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 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.