title: Hepatic safety of maraviroc in HIV-1-infected patients with hepatitis C and/or B co-infection. The Maraviroc Cohort Spanish Group.
abstract: BACKGROUND
  Limited data is available regarding the hepatic safety of maraviroc in patients co-infected with HIV and HCV and/or HBV. Our objective was to compare the hepatic safety profile and fibrosis progression in HIV-mono-infected patients and co-infected with HCV and/or HBV treated with maraviroc.
  
  
  METHODS
  Retrospective multicentre cohort study of HIV-infected patients receiving treatment with a maraviroc-containing regimen in 27 hospitals in Spain.
  
  
  RESULTS
  A total of 667 patients were analyzed, of whom 313 were co-infected with HCV (n=282), HBV (n=14), or both (n=17). Maraviroc main indications were salvage therapy (52%) and drug toxicity (20%). Grade 3-4 hypertransaminasaemia (AST/ALT >5 times ULN) per 100 patient-years of maraviroc exposure, was 5.84 (95% CI, 4.04-8.16) and 1.23 (95% CI, 0.56-2.33) in co-infected and HIV-mono-infected patients, respectively (incidence rate ratio, 4.77; 95% CI, 2.35-10.5). However, the degree of aminotransferase abnormalities remained stable throughout the study in both groups, and no significant between-group differences were seen in the cumulative proportion of patients showing an increase in AST/ALT levels greater than 3.5 times baseline levels. No between-group differences were seen in liver fibrosis over time. With a maraviroc median exposure of 20 months (IQR, 12-41), two patients (0.3%) discontinued maraviroc because of grade 4 hepatitis, and other 2 died due to complications associated to end-stage-liver disease.
  
  
  CONCLUSIONS
  Maraviroc-containing regimens showed a low incidence of hepatitis in a large Spanish cohort of HIV-infected patients, including more than 300 patients co-infected with HCV and/or HBV. Co-infection did not influence the maximum liver enzyme level or the fibrosis progression throughout the study.
authors.affiliation: Hospital Universitari Vall d'Hebrón, Universitat Autònoma de Barcelona, Spain; Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain. Electronic address: mcrespo@vhebron.net.
authors.forename: Manuel
authors.initials: M
authors.lastname: Crespo
authors.affiliation: Hospital Universitari Vall d'Hebrón, Universitat Autònoma de Barcelona, Spain; Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Navarro
authors.affiliation: Hospital Ramón y Cajal-IRYCIS, Madrid, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Moreno
authors.affiliation: Hospital Universitario La Princesa, Madrid, Spain.
authors.forename: Jesus
authors.initials: J
authors.lastname: Sanz
authors.affiliation: Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Márquez
authors.affiliation: Hospital Ramón y Cajal-IRYCIS, Madrid, Spain; CIBER Epidemiology and Public Heath, Spain; Barts and the London School of Medicine, Queen Mary University London, UK.
authors.forename: Javier
authors.initials: J
authors.lastname: Zamora
authors.affiliation: Complejo Hospitalario Universitario de Vigo, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Ocampo
authors.affiliation: Hospital Universitario Donostia, San Sebastián, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: Iribaren
authors.affiliation: Hospital Reina Sofía-IMIBIC, Córdoba, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Rivero
authors.affiliation: Hospital Universitari Germans Trias i Pujol, Badalona; Universitat Autònoma de Barcelona, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology / Q000209:etiology*; D060085:Coinfection / Q000150:complications*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D015497:HIV-1; D006509:Hepatitis B / Q000150:complications*; D006526:Hepatitis C / Q000150:complications*; D006801:Humans; D008103:Liver Cirrhosis / Q000209:etiology*; D008297:Male; D000077592:Maraviroc / Q000009:adverse effects* / Q000627:therapeutic use; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D013030:Spain / Q000453:epidemiology
chemical_list: D019380:Anti-HIV Agents; D000077592:Maraviroc
keywords: Co-infection; Coinfección; Fibrosis hepática; HBV; HCV; HIV; Hepatitis; Liver fibrosis; Maraviroc; VHB; VHC; VIH