Primary Endpoint:
LIVTENCITY was statistically superior to IAT1
More than twice the proportion of patients achieved CMV DNA level <LLOQ vs IAT1
131/235
28/117
Adjusted difference
95% CI [23, 43]
P<0.001
Confirmed CMV DNA level <LLOQ at Week 8 vs IAT
(% of patient responders)
Primary Endpoint in post-transplant adult patients with refractory or resistant CMV:
- CMV DNA level <LLOQ (<137 IU/mL) at the end of Week 8 confirmed by central laboratory in 2 consecutive samples separated by ≥5 days1*
Rate of all-cause mortality was similar in both treatment arms (LIVTENCITY, 11% [27/235] vs IAT, 11% [13/117]).1
*As assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV test.
Cochran-Mantel-Haenszel weighted average approach was used for the adjusted difference in proportion of responders (MBV-IAT), 95% CI, and p-value, after adjusting for transplant type and baseline plasma CMV DNA level concentration. Computation included only those with both stratification factors.1