03030nas a2200457   4500000000100000008004100001260001200042653004700054653001800101653001300119653001100132653001600143653001400159100001300173700001300186700001300199700001500212700001200227700001200239700001200251700001200263700001800275700001400293700001300307700001300320700001200333700001200345700001100357700001100368700001100379700001000390700001200400700001200412700001200424245018300436856007900619300000900698490000700707520184400714022001402558       2024                            d  c06/202410aPost-kala-azar dermal leishmaniasis (PKDL)10aSocial Stigma10aEfficacy10aSafety10aElimination10aTreatment1 aSundar S1 aPandey K1 aMondal D1 aMadhukar M1 aTopno R1 aKumar A1 aKumar V1 aVerma D1 aChakravarty J1 aChaubey R1 aKumari P1 aRashid M1 aMaruf S1 aGhosh P1 aRaja S1 aRode J1 aBoer M1 aDas P1 aAlvar J1 aRijal S1 aAlves F00aA phase II, non-comparative randomised trial of two treatments involving liposomal amphotericin B and miltefosine for post-kala-azar dermal leishmaniasis in India and Bangladesh.  uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11189210/pdf/pntd.0012242.pdf  a1-150 v183 a<p><strong>Background: </strong>In Southeast Asia, treatment is recommended for all patients with post-kala-azar dermal leishmaniasis (PKDL). Adherence to the first-line regimen, twelve weeks of miltefosine (MF), is low and ocular toxicity has been observed with this exposure period. We assessed the safety and efficacy of two shorter-course treatments: liposomal amphotericin B (LAmB) alone and combined with MF.</p>

<p><strong>Methodlogy/principal findings: </strong>An open-label, phase II, randomized, parallel-arm, non-comparative trial was conducted in patients with parasitologically confirmed PKDL, 6 to ≤60 years. Patients were assigned to 20 mg/kg LAmB (total dose, in five injections over 15 days) alone or combined with allometric MF (3 weeks). The primary endpoint was definitive cure at 12 months, defined as complete resolution of papular and nodular lesions and &gt;80% re-pigmentation of macular lesions. Definitive cure at 24 months was a secondary efficacy endpoint. 118/126 patients completed the trial. Definitive cure at 12 months was observed in 29% (18/63) patients receiving LAmB and 30% (19/63) receiving LAmB/MF (mITT), increasing to 58% and 66%, respectively, at 24 months. Most lesions had resolved/improved at 12 and 24 months for patients receiving LAmB (90%, 83%) and LAmB/MF (85%, 88%) by qualitative assessment. One death, unrelated to study drugs, was reported; no study drug-related serious adverse events were observed. The most frequent adverse drug reactions were MF-related vomiting and nausea, and LAmB-related hypokalaemia and infusion reactions. Most adverse events were mild; no ocular adverse events occurred.</p>

<p><strong>Conclusions/significance: </strong>Both regimens are suitably safe and efficacious alternatives to long-course MF for PKDL in South Asia.</p>

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