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April 1994

Prophylaxis of Primary Cytomegalovirus Disease in Renal Transplant Recipients: A Trial of Ganciclovir vs Immunoglobulin

Author Affiliations

From the Department of Surgery, Section of Transplantation, Albany (NY) Medical College.

Arch Surg. 1994;129(4):443-447. doi:10.1001/archsurg.1994.01420280121016

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 positive donors between 1987 and 1989, and who did n-positive 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.(Arch Surg. 1994;129:443-447)

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