title: [Hepatotoxicity in healthy infants exposed to nevirapine during pregnancy].
abstract: BACKGROUND
  The use of nevirapine in HIV-infected pregnant women is discouraged due to its potential to cause hepatotoxicity. There is limited information available on the toxicity in non-HIV infected newborn exposed to this drug during pregnancy. The aim of the study is to determine the extent of hepatotoxicity in the newborn exposed to nevirapine and HIV during pregnancy.
  
  
  METHODS
  A cross-sectional, observational, multicenter study was conducted on a cohort of healthy infants born to HIV-infected mothers, in whom the first determination of alanine aminotransferase (ALT), before 6weeks of age, was collected. Patients were allocated to 2groups according to exposure to nevirapine during pregnancy. Hepatotoxicity was rated according to the AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS).
  
  
  RESULTS
  This study included 160newborns from 159pregnancies (88exposed to nevirapine-based regimens and 71 exposed to protease inhibitors-based therapies). No cases of hepatotoxicity were observed according to the DAIDS Table for Grading. Two cases of ALT above normal values (2.8%; 95%CI: 0.3-9.8%) were observed in patients not exposed to nevirapine, and one case (1.1%; 95%CI: 0.0-6.1%) in the group exposed to nevirapine (P=.585).
  
  
  CONCLUSIONS
  The lack of differences between groups suggests that highly active antiretroviral treatment regimens including nevirapine administered during pregnancy do not involve a higher risk of liver disease compared to other treatment combinations.
authors.affiliation: Unitat de Patologia Infecciosa i Immunodeficiències Pediàtriques, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, España.
authors.forename: Pablo
authors.initials: P
authors.lastname: Iveli
authors.affiliation: Unitat d'Infeccions, Servei de Pediatria, Hospital Universitari Sant Joan de Déu, Universitat de Barcelona, Barcelona, España.
authors.forename: Antoni
authors.initials: A
authors.lastname: Noguera-Julian
authors.affiliation: Unitat de Patologia Infecciosa i Immunodeficiències Pediàtriques, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, España. Electronic address: psoler@vhebron.net.
authors.forename: Pere
authors.initials: P
authors.lastname: Soler-Palacín
authors.affiliation: Unitat de Patologia Infecciosa i Immunodeficiències Pediàtriques, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, España.
authors.forename: Andrea
authors.initials: A
authors.lastname: Martín-Nalda
authors.affiliation: Servei de Pediatria, Hospital Sant Joan de Déu, Xarxa Assistencial Althaia Sant Joan de Déu, Manresa, Barcelona, España.
authors.forename: Núria
authors.initials: N
authors.lastname: Rovira-Girabal
authors.affiliation: Unitat d'Infeccions, Servei de Pediatria, Hospital Universitari Sant Joan de Déu, Universitat de Barcelona, Barcelona, España.
authors.forename: Clàudia
authors.initials: C
authors.lastname: Fortuny-Guasch
authors.affiliation: Unitat de Patologia Infecciosa i Immunodeficiències Pediàtriques, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, España.
authors.forename: Concepció
authors.initials: C
authors.lastname: Figueras-Nadal
mesh_terms: D019380:Anti-HIV Agents / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology*; D003430:Cross-Sectional Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018811:Maternal Exposure / Q000009:adverse effects*; D019829:Nevirapine / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine
keywords: Embarazo; Hepatotoxicidad; Hepatotoxicity; Human immunodeficiency virus; Nevirapina; Nevirapine; Pregnancy; Virus de la inmunodeficiencia humana