TABLE 6.
Virologic and clinical outcomes in presatovir-treated subjects with and without genotypic resistance development in RSV F in studies of HCT recipients (GS-US-218-0108 and GS-US-218-1502)a
| Study group and outcome | Value for subjects: |
P value | Value for all subjects | |
|---|---|---|---|---|
| With resistance | Without resistance | |||
| HCT URTI (GS-US-218-0108) | ||||
| No. of subjects | 10 | 79 | 89 | |
| Change in viral load from day 1–9 (log10 copies/ml)b,c | −0.19 (−0.51, −0.06) | −1.42 (−1.96, −0.79) | 0.002d | −1.35 (−1.84, −0.51) |
| No. (%) with LRTC through day 28 | 1 (10) | 9 (11) | 1.0e | 10 (11) |
| No. (%) with respiratory failure or mortality through day 28 | 0 | 5 (6) | 1.0e | 5 (6) |
| HCT LRTI (GS-US-218-1502) | ||||
| No. of subjects | 6 | 23 | 29 | |
| Change in viral load from day 1–9 (log10 copies/ml)b,c | −0.34 (−0.49, 1.19) | −1.44 (−2.34, −0.78) | 0.019 | −1.03 (−1.84, −0.44) |
| No. of supplemental-O2-free days through day 28c | 3 (0, 6) | 28 (25, 28) | <0.001f | 26 (10, 28) |
| No. (%) with mechanical ventilation use through day 28 | 2 (33) | 1 (4) | 0.100e | 3 (10) |
| No. (%) with all-cause mortality through day 28 | 0 | 0 | NA | 0 |
HCT, hematopoietic cell transplant; LRTC, lower respiratory tract complications; LRTI, lower respiratory tract infection; NA, not applicable; URTI, upper respiratory tract infection.
Time-weighted average change in nasal RSV viral load.
Median (interquartile range).
P value for resistance versus no resistance calculated from the ANCOVA model including baseline values and stratification factors.
P value for resistance versus no resistance calculated using Fisher’s exact test.
P value for resistance versus no resistance calculated from the negative binomial model with stratification factors as covariates. Five of 6 (83%) subjects with resistance and 5 of 23 (22%) subjects without resistance required supplemental oxygen at baseline.