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Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study.
PLoS Negl Trop Dis. 2020 06; 14(6):e0008298.PN

Abstract

In Haiti, 22 communes still require mass drug administration (MDA) to eliminate lymphatic filariasis (LF) as a public health problem. Several clinical trials have shown that a single oral dose of ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA) is more effective than DEC plus ALB (DA) for clearing Wuchereria bancrofti microfilariae (Mf). We performed a cluster-randomized community study to compare the safety and efficacy of IDA and DA in an LF-endemic area in northern Haiti. Ten localities were randomized to receive either DA or IDA. Participants were monitored for adverse events (AE), parasite antigenemia, and microfilaremia. Antigen-positive participants were retested one year after MDA to assess treatment efficacy. Fewer participants (11.0%, 321/2917) experienced at least one AE after IDA compared to DA (17.3%, 491/2844, P<0.001). Most AEs were mild, and the three most common AEs reported were headaches, dizziness and abdominal pain. Serious AEs developed in three participants who received DA. Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001). Of those with positive antigenemia, 17.6% (42/239) in IDA localities and 20.9% (72/344, P = 0.25) in DA localities were microfilaremic. One year after treatment, 84% percent of persons with positive filarial antigen tests at baseline could be retested. Clearance rates for filarial antigenemia were 20.5% (41/200) after IDA versus 25.4% (74/289) after DA (P = 0.3). However, 94.4% (34/36) of IDA recipients and 75.9% (44/58) of DA recipients with baseline microfilaremia were Mf negative at the time of retest (P = 0.02). Thus, MDA with IDA was at least as well tolerated and significantly more effective for clearing Mf compared to the standard DA regimen in this study. Effective MDA coverage with IDA could accelerate the elimination of LF as a public health problem in the 22 communes that still require MDA in Haiti.

Authors+Show Affiliations

Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.University of Florida, Gainsville, Florida, United States of America.Washington University in St. Louis, St. Louis, Missouri, United States of America.RTI International, Washington, District of Columbia, United States of America.IMA World Health, Port-au-Prince, Haiti.IMA World Health, Port-au-Prince, Haiti.Washington University in St. Louis, St. Louis, Missouri, United States of America.Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.Washington University in St. Louis, St. Louis, Missouri, United States of America.IMA World Health, Port-au-Prince, Haiti.IMA World Health, Port-au-Prince, Haiti.Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.Washington University in St. Louis, St. Louis, Missouri, United States of America.Ministère de la Santé et de la Population, Port-au-Prince, Haïti.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32511226

Citation

Dubray, Christine L., et al. "Safety and Efficacy of Co-administered Diethylcarbamazine, Albendazole and Ivermectin During Mass Drug Administration for Lymphatic Filariasis in Haiti: Results From a Two-armed, Open-label, Cluster-randomized, Community Study." PLoS Neglected Tropical Diseases, vol. 14, no. 6, 2020, pp. e0008298.
Dubray CL, Sircar AD, Beau de Rochars VM, et al. Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study. PLoS Negl Trop Dis. 2020;14(6):e0008298.
Dubray, C. L., Sircar, A. D., Beau de Rochars, V. M., Bogus, J., Direny, A. N., Ernest, J. R., Fayette, C. R., Goss, C. W., Hast, M., O'Brian, K., Pavilus, G. E., Sabin, D. F., Wiegand, R. E., Weil, G. J., & Lemoine, J. F. (2020). Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study. PLoS Neglected Tropical Diseases, 14(6), e0008298. https://doi.org/10.1371/journal.pntd.0008298
Dubray CL, et al. Safety and Efficacy of Co-administered Diethylcarbamazine, Albendazole and Ivermectin During Mass Drug Administration for Lymphatic Filariasis in Haiti: Results From a Two-armed, Open-label, Cluster-randomized, Community Study. PLoS Negl Trop Dis. 2020;14(6):e0008298. PubMed PMID: 32511226.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of co-administered diethylcarbamazine, albendazole and ivermectin during mass drug administration for lymphatic filariasis in Haiti: Results from a two-armed, open-label, cluster-randomized, community study. AU - Dubray,Christine L, AU - Sircar,Anita D, AU - Beau de Rochars,Valery Madsen, AU - Bogus,Joshua, AU - Direny,Abdel N, AU - Ernest,Jean Romuald, AU - Fayette,Carl R, AU - Goss,Charles W, AU - Hast,Marisa, AU - O'Brian,Kobie, AU - Pavilus,Guy Emmanuel, AU - Sabin,Daniel Frantz, AU - Wiegand,Ryan E, AU - Weil,Gary J, AU - Lemoine,Jean Frantz, Y1 - 2020/06/08/ PY - 2020/01/17/received PY - 2020/04/15/accepted PY - 2020/06/18/revised PY - 2020/6/9/pubmed PY - 2020/6/9/medline PY - 2020/6/9/entrez SP - e0008298 EP - e0008298 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 14 IS - 6 N2 - In Haiti, 22 communes still require mass drug administration (MDA) to eliminate lymphatic filariasis (LF) as a public health problem. Several clinical trials have shown that a single oral dose of ivermectin (IVM), diethylcarbamazine (DEC) and albendazole (ALB) (IDA) is more effective than DEC plus ALB (DA) for clearing Wuchereria bancrofti microfilariae (Mf). We performed a cluster-randomized community study to compare the safety and efficacy of IDA and DA in an LF-endemic area in northern Haiti. Ten localities were randomized to receive either DA or IDA. Participants were monitored for adverse events (AE), parasite antigenemia, and microfilaremia. Antigen-positive participants were retested one year after MDA to assess treatment efficacy. Fewer participants (11.0%, 321/2917) experienced at least one AE after IDA compared to DA (17.3%, 491/2844, P<0.001). Most AEs were mild, and the three most common AEs reported were headaches, dizziness and abdominal pain. Serious AEs developed in three participants who received DA. Baseline prevalence for filarial antigenemia was 8.0% (239/3004) in IDA localities and 11.5% (344/2994) in DA localities (<0.001). Of those with positive antigenemia, 17.6% (42/239) in IDA localities and 20.9% (72/344, P = 0.25) in DA localities were microfilaremic. One year after treatment, 84% percent of persons with positive filarial antigen tests at baseline could be retested. Clearance rates for filarial antigenemia were 20.5% (41/200) after IDA versus 25.4% (74/289) after DA (P = 0.3). However, 94.4% (34/36) of IDA recipients and 75.9% (44/58) of DA recipients with baseline microfilaremia were Mf negative at the time of retest (P = 0.02). Thus, MDA with IDA was at least as well tolerated and significantly more effective for clearing Mf compared to the standard DA regimen in this study. Effective MDA coverage with IDA could accelerate the elimination of LF as a public health problem in the 22 communes that still require MDA in Haiti. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/32511226/Safety_and_efficacy_of_co-administered_diethylcarbamazine,_albendazole_and_ivermectin_during_mass_drug_administration_for_lymphatic_filariasis_in_Haiti:_Results_from_a_two-armed,_open-label,_cluster-randomized,_community_study L2 - https://dx.plos.org/10.1371/journal.pntd.0008298 DB - PRIME DP - Unbound Medicine ER -
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