Fig 1.
Screening, enrollment, PK study, and one-year follow-up to assess drug efficacy.
Table 1.
Study population.
Fig 2.
Plasma concentration-time profiles of (A) ALB-OX, (B) DEC, and (C) IVM, after a single dose of IVM+DEC+ALB stratified by LF infection status (infected = 32, uninfected = 24). Mean (±SD) are shown.
Fig 3.
Distribution of dose adjusted Cmax and AUC0-t of DEC (A and B), IVM (C and D), and ALB-OX (E and F) stratified by LF infection status. The median, 25th, and 75th quartiles and 95% CI are shown. Significance was assessed with the Kruskal-Wallis test and all P values were >0.05. There were 32 LF-infected and 24 uninfected participants.
Fig 4.
Distribution of dose adjusted Cmax and AUC0-t of DEC (A and B), IVM (C and D), and ALB-OX (E and F) stratified by sex. The median, 25th, and 75th quartiles and 95% CI are shown. Significance was determined by using the Kruskal-Wallis test. P values for all comparison were >0.05 except Cmax for DEC (P = 0.004). There were 24 women and 32 men.
Table 2.
Adverse events (AEs) following treatment with a single dose of IVM, DEC, and ALB.
Fig 5.
The efficacy of a single co-administered dose of the triple-drug regimen before and after treatment with respect to (A) Mf counts, (B) circulating filarial antigen levels as determined by mean filarial test strip (FTS) scores at 1 year after treatment, and (C) the number of active worm nests at one-year follow-up. Significance was determined by using the Mann Whitney test for FTS and worm nests (*** <0.001).
Fig 6.
Variation in drug levels from the mean AUC0-inf for all 56 study participants.
DEC is depicted as blue circles, ALB-OX as red triangles, and IVM as black asterisks. Four Mf+ individuals at baseline failed to completely clear Mf at 1 year following triple- drug therapy and are highlighted (ellipses).