Prophylaxis of cytomegalovirus disease in mismatched patients after heart transplantation using combined antiviral and immunoglobulin therapy.

BACKGROUND: Cytomegalovirus (CMV) is a common cause of infection and morbidity after heart transplantation. Seronegative recipients (R-) of seropositive donor hearts (D+) are at high risk for CMV disease. We compared three different CMV prophylaxis regimens using combined antiviral and immunoglobulin therapy. METHODS: In 99 patients who survived more than 30 days after heart transplant, all received induction with antilymphocytic therapy and triple-drug therapy. In group A, D+R- patients received one dose of intravenous immunoglobulin (IVIG) followed by one dose of CMV-specific immunoglobulin (CMV-IVIG), and intravenous ganciclovir (GCV) for 4 weeks followed by 11 months of oral acyclovir (ACV). In group B, D+R- patients received one dose IVIG followed by five doses of CMV-IVIG and intravenous GCV for 14 weeks followed by 9 months of oral ACV. In group C, D+R- patients were treated with the same regimen as for group B, except oral ACV was replaced with oral GCV. RESULTS: The actuarial freedom from CMV disease for D+R- patients at 1 month, 1 year, and 2 years after transplantation in group A was 100%, 25% ± 15%, and 25% ± 15%, respectively; group B was 100%, 67% ± 27%, and 67% ± 27%; group C was 100%, 83% ± 15%, and 83% ± 15% (P < .01, groups B and C vs group A). By comparison, the actuarial freedom from CMV disease for seropositive recipients (D-R+ or D+R+) at 1 month, 1 year, and 2 years in group A was 100%, 87% ± 7%, and 82% ± 8%, respectively; group B was 100%, 88% ± 8%, and 75% ± 11%; group C was 100%, 72% ± 9%, and 72% ± 9% (P = NS among groups). Rejection rates did not differ among the three groups. CONCLUSIONS: A longer course of intravenous GCV with multiple doses of CMV-IVIG was a more effective prophylaxis regimen against CMV disease for the high-risk group of seronegative recipients of seropositive donor hearts.