Abstract | BACKGROUND: METHODS: This open-label, cluster-randomised study was done in 24 villages in a district endemic for lymphatic filariasis in Papua New Guinea. Villages paired by population size were randomly assigned to receive mass drug administration with a single dose of the triple- drug oral regimen of ivermectin (200 μg per kg of bodyweight) plus diethylcarbamazine (6 mg per kg of bodyweight) plus albendazole (400 mg) or a single dose of the two- drug oral regimen of diethylcarbamazine (6 mg per kg of bodyweight) plus albendazole (400 mg). This is a follow-on study of a previously reported safety study (ClinicalTrials.govNCT02899936). All residents aged 5 years or older and non-pregnant women were asked to participate. After cross-sectional night blood microfilariae and circulating filarial antigen surveys, mass drug administration was provided at baseline and repeated 12 months later. The primary outcomes were mean prevalence of microfilariae and circulating filarial antigen at 12 months and 24 months, assessed in all residents willing to participate at each timepoint. This study is registered with ClinicalTrials.gov, NCT03352206. FINDINGS: Between Nov 18, 2016, and May 26, 2017, 4563 individuals were enrolled in 24 clusters; 12 clusters (2382 participants) were assigned to the triple- drug regimen and 12 clusters (2181 participants) to the two- drug regimen. Mean drug ingestion rates (of residents aged ≥5 years) were 66·1% at baseline and 63·2% at 12 months in communities assigned to the triple- drug regimen and 65·9% at baseline and 54·9% at 12 months in communities assigned to the two- drug regimen. Microfilariae prevalence in the triple- drug regimen group decreased from 105 (4·4%) of 2382 participants (95% CI 3·6-5·3) at baseline to nine (0·4%) of 2319 (0·1-0·7) at 12 months and four (0·2%) of 2086 (0·1-0·5) at 24 months. In the two- drug regimen group, microfilariae prevalence decreased from 93 (4·3%) of 2181 participants (95% CI 3·5-5·2) at baseline to 29 (1·5%) of 1963 (1·0-2·1) at 12 months and eight (0·4%) of 1844 (0·2-0·9) at 24 months (adjusted estimated risk ratio 4·5, 95% CI 1·4-13·8, p=0·0087, at 12 months; 2·9, 95% CI 1·0-8·8, p=0·058, at 24 months). The prevalence of circulating filarial antigen decreased from 523 (22·0%) of 2382 participants (95% CI 20·3-23·6) at baseline to 378 (16·3%) of 2319 (14·9-17·9) at 12 months and 156 (7·5%) of 2086 (6·4-8·7) at 24 months in the triple- drug regimen group and from 489 (22·6%) of 2168 participants (20·7-24·2) at baseline to 358 (18·2%) of 1963 (16·7-20·1) at 12 months and 184 (10·0%) of 1840 (8·7-11·5) at 24 months in the two- drug regimen group; after adjustment, differences between groups were not significant. INTERPRETATION: FUNDING: Bill & Melinda Gates Foundation.
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Authors | Moses Laman, Livingstone Tavul, Stephan Karl, Bethuel Kotty, Zebede Kerry, Stephen Kumai, Anna Samuel, Lina Lorry, Lincoln Timinao, S Cade Howard, Leo Makita, Lucy John, Sibauk Bieb, James Wangi, Jeffrey M Albert, Michael Payne, Gary J Weil, Daniel J Tisch, Catherine M Bjerum, Leanne J Robinson, Christopher L King |
Journal | The Lancet. Infectious diseases
(Lancet Infect Dis)
Vol. 22
Issue 8
Pg. 1200-1209
(08 2022)
ISSN: 1474-4457 [Electronic] United States |
PMID | 35533701
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL. |
Chemical References |
- Filaricides
- Ivermectin
- Albendazole
- Diethylcarbamazine
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Topics |
- Albendazole
(therapeutic use)
- Cross-Sectional Studies
- Diethylcarbamazine
(therapeutic use)
- Drug Therapy, Combination
- Elephantiasis, Filarial
(drug therapy, epidemiology, prevention & control)
- Female
- Filaricides
(therapeutic use)
- Humans
- Ivermectin
(therapeutic use)
- Mass Drug Administration
- Papua New Guinea
(epidemiology)
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