Pharmacokinetics, safety, and efficacy of a single co-administered dose of diethylcarbamazine, albendazole and ivermectin in adults with and without Wuchereria bancrofti infection in Côte d’Ivoire

Edi, Constant; Bjerum, Catherine M.; Amidou, Ouattara; Chhonker, Yashpal S.; Pénali, Louis K.; Meïté, Aboulaye; Koudou, Benjamin G.; Weil, Gary J.; King, Christopher L.; Murry, Daryl J.

doi:10.1371/journal.pntd.0007325

Cited by 36 publications

(52 citation statements)

References 23 publications

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“…We noted that women were more likely to report an AE despite being less likely to have microfilaremia. This gender difference has been reported in other studies [10,13], and is hypothesised to be because women are more likely to report subjective AEs than men.…”

Section: Discussionsupporting

confidence: 71%

“…[37] We observed fever in participants with microfilaremia less frequently than expected from the smaller safety trials. [8][9][10] This may have been due to reduced intensity of monitoring in our study and the absence of other febrile infectious syndromes including malaria. We noted that women were more likely to report an AE despite being less likely to have microfilaremia.…”

Section: Discussionmentioning

confidence: 90%

“…The type of AEs in our study were consistent with those reported in previous studies. [8,13,36] The safety of IDA has been demonstrated in small randomised trials [8,10], and now in a large multi-site community safety trial that included Fiji. [13] However, these studies have not reported on the effect of scabies and STH infections on the reporting of AEs.…”

Section: Discussionmentioning

confidence: 99%

“…Safety was assessed in two periods, consistent with the timing of AEs observed in previous studies. [8][9][10][11] Active follow-up of all participants occurred daily in the first two days following treatment, when more severe symptoms are expected with death of microfilariae. [11] For continuity, participants were seen by the same nurse on the day of taking tablets and day 1 and day 2 afterwards, and asked a standard open-ended question about their health.…”

Section: Safety Assessmentsmentioning

confidence: 99%

“…[1] Combining the three active agents into the one MDA combination, known as IDA, does not create any drug-drug interactions, and is superior to DA in clearing microfilaremia at least as long as 36 months after a single round of treatment. [8][9][10] With more effective filariasis treatments it is expected that persons with microfilaremia will experience more adverse events (AEs), attributable to the response to dead or dying parasites. [11,12] This effect on AEs was reported from a small efficacy trial based in Papua New Guinea.…”

mentioning

confidence: 99%

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The safety of combined triple drug therapy with ivermectin, diethylcarbamazine and albendazole in the neglected tropical diseases co-endemic setting of Fiji: A cluster randomised trial

et al. 2020

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Lymphatic filariasis has remained endemic in Fiji despite repeated mass drug administration using the well-established and safe combination of diethylcarbamazine and albendazole (DA) since 2002. In certain settings the addition of ivermectin to this combination (IDA) remains a safe strategy and is more efficacious. However, the safety has yet to be described in scabies and soil-transmitted helminth endemic settings like Fiji. Villages of Rotuma and Gau islands were randomised to either DA or IDA. Residents received weight-based treatment unblinded with standard exclusions. Participants were actively found and asked by a nurse about their health daily for the first two days and then asked to seek review for the next five days if unwell. Anyone with severe symptoms were reviewed by a doctor and any serious adverse event was reported to the Medical Monitor and Data Safety Monitoring Board. Of 3612 enrolled and eligible participants, 1216 were randomised to DA and 2396 to IDA. Age and sex in both groups were representative of the population. Over 99% (3598) of participants completed 7 days follow-up. Adverse events were reported by 600 participants (16.7%), distributed equally between treatment groups, with most graded as mild (93.2%). There were three serious adverse events, all judged not attributable to treatment by an independent medical monitor. Fatigue was the most common symptom reported by 8.5%, with headache, dizziness, nausea and arthralgia being the next four most common symptoms. Adverse events were more likely in participants with microfilaremia (43.2% versus 15.7%), but adverse event frequency was not related to the presence of scabies or soil-transmitted helminth infection. IDA has comparable safety to DA with the same frequency of adverse events experienced following community mass drug administration. The presence of co-PLOS NEGLECTED TROPICAL DISEASES PLOS Neglected Tropical Diseases | https://doi.org/10.1371/journal.pntd.0008106 March 16, 2020 1 / 17 OPEN ACCESS Citation: Hardy M, Samuela J, Kama M, Tuicakau M, Romani L, Whitfeld MJ, et al. (2020) The safety of combined triple drug therapy with ivermectin, diethylcarbamazine and albendazole in the neglected tropical diseases co-endemic setting of Fiji: A cluster randomised trial. PLoS Negl Trop Dis 14(3): e0008106. https://doi.org/10.

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Section: Discussionsupporting

confidence: 71%

Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Safety Assessmentsmentioning

confidence: 99%

mentioning

confidence: 99%

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The safety of combined triple drug therapy with ivermectin, diethylcarbamazine and albendazole in the neglected tropical diseases co-endemic setting of Fiji: A cluster randomised trial

et al. 2020

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Filarial Nematodes

Showler,

Nutman

2023

ClinMicroNow

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Filarial worms are arthropod‐transmitted nematodes that dwell, as adults, in the subcutaneous tissues and the lymphatics. Although eight filarial species infect humans, four are responsible for most of the pathology associated with these infections: Wuchereria bancrofti , Brugia malayi , Onchocerca volvulus , and Loa loa . The taxonomy of these parasites follows a newly adopted molecular approach. All filariae go through a complex life cycle that includes an infective larval stage carried by the insects and an adult worm stage that resides in humans, either in the lymph nodes, the adjacent lymphatics, the subcutaneous tissue, or the pleural/peritoneal cavities. There are significant differences in the clinical manifestations of filarial infections, or at least in the period over which the manifestations present, between patients native to the areas of endemicity and those who are travelers or recent arrivals in these same areas.

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