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Ivermectin, a new antifilarial drug and currently the drug of choice for the treatment of onchocerciasis, has been shown to be effective in bancroftian filariasis. We report here, for the first time, the efficacy and safety of the drug in the treatment of filariasis caused by periodic Brugia malayi. Sixty male, asymptomatic microfilaraemics of Alleppey district, Kerala, South India, received single oral doses of ivermectin in a double blind study. Four dosages were used: 20, 50, 100 and 200 micrograms kg-1 body weight. Clearance of microfilariae, which was not complete, began as early as 12 hours post-treatment and was maximal at the end of one month. Microfilaria levels began to rise thereafter and reached 20-50% of pretreatment levels at six months. The two higher doses (100 and 200 micrograms kg-1) were more effective in suppressing microfilaraemia at six months (P < 0.05). After six months, 32 patients were retreated using the same dose of ivermectin that they had received initially. The pattern of clearance was essentially similar to that seen during the first treatment phase and microfilaria levels were 10-35% of pretreatment levels at the end of the next six months. Twenty-eight individuals who were not retreated at six months continued to have increasing levels of microfilariae, reaching 60% of pretreatment levels at the end of the next six months. Side effects (such as fever, headache, myalgia), which were mild to moderate, were seen in most patients and were unrelated to the dose (P > 0.05) or pretreatment levels of microfilariae.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Ivermectin for the treatment of periodic malayan filariasis: a study of efficacy and side effects following a single oral dose and retreatment at six months. 144 75

This three-phase study was designed to compare high dose ivermectin with a standard diethylcarbamazine (DEC) regimen for patient tolerability, potential to kill adult filaria, and duration of microfilarial suppression in 30 Haitian subjects with Wuchereria bancrofti microfilaremia. All were first given a 1-mg oral dose of ivermectin (phase 1) to reduce microfilaria densities. Participants were randomized into three groups: Group 1 received DEC (6mg/kg per day for 12 days), Group 2 received 200 mcg/kg of ivermectin, and Group 3 received 400 mcg/kg of ivermectin (200 mcg/kg per day for 2 days). All drug regimens were well tolerated with few adverse reactions. Most reactions occurred during phase I and consisted primarily of headache, fever, and myalgia. At the end of phase 1, 27 of 30 (90%) patients were microfilaria negative. During phase 2, four of the six men receiving DEC developed scrotal reactions suggesting killing adult worms; no such reactions were noted in 10 men receiving ivermectin (p less than 0.05). At one-year follow up (phase 3), all treatment groups had less than 10% return to pretreatment microfilaria levels. The mean percent of baseline microfilaria counts were for Group 1, 0.9% (range 0-5%); Group 2, 8.2% (range 0-31%); and Group 3, 3.8% (range 0-25%). Seven individuals in Group 1 were microfilaria-negative, while only one and three individuals were microfilaria-negative in Groups 2 and 3, respectively. These results suggest that DEC causes more damage to the adult worms and greater reduction in microfilaria densities than ivermectin, but that high doses of ivermectin may suppress microfilaremia in lymphatic filariasis for periods much longer than previously reported.
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PMID:Comparison of high dose ivermectin and diethylcarbamazine for activity against bancroftian filariasis in Haiti. 199 38

Clinical and biological evaluations were carried out on 84 Congolese patients with parasitologically confirmed Loa loa filariasis (without concurrent infection with other filariae) and on 98 controls without filariasis. On the patients, 72 presented with microfilaremia; another 12 with negative blood tests were seen towards the end of an episode of subconjunctival migration of the adult worm. The incidence and severity of the clinical signs depended upon the method of recruitment. The 3 most common signs were pruritus and edema (both occurring in successive acute episodes affecting mainly the hands and forearms) and subconjunctival migration of adult filariae. Papulovesicular eruptions were located mainly on the arms. Headaches and arthralgia were noted more frequently than in the controls. No relation was found between the ABO blood groups and loiasis. Eosinophilia (higher in patients with symptoms) and raised serum IgE levels were found in nearly all patients and were strongly marked in approximately 66%. A positive correlation was observed between these 2 parameters. Fluorescent antibody levels (adult filaria Dipetalonema viteae antigen) were comparatively low in patients with microfilaremia.
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PMID:Clinical and biological study of Loa loa filariasis in Congolese. 267 58

Ivermectin treatment was evaluated for efficacy and side effects in 40 patients in South India who had microfilaremia and bancroftian filariasis. Ivermectin was administered once orally at four dose levels (range, 25 to 200 micrograms/kg), and at each it was found to be completely effective in clearing blood microfilariae within five to 12 days. In most patients, microfilariae reappeared by three months; by six months the levels averaged 14% to 32% of pretreatment values in the four study groups, and all groups showed equivalent efficacy. Detailed monitoring identified some side effects in almost all patients: usually fever, headache, light-headedness, myalgia, sore throat, or cough that occurred most prominently 18 to 36 hours after treatment. These were most frequent and severe in patients with the greatest microfilaremia, but only when treated with the two higher doses of ivermectin (100 and 200 micrograms/kg). The low-dose (25 micrograms/kg) ivermectin group, despite equivalent efficacy in parasite killing, had clinical reaction scores that were minimal and that were not correlated with parasitemia. Since efficacy and side effects of ivermectin therapy compare favorably with those reported for treatment with the standard antifilarial drug diethylcarbamazine citrate, the major advantage of single-oral-dose administration makes ivermectin the best candidate to replace diethylcarbamazine as the treatment of choice for bancroftian filariasis.
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PMID:Ivermectin for the treatment of Wuchereria bancrofti filariasis. Efficacy and adverse reactions. 328 45

To determine the effectiveness of single oral dosages of ivermectin ranging between 20 and 200 micrograms/kg and to make detailed observations of both the kinetics of parasite killing and the adverse reactions induced by treatment, the present double-blind study on ivermectin treatment of lymphatic filariasis caused by Wuchereria bancrofti was undertaken with 43 microfilaremic patients in Recife, Brazil. Follow-up at one year indicated equivalent efficacy for the 20-, 100-, and 200-micrograms/kg drug dosages in reducing microfilaremia to geometric means of 13-25% of pretreatment levels. Adverse clinical reactions (predominantly fever, headache, weakness, and myalgia) occurred to some degree in almost all patients but generally lasted only 24-48 hr and were easily managed symptomatically. Adverse reactions were significantly milder in those receiving the lowest (20 micrograms/kg) ivermectin dose, and they were significantly correlated with individuals' pretreatment microfilaremia levels in all groups. Posttreatment eosinophilia was a regular feature of the response to treatment, with the magnitude and kinetics also proportional to pretreatment microfilarial levels. Transient pulmonary function abnormalities (16 of 42, 38%), liver enzyme elevations (10 of 43, 23%), and hematuria (9 of 42, 22%) developed posttreatment, but all cleared without significant complications. The results indicate that W. bancrofti from Brazil is similar to strains of the parasites studied elsewhere in susceptibility to ivermectin, that the drug's systemic adverse reactions are essentially those resulting from parasite clearance, and that the intensity of these reactions can be significantly reduced by using the low (20 micrograms/kg) dose of ivermectin. This detailed dose-finding study provides information necessary for developing optimal regimens to treat bancroftian filariasis with ivermectin either alone or in combination with other medications.
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PMID:Ivermectin treatment of bancroftian filariasis in Recife, Brazil. 814 92

To evaluate the efficacy and longitudinal effect of two single (100 micrograms/kg) doses of ivermectin, 3 months apart, 240 asymptomatic male subjects from 2 endemic Egyptian villages were enrolled in a one-year double-blind study. Subjects aged 15-55 years were randomly assigned placebo (40) or ivermectin (200). Microfilaria (MF) density in 1 ml blood was measured by membrane filtration before and every 3 months after treatment. Initial mean MF density was 462 (range 14-2869/ml). Clinical examination performed daily for 3 days after each treatment revealed brief, mild side effects: fever, headache, weakness, nausea, and epigastric pain, with no adverse physical or laboratory findings. Three months after initial dose, 31% of MF counts had completely cleared; in the remainder, mean MF density was 11.0 (2.4% of pretreatment level). At 3, 6 and 9 months after the second dose there was complete MF clearance in 60%, 45% and 47%; in those still infected, MF densities were 1.7, 4.6 and 6.1% of the pretreatment level. Therefore, treatment with two doses of ivermectin reduced microfilaremia, without inducing severe side effects. Prolonged suppression of microfilaremia may indicate an effect of ivermectin on the adult worms and may reduce the potential for MF acquisition by mosquitoes, reducing transmission of lymphatic filariasis. It was concluded that ivermectin is a useful drug for public health measure, including asymptomatic filariasis patients.
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PMID:Effect of two single doses of ivermectin in treatment of asymptomatic bancroftian filariasis in two villages in the Nile Delta, Egypt. 909 30

Although combinations of ivermectin and diethylcarbamazine (DEC) have been shown to be superior to either drug alone in the suppression of bancroftian microfilariae, their efficacy against infections with Brugia malayi has never been investigated. The present, open trial is the first on the efficacy and safety of a combination of single doses of ivermectin and DEC when used against microfilaraemias of brugian filariasis. Twenty-one, asymptomatic but microfilaraemic (109-6934 microfilariae/ml blood, with a median of 841/ml) men, aged 18-48 years, each received oral doses of ivermectin (400 micrograms/kg) and DEC (6 mg/kg) as a single treatment. Twelve hours post-treatment, 96.5%-100% of the microfilariae in each subject had been cleared and 12 of the subjects were amicrofilaraemic. A further reduction in microfilarial counts was evident 1 month post-treatment (mean clearance = 99.0%) and the counts continued to fall at least until the last follow-up, at 1 year post-treatment, when the mean clearance was 99.9% and 13 (68.4%) of the 19 subjects then investigated were amicrofilaraemic. All subjects experienced adverse reactions of one form or another, lasting for up to 48 h post-treatment; these included fever, myalgia, headache, and lethargy. Postural hypotension was recorded in two subjects and dilated, inflamed lymphatic channels were seen in another two. The combination of ivermectin and DEC demonstrated a microfilaricidal effect superior to that of either drug used alone, both in the initial rapid clearance of microfilariae and in sustaining the effect for 1 year. This finding has important implications for the control of lymphatic filariasis.
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PMID:Treatment of microfilaraemia in asymptomatic brugian filariasis: the efficacy and safety of the combination of single doses of ivermectin and diethylcarbamazine. 979 31

This paper reports on adverse reactions following a 12-day course of 6 mg/kg diethylcarbamazine (DEC) therapy in brugian filariasis patients in Indonesia. Microfilaria-positive individuals (n = 26), 'endemic normals' (n = 12) and elephantiasis patients (n = 17) were included in the study. Fever, headache and body aches started between 2 and 24 h after DEC intake. Adverse reactions were categorized into 'no or mild', 'moderate' or 'severe' depending on the total reaction score. Four microfilaraemic individuals (15.4%) suffered from severe adverse reactions and their pre-treatment microfilarial levels (geometric mean, GM = 3060 mf/10 mL) were significantly higher than in the 5 microfilaraemic individuals (19.2%) suffering from moderate reactions (GM = 1268 mf/10 mL) and in the 17 microfilaraemic patients (65.4%) who experienced no or mild reactions (GM = 6 mf/10 mL)(P < 0.001 and P < 0.001, respectively). Endemic normals showed no or mild adverse reactions. No or mild adverse reactions were also recorded in all but 2 elephantiasis patients after DEC intake. Two elephantiasis patients with moderate reactions had high levels of circulating microfilariae at pre-treatment (2097 and 7375 mf/10 mL). Concentrations of DEC were measured in plasma, but could not explain the differences in the severity of adverse reactions.
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PMID:Adverse reactions following diethylcarbamazine (DEC) intake in 'endemic normals', microfilaraemics and elephantiasis patients. 1049

Filariasis caused by Brugia timori and Wuchereria bancrofti is an important public health problem on Alor island, East Nusa Tenggara, Indonesia. To implement a control programme, adverse reactions and short-term effects on the microfilaria (mf) density were studied following a divided dose of diethylcarbamazine (DEC, 6 mg/kg body weight - 100 mg on day 1 and the rest on day 3) or a single dose of DEC (6 mg/kg body weight on day 3) and albendazole (Alb, 400 mg). In order to define the most appropriate regimen, 30 persons infected with B. timori were treated in the hospital and results were compared with those obtained from the treatment of 27 persons infected with W. bancrofti. Adverse reactions consisted of systemic reactions such as fever, headache, myalgia, itching and local reactions such as adenolymphangitis. Fever experienced by a number of patients in both treatment groups generally occurred 12-24 h after drug administration and lasted up to 2 days. Adenolymphangitis tended to occur later and was resolved within 4 days. The number of W. bancrofti patients suffering from adverse reactions was lower and the reactions were milder than those of the B. timori patients. There was no difference in adverse reactions between DEC alone and DEC-Alb treatment for either infection. The geometric mean mf count decreased on day 7 in the B. timori infected patients from 234 mf/ml in the DEC group and from 257 mf/ml in the DEC-Alb group to 7 and 8 mf/ml, respectively. The mf densities of the W. bancrofti infected patients decreased on day 7 from 214 mf/ml in the DEC group and from 559 mf/ml in the DEC-Alb group to 15 and 14 mf/ml, respectively. Our data indicate that the microfilaricidal effect of the drugs is achieved more rapidly for B. timori, which is associated with more adverse reactions than W. bancrofti. In addition, 111 B. timori infected persons were treated in the community with DEC-Alb in one selected village. The adverse reactions and the reduction of mf density was similar to the findings of the hospital-based study. In this group, there was a strong correlation of mf density with the frequency and severity of adverse reactions. The addition of Alb resulted in no additional adverse reactions compared with DEC treatment alone and can also be used for the treatment of B. timori infection. In Indonesia, where the prevalence of intestinal helminths is high, the use of a combination of DEC and Alb to control lymphatic filariasis may also have impact on the control of intestinal helminths.
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PMID:Treatment of Brugia timori and Wuchereria bancrofti infections in Indonesia using DEC or a combination of DEC and albendazole: adverse reactions and short-term effects on microfilariae. 1235 26

This study was carried out for three years from 1968 to 1970. Three coastal villages and four remote islets of Che Ju Island were surveyed and 90% of all inhabitants were blood smeared. These study areas were grouped into five according to its characteristic for evaluation of mass treatment with diethylcarbamazine citrate (Hetrazan U.S.P.) and insecticide spray in control of human filariasis. To set baseline up for control group, placebo was administered. Followings are the results obtained: 1. 81.1% of all mf positives accepted and completed the mass chemotherapy; main reason for refusal was side reactions told by neighboring villagers who experienced them. 2. 6 mg of hetrazan/kg B.W. X12 doses given every day turned mf postives to mf negative in 92.1%. The patients who had high mf density remained mf positive in 16.5% whereas only 2.1% for low mf density. 3. 73.8% of mf positives after the treatment showed marked decrease in mf density. Most of them to less than 15n mg/20 mm(3) of blood that can not infect mosquito effectively. 4. Mosquito infection rates were also dropped markedly in areas where mf positive were mass treated. 5. Side reaction induced by diethylcarbamazine was frequent(64%-90%) and various. The most frequent symptom was headache and fever. 6. DDT spray did not influence human mf rate and mosquito infection rate.
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PMID:Efficacy Of Mass Treatment For Control Of Human Filariasis. 1291 97


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