Prophylaxis of primary cytomegalovirus disease in renal transplant recipients. A trial of ganciclovir vs immunoglobulin
D. J. Conti, B. M. Freed, S. A. Gruber and N. Lempert
Department of Surgery, Albany Medical College, NY.
OBJECTIVE: To compare the efficacy, safety, and cost of prophylactic
low-dose ganciclovir with that of immunoglobulin in renal transplant
recipients at risk for primary cytomegalovirus (CMV) disease. DESIGN AND
SETTING: A prospective, randomized trial at a 650-bed tertiary medical
center hospital. PATIENTS: Fifty-one consecutive CMV-seronegative patients
who received renal allografts from seropositive donors between March 1990
and April 1992. MAIN OUTCOME MEASURES: Patient and allograft survival, and
the incidence and severity of CMV disease. INTERVENTION: Cytomegalovirus
prophylaxis with seven doses of intravenous immunoglobulin for 6-week
periods (group 1, n = 27) or low-dose intravenous ganciclovir for 3 weeks
(group 2, n = 24). Results were compared with those obtained in 23
CMV-seronegative historical controls who received renal allografts from
CMV-seropositive donors between 1987 and 1989, and who did not receive
prophylaxis for CMV (group 3). RESULTS: Both prophylactic regimens
significantly reduced the incidence of invasive CMV infection (P < .05)
and were well tolerated. However, the cost of ganciclovir ($350 per
patient) was substantially less than that of immunoglobulin ($4000 per
patient). CONCLUSIONS: These data suggest that prophylactic ganciclovir
therapy provides a cost-effective approach toward significantly improving
the outcome of renal transplantation in recipients at risk for primary CMV
disease.
