Predictors of relapse of visceral leishmaniasis in inner São Paulo State, Brazil

•Visceral leishmaniasis (VL) is a public health threat for several countries.•In Brazil, VL spread southward from the poorest Northeastern States, and emerged in São Paulo (Brazil most populous and developed state) in the early 2000s. During that expansion, the epidemics of VL and AIDS intertwined.•Despite universal access to healthcare and the expedition of local therapeutic guidelines, the mortality and relapse rates of VL remain high in Brazil.•We studied a nonconcurrent cohort of 571 subjects who successfully completed VL therapy in Bauru, inner São Paulo State, Brazil. The cohort was followed for 24 months in order to identify the incidence and predictors of relapse.•Relapses occurred in 6.8% of treated subjects (4.5% of mono-infected and 23.7% of HIV-coinfected subjects).•In multivariable Cox regression models, relapse was associated with HIV-Coinfection, the presence of lower limb edema and low platelet count upon admission, and secondary pneumonia. There was no significant association with the therapy (Antimoniate or Liposomal Amphotericin). Visceral leishmaniasis (VL) is a public health threat for several tropical countries, including Brazil. Therapy failures and relapses aggravate VL morbidity and mortality. Our study aimed at identifying predictors of relapse and thus contributes to directing therapeutic options and patient follow-up. A nonconcurrent cohort of 571 subjects who completed successful therapy for VL in the city of Bauru, São Paulo State, Brazil, was followed for 24 months in order to identify the incidence and predictors of relapse. Extensive review of medical charts and laboratory files was conducted. Univariate and multivariable Cox regression models were used to identify predictors for the outcome of interest. A hierarchical strategy was used for variable selection in multivariable models. Relapses occurred in 6.8% of treated subjects, after a median of 6 months (interquartile range, 4–9). In a comprehensive multivariable model, relapse was associated with: HIV-coinfection (hazard ratio [HR], 7.47; 95% confidence interval [CI], 2.58–21.55); the presence of lower limb edema (HR, 6.06; 95%CI, 1.38–26.77) and low platelet count upon admission (HR for platelet count × 1000, 0.99; 95%CI, 0.98–0.99) ; and secondary pneumonia (HR, 5.49; 95%CI, 1.49–20.18). On the other hand, therapy with Liposomal Amphotericin (as opposed to Antimoniate) was not independently associated with relapse (HR, 5.97; 95%CI, 0.63–56.29). Besides reinforcing the