title: Low incidence of severe liver events in HIV patients with and without hepatitis C or B coinfection receiving lopinavir/ritonavir.
abstract: OBJECTIVE
  To analyze the incidence of severe liver events in HIV patients treated with lopinavir/ritonavir and the role of coinfection in the development of this toxicity.
  
  
  METHODS
  This was a retrospective, multicenter, cohort study of all HIV-positive patients who started a regimen of HAART that included lopinavir/ritonavir (LPV/r). The main outcome variable was the emergence of a severe liver event, defined as decompensation of pre-existing chronic liver disease and grade 3-4 hypertransaminasemia (HT), that is, plasma AST or ALT values >5 times above the upper limit of normality, if baseline levels were normal, or >3.5 times the baseline values when they were abnormal.
  
  
  RESULTS
  388 HIV-infected patients were included, with a median follow-up of 25.6 months. Coinfection with HCV was present in 61% of the patients and with HBV in 6.7%. There were 6 cases of severe liver events, all involving patients who were coinfected with HCV and all within the first 6 months. This represents 0.72 events per 100 patient-years (95% confidence interval [CI] 0.36-2.98) and 1.21 events per 100 patient-years (95% CI 0.60-5.86) in coinfected patients. The only factors associated with severe liver events at 6 months were baseline HT and HCV coinfection.
  
  
  CONCLUSIONS
  The incidence of severe hepatic events in HIV-positive patients receiving a HAART regimen including LPV/r was very low, even in coinfected patients. HCV coinfection and baseline HT were the only factors associated with severe liver events. LPV/r can be considered a safe and well-tolerated option in HIV patients with hepatotropic virus coinfections.
authors.affiliation: Hospital Virgen de la Victoria, Málaga.
authors.forename: Rosario
authors.initials: R
authors.lastname: Palacios
authors.forename: Salvador
authors.initials: S
authors.lastname: Vergara
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero
authors.forename: Isabel
authors.initials: I
authors.lastname: Aguilar
authors.forename: Juan
authors.initials: J
authors.lastname: Macías
authors.forename: Angela
authors.initials: A
authors.lastname: Camacho
authors.forename: Fernando
authors.initials: F
authors.lastname: Lozano
authors.forename: Milagros
authors.initials: M
authors.lastname: García-Lázaro
authors.forename: Juan Antonio
authors.initials: JA
authors.lastname: Pineda
authors.forename: Julián
authors.initials: J
authors.lastname: Torre-Cisneros
authors.forename: Manuel
authors.initials: M
authors.lastname: Márquez
authors.forename: Jesús
authors.initials: J
authors.lastname: Santos
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy; D006509:Hepatitis B / Q000150:complications / Q000821:virology; D006526:Hepatitis C / Q000150:complications / Q000821:virology; D006801:Humans; D008107:Liver Diseases / Q000453:epidemiology*; D061466:Lopinavir; D008297:Male; D011744:Pyrimidinones / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D019438:Ritonavir / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D011744:Pyrimidinones; D061466:Lopinavir; D019438:Ritonavir