Safety and tolerability of intrathecal liposomal amphotericin

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.

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.

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.

Intrathecal lAmB was safe and well tolerated in HIV-infected patients with CM.