Treatment of Visceral Leishmaniasis in Italy: A Five Year Retrospective Multicentric Study

Background In Italy, Visceral Leishmaniasis (VL) is a rare but still relevant disease, whose treatment is still poorly standardized, in spite of the existing evidence. Methods All consecutive patients with VL admitted at 15 Italian centers as inpatients or outpatients were retrospectively considered between January 2004 and December 2008. Demographic characteristics, underlying diseases, diagnostic procedures, treatment regimens and outcomes, as well as side effects were recorded. Results A confirmed diagnosis of VL was reported for 166 patients (145 of European Descent). Cases decreased among immunocompetent hosts across study years (from 41 in 2004 to 13 in 2008). Liposomal Amphotericin B (L-AmB) was the drug almost universally used for treatment. It was administered to 153 (92.2%) patients. Twenty-three different regimens including L-AmB were used, with mean cumulative doses of 40.8±6.7 mg/Kg in HIV-infected patients and 29.5±8.0 mg/Kg in the others (p <0.001). Mild and reversible adverse events were observed in 12.2% of patients. Responsive patients were 148 (89,7%). Among predictors of unfavorable outcome, HIV infection and age held independent association in the final multivariate models, whereas doses and duration of L-AmB treatment were not significantly associated. Conclusions HIV co-infection and, to a lesser extent, older age predicted treatment failure among Italian patients diagnosed with VL in recent years. Longer treatments and higher doses of L-AmB were not able to significantly modify treatment outcomes neither in the immunocompetent nor in the immunocompromised population. Cases of VL decreased in immunocompetent hosts during the study period, a potentially relevant observation deserving further confirmation.