Safety and tolerability of intrathecal liposomal amphotericin B (AmBisome) for cryptococcal meningitis: a retrospective study in HIV-infected patients

Abstract

Background: While mortality of HIV-related cryptococcal meningitis (CM) in developed countries is relatively low, in developing countries over half of patients die within 10 weeks. Current recommended therapies are often not suitable for resource-poor settings, and new shorter regimens are urgently needed. Intrathecal administration of liposomal amphotericin B (lAmB) has shown promising results in animal models. However, the safety and tolerability of intrathecal lAmB in humans are not well known. Methods: In this retrospective observational study, we report the tolerability and safety of intrathecal lAmB in patients with CM from an HIV cohort study in India. Results: In all, 18 patients were included in the analysis. Six were female and the median age was 40 years [interquartile range (IQR): 35–45]. The median CD4 count was 42 cells/µl (IQR: 19–127). Compared with a historical control group, the hazard ratio for mortality was 0.59 (95% confidence interval: 0.26–1.29). Two patients complained of transient lumbar pain in single occasion. One patient had a skin reaction to chlorhexidine, which was used as skin disinfectant. After initial improvement, one patient requested to stop lumbar punctures for the last 2 days of treatment. Conclusion: Intrathecal lAmB was safe and well tolerated in HIV-infected patients with CM.