WHO guideline for the treatment of visceral leishmaniasis in HIV co-infected patients in East Africa and South-East Asia  - World Health Organization

Overview

The leishmaniases are a group of diseases caused by Leishmania spp., which occur in cutaneous, mucocutaneous and visceral forms. They are neglected tropical diseases (NTDs), which disproportionately affect marginalized populations who have limited access to health care. HIV co-infected patients with Leishmania infection are highly infectious to sandflies, and an increase in the coinfection rate in an endemic area is likely to increase the effective infective reservoir.

Leishmania and HIV reinforce each other, posing clinical and public health problems. In areas where the endemicity of HIV and Leishmania overlap, people living with HIV are more likely to develop visceral leishmaniasis (VL), possibly due to reactivation of a dormant infection or clinical manifestation after primary infection. VL is an AIDS-defining condition, as HIV and Leishmania both suppress the immune system, resulting in more severe VL disease, higher rates of relapse and treatment failure, more toxicity of drugs and higher mortality rates than from either infection in isolation. Patients characteristically have high disseminated parasite loads. VL negatively affects responses to antiretroviral therapy (ART), and co-infected patients are difficult to cure, especially when their CD4 cell count is < 200 cells/mm³, as they typically relapse.

Leishmania–HIV coinfection was first reported in the mid-1980s in southern Europe and has since been reported in as many as 45 countries.

What's new in these guidelines?

This document describes the management of VL caused by L. donovani in HIV co-infected patients in East Africa and South-East Asia. The recommendations are also applicable to other areas endemic for L. donovani. The guidelines update the recommendations in the report of a meeting of the WHO Expert Committee on the Control of Leishmaniases (WHO Technical Report Series 949) in 2010. Previously, treatment for VL in HIV co-infected patients was based on limited evidence, extrapolated mainly from experience in countries around the Mediterranean Basin, with L. infantum as the main species. As parasite virulence and drug susceptibility differ, the optimal treatment regimens for VL in HIV co-infected patients in areas in which VL is caused by L. donovani (East Africa and South-East Asia) were not known. The few studies conducted in leishmaniasis-endemic regions other than Europe made it difficult to provide clear, region-specific recommendations. These guidelines, based on recent evidence from clinical trials in Ethiopia and India, fill this gap.

Until now, the generic recommendation for treatment of a VL episode in an HIV co-infected patient was first to consider lipid formulations of amphotericin B, infused at a dose of 3–5 mg/kg daily or in 10 intermittent doses (on days 1–5, 10, 17, 24, 31 and 38) to a total dose of 40 mg/kg. Evidence from clinical trials in Ethiopia and India on the efficacy and safety of combination therapy (liposomal amphotericin B (L-AMB) plus miltefosine) to treat VL in HIV co-infected patients instead of monotherapy has offered new possibilities for case management. Some evidence has emerged for considering secondary prophylaxis after the first episode of VL, with pentamidine in Ethiopia and with amphotericin B or its lipid formulation in India.

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