A trial of a triple-drug treatment for lymphatic filariasis

Christopher L. King, James Suamani, Nelly Sanuku, Yao Chieh Cheng, Samson Satofan, Brooke Mancuso, Charles W. Goss, Leanne J. Robinson, Peter M. Siba, Gary J. Weil, James W. Kazura

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Abstract

BACKGROUND: The World Health Organization has targeted lymphatic filariasis for global elimination by 2020 with a strategy of mass drug administration. This trial tested whether a single dose of a three-drug regimen of ivermectin plus diethylcarbamazine plus albendazole results in a greater sustained clearance of microfilariae than a single dose of a two-drug regimen of diethylcarbamazine plus albendazole and is noninferior to the two-drug regimen administered once a year for 3 years. METHODS: In a randomized, controlled trial involving adults from Papua New Guinea with Wuchereria bancrofti microfilaremia, we assigned 182 participants to receive a single dose of the three-drug regimen (60 participants), a single dose of the two-drug regimen (61 participants), or the two-drug regimen once a year for 3 years (61 participants). Clearance of microfilariae from the blood was measured at 12, 24, and 36 months after trial initiation. RESULTS: The three-drug regimen cleared microfilaremia in 55 of 57 participants (96%) at 12 months, in 52 of 54 participants (96%) at 24 months, and in 55 of 57 participants (96%) at 36 months. A single dose of the two-drug regimen cleared microfilaremia in 18 of 56 participants (32%) at 12 months, in 31 of 55 participants (56%) at 24 months, and in 43 of 52 participants (83%) at 36 months (P=0.02 for the three-drug regimen vs. a single dose of the two-drug regimen at 36 months). The two-drug regimen administered once a year for 3 years cleared microfilaremia in 20 of 59 participants (34%) at 12 months, in 42 of 56 participants (75%) at 24 months, and in 51 of 52 participants (98%) at 36 months (P=0.004 for noninferiority of the three-drug regimen vs. the two-drug regimen administered once a year for 3 years at 36 months). Moderate adverse events were more common in the group that received the three-drug regimen than in the combined two-drug-regimen groups (27% vs. 5%, P<0.001). There were no serious adverse events. CONCLUSIONS: The three-drug regimen induced clearance of microfilariae from the blood for 3 years in almost all participants who received the treatment and was superior to the two-drug regimen administered once and noninferior to the two-drug regimen administered once a year for 3 years.

Original languageEnglish
Pages (from-to)1801-1810
Number of pages10
JournalNew England Journal of Medicine
Volume379
Issue number19
DOIs
StatePublished - Nov 8 2018
Externally publishedYes

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    King, C. L., Suamani, J., Sanuku, N., Cheng, Y. C., Satofan, S., Mancuso, B., Goss, C. W., Robinson, L. J., Siba, P. M., Weil, G. J., & Kazura, J. W. (2018). A trial of a triple-drug treatment for lymphatic filariasis. New England Journal of Medicine, 379(19), 1801-1810. https://doi.org/10.1056/NEJMoa1706854