Hepatic safety of maraviroc in HIV-1-infected patients with hepatitis C and/or B co-infection. The Maraviroc Cohort Spanish Group

Enferm Infecc Microbiol Clin. 2017 Oct;35(8):493-498. doi: 10.1016/j.eimc.2016.02.029. Epub 2016 Apr 6.
[Article in English, Spanish]

Abstract

Introduction: 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.

Keywords: Co-infection; Coinfección; Fibrosis hepática; HBV; HCV; HIV; Hepatitis; Liver fibrosis; Maraviroc; VHB; VHC; VIH.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Adult
  • Anti-HIV Agents / adverse effects*
  • Anti-HIV Agents / therapeutic use
  • Chemical and Drug Induced Liver Injury / epidemiology
  • Chemical and Drug Induced Liver Injury / etiology*
  • Coinfection / complications*
  • Disease Progression
  • Female
  • Follow-Up Studies
  • HIV Infections / complications
  • HIV Infections / drug therapy*
  • HIV-1*
  • Hepatitis B / complications*
  • Hepatitis C / complications*
  • Humans
  • Liver Cirrhosis / etiology*
  • Male
  • Maraviroc / adverse effects*
  • Maraviroc / therapeutic use
  • Middle Aged
  • Proportional Hazards Models
  • Retrospective Studies
  • Spain / epidemiology

Substances

  • Anti-HIV Agents
  • Maraviroc