINICAL TRIALS GROUP PROTOCOL A5153S: A SUBSTUDY TO A5150.
abstract: OBJECTIVE
  We studied the pharmacokinetics and pharmacodynamics of boosted soft-gel lopinavir/ritonavir to assess if the area under the plasma concentration versus time curve (AUC) is altered in pregnancy and whether changes in AUC impacted HIV-1 control.
  
  
  METHODS
  We enrolled pregnant women ≥13 years of age between 22 to 30 weeks gestation who expected to be on stable lopinavir/ritonavir for ≥8 weeks pre-delivery and ≥24 weeks post-delivery. Pharmacokinetic evaluations for lopinavir and ritonavir occurred at 36 weeks gestation and 6 and 24 weeks postpartum.
  
  
  RESULTS
  Ten women underwent intensive pharmacokinetic evaluations for lopinavir and ritonavir at 36 weeks gestation and at 6 and 24 weeks postpartum. Estimated geometric mean (GM) AUC 0-6h (95% CI) for lopinavir were not significantly different at 26.5 (17.0, 41.4) and 41.9 (26.1, 67.5) mcg*hr/mL at 36 weeks gestation and 6 weeks postpartum, respectively (within-subject GM ratio 0.60 (0.25, 1.43); p=0.19). At 36 weeks gestation, 5 of 10 women had viral load <50 copies/mL and at 6 weeks postpartum 5 of 9 had viral load <50 copies/mL. Nine of ten infants for whom data were available were HIV negative.
  
  
  CONCLUSIONS
  Despite below target lopinavir levels (< 52 mcg*hr/mL except at 2 postpartum measurements), women maintained virologic control postpartum. Higher doses of lopinavir/ritonavir during pregnancy may not be necessary in all women.
authors.affiliation: Division of Infectious Diseases, Rush University Medical Center, Chicago, IL USA.
authors.forename: Beverly E
authors.initials: BE
authors.lastname: Sha
authors.affiliation: Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA USA.
authors.forename: Camlin
authors.initials: C
authors.lastname: Tierney
authors.affiliation: Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA USA.
authors.forename: Xin
authors.initials: X
authors.lastname: Sun
authors.affiliation: Department of Obstetrics and Gynecology, Los Angeles County and University of Southern California Medical Center, Los Angeles, CA USA.
authors.forename: Alice
authors.initials: A
authors.lastname: Stek
authors.affiliation: Division of Infectious Diseases, Northwestern University Feinberg School of Medicine, Chicago, IL USA.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Cohn
authors.affiliation: Departments of Laboratory Medicine and Medicine, University of Washington, Seattle, WA USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Coombs
authors.affiliation: Social & Scientific Systems, Inc., Silver Spring, MD USA.
authors.forename: Barbara
authors.initials: B
authors.lastname: Bastow
authors.affiliation: University of California, San Francisco, San Francisco, CA USA.
authors.forename: Francesca T
authors.initials: FT
authors.lastname: Aweeka
keywords: HIV viral load; lopinavir; pharmacokinetics; pregnancy; ritonavir