An open label, randomized clinical trial to compare the tolerability and efficacy of ivermectin plus diethylcarbamazine and albendazole vs. diethylcarbamazine plus albendazole for treatment of brugian filariasis in Indonesia

Improved treatments for lymphatic filariasis (LF) could accelerate the global elimination program this disease. A triple drug combination of anti-filarial drugs ivermectin, diethylcarbamazine (DEC) and albendazole (IDA) has been shown to be safe effective achieving sustained clearance microfilariae (Mf) filarial parasite Wuchereria bancrofti from human blood. However, not previously evaluated treatment brugian filariasis, which accounts about 10% LF burden. This hospital-based clinical trial compared safety efficacy IDA with that standard (DEC plus albendazole, DA) in persons Brugia timori infections on Sumba island, Indonesia. Fifty-five asymptomatic B . Mf were treated either a single oral dose (28 subjects) or DEC (DA, 27 subjects). Participants actively monitored adverse events (AE) two days after by nurses physicians who masked regarding assignments. Passive monitoring was performed teams visited participant’s home villages an additional five days. Microfilaremia assessed membrane filtration 1 ml night blood at baseline, 24h one year treatment. more than DA completely clearing 24 hours (25/28, 89% vs. 8/27, 30%, P < 0.001). By 12 months treatment, only recipients had their (4%) 10 25 (40%) (P = 0.002). Approximately 90% participants antibodies recombinant antigen BmR1 baseline. Antibody prevalence decreased approximately 30% both groups months. About 45% experienced AE such as fever, muscle aches, lower back, joint abdominal pain. These mostly mild most common during first No participant severe serious AE. study showed well-tolerated significantly DA. Larger studies should further assess mass administration regimen eliminate filariasis. Trial Registration: NCT02899936