Background: Drug regimens with better efficacy than that of the current regimen (diethylcarbamazine and albendazole - DA) used in mass drug administration(MDA) for lymphatic filariasis (LF) can accelerate the progress to elimination. This study was evaluated the safety, efficacy, effectiveness and community acceptability of a newer triple drug regimen(ivermectin, diethylcarbamazine and albendazole-IDA) for LF elimination.

Methods: This two arm open label community study was conducted in selected LF endemic villages of Yadgir, Karnataka as part of the multi-country study (India, Indonesia, Haiti, Papua New Guinea and Fiji). Study villages were block randomized to either arm. Participants were tested for filarial antigenemia and microfilaraemia and subsequently MDA was conducted. Participants were followed up for adverse events (AEs). Acceptability of MDA was assessed by a community survey( proforma, focus group discussions, in-depth interviews). Infected individuals were re-tested after an year for efficacy assessment. A community prevalence survey was done for assessment of effectiveness.

Results: 4758 participants received IDA; 4160, DA. Baseline antigenemia and microfilaraemia rate was 26.4% and 6.8% in IDA arm and 24.2% and 6.2%  in DA arm. AEs  rates were 8% in  IDA arm and 6.2% in DA arm(P<0.05). All the AEs resolved with symptomatic treatment. There were no serious AEs. AEs were significantly more common in persons with filarial infection. Complete clearance of Mf was observed in 84%  and 62% of MF positives in IDA arm and DA arm respectively(P<0.05). Community Mf prevalence reduced from 6.8% to 3.5% in IDA arm and 6.2 to 5.4% in DA arm(P<0.05).  Mean acceptability score of treatment was 27 and 26 in IDA and DA arms respectively, well above the acceptable critical level of 18.