title: Five-year retrospective Italian multicenter study of visceral leishmaniasis treatment.
abstract: The treatment of visceral leishmaniasis (VL) is poorly standardized in Italy in spite of the existing evidence. All consecutive patients with VL admitted at 15 Italian centers as inpatients or outpatients between January 2004 and December 2008 were retrospectively considered; outcome data at 1 year after treatment were obtained for all but 1 patient. Demographic characteristics, underlying diseases, diagnostic procedures, treatment regimens and outcomes, as well as side effects were recorded. A confirmed diagnosis of VL was reported for 166 patients: 120 (72.3%) immunocompetent, 21 (12.6%) patients with immune deficiencies other than HIV infection, and 25 (15.1%) coinfected with HIV. Liposomal amphotericin B (L-AmB) was the drug almost universally used for treatment, administered to 153 (92.2%) patients. Thirty-seven different regimens, including L-AmB were used. The mean doses were 29.4 ± 7.9 mg/kg in immunocompetent patients, 32.9 ± 8.6 mg/kg in patients with non-HIV-related immunodeficiencies, and 40.8 ± 6.7 mg/kg in HIV-infected patients (P < 0.001). The mean numbers of infusion days were 7.8 ± 3.1 in immunocompetent patients, 9.6 ± 3.9 in non-HIV-immunodeficient patients, and 12.0 ± 3.4 in HIV-infected patients (P < 0.001). Mild and reversible adverse events were observed in 12.2% of cases. Responsive patients were 154 (93.3%). Successes were 98.4% among immunocompetent patients, 90.5% among non-HIV-immunodeficient patients, and 72.0% among HIV-infected patients. Among predictors of primary response to treatment, HIV infection and age held independent associations in the final multivariate models, whereas the doses and duration of L-AmB treatment were not significantly associated. Longer treatments and higher doses of L-AmB were not able to significantly modify treatment outcomes either in the immunocompetent or in the immunocompromised population.
authors.affiliation: Division of Infectious Diseases, Pescara General Hospital, Pescara, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Masi
authors.forename: Tamara
authors.initials: T
authors.lastname: Ursini
authors.forename: Maria Donata
authors.initials: MD
authors.lastname: Iannece
authors.forename: Leonardo
authors.initials: L
authors.lastname: Chianura
authors.forename: Francesco
authors.initials: F
authors.lastname: Baldasso
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Foti
authors.forename: Pietro
authors.initials: P
authors.lastname: Di Gregorio
authors.forename: Angelo
authors.initials: A
authors.lastname: Casabianca
authors.forename: Nunzio
authors.initials: N
authors.lastname: Storaci
authors.forename: Luciano
authors.initials: L
authors.lastname: Nigro
authors.forename: Claudia
authors.initials: C
authors.lastname: Colomba
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Marazzi
authors.forename: Giovanni
authors.initials: G
authors.lastname: Todaro
authors.forename: Giacinta
authors.initials: G
authors.lastname: Tordini
authors.forename: Giacomo
authors.initials: G
authors.lastname: Zanelli
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cenderello
authors.forename: Nicola
authors.initials: N
authors.lastname: Acone
authors.forename: Ennio
authors.initials: E
authors.lastname: Polilli
authors.forename: Simona
authors.initials: S
authors.lastname: Migliore
authors.forename: Paolo
authors.initials: P
authors.lastname: Almi
authors.forename: Eligio
authors.initials: E
authors.lastname: Pizzigallo
authors.forename: Evangelista
authors.initials: E
authors.lastname: Sagnelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Mazzotta
authors.forename: Rosario
authors.initials: R
authors.lastname: Russo
authors.forename: Lamberto
authors.initials: L
authors.lastname: Manzoli
authors.forename: Giustino
authors.initials: G
authors.lastname: Parruti
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000666:Amphotericin B / Q000627:therapeutic use; D000981:Antiprotozoal Agents / Q000627:therapeutic use; D002648:Child; D005260:Female; D006801:Humans; D007558:Italy; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B