title: Liver Toxicity of Current Antiretroviral Regimens in HIV-Infected Patients with Chronic Viral Hepatitis in a Real-Life Setting: The HEPAVIR SEG-HEP Cohort.
abstract: OBJECTIVE
  To assess the current frequency of ART-associated grade 3-4 transaminase elevations (TE) and grade 4 total bilirubin elevations (TBE) in HIV-infected patients with chronic hepatitis B and/or C, who start a new regimen of ART.
  
  
  METHODS
  A total of 192 pre-treated or treatment-naive HIV infected patients with HBV and/or HCV-coinfection who started ART in eight Southern Spanish centers from July/2011-December/2013, were followed for 12 months in this prospective study.
  
  
  RESULTS
  Forty-one (21.4%) subjects had been naïve to ART, median (IQR) follow-up was 11.6 (5.6-12.9) months. The most frequently initiated NRTI were tenofovir/emtricitabine [49 patients (25.5%)]. Eighty-nine (46.4%) patients started a ritonavir-boosted protease inhibitor and 77 (40.1%) individuals a NNRTI. Raltegravir and maraviroc were initiated in 24 (12.5%) and 9 (4.7%) individuals. Ten [5.21%; 95% confidence interval (CI): 2.53%-9.37%] patients presented grade 3 TE, while 8 (4.17%; 95%CI: 1.82%-8.04%) subjects showed grade 4 TBE. No episodes of grade 4 TE or ART discontinuation due to hepatotoxic events were observed. The use of ritonavir-boosted atazanavir was the only independent predictor for grade 4 TBE [adjusted odds ratio: 7.327 (95%CI: 1.417-37.89); p = 0.018] in an analysis adjusted for age, sex and baseline HIV-RNA levels, while no factor could be independently associated with grade 3-4 TE.
  
  
  CONCLUSIONS
  Currently, the frequency of severe ART-associated TE and TBE under real-life conditions in patients with chronic viral hepatitis is similar to what has been reported previously. However, episodes of grade 4 TE are less frequent and severe TE appears to be of lesser concern.
authors: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.|Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain.
authors: Karin
authors: K
authors: Neukam
authors: Internal Medicine Service, Hospital Universitario de Valme, Seville, Spain.
authors: José A
authors: JA
authors: Mira
authors: Internal Medicine Department, Hospital Torrecárdenas, Almeria, Spain.
authors: Antonio
authors: A
authors: Collado
authors: Internal Medicine Department, Hospital Torrecárdenas, Almeria, Spain.
authors: Antonio
authors: A
authors: Rivero-Juárez
authors: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.|Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain.
authors: Patricia
authors: P
authors: Monje-Agudo
authors: Unit of Infectious Diseases, Hospital Universitario Virgen de la Victoria, Malaga, Spain.
authors: Josefa
authors: J
authors: Ruiz-Morales
authors: Unit of Infectious Diseases, Hospital Universitario Virgen de la Macarena, Seville, Spain.
authors: María José
authors: MJ
authors: Ríos
authors: Internal Medicine Service, Hospital Juan Ramón Jiménez. Huelva, Spain.
authors: Dolores
authors: D
authors: Merino
authors: Unit of Infectious Diseases, Hospital de La Línea de la Concepción, Cadiz, Spain.
authors: Francisco
authors: F
authors: Téllez
authors: Unit of Tropical Medicine, Hospital Poniente, El Ejido, Spain.
authors: Inés
authors: I
authors: Pérez-Camacho
authors: Internal Medicine Department, Hospital Torrecárdenas, Almeria, Spain.
authors: María Carmen
authors: MC
authors: Gálvez-Contreras
authors: Unit of Infectious Diseases, Hospital Universitario Reina Sofia, Maimonides Institute for Biomedical Research (IMIBIC), University of Cordoba, Cordoba, Spain.
authors: Antonio
authors: A
authors: Rivero
authors: Unit of Infectious Diseases and Microbiology, Hospital Universitario de Valme, Seville, Spain.
authors: Juan A
authors: JA
authors: Pineda
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001663:Bilirubin / Q000378:metabolism; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy*; D019694:Hepatitis B, Chronic / Q000150:complications* / Q000378:metabolism; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000378:metabolism; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D000637:Transaminases / Q000378:metabolism
chemical_list: D019380:Anti-HIV Agents; D000637:Transaminases; D001663:Bilirubin