TABLE 5.
Study and subject | RSV subtype | Baseline lymphocyte count (cells/μl)b | Time-weighted avg change in nasal RSV viral load (log10 copies/ml)c | Visit | RSV RNA (copies/ml) | Resistance-associated substitution(s) |
---|---|---|---|---|---|---|
HCT URTI (GS-US-218-0108) | ||||||
1 | A | <200 | −1.88 | Baseline | 7,900,000 | None |
Day 9 | 12,000,000 | None | ||||
Day 17 | 87,100 | None | ||||
Day 22 | 92,400 | None | ||||
Day 28 | 11,100 | F140F/I, T400T/I | ||||
2 | B | <200 | −0.06 | Baseline | 11,000,000 | None |
Day 9 | 81,000,000 | M396M/I, S398S/L | ||||
Day 13 | 54,700 | T400T/A | ||||
3 | A | 160 | −0.46 | Baseline | 83,000,000 | None |
Day 9 | 12,000,000 | None | ||||
Day 17 | 55,000,000 | None | ||||
Day 22 | 532,000 | S398S/L, T400T/I | ||||
Day 28 | 10,900 | D486D/V | ||||
4 | A | 480 | −0.13 | Baseline | 28,000,000 | None |
Day 9 | 24,000,000 | None | ||||
Day 17 | 199,000 | D338D/Y | ||||
5 | B | <200 | −0.66 | Baseline | 54,000,000 | None |
Day 9 | 85,000,000 | K394K/R | ||||
Day 13 | 18,700 | None | ||||
Day 22 | 3,400 | Assay failure | ||||
6 | B | 610 | 0.28 | Baseline | 10,000,000 | None |
Day 9 | 11,000,000 | None | ||||
Day 17 | 10,700 | F140F/I | ||||
Day 22 | 157,000 | E487E/G | ||||
7 | A | 420 | −0.25 | Baseline | 4,400,000 | None |
Day 9 | 36,000 | None | ||||
Day 28 | 10,600 | G143S | ||||
8 | A | 100 | −0.08 | Baseline | 1,300,000 | None |
Day 9 | 4,200 | None | ||||
Day 17 | 47,600 | L141L/F | ||||
Day 28 | 3,400 | L141F | ||||
9 | B | <200 | −0.03 | Baseline | 10,000,000 | None |
Day 9 | 93,200 | L141W | ||||
Day 13 | 14,100 | None | ||||
10 | A | <200 | −0.51 | Baseline | 69,000,000 | None |
Day 9 | 18,000,000 | None | ||||
Day 17 | 2,900,000 | T400T/I | ||||
Day 28 | 4,300 | None | ||||
Day 42 | 524,000 | T400I | ||||
Day 49 | 902,000 | None | ||||
Day 56 | 33,900 | None | ||||
HCT LRTI (GS-US-218-1502) | ||||||
1 | A | 1,140 | 1.19 | Baseline | 40,600 | None |
Day 9 | 419,000 | None | ||||
Day 28 | 4,200 | D486V | ||||
2 | A | 180 | −0.24 | Baseline | 15,000,000 | None |
Day 9 | 8,900,000 | None | ||||
Day 22 | 3,800,000 | None | ||||
Day 56 | 5,400,000 | T400I | ||||
3 | B | 400 | −0.44 | Baseline | 28,000,000 | None |
Day 9 | 23,000,000 | None | ||||
Day 22 | 7,400,000 | L141L/F | ||||
Day 28 | 54,000 | L141F | ||||
4 | B | 1,000 | −0.98 | Baseline | 42,000,000 | None |
Day 9 | 7,800 | None | ||||
Day 22 | 11,000,000 | D486E | ||||
Day 28 | 290,000 | D486E | ||||
5 | A | 270 | −0.49 | Baseline | 28,000,000 | None |
Day 9 | 1,600,000 | None | ||||
Day 28 | 1,100,000 | D486D/N | ||||
6 | B | 270 | 1.44 | Baseline | 6,200 | None |
Day 7 | 2,100,000 | S398L | ||||
Day 17 | 134,000 | T400I | ||||
Lung transplant (GS-US-218-1797) | ||||||
1 | A | 370 | 0.60 | Baseline | 13,000,000 | None |
Day 7 | 52,000,000 | None | ||||
Day 9 | 8,300,000 | None | ||||
Day 21 | 307,000 | D486D/V | ||||
Day 28 | 16,500 | T400I | ||||
Hospital inpatients (GS-US-218-1227) | ||||||
1 | A | 430 | 0.11 | Baseline | 1,700,000 | None |
Day 5 | 6,000,000 | None | ||||
Day 14 | 5,100 | L138L/I |
HCT, hematopoietic cell transplant; LRTI, lower respiratory tract infection; RSV, respiratory syncytial virus; URTI, upper respiratory tract infection.
Lymphocyte count is listed as <200 cells/μl when the patient was recorded as lymphopenic for stratification but the exact lymphocyte count was not recorded.
From baseline to day 9 for HCT recipients, day 7 for lung transplant recipients, and day 5 for hospitalized patients.