Table 2.
Summary of hemoglobin outcome for the three dosing regimens stratified by IL28B and ITPA genetics (mean baseline hemoglobin is 14.9 g/dL)
1,200/1,000 | 1,000/800 | 800/600 | |
Steady‐state Hb, g/dL: median (5th–95th percentiles) | |||
IL28B non‐CC, ITPA variant | 11.5 (9.4, 13.9) | 11.8 (9.6, 14.2) | 12.1 (9.9, 14.2) |
IL28B non‐CC, ITPA wild‐type | 11.3 (8.8, 13.7) | 11.7 (9.7, 13.8) | 11.9 (9.8, 14.5) |
IL28B CC, ITPA variant | 10.5 (8.2, 12.7) | 10.8 (8.5, 13.4) | 11.3 (8.9, 13.8) |
IL28B CC, ITPA wild‐type | 10.2 (7.7, 13.3) | 10.7 (8.2, 13.0) | 11.1 (8.8, 13.4) |
Steady‐state RBC lifespan, days: median (5th–95th percentiles) | |||
IL28B non‐CC, ITPA variant | 38.8 (17.1, 68.2) | 43.9 (20.5, 72.7) | 49.8 (25.2, 80.1) |
IL28B non‐CC, ITPA wild‐type | 33.7 (16.4, 61.8) | 41.4 (20.3, 69.0) | 45.6 (22.6, 77.0) |
IL28B CC, ITPA variant | 36.5 (19.3, 67.2) | 42.9 (19.4, 70.3) | 50.1 (26.1, 79.5) |
IL28B CC, ITPA wild‐type | 34.4 (15.4, 63.8) | 40.9 (18.6, 68.7) | 46.3 (23.0, 76.4) |
W4 Hb decline, g/dL: median (5th–95th percentiles) | |||
IL28B non‐CC, ITPA variant | −1.81 (−3.44, −0.17) | −1.66 (−3.39, −0.12) | −1.30 (−2.91, 0.06) |
IL28B non‐CC, ITPA wild‐type | −2.43 (−4.33, −0.79) | −2.09 (−3.85, −0.42) | −1.79 (−3.32, −0.18) |
IL28B CC, ITPA variant | −2.30 (−3.95, −0.44) | −1.99 (−4.08, −0.28) | −1.51 (−3.19, −0.05) |
IL28B CC, ITPA wild‐type | −3.02 (−5.38, −1.06) | −2.55 (−4.63, −0.51) | −2.14 (−4.14, −0.49) |
W12 Hb decline >3 g/dL (% subjects) | |||
IL28B non‐CC, ITPA variant | 39.2 | 31.2 | 21.6 |
IL28B non‐CC, ITPA wild‐type | 52.8 | 37.6 | 28.8 |
IL28B CC, ITPA variant | 75.8 | 63.6 | 45.2 |
IL28B CC, ITPA wild‐type | 81.2 | 66.6 | 61.2 |
W12 Hb <10 g/dL (% subjects) | |||
IL28B non‐CC, ITPA variant | 13.4 | 9.8 | 6.4 |
IL28B non‐CC, ITPA wild‐type | 17.6 | 9.0 | 7.2 |
IL28B CC, ITPA variant | 38.6 | 29.0 | 18.0 |
IL28B CC, ITPA wild‐type | 45.8 | 31.2 | 22.2 |
Hb, hemoglobin; IL, interleukin; ITPA, inosine triphosphatase; RBC, red blood cell.