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Efficacy of miltefosine declined for visceral leishmaniasis in India
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The failure rate of miltefosine for the treatment of visceral leishmaniasis in India has increased significantly since the drug was approved in 2002.
“After only a few years of deployment in the field, the relapse rate for miltefosine has doubled and we have data to suggest that there is increased tolerance of miltefosine in clinical isolates,” Shyam Sundar, MD, professor of medicine at Banaras Hindu University in India, told Infectious Disease News. “For most neglected infectious diseases, where the tools are limited, proper preparation of the field is mandatory.”
Sundar and colleagues conducted an open-label noncomparative study, which included 567 patients who received oral miltefosine for visceral leishmaniasis. Patients who weighed less than 25 kg received a 50 mg dose and patients who weight 25 kg or more received 100 mg in divided doses. Children aged less than 12 years received 2.5 mg per kg. The patients received the medicine daily for 28 days and were followed up for 6 months.
The initial cure rate was 97.5% at the end of treatment. During follow-up, 39 patients relapsed and three patients died. Two of the deaths were related to drug toxicity. After 6 months of follow up, the cure rate was 90.3%. The most frequent adverse effect was gastrointestinal intolerance, which occurred in 64.5% of the study group. Nine patients experienced drug interruptions due to adverse effects.
The researchers noted that the cure rate observed was significantly less than the 94% cure rate observed during the phase 3 trial of the drug in 1999-2000. In addition, the relapse rate doubled from 3% to 6.8%.
“Now that better options are available, such as single-dose amphotericin B (AmBisome, Astellas) and short-course combination treatment, the treatment strategy should change and miltefosine monotherapy should be replaced by these better options,” Sundar said.
References:
Sundar S. Clin Infect Dis. 2012;55:543-550.
Disclosures:
Dr. Sundar has reported financial relationships with GlaxoSmithKline, Institute for One World Health and Paladin Labs.