title: Atazanavir and lopinavir profile in pregnant women with HIV: tolerability, activity and pregnancy outcomes in an observational national study.
abstract: BACKGROUND
  Atazanavir and lopinavir represent the main HIV protease inhibitors recommended in pregnancy, but comparative data in pregnant women are limited.
  
  
  METHODS
  Women from a national observational study, exposed in pregnancy to either atazanavir or lopinavir, were compared for glucose and lipid profiles, liver function tests, CD4 count, HIV RNA and main pregnancy outcomes. Statistical methods included univariate and multivariable analyses.
  
  
  RESULTS
  The study population included 428 pregnancies (lopinavir, 322; atazanavir, 106). The lopinavir group was characterized by higher rates of HIV diagnosis in pregnancy and treatment indication for maternal health, lower CD4 counts, higher HIV RNA levels, less frequent antiretroviral treatment at conception and shorter duration of drug exposure during pregnancy. No differences in pregnancy outcomes, glucose metabolism and weight gain were observed. The two groups also showed in a multivariable analysis similar odds for detectable HIV RNA in the third trimester (adjusted OR 0.85, 95% CI 0.35-2.10, P = 0.730). Total lipid levels were significantly higher in the lopinavir group (median values in the third trimester 239 versus 221 mg/dL for total cholesterol and 226 versus 181 mg/dL for triglycerides; P < 0.001 for both comparisons) and bilirubin levels were significantly higher in the atazanavir group (1.53 versus 0.46 mg/dL, P < 0.001).
  
  
  CONCLUSIONS
  In this observational study atazanavir and lopinavir showed similar safety and activity in pregnancy, with no differences in the main pregnancy outcomes. Atazanavir use was associated with a better lipid profile and with higher bilirubin levels. Overall, the study findings confirm that these two HIV protease inhibitors represent equally valid alternative options.
authors.affiliation: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Floridia
authors.forename: Marina
authors.initials: M
authors.lastname: Ravizza
authors.forename: Giulia
authors.initials: G
authors.lastname: Masuelli
authors.forename: Vania
authors.initials: V
authors.lastname: Giacomet
authors.forename: Pasquale
authors.initials: P
authors.lastname: Martinelli
authors.forename: Anna
authors.initials: A
authors.lastname: Degli Antoni
authors.forename: Arsenio
authors.initials: A
authors.lastname: Spinillo
authors.forename: Marta
authors.initials: M
authors.lastname: Fiscon
authors.forename: Daniela
authors.initials: D
authors.lastname: Francisci
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Liuzzi
authors.forename: Carmela
authors.initials: C
authors.lastname: Pinnetti
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Marconi
authors.forename: Enrica
authors.initials: E
authors.lastname: Tamburrini
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000069446:Atazanavir Sulfate; D018791:CD4 Lymphocyte Count; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008055:Lipids / Q000097:blood; D008111:Liver Function Tests; D061466:Lopinavir / Q000008:administration & dosage* / Q000009:adverse effects; D009842:Oligopeptides / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011256:Pregnancy Outcome; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D012367:RNA, Viral / Q000097:blood; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D008055:Lipids; D009842:Oligopeptides; D011725:Pyridines; D012367:RNA, Viral; D061466:Lopinavir; D000069446:Atazanavir Sulfate
keywords: HIV RNA; bilirubin; cholesterol; pre-term delivery; triglycerides