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Paromomycin effective with or without gentamicin in leishmaniasis
Topical paromomycin alone or a combination of paromomycin and gentamicin were both efficacious treatments for cutaneous leishmaniasis caused by Leishmania major, according to data from a study published in The New England Journal of Medicine.
“We predicted that both formulations would have a similar cure rate for L. major in Tunisia,” Col. Max Grögl, division director of experimental therapeutics at Walter Reed Army Institute of Research, told Infectious Disease News. “However, we know that the combination therapy, known as WR 279,396, could hold additional promise for global use since early research showed that it may be effective against the parasitic species found in Central and South America.”
Max Grögl
Grögl and colleagues conducted a randomized, vehicle-controlled phase 3 trial that included 375 patients in Tunisia who had five or fewer lesions caused by leishmaniasis. The patients received a cream that contained 15% paromomycin and 0.5% gentamicin (WR 279,396); a cream that contained only 15% paromomycin; or a cream that had the same base, but neither of the agents. Each lesion was treated once daily for 20 days.
For the WR 279,396 group, the rate of cure for the index lesion was 81% (95% CI, 73-87) and for the paromomycin-alone group, the rate of cure was 82% (95% CI, 74-87). The vehicle-control group had a 58% cure rate (95% CI, 50-67). With the exception of five patients, cure of the index lesion was followed by cure of all other lesions.
Absence of initial improvement by 42 days was the main reason for treatment failure, which was twice as common in the vehicle-control group. In all groups, erythema and skin irritation were present and minute vesicles were more frequent in the active-drug groups compared with the vehicle-control group. Superinfection was more common in the vehicle-control group.
“Current treatments for cutaneous leishmaniasis, antimonials, contain toxic heavy metals that must be administered either intravenously or injected directly into the lesion and because of the toxicity, many health care providers are hesitant to use them to treat the disease,” Grögl said. “With these results, we are on the verge of being able to provide non-toxic and easy-to-use treatments to the people who need them most, including US service members.”
Grögl said 350 million people worldwide are at risk for cutaneous leishmaniasis, and there are 1.5 million new cases annually. In addition, because of the disease’s status as a neglected disease, the FDA has designated WR 279,396 as eligible for fast-track review.