Efficacy of liposomal amphotericin B for treating post-kala-azar dermal leishmaniasis (PKDL): A systematic review and single-arm meta-analysis
Deivyd Vieira Silva Cavalcante, Lilia Maria Lima de Oliveira, Noor Husain, Beatriz Ximenes Mendes, Ana Clara Felix de Farias Santos, Luciana Borrigueiro, Lyria de Oliveira Rosa, Christian Ndikuryayo, Sarah Soares Amorim, Lalit Mohan, Fabiana Castro Porto Silva Lopes
Abstract
Background
Post-kala-azar dermal leishmaniasis (PKDL) is a skin condition that can become a complication in about 15 % of patients who have had kala-azar. Despite its significance, treatment options for PKDL are still limited. This systematic review and meta-analysis aim to evaluate the efficacy of amphotericin B for this condition.
Methods
PubMed, Embase, Cochrane, and Web of Science databases were searched for randomized controlled trials (RCTs) that reported the efficacy of Liposomal Amphotericin B in the treatment of PKDL. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Events per 100 observations with 95 % confidence intervals were performed for outcomes.
Results
Nine studies with 639 patients were included, the treatment durations ranging from 7 to 60 days. The mean age ranged from 9.2 to 31.0 years, and 359 patients were male. The PKDL treatment with liposomal amphotericin B resulted in a cure rate of 91.36 % (95 % CI: 76.60-97.15). However, a relapse was observed in 11.42 % (95 % CI: 6.20-20.8) of patients. Adverse events were common, with hepatic enzyme elevation (ALT/AST) being the most frequent (61.75 %; 95 % CI: 21.81–90.33), followed by fever in 29.93 % of cases (95 % CI: 5.09–77.30). Among the more serious side effects, decreased serum potassium was observed in 19.27 % (95 % CI: 3.84–58.82), and increased serum creatinine, indicative of nephrotoxicity, occurred in 15.08 % (95 % CI: 3.97–43.27). Nausea or vomiting, although less severe, affected 12.36 % of patients (95 % CI: 4.81–28.25).
Conclusions
These findings highlight that while liposomal amphotericin B is a potent therapeutic option for PKDL, its administration requires careful management and clinical vigilance to optimize outcomes and minimize risks.
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Lyria Rosa
12/9/2025
This paper offers a practical synthesis of evidence on liposomal amphotericin B for the treatment of PKDL, a condition that is often underrecognized despite its public health implications. PKDL plays a key role in sustaining transmission, especially in endemic regions that aim for leishmaniasis elimination. As one of the authors, I can say that the strength of this paper lies in translating the data into meaningful estimates of cure, relapse, and toxicity: the high pooled cure rate reinforces why liposomal amphotericin B is often considered the backbone of PKDL therapy, while the documented relapse rates and adverse events are a reminder that this is not a risk-free intervention. The side effects, particularly hepatic and renal, highlight the need for careful monitoring. Overall, this study provides solid evidence base for those working in endemic settings. It also underscores how much more research is still needed to refine treatment regimens that are safer and more accessible for patients with PKDL.