Clinical Infectious Diseases Advance Access published May 31, 2012

MAJOR ARTICLE

Efficacy of Miltefosine in the Treatment of Visceral Leishmaniasis in India After a Decade of Use Shyam Sundar,1,a Anup Singh,1,a Madhukar Rai,1 Vijay K. Prajapati,1 Avinash K. Singh,1 Bart Ostyn,2 Marleen Boelaert,2 Jean-Claude Dujardin,2,3 and Jaya Chakravarty1 1

Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India; and 2Institute of Tropical Medicine, and Department of Biomedical Sciences, Antwerp University, Antwerp, Belgium

3

Background. Miltefosine is the only oral drug available for treatment of Indian visceral leishmaniasis (VL), which was shown to have an efficacy of 94% in a phase III trial in the Indian subcontinent. Its unrestricted use has raised concern about its continued effectiveness. This study evaluates the efficacy and safety of miltefosine for the treatment of VL after a decade of use in India. Methods. An open-label, noncomparative study was performed in which 567 patients received oral miltefosine (50 mg for patients weighing