Six-Month Prophylaxis Is Cost Effective in Transplant Patients at High Risk for Cytomegalovirus Infection

Abstract

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.

Pre-emptive intravenous ganciclovir versus valganciclovir prophylaxis for de novo cytomegalovirus-seropositive kidney-transplant recipients

“…In order to circumvent the occurrence of late HCMV disease after prophylaxis, attempts have been made to prolong prophylaxis to 6 months [25,26]. In our study, late onset HCMV disease was not increased in patients receiving the prophylactic strategy.…”

Primary CMV Infections Are Common in Kidney Transplant Recipients After 6 Months Valganciclovir Prophylaxis

“…Some evidence suggests that prolonging prophylaxis up to 6 months may reduce the incidence of late-onset infections (7,10,11). However, preliminary study of our material showed a high frequency of late-onset primary CMV infections in 48% of patients despite prolonged 6 months prophylaxis with valganciclovir (12) (5,9).…”

“…After 3 months of antiviral prophylaxis, late-onset primary CMV infections are reported to occur in 18-31% of kidney transplant recipients (7)(8)(9). Evidence suggests that prolonging prophylaxis for 6 months reduces the incidence of late-onset infections (7,10,11). In a study by Doyle et (26,27), a novel strategy to predict CMV infections could be to measure CMV-specific T-cell responses (20,(28)(29)(30).…”

CMV: Prevention, Diagnosis and Therapy

“…A metaanalysis of 11 randomized trials (698 patients; median follow-up: 12 months, range: 3-22 months), with six randomized trials (302 patients) after kidney transplantation, demonstrated a beneficial effect of the prophylactic use of CMV immunoglobulin on total survival and prevention of Should not be used 1500 mg once a day, or 500 mg three times a day Should not be used 1000 mg once a day, or 500 mg twice a day [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24] Should not be used 500 mg once a day <10…”