The risk of late-onset cytomegalovirus (CMV)
infection remains a concern in seronegative kidney and/or pancreas transplant recipients of seropositive organs despite the use of
antiviral prophylaxis. The optimal duration of prophylaxis is unknown. We studied the cost effectiveness of 6- versus 3-mo prophylaxis with
valganciclovir. A total of 222 seronegative recipients of seropositive kidney and/or pancreas transplants received
valganciclovir prophylaxis for either 3 or 6 mo during two consecutive time periods. We assessed the incidence of CMV
infection and disease 12 mo after completion of prophylaxis and performed cost-effectiveness analyses. The overall incidence of CMV
infection and disease was 26.7% and 24.4% in the 3-mo group and 20.9% and 12.1% in the 6-mo group, respectively. Six-month prophylaxis was associated with a statistically significant reduction in risk for CMV disease (HR, 0.35; 95% CI, 0.17 to 0.72), but not
infection (HR, 0.65; 95% CI, 0.37 to 1.14). Cost-effectiveness analyses showed that 6-mo prophylaxis combined with a one-time
viremia determination at the end of the prophylaxis period incurred an incremental cost of $34,362 and $16,215 per case of
infection and disease avoided, respectively, and $8,304 per one quality adjusted life-year gained. Sensitivity analyses supported the cost effectiveness of 6-mo prophylaxis over a wide range of
valganciclovir and hospital costs, as well as variation in the incidence of CMV disease. In summary, 6-mo prophylaxis with
valganciclovir combined with a one-time determination of
viremia is cost effective in reducing CMV
infection and disease in seronegative recipients of seropositive kidney and/or pancreas transplants.