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Summary

Background  Post-kala-azar dermal leishmaniasis (PKDL) constitutes a parasite reservoir important in the transmission of visceral leishmaniasis (VL). Unacceptable treatment regimens and increasing drug resistance blight control programmes. The success of oral miltefosine in VL prompted a clinical, histopathological and parasitological study of this drug in PKDL.

Objectives  To define the dose and duration of miltefosine for treatment of PKDL.

Methods  Twenty-six patients confirmed by slit-skin smear, histopathology and molecular tests were enrolled in the study. They received miltefosine capsules 50 mg thrice daily after food. Treatment was for 60 days with a provision to increase by 30 days if a responder had not attained a cure. Cure was ascertained by clinical and histopathological examination, and measuring parasite burden using real-time polymerase chain reaction.

Results  Twenty-four patients with a wide range of parasite burden completed the study. Twenty-three achieved a cure giving an initial cure rate of 96% (95% confidence interval 79–99%). Sixteen patients were cured with 50 mg thrice daily, 13 in 60 days and three within 90 days. In seven cases, miltefosine had to be reduced, because of gastrointestinal intolerance, to 50 mg twice daily to a total of 180 capsules. Lesional parasites were undetectable at 1 month post-treatment. Treatment was safe with no relapses at 1-year follow-up.

Conclusion  Oral miltefosine, 50 mg thrice daily for 60 days or twice daily for 90 days, could be an effective treatment for PKDL.