Efficacy and Safety of Paromomycin in Treatment of Post-Kala-Azar Dermal Leishmaniasis

Background. Post-kala-azar dermal leishmaniasis (PKDL) plays an important role in maintaining endemicity of visceral leishmaniasis and its transmission. Treatment regimens for PKDL are toxic and require 3-4 months of hospitalization. These long and arduous regimens result in extensive noncompliance. There is an urgent need to develop a safe, effective, and acceptable regimen for the treatment of PKDL. Paromomycin (PM) has been recently approved in India for treatment of visceral leishmaniasis (VL); hence we tested its efficacy in patients with PKDL. Methods. In this exploratory study, 31 patients with PKDL aged 10 years and above were administered PM 11？mg/kg daily intramuscularly for 45？？days and followed up for one year. Results. Out of 31 patients, 7 patients were lost to followup at 1？？year and 9 (37.5%) got cured with complete disappearance of lesion, while 15 (62.5%) showed no improvement by per protocol analysis. Conclusion. Cure rate with 45 intramuscular injections of PM was unacceptably low though there was no serious side effect of the drug. Whether paromomycin can be used in multidrug therapy to shorten the duration of treatment should be the next logical step for investigation. 1. Introduction Post-kala-azar dermal leishmaniasis (PKDL) is a dermal manifestation of Leishmania donovani infection and often follows resolution of clinical visceral leishmaniasis (VL). However, it may also manifest without prior history of VL in a small minority of patients [1]. PKDL is characterized by macular, papular, or nodular lesions or a mixture of them. It is quite common in Sudan (occurring in >50% of patients with VL), where it may occur concurrently or follows immediately after an episode of VL and heals spontaneously in majority of patients [2], whereas in the Indian subcontinent it occurs in 2–20% of patients, 6 months to several years after an episode of VL [3]. In a recent trial the prevalence of confirmed PKDL cases was 4.4 per 10 000 individuals and 7.8 if probable cases were also considered [4]. Several treatment regimens have been recommended for the treatment of PKDL in India, for example, 120 days of parenteral sodium stibogluconate (20？mg/kg body weight) [1] or three courses of 20 daily infusions of amphotericin B with an interval of 20 days in between the courses [5]. These inordinately long parenteral regimens invariably lead to either nonacceptance or poor compliance. In the last decade two new antileishmanial compounds, miltefosine and paromomycin, have been approved for the treatment of VL in India. There is a report about the efficacy