title: Hepatotoxicity in HIV-infected children and adolescents on antiretroviral therapy.
abstract: OBJECTIVE
  Adverse drug reactions are a significant problem in patients on antiretroviral therapy (ART). We determined liver enzyme elevation frequencies in HIV-infected children and adolescents receiving ART, and their association with risk factors.
  
  
  METHODS
  Cross-sectional study, at the Pediatrics Immunodeficiency Division, University Hospital, Universidade Estadual de Campinas.
  
  
  METHODS
  Medical records of 152 children and adolescents (54.6% male; median age 7.48 years) were analyzed, with a mean of 2.6 liver enzyme determinations per patient. Clinically, patients were classified in categories N (6), A (29), B (78) and C (39). Serum levels of aspartate aminotransferase and alanine aminotransferase were evaluated. Hepatotoxicity was scored as grade 1 (1.1-4.9 times upper limit of normality, ULN), grade 2 (5.0-9.9 times ULN), grade 3 (10.0-15.0 times ULN) and grade 4 (> 15.0 times ULN). To assess hepatotoxicity risk factors, odds ratios (OR) and adjusted odds ratios (aOR) for age, gender, TCD4+ cell count, viral load and medication usage were calculated.
  
  
  RESULTS
  We observed grade 1 hepatotoxicity in 19.7 % (30/152) patients. No cases of grade 2, 3 or 4 were detected. There was a significant association between hepatotoxicity and use of sulfonamides (OR, 3.61; 95% confidence interval (CI), 1.50-8.70; aOR, 3.58; 95% CI, 1.44-8.85) and antituberculous agents (OR, 9.23; 95% CI, 1.60-53.08; aOR, 9.05; 95% CI, 1.48-55.25). No toxicity was associated with ART.
  
  
  CONCLUSIONS
  One fifth of patients experienced mild hepatotoxicity, attributed to antituberculous agents and sulfonamides. Our results suggest that ART was well tolerated.
authors.affiliation: Pediatric Immunodeficiency Division, Faculdade de Ciências Médicas, Universidade Estadual de Campinas, Campinas, São Paulo, Brazil.
authors.forename: Ana Cecília Montes
authors.initials: AC
authors.lastname: Gil
authors.forename: Raquel
authors.initials: R
authors.lastname: Lorenzetti
authors.forename: Gun Bergsten
authors.initials: GB
authors.lastname: Mendes
authors.forename: André Moreno
authors.initials: AM
authors.lastname: Morcillo
authors.forename: Adyléia Aparecida Dalbo Contrera
authors.initials: AA
authors.lastname: Toro
authors.forename: Marcos Tadeu Nolasco da
authors.initials: MT
authors.lastname: Silva
authors.forename: Maria Marluce dos Santos
authors.initials: MM
authors.lastname: Vilela
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000097:blood; D056486:Chemical and Drug Induced Liver Injury / Q000201:enzymology / Q000209:etiology*; D002648:Child; D004812:Epidemiologic Methods; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006526:Hepatitis C / Q000139:chemically induced / Q000201:enzymology; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000201:enzymology; D008297:Male; D019562:Viral Load
chemical_list: D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase