Treatment of Visceral Leishmaniasis in HIV Co-Infected Patients in East Africa and South-East Asia

Publication Date: June 6, 2022
Last Updated: July 5, 2022

WHO recommendations on treatment of visceral leishmaniasis in HIV co-infected patients

Visceral Leishmaniasis patients with HIV coinfection in East Africa

Liposomal amphotericin B + miltefosine: L-AMB (up to a total of 30 mg/kg, at 5 mg/kg on days 1, 3, 5, 7, 9 and 11) + miltefosine (100 mg/day for 28 days) over L-AMB: L-AMB (up to a total of 40 mg/kg, at 5 mg/kg on days 1-5, 10, 17 and 24). (C, VL)
620

Visceral Leishmaniasis patients with HIV coinfection in South-East Asia

Liposomal amphotericin B + miltefosine: L-AMB (up to a total of 30 mg/kg, at 5 mg/kg on days 1, 3, 5, 7, 9 and 11) + miltefosine (100 mg/day for 14 days) over L-AMB: L-AMB (up to a total of 40 mg/kg, at 5 mg/kg on days 1–4, 8, 10, 17 and 24). (C, VL)
620

Considerations

  • Determine the HIV status of patients diagnosed with VL. Routinely screen for tuberculosis at visceral leishmaniasis diagnosis and follow-up.
  • In patients who do not show a good clinical response, after ruling out other diagnoses, consider providing extended therapy (one repetition of the same therapy, based on evidence from trials in Ethiopia).
  • When miltefosine is not available, consider using monotherapy with L-AMB (up to a total of 40 mg/kg) as per the L-AMB regimen.
  • Provide comprehensive clinical management, including adequate HIV treatment and nutritional support.
  • Ensure access to contraception and pregnancy testing for women of child-bearing potential before administering miltefosine.

WHO recommendation for secondary prophylaxis after recovery from a first episode of visceral leishmaniasis in HIV co-infected patients

Use secondary prophylaxis after recovery from a first episode of VL in HIV co-infected patients in East Africa. (C, VL)
620
Use secondary prophylaxis after a first episode of VL in HIV co-infected patients in South-East Asia. (C, VL)
620

Remarks

  • Secondary prophylaxis is recommended in particular for patients at high risk of relapse (e.g., patients not on ART, with a low CD4 cell count (< 200 cells/mm3), multiple previous VL episodes, failure to achieve clinical or parasitological cure during the first episode of VL, no increase in CD4 cell count at follow-up). Patients should be evaluated case by case.
  • As the recommendation for secondary prophylaxis applies specifically to HIV-positive individuals, it is important to determine the HIV status of patients diagnosed with VL.
  • In East Africa: pentamidine isethionate at 4 mg/kg per day [300 mg for an adult]) every 3–4 weeks. In South-East Asia: amphotericin B deoxycholate at 1 mg/kg every 3–4 weeks or Liposomal amphotericin B (L-AMB) at 3–5 mg/kg per day every 3–4 weeks
  • Prophylaxis can be stopped if the CD4 cell count is maintained at or > 350 cells/mm3 or the HIV viral load is undetectable for at least 6 months and there is no clinical evidence of VL relapse.
  • When choosing a drug for secondary prophylaxis, consider: using drugs that were not used to treat the primary VL episode, the benefits and safety profiles of the proposed drug, potential collateral benefits in terms of prevention of other infections, and potential drug resistance.

Considerations

For both recommendations, people who manage VL in HIV co-infected patients are urged to:
  • Improve access to HIV testing for all patients with VL.
  • Ensure uninterrupted, free access to quality-assured medicines.
  • Ensure appropriate access to health-care services at the lowest possible direct and indirect cost.
  • Extend the supplier base of antileishmanial diagnostic tests and medicines.
  • Strengthen the relevant health infrastructure and human resource capacity.
  • Improve coordination among HIV, VL and related programmes, such as for pharmacovigilance, TB and vector control.

Recommendation Grading

Overview

Title

Treatment of Visceral Leishmaniasis in HIV Co-Infected Patients in East Africa and South-East Asia

Authoring Organization

World Health Organization

Publication Month/Year

June 6, 2022

Last Updated Month/Year

April 1, 2024

Document Type

Guideline

Country of Publication

US

Document Objectives

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.

Inclusion Criteria

Male, Female, Adult, Older adult

Health Care Settings

Ambulatory, Hospital, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Treatment, Management

Diseases/Conditions (MeSH)

D006678 - HIV, D007896 - Leishmaniasis, D007898 - Leishmaniasis, Visceral

Keywords

leishmaniasis, HIV infections, HIV/AIDS, HIV, HIV-1, visceral leishmaniasis, co-infections

Source Citation

WHO guideline for the treatment of visceral leishmaniasis in HIV co-infected patients in East Africa and South-East Asia [Internet]. Geneva: World Health Organization; 2022. PMID: 35763584.

Supplemental Methodology Resources

Systematic Review Document, Evidence Tables

Methodology

Number of Source Documents
88
Literature Search Start Date
October 31, 2011
Literature Search End Date
August 31, 2013