title: Lopinavir/ritonavir dosing during pregnancy in Brazil and maternal/infant laboratory abnormalities.
abstract: OBJECTIVE
  To describe laboratory abnormalities among HIV-infected women and their infants with standard and increased lopinavir/ritonavir (LPV/r) dosing during the third trimester of pregnancy.
  
  
  METHODS
  We evaluated data on pregnant women from NISDI cohorts (2002-2009) enrolled in Brazil, who received at least 28 days of LPV/r during the third pregnancy trimester and gave birth to singleton infants.
  
  
  RESULTS
  164 women received LPV/r standard dosing [(798/198 or 800/200 mg/day) (Group 1)] and 70 increased dosing [(> 800/200 mg/day) (Group 2)]. Group 1 was more likely to have advanced clinical disease and to use ARVs for treatment, and less likely to have CD4 counts > 500 cells/mm³. Mean plasma viral load was higher in Group 2. There were statistically significant, but not clinically meaningful, differences between groups in mean AST, ALT, cholesterol, and triglycerides. The proportion of women with Grade 3 or 4 adverse events was very low, with no statistically significant differences between groups in severe adverse events related to ALT, AST, total bilirubin, cholesterol, or triglycerides. There were statistically significant, but not clinically meaningful, differences between infant groups in ALT and creatinine. The proportion of infants with Grade 3 or 4 adverse events was very low, and there were no statistically significant differences in severe adverse events related to ALT, AST, BUN, or creatinine.
  
  
  CONCLUSIONS
  The proportions of women and infants with severe laboratory adverse events were very low. Increased LPV/r dosing during the third trimester of pregnancy appears to be safe for HIV-infected women and their infants.
authors.affiliation: Unidade de Prevenção à Transmissão Vertical, Hospital Femina, Porto Alegre, Rio Grande do Sul, Brazil. peixoto3@terra.com.br
authors.forename: Mario Ferreira
authors.initials: MF
authors.lastname: Peixoto
authors.forename: José Henrique
authors.initials: JH
authors.lastname: Pilotto
authors.forename: Sonia Karolina
authors.initials: SK
authors.lastname: Stoszek
authors.forename: Regis
authors.initials: R
authors.lastname: Kreitchmann
authors.forename: Marisa Márcia
authors.initials: MM
authors.lastname: Mussi-Pinhata
authors.forename: Victor Hugo
authors.initials: VH
authors.lastname: Melo
authors.forename: Esaú Custodio
authors.initials: EC
authors.lastname: João
authors.forename: Mariana
authors.initials: M
authors.lastname: Ceriotto
authors.forename: Ricardo da Silva de
authors.initials: Rda S
authors.lastname: Souza
authors.forename: Jennifer
authors.initials: J
authors.lastname: Read
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D007231:Infant, Newborn; D061466:Lopinavir; D008297:Male; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000097:blood / Q000188:drug therapy*; D011263:Pregnancy Trimester, Third; D011744:Pyrimidinones / Q000008:administration & dosage / Q000009:adverse effects*; D012307:Risk Factors; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D011744:Pyrimidinones; D061466:Lopinavir; D019438:Ritonavir