by Musa AM, Mbui J, Mohammed R, Olobo J, Ritmeijer K, Alcoba G, Ouattara GM, Egondi T, Nakanwagi P, Omollo T, Wasunna M, Verrest L, Dorlo TPC, Younis BM, Nour A, Elmukashfi ETA, Haroun AIO, Khalil EAG, Njenga S, Fikre H, Mekonnen T, Mersha D, Sisay K, Sagaki P, Alvar J, Solomos A, Alves F. Clinical Infectious Diseases 2022, 76(3): e1177–e1185. doi: 10.1093/cid/ciac643
Summary: Since 2010, a combination of sodium stibogluconate (SSG) and paromomycin (PM) has been the standard of care for visceral leishmaniasis in Africa – an improvement on previous therapies but still requiring painful twice-daily injections for 17 days and risking potential toxicities associated with SSG. This open-label, Phase III, randomized, controlled trial was conducted in adult and paediatric patients in Ethiopia, Kenya, Sudan, and Uganda to determine whether paromomycin plus miltefosine (PM/MF) is noninferior to SSG/PM for the treatment of primary visceral leishmaniasis in eastern Africa. Patients received either 20 mg/kg PM plus allometric dose of MF for 14 days, or 20 mg/kg SSG plus 15 mg/kg PM for 17 days. The study showed that a PM/MF combination achieved similar cure rates at six months follow-up as the standard of care SSG/PM in adult and paediatric patients with visceral leishmaniasis in Eastern Africa (91.2% and 91.8%, respectively). PM/MF also reduced the risk of subsequent post-kala azar dermal leishmaniasis (PKDL): 20.9% of those treated with SSG/PM went on to develop PKDL versus 4.4% of those treated with PM/MF in Ethiopia and Sudan.