title: Liver toxicity after switching or simplifying to nevirapine-based therapy is not related to CD4 cell counts: results of the TOSCANA study.
abstract: OBJECTIVE
  The TOSCANA study aimed to determine the relationship between CD4 cell counts and liver toxicity in patients undergoing treatment simplification or substitution with nevirapine due to the toxicity or poor tolerability of a previous regimen.
  
  
  METHODS
  A retrospective analysis was conducted of patients with prior viral suppression who were switched to nevirapine.
  
  
  RESULTS
  Overall, 221 patients were included, representing 1134.83 patient-years. The median baseline CD4 cell count at the switch was 464 cells/microL, with 75.6% showing high CD4 cell counts (> or =250 cells/microL in women or > or =400 cells/microL in men). Hepatotoxicity, defined as liver aminotransferase levels 5 times above the upper limit of normal, was detected in 6.7% of the participants with high CD4 cell counts and 13.0% in those with low counts. The relative risk was 0.51 (95% CI 0.21-1.25), and the incidence rates were 2.63 and 1.26 per 100 patient-years for the low- and high-count subpopulations, respectively. Liver toxicity was mild, reversible upon discontinuation, and more likely to appear after 6 months of nevirapine therapy.
  
  
  CONCLUSIONS
  Switching to nevirapine was associated with a low incidence of liver toxicity that was unrelated to high CD4 cell counts in patients on prior antiretroviral therapy undergoing simplification or substitution therapy.
authors.affiliation: Hospital Clínico Universitario de Santiago de Compostela, Spain. antonioantela@mundo-r.com
authors.forename: Antonio
authors.initials: A
authors.lastname: Antela
authors.forename: Antonio
authors.initials: A
authors.lastname: Ocampo
authors.forename: Rocío
authors.initials: R
authors.lastname: Gómez
authors.forename: María J
authors.initials: MJ
authors.lastname: López
authors.forename: Ana
authors.initials: A
authors.lastname: Mariño
authors.forename: Elena
authors.initials: E
authors.lastname: Losada
authors.forename: Raúl
authors.initials: R
authors.lastname: Rodríguez
authors.forename: Ricardo
authors.initials: R
authors.lastname: Fernández
authors.forename: Juan C
authors.initials: JC
authors.lastname: Corredoira
authors.forename: Genoveva
authors.initials: G
authors.lastname: Naval
authors.forename: Alfredo
authors.initials: A
authors.lastname: Rodríguez
authors.forename: Celia
authors.initials: C
authors.lastname: Miralles
authors.forename: Arturo
authors.initials: A
authors.lastname: Prieto
authors.lastname: Gevihga Galician HIV Study Group
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001219:Aspartate Aminotransferases / Q000097:blood; D018791:CD4 Lymphocyte Count; D056486:Chemical and Drug Induced Liver Injury / Q000097:blood / Q000209:etiology* / Q000276:immunology / Q000821:virology; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies
chemical_list: D019380:Anti-HIV Agents; D019829:Nevirapine; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase