Table 2.
Influenza Virus Over Time (Efficacy Population)
Total (N=454) | Combination Antivirals (N=230) |
Oseltamivir (N=224) |
p-value | |
---|---|---|---|---|
Day 0 | 454 | 230 | 224 | |
Median (quartiles) log10 copies/mL | 6·50 (5·40, 7·40) | 6·40 (5·60, 7·20) | 6·70 (5·10, 7·70) | |
Min, Max log10 copies/mL | <3·20, 9·40 | <3·20, 9·00 | <3·20, 9·40 | |
≥ LLOQ | 421 (93%) | 221 (96%) | 200 (89%) | |
≥ LOD, < LLOQ | 13 (3%) | 4 (2%) | 9 (4%) | |
< LOD | 20 (4%) | 5 (2%) | 15 (7%) | |
Day 3 | 437 | 221 | 216 | |
Median (quartiles) log10 copies/mL | 3·40 (3·20, 4·60) | 3·40 (3·20, 4·20) | 3·90 (3·20, 4·95) | 0·004 |
Min, Max log10 copies/mL | <3·20, 7·80 | <3·20, 7·60 | <3·20, 7·80 | |
# missing | 17 | 9 | 8 | |
≥ LLOQ | 152 (35%) | 65 (29%) | 87 (40%) | 0·009 |
≥ LOD, <LLOQ | 47 (11%) | 22 (10%) | 25 (12%) | |
< LOD | 238 (54%) | 134 (61%) | 104 (48%) | |
Day 7 | 431 | 216 | 215 | |
Median (quartiles) log10 copies/mL | <3·20 (<3·20, 3·40) | <3·20 (<3·20, 3·40) | <3·20 (<3·20, 3·40) | 0·38 |
Min, Max log10 copies/mL | <3·20, 7·60 | <3·20, 6·90 | <3·20, 7·60 | |
# missing | 23 | 14 | 9 | |
≥ LLOQ | 43 (10%) | 19 (9%) | 24 (11%) | 0·24 |
≥ LOD, < LLOQ | 11 (3%) | 4 (2%) | 7 (3%) | |
< LOD | 377 (87%) | 193 (89%) | 184 (86%) |
LLOQ: lower limit of quantification of PCR assay; LOD: limit of detection of PCR assay. Primary endpoint percentage of participants with virus detectable by PCR (i.e. ≥ LLOQ + ≥ LOD, < LLOQ)