Manuel Crespo1, Jordi Navarro2, Santiago Moreno3, Jesus Sanz4, Manuel Márquez5, Javier Zamora6, Antonio Ocampo7, José A Iribaren8, Antonio Rivero9, Josep M Llibre10. 1. Hospital Universitari Vall d'Hebrón, Universitat Autònoma de Barcelona, Spain; Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain. Electronic address: mcrespo@vhebron.net. 2. Hospital Universitari Vall d'Hebrón, Universitat Autònoma de Barcelona, Spain; Vall d'Hebron Institute of Research (VHIR), Barcelona, Spain. 3. Hospital Ramón y Cajal-IRYCIS, Madrid, Spain. 4. Hospital Universitario La Princesa, Madrid, Spain. 5. Hospital Clínico Universitario Virgen de la Victoria, Málaga, Spain. 6. 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. 7. Complejo Hospitalario Universitario de Vigo, Spain. 8. Hospital Universitario Donostia, San Sebastián, Spain. 9. Hospital Reina Sofía-IMIBIC, Córdoba, Spain. 10. Hospital Universitari Germans Trias i Pujol, Badalona; Universitat Autònoma de Barcelona, Spain.
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.
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-infectedpatients and co-infected with HCV and/or HBV treated with maraviroc. METHODS: Retrospective multicentre cohort study of HIV-infectedpatients 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-infectedpatients, 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-infectedpatients, 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.