Abstract
BackgroundA proportion of all immunocompetent patients treated for visceral leishmaniasis (VL) are known to relapse; however, the risk factors for relapse are not well understood. With the support of the Rajendra Memorial Research Institute (RMRI), Médecins Sans Frontières (MSF) implemented a program in Bihar, India, using intravenous liposomal amphotericin B (Ambisome) as a first-line treatment for VL. The aim of this study was to identify risk factors for VL relapse by examining the characteristics of immunocompetent patients who relapsed following this regimen.Methods and Principal FindingsThis is an observational retrospective cohort study of all VL patients treated by the MSF program from July 2007 to August 2012. Intravenous Ambisome was administered to 8749 patients with VL in four doses of 5 mg/kg (for a total dose of 20 mg/kg) over 4–10 days, depending on the severity of disease. Out of 8588 patients not known to be HIV-positive, 8537 (99.4%) were discharged as initial cures, 24 (0.3%) defaulted, and 27 (0.3%) died during or immediately after treatment. In total, 1.4% (n = 119) of the initial cured patients re-attended the programme with parasitologically confirmed VL relapse, with a median time to relapse of 10.1 months. Male sex, age <5 years and ≥45 years, a decrease in spleen size at time of discharge of ≤0.5 cm/day, and a shorter duration of symptoms prior to seeking treatment were significantly associated with relapse. Spleen size at admission, hemoglobin level, nutritional status, and previous history of relapse were not associated with relapse.ConclusionsThis is the largest cohort of VL patients treated with Ambisome worldwide. The risk factors for relapse included male sex, age <5 and ≥45 years, a smaller decrease in splenomegaly at discharge, and a shorter duration of symptoms prior to seeking treatment. The majority of relapses in this cohort occurred 6–12 months following treatment, suggesting that a 1-year follow-up is appropriate in future studies.
Highlights
Visceral leishmaniasis (VL) is a neglected tropical disease that results in the loss of an estimated 1 million disability-adjusted life years annually in South East Asia [1]; it is typically fatal if untreated
This is the largest cohort of VL patients treated with Ambisome worldwide
Patients diagnosed with VL at the primary health center level who were aged,2 years or .55 years, pregnant or lactating, severely malnourished, had a hemoglobin (Hb) level of,5 g/dL, or had a history of relapse or HIV infection were referred to the district hospital for further assessment
Summary
Visceral leishmaniasis (VL) is a neglected tropical disease that results in the loss of an estimated 1 million disability-adjusted life years annually in South East Asia [1]; it is typically fatal if untreated. Fifty percent of VL cases worldwide occur in India, and up to 90% of these in the state of Bihar. In most studies assessing treatment effectiveness, a proportion of immunocompetent patients relapse following treatment despite negative end-of-treatment test-of-cure results. These relapses occur within 6 months of initial treatment with later recurrence considered rare [7]. A proportion of all immunocompetent patients treated for visceral leishmaniasis (VL) are known to relapse; the risk factors for relapse are not well understood. The aim of this study was to identify risk factors for VL relapse by examining the characteristics of immunocompetent patients who relapsed following this regimen
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