Table 2.
Primary efficacy outcomes, Uganda therapeutic efficacy monitoring, 2018–2019
| Outcome | Kwania district | Arua district | Busia district | ||||||
|---|---|---|---|---|---|---|---|---|---|
| AL (28 days) | DP (28 days) | DP (42 days) | AL (28 days) | DP (28 days) | DP (42 days) | AL (28 days) | DP (28 days) | DP (42 days) | |
| ETF n (%) | 0 (0.0) | 0 (0,0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| LCF n (%) | 5 (4.8) | 1 (1.0) | 2 (2.1) | 11 (11.1) | 0 (0.0) | 0 (0.0) | 13 (12.7) | 2 (2.1) | 4 (4.2) |
| LPF n (%) | 25 (24.0) | 1 (1.0) | 10 (10.5) | 28 (28.3) | 3 (3.1) | 20 (20.8) | 47 (46.1) | 2 (2.1) | 21 (22.3) |
| ACPR n (%) | 74 (71.2) | 93 (97.9) | 83 (87.4) | 60 (60.6) | 93 (96.9) | 76 (79.2) | 42 (41.2) | 91 (95.8) | 69 (73.4) |
| Reinfectiona n (%) | 25 (83.3) | 2 (100) | 10 (83.3) | 32 (82.1) | 3 (100) | 15 (75.0) | 50 (83.3) | 3 (75.0) | 18 (72.0) |
| Recrudescenceb n (%) | 5 (16.7) | 0 (0.0) | 2 (16.7) | 7 (17.9) | 0 (0.0) | 5 (25.0) | 10 (16.7) | 1 (25.0) | 7 (28.0) |
| Uncorrected Kaplan Meier % [95% CI] | 71.2 [63, 80] | 97.9 [95, 100] | 87.4 [81, 94] | 60.6 [52, 71] | 96.9 [94, 100] | 79.2 [71, 88] | 41.2 [33, 52] | 95.8 [92, 100] | 73.5 [65, 83] |
| Corrected Kaplan Meier % [95% CI] | 94.4 [90, 99] | 99.5 [99, 100] | 97.5 [95, 100] | 92.1 [86, 98] | 100.0 [100, 100] | 94.4 [90, 99] | 87.2 [79, 95] | 98.9 [97, 100] | 92.1 [87, 98] |
| Uncorrected per protocol efficacy % [95% CI] | 71.2 [61, 80] | 97.9 [91, 100] | 87.4 [79, 93] | 60.6 [50, 70] | 96.9 [88, 98] | 79.2 [70, 87] | 41.2 [32, 51] | 95.8 [90, 99] | 73.4 [63, 82] |
| Corrected per protocol efficacy % [95% CI] | 93.1 [85, 98] | 99.5 [95, 100] | 97.3 [91, 100] | 89.7 [80, 96] | 100.0 [96, 100] | 93.7 [86, 98] | 80.1 [67, 90] | 98.9 [94, 100] | 90.8 [82, 96] |
ETF, early treatment failure; LCF, late clinical failure; LPF, late parasitological failure, ACPR, adequate clinical and parasitological response; AL, artemether-lumefantrine; DP, dihydroartemisinin-piperaquine
aFor tabulation, reinfection defined as a recurrent infection with a posterior probability of recrudescence of < 50%
bFor tabulation, recrudescence defined as a recurrent infection with a posterior probability of recrudescence of ≥ 50%