Efficacy of Posaconazole Prophylaxis in Patients with Acute Myeloid Leukemia Undergoing Induction Chemotherapy: An Observational Study in Resource Limited Settings.

Large randomized controlled trials have shown significant decrease in incidence of invasive fungal infection in acute myeloid leukemia patients with Posaconazole prophylaxis. However, very less is known about value of Posaconazole prophylaxis in resource limited settings. This observational cohort study evaluated the incidence of fungal infection in patients with hematological malignancies undergoing induction chemotherapy with Posaconazole as antifungal prophylaxis and was compared with historical controls who received Fluconazole as fungal prophylaxis. The study was conducted from Oct 2013 to July 2015 in Department of Hematology of a tertiary care center. Fifty-three patients of acute myeloid leukemia on Posaconazole as fungal prophylaxis and 53 historical controls on Fluconazole as fungal prophylaxis were included for final analysis. Baseline characteristics were well matched between groups. Patients on Fluconazole were more likely to experience breakthrough IFDs (28.3 and 11.3%; p = 0.028) than in patients receiving Posaconazole prophylaxis. No significant difference was observed in overall, attributable mortality or in shift to first line antifungal. Both Posaconazole and Fluconazole were well tolerated with no major adverse effects requiring discontinuation of the drug. Minor side effects were seen in 39 and 47% patients in study and control group respectively. Vomiting and nausea were the commonest side effects seen in both study and control group (26 vs. 34% and 38 vs. 40% of patients, respectively). The results of our study in patients with acute myeloid leukemia provide evidence that Posaconazole prophylaxis significantly decreases the incidence of fungal infection and is well tolerated.