TABLE 2.
Efficacy endpoints
| Endpointa | Value(s) for: |
|
|---|---|---|
| RG7667 (n = 59) | Placebo (n = 57) | |
| CMV viremia within 12 weeks posttransplant | ||
| n (%) | 27 (45.8) | 35 (61.4) |
| Stratum-adjusted difference, % (95% CI) | 15.3 (−2.8–32.2) | |
| P value | 0.100 | |
| CMV viremia within 24 weeks posttransplant | ||
| n (%) | 30 (50.8) | 40 (70.2) |
| Stratum-adjusted difference, % (95% CI) | 19.3 (1.4–35.6) | |
| P value | 0.040 | |
| Median time to viremia (days) | 139 | 46 |
| HR (95% CI) | 0.53 (0.33–0.86) | |
| P value | 0.009 | |
| Median viral load at initial detection, copies/ml (IU/ml) | 342 (311) | 1051 (956) |
| Median peak viral load, copies/ml (IU/ml) | 2,965 (2,698) | 6,397 (5,821) |
| Receipt of preemptive anti-CMV therapy, n (%) | ||
| Within 12 weeks posttransplant | 29b (49.2) | 36b (63.2) |
| Within 24 weeks posttransplant | 32 (54.2) | 40 (70.2) |
| CMV disease within 24 weeks posttransplant | ||
| n (%) | 2 (3.4) | 9 (15.8) |
| P value | 0.030 | |
a
CI, confidence interval; HR, hazard ratio.
b
Some patients in the RG7667-treated (n = 2) and placebo-treated (n = 1) groups received valganciclovir therapy on day 1 before there was any evidence of viremia, in violation of the protocol, and were counted in the group of patients that received preemptive therapy. The medical monitor informed the site investigator of the error, who stopped the prophylactic therapy or withdrew the patient.