Table 1.
Patient Characteristics at Baseline (Randomized Population)
| Characteristics | Maribavir (n = 235) | IAT (n = 117) |
|---|---|---|
| Age, years | ||
| Median | 57.0 | 54.0 |
| Range | (19–79) | (19–77) |
| Male sex, n (%) | 148 (63.0) | 65 (55.6) |
| Race, n (%) | ||
| White | 179 (76.2) | 87 (74.4) |
| Black or African American | 29 (12.3) | 18 (15.4) |
| Asian | 9 (3.8) | 7 (6.0) |
| Other | 16 (6.8) | 5 (4.3) |
| Missing | 2 (0.9) | 0 |
| Solid-organ transplant,a n (%) | 142 (60.4) | 69 (59.0) |
| Kidneyb | 74 (52.1) | 32 (46.4) |
| Lungb | 40 (28.2) | 22 (31.9) |
| Heartb | 14 (9.9) | 9 (13.0) |
| Multipleb | 5 (3.5) | 5 (7.2) |
| Liverb | 6 (4.2) | 1 (1.4) |
| Pancreasb | 2 (1.4) | 0 |
| Intestineb | 1 (0.7) | 0 |
| Hematopoietic-cell transplant,c n (%) | 93 (39.6) | 48 (41.0) |
| Allogeneicd | 92 (98.9) | 48 (100.0) |
| Donor typee | ||
| HLA identical sibling | 13 (14.1) | 2 (4.2) |
| HLA matched other relative | 12 (13.0) | 10 (20.8) |
| HLA mismatched relative | 11 (12.0) | 7 (14.6) |
| Unrelated donor | 56 (60.9) | 29 (60.4) |
| Stem cell sourcee | ||
| Peripheral blood stem cell | 71 (77.2) | 30 (62.5) |
| Bone marrow | 16 (17.4) | 13 (27.1) |
| Cord blood | 5 (5.4) | 5 (10.4) |
| Presence of acute GvHD confirmed for HCT recipientsf | 23 (25.0) | 8 (17.0) |
| Presence of chronic GvHD confirmed for HCT recipientsf | 6 (6.5) | 5 (10.6) |
| CMV DNA levels by central laboratory at baseline, IU/mL | ||
| Median (IQR)g | 3377.0 (1036.0–12 544.0) | 2869.0 (927.0–11 636.0) |
| CMV DNA levels category as reported by central laboratory at baseline, n (%) | ||
| Low (<9100 IU/mL) | 153 (65.1) | 85 (72.6) |
| Intermediate (≥9100 and <91 000 IU/mL) | 68 (28.9) | 25 (21.4) |
| High (≥91 000 IU/mL) | 14 (6.0) | 7 (6.0) |
| Symptomatic CMV infection by Endpoint Adjudication Committee,h n (%) | 21 (8.9) | 8 (6.8) |
| CMV syndrome in SOT recipients | 10 (47.6) | 7 (87.5) |
| CMV diseasei | 12 (57.1) | 1 (12.5) |
| CMV serostatus for SOT recipients, n (%) | n = 142 | n = 69 |
| Donor +/recipient + | 11 (7.7) | 8 (11.6) |
| Donor −/recipient + | 3 (2.1) | 1 (1.4) |
| Donor +/recipient − | 120 (84.5) | 56 (81.2) |
| Donor −/recipient − | 7 (4.9) | 3 (4.3) |
| Missing | 1 (0.7) | 1 (1.4) |
| CMV serostatus for HCT recipients, n (%) | n = 93 | n = 48 |
| Donor +/recipient + | 42 (45.2) | 17 (35.4) |
| Donor −/recipient + | 39 (41.9) | 26 (54.2) |
| Donor +/recipient − | 6 (6.5) | 3 (6.3) |
| Donor −/recipient − | 5 (5.4) | 1 (2.1) |
| Missing | 1 (1.1) | 1 (2.1) |
| Patients with or without CMV mutations known to confer resistance to ganciclovir, foscarnet, and/or cidofovir,j n (%) | ||
| Refractory CMV infection with resistance | 121 (51.5) | 69 (59.0) |
| Refractory CMV infection without resistance | 96 (40.9) | 34 (29.1) |
| Missing resistance results | 18 (7.7) | 14 (12.0) |
| Most recent anti-CMV agent prior to randomization,k n (%) | ||
| Ganciclovir/valganciclovir | 204 (86.8) | 98 (83.8) |
| Foscarnet | 27 (11.5) | 18 (15.4) |
| Cidofovir | 4 (1.7) | 1 (0.9) |
Maribavir, n = 235, and IAT, n = 117, unless otherwise specified. All CMV DNA levels reported by central laboratory were based on plasma concentration.
Abbreviations: CMV, cytomegalovirus; GvHD, graft-versus-host disease; HCT, hematopoietic-cell transplant; HLA, human leukocyte antigen; IAT, investigator-assigned therapy; IQR, interquartile range; LLOQ, lower limit of quantification; SOT, solid-organ transplant.
Based on most recent transplant type. Those classed as “multiple” had multiple organs transplanted at once.
The denominator is the number of patients who received SOT within each treatment arm.
There was 1 (1.1%) autologous HCT in the maribavir group.
The denominator is the number of patients who received HCT within each treatment arm.
The denominator is the number of patients who received allogenic HCT within each treatment arm.
Based on the safety population.
Half of the LLOQ value (ie, 137/2 = 68.5) was imputed for those who had <LLOQ.
Patients were not stratified by symptomatic infection at randomization. One patient had both CMV disease and syndrome at baseline.
Most patients had CMV gastrointestinal disease: 10/12 for the maribavir arm and 1/1 for the IAT arm.
Per central laboratory results.
Defined as the most recent anti-CMV agent, used to confirm refractory eligibility criteria.