PROPHYLAXIS OF PRIMARY CYTOMEGALOVIRUS DISEASE IN RENAL-TRANSPLANT RECIPIENTS - A TRIAL OF GANCICLOVIR VS IMMUNOGLOBULIN

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 ganciclo-vir 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.