A randomized trial of AmBisome® monotherapy and AmBisome® and miltefosine combination to treat visceral leishmaniasis in HIV co-infected patients in Ethiopia

by Diro E, Blesson S, Edwards T, Ritmeijer K, Fikre H, Admassu H, Kibret A, Ellis S, Bardonneau C, Zijlstra EE, Soipei P, Mutinda BOmollo R, Kimutai R, Omwalo G, Wasunna M, Tadesse F, Alves F, Strub-Wourgaft N, Hailu A, Alexander N, Alvar JPLOS Neglected Tropical Diseases 2019, 13(1): e0006988.

Summary: Visceral Leishmaniasis (VL) is particularly challenging to treat in patients coinfected with human immunodeficiency virus (HIV). Antimonial drugs used in first-line treatments in eastern Africa are more toxic in immunocompromised patients. This trial was designed to assess the efficacy and safety of both the currently internationally recommended treatment of AmBisome® (30 mg/kg) monotherapy and the new AmBisome® (40 mg/kg)-miltefosine (100 mg/day for 28 days) combination regimen, in Ethiopian patients. Patients with clinical improvement but without parasite clearance at day 29 received a second round of the allocated treatment. The extended treatment strategy with the combination regimen showed the highest documented efficacy in HIV-VL patients, supporting recommendation of this regimen as first-line treatment strategy for HIV-VL patients in eastern Africa.

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