Results of a safety trial on single-dose treatments with 400 mcg/kg of ivermectin in bancroftian filariasis.

Two groups of Polynesian Wuchereria bancrofti carriers, 17 females aged 21 to 84 years and 20 males aged 26 to 57 years, in whom microfilaraemia ranged from 1 to 10,121 mf/ml and from 1 to 6,484 mf/ml, respectively, were given a supervised singledose treatment with 400 mcg/kg of ivermectin. Carriers were examined and questioned regarding their experience of adverse reactions, which were graded 0 to 3 according to severity, at 6, 12 and 24 hours and at 4 days after treatment. Biological examinations which included determination of microfilaraemia, complete blood count, liver function tests and assessment of creatinine and urea levels were performed at 4 days before and 4 days after treatment. Adverse reactions were observed in 65% of female and in 70% of male carriers; they were of grade > or = 2 in 35% of carriers in both groups. None as considered serious; they all disappeared in 24-48 hours. The main symptoms were headache, fever > or = 37.5 degrees C and myalgia in females. One male vomited 3 hours after treatment; as a result the drug was not ingested and no decrease of microfilaraemia was noted. Twelve days afterwards, he was given a second 400 mcg/kg dose, he experienced again a grade 1 reaction and his microfilaraemia fell to zero. The 37 carriers in the present study were matched with 37 other Polynesian carriers treated with a 100 mcg/kg single dose of ivermectin in previous trials for pretreatment mf density and sex: no significant difference could be found in adverse reactions between the 2 treatment groups.(ABSTRACT TRUNCATED AT 250 WORDS)