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Ivermectin: Observational studies

Among the published studies some have specifically sought to define the pattern of adverse effects. In one such study, although a single dose of the drug was combined in some patients with diethylcarbamazine, the adverse effect pattern was similar to that when ivermectin was used alone. There now seem to be some circumstances in which a single low dose of ivermectin is sufficient to have a prolonged effect, for example in loaiasis a dose of 150 micrograms/kg resulted in a very much reduced level of microfilaria as much as a year later, and seemed to eliminate the infestation entirely in more than half the users. If further work confirms the validity of this approach, the adverse reactions problem may be lessened, since at these doses the few reactions experienced were limited to the skin and joints, although some calabar-like swellings were also noted.

Brugia malayi

In an open study from India 21 asymptomatic microfilaria carriers (with counts of 109-6934/ml of blood) were treated with a single oral dose of ivermectin 400 micrograms/kg and a single oral dose of diethylcarbamazine 6 mg/kg for infection with Brugia malayi. Twelve hours after treatment microfilaria counts fell by 96-100% in all patients and 12 patients had become afilaremic. All had an adverse reaction, lasting up to 48 hours after treatment: fever, myalgia, headache, lethargy, chills, sweating, anorexia, sore throat and pharyngeal congestion, arthralgia, giddiness, nausea and vomiting, abdominal pain, and cough. Postural hypotension, lasting 1 day, was noted in two individuals. Transient dilated and painfully inflamed lymphatic channels, which stood out in cords, were seen in two individuals. Most adverse effects were mild and self-limiting.

Loa loa

The use of ivermectin and its adverse effects in patients infected with Loa loa have been reviewed. It was concluded that ivermectin in a single dose of 150-300 micrograms/kg is effective in reducing microfilaria counts by over 90% with suppressed counts to 25% of pretreatment values after 1 year. An even more sustained effect can be reached by more frequent dosing. There is also some evidence that ivermectin in higher doses (400 micrograms/kg twice yearly) can affect the adult Loa loa. Tolerance to ivermectin is generally excellent, but serious adverse effects, especially encephalopa-thy, can occur, principally in more heavily infected individuals.

Onchocerciasis

The impact of 5 years of annual community treatment with ivermectin on the prevalence of onchocerciasis and onchocerciasis-associated morbidity in the village of Gami (Central African Republic) has been assessed. Pruritus, onchocercal nodules, and impaired vision were all significantly reduced by annual treatment with ivermectin.

In a study of the effect of ivermectin on adult Onchocerca worms the following regimens were compared:

• 150 micrograms/kg yearly (reference group)
• 400 micrograms/kg then 800 micrograms/kg yearly
• 150 micrograms/kg 3-monthly
• 400 micrograms/kg then 800 micrograms/kg 3-monthly

After 3 years of treatment more female worms had died in those who were treated every 3 months than in the reference group; female worms were also less fertile. There was no difference between the two groups of patients who were treated yearly.

There were no serious adverse events, even at high doses. However, subjective complaints of visual disturbances, such as blurred vision, ocular pain, or dyschromatopsia, were more frequent in those who were given 800 micrograms/kg than in those who were given 150 micrograms/kg; the effects lasted less than 1 week. Detailed ocular examination showed no differences between patients from the reference group and the three other groups.

Sarcoptes scabiei

In an uncontrolled open study 101 patients with scabies were treated with a single oral dose of ivermectin 200 micrograms/kg and then followed at 3 days and at 2 and 4 weeks. Two weeks after the start of treatment 89 patients were completely free of scabies, while another three had only mild lesions and pruritus with negative skin scrapings. The other nine patients had persistent pruritus and new lesions and were treated with a second dose, with a complete cure in all cases after 4 weeks.

Twelve patients reported minor adverse effects, consisting of drowsiness, arthralgia and bone aches, dyspnea, headache, nausea, and blurred vision. The adverse effects were mostly reported at the first follow-up and were easily tolerated. Ivermectin appears to be a safe and effective treatment for scabies in a dose of 200 micrograms/kg, although a second dose is necessary for complete cure in a few patients.

An 11-year-old girl developed severe crusted Norwegian scabies. Gamma-benzene hexachlor-ide lotion and topical keratolytics had no significant effect. She was given a single oral dose of ivermectin 6 mg/kg with dramatic effect. The pruritus subsided in 4 hours and the lesions started to clear 2 days later. A second dose of 6 mg was given after 3 weeks when no skin lesions were found anymore. The only adverse effect was some edema of the skin after the first dose, which did not occur after the second dose, suggesting that the reaction was more related to the intensity of the infection then to the effect of the drug itself.

Outbreaks of scabies in elderly people require special management for disease control. Owing to the frequent failure of repeated non-synchronized therapeutic efforts with conventional external antiscabie treatments, special eradication programs are required.

The management of outbreaks of scabies with allethrin, permethrin, and ivermectin has been evaluated. Healthy infested people were treated once simultaneously with an external scabicide, such as allethrin or permethrin; this was effective in 99%. Those with crusted scabies were hospitalized and treated with systemic ivermectin or ivermectin plus permethrin; seven patients received ivermectin twice after an interval of 8 days and one received permethrin three times. Unfortunately, no details of adverse effects were given.

Strongyloidiasis

The efficacy and adverse effects of ivermectin 200 micro-grams/kg, repeated 2 weeks later, have been studied in 50 patients with chronic strongyloidiasis, aged 30-79 years. The eradication rate was 96% at 2 weeks after the first dose and 98% after the second dose. There was no recurrence after follow-up of 4 months. One patient had nausea and vomiting 3 hours after the first dose and again after the second dose, but they were transient and required no therapy. In four patients there were mild laboratory abnormalities (slight increases in liver function tests in two, microscopic hematuria in one, and mild leukopenia and lymphocytosis in one). Of the 50 patients 12 were positive for human T lymphotropic virus type-1.

Wuchereria bancrofti

Early-stage elephantiasis caused by bancroftian filariasis in a 27-year-old traveller was treated with a single-dose oral combination of ivermectin 24 mg plus albendazole 400 mg, followed by albendazole 800 mg for 21 days. To avoid a severe Mazzotti-like reaction, he was given oral glucocorticoids and antihistamines for 3 days. He had a transient rash, pruritus, and mild hypotension on the days after the initial treatment, but otherwise remained well and the swelling subsided. Within 1 month he was free of symptoms. At the last follow-up examination, 3 years after treatment, there was no clinical or laboratory evidence of relapse. The authors thought that this type of treatment should be evaluated on a wider scale, given the minimal adverse events and apparent therapeutic efficacy.

The efficacy of annual mass chemotherapy with a combination of diethylcarbamazine and ivermectin on bancroftian filariasis in rural southern India has been studied, as has the supplementary role of controlling the vector mosquito Culex quinquefasciatus . Nine villages, topographically and ecologically similar but reasonably isolated from each other, were selected and split into three comparable groups of three villages each.

Group A received chemotherapy with diethylcarbamazine at about 6 mg/kg and ivermectin at 400 micro-grams/kg. Group B received chemotherapy and vector control. The most important vector-breeding sites were soakage pits, which were treated with expanded polystyrene beads. Minor vector-breeding sources, such as domestic or irrigation wells, were treated by adding larvae-eating Talapia fish or a commercial insecticide based on Bacillus sphaericus. Group C received no intervention.

After the first round of treatment, combination chemotherapy alone caused a 60% drop in the annual filarial transmission potential, whereas the combined strategy reduced the transmission potential by 96%. After two rounds of treatment, the reduction in transmission potential was similar with the two strategies (about 91-96% reduction), whereas the prevalence of microfilaremia was reduced by 88-92%.

Adverse events after combination therapy were reported in 20% of those who had taken diethylcarbamazine and ivermectin for the first time. The patients with adverse events had increased microfilarial counts. The most common adverse effects were headache (72% of adverse events), giddiness (67%), fever, and weakness. The incidence of adverse events among those taking combination therapy for a second time was relatively low (5.5%).

The adverse events were also less severe in the second round than in the first. When antifilarial treatment was withdrawn in the third and final year of the study, transmission was resumed in the absence of vector control, whereas no infective female mosquitoes were detected in villages with vector control. Vector control, although obviously not cost-effective in the short term, could therefore play an important supplementary role in an integrated program, by preventing re-establishment of transmission after chemotherapy has been completed.

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