Table 1.
Enrollment Demographic and Illness Characteristics of the Participants in the Intention-to-Treat, Influenza-Infected Populations
| Characteristic | US316 | US317 | ||
|---|---|---|---|---|
| Placebo (n = 322) |
Favipiravir (n = 301) |
Placebo (n = 169) |
Favipiravir (n = 526) |
|
| Age, y, mean (SD) | 41.3 (14.8) | 41.3 (14.2) | 39.3 (14.19) | 40.1 (13.61) |
| Female sex | 192 (59.6) | 176 (58.5) | 87 (51.5) | 305 (58.0) |
| Race | ||||
| African American | 54 (16.8) | 40 (13.3) | 14 (8.3) | 64 (12.2) |
| American Indian/Alaska Native | 0 (0.0) | 2 (0.7) | 8 (4.7) | 17 (3.2) |
| Asian | 14 (4.3) | 5 (1.7) | 0 (0.0) | 9 (1.7) |
| Native Hawaiian/other Pacific Islander | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| White | 241 (74.8) | 246 (81.7) | 118 (69.8) | 348 (66.2) |
| Multiple | 0 (0.0) | 0 (0.0) | 2 (1.2) | 4 (0.8) |
| Other | 13 (4.0) | 10 (3.4) | 27 (16.0) | 84 (16.0) |
| Ethnicity | ||||
| Hispanic or Latino | 46 (14.3) | 46 (15.3) | 85 (50.3) | 250 (47.5) |
| BMI, kg/m2, mean (SD) | 29.0 (7.0) | 29.0 (7.4) | 28.6 (6.2) | 29.0 (6.4) |
| Weight, kg, mean (SD) | 81.8 (20.8) | 83.2 (22.4) | 80.4 (20.7) | 81.5 (20.8) |
| Influenza vaccine in current season | 68 (21.1) | 64 (21.3) | 20 (11.8) | 45 (8.6) |
| Geographical region | ||||
| Australia and New Zealand | 23 (7.1) | 17 (5.6) | NA | NA |
| Europe | 61 (18.9) | 53 (17.6) | NA | NA |
| North America | 191 (59.3) | 184 (61.1) | 120 (71.0) | 384 (73.0) |
| South Africa | 47 (14.6) | 47 (15.6) | 49 (29.0) | 142 (27.0) |
| Time from symptom onset to first dose, mean (SD) | 29.9 (10.6) | 29.2 (10.5) | 30.2 (10.2) | 29.3 (10.7) |
| Time from symptom onset to first dose <24 h | 96 (29.8) | 90 (29.9) | 42 (24.9) | 164 (31.2) |
| Temperature, °C, mean (SD) | 38.0 (0.9) | 37.9 (0.8) | 37.8 (0.8) | 37.9 (0.8) |
| Baseline symptom score ≥15 | 60 (20.1) | 67 (23.5) | 41 (26.3) | 132 (26.5) |
| Viral titer, log10 TCID50/mL, mean (SD) | 3.0 (1.8) (n = 321) |
2.8 (1.7) (n = 301) |
3.3 (2.0) (n = 169) |
3.4 (1.9) (n = 526) |
| Viral RNA load, log10 viral particles/mL, mean (SD) | 6.8 (1.8) | 6.9 (1.5) | 6.9 (1.5) | 6.9 (1.6) |
| Influenza type | ||||
| A | 281 (87.3) | 263 (87.4) | 130 (76.9) | 399 (75.9) |
| B | 38 (11.8) | 34 (11.3) | 37 (21.9) | 124 (23.6) |
| A + B | 3 (0.9) | 4 (1.3) | 2 (1.2) | 3 (0.6) |
| Influenza A subtype | ||||
| A(H1N1)pdm09 | 38 (11.8) | 23 (7.6) | 57 (33.7) | 159 (30.2) |
| A(H3N2) | 237 (73.6) | 235 (78.1) | 67 (39.6) | 224 (42.6) |
| A(H1) + A(H3) | 2 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Missing or negative subtyping (including B, A + B) | 45 (14.0) | 43 (14.3) | 45 (26.6) | 143 (27.2) |
Data are presented as No. (%) unless otherwise indicated. The ITTI population comprised participants with reverse-transcription polymerase chain reaction–confirmed influenza virus infection.
Abbreviations: NA, not applicable; SD, standard deviation; TCID50, median tissue culture infectious dose.