Cytomegalovirus is a major viral pathogen in patients who undergo
renal transplantation, and cytomegalovirus disease is difficult to treat. We therefore conducted a randomized, placebo-controlled, double-blind trial of
acyclovir for the prevention of cytomegalovirus disease in recipients of renal allografts from cadavers.
Acyclovir was given orally in doses of 800 to 3200 mg per day, according to the patients' estimated level of renal function. Patients took the first dose of either
acyclovir or placebo six hours before
transplantation and continued to take the assigned medication for 12 weeks. Of 118 patients enrolled in the study, 104 completed at least 30 days on the study medication and were included in our analysis of the results. During the first year after
transplantation, 4 of 53 patients (7.5 percent) in the
acyclovir group had symptomatic cytomegalovirus disease, as compared with 15 of 51 (29 percent) in the placebo group (P = 0.002). There was a single case of cytomegalovirus
pneumonia in the
acyclovir group, as compared with nine in the placebo group. The greatest prophylactic benefit of
acyclovir was observed among seronegative patients who had received a kidney from a seropositive donor; only one of six such patients in the
acyclovir group had cytomegalovirus disease, as compared with all seven in the placebo group.
Acyclovir decreased the incidence of documented
cytomegalovirus infection (with or without symptomatic disease) to 36 percent from 61 percent among the patients who received the placebo (P = 0.011). Among the patients who received
acyclovir, the rates of recovery of virus from the blood and urine were significantly reduced, but the rate of viral shedding from the pharynx was not significantly different from that in the placebo group. There were no differences between the groups in the frequency of adverse events or in the rate of survival of either grafts or patients. We conclude that the
oral administration of
acyclovir, beginning before the
transplantation of a renal allograft from a cadaver, reduces the rate of
cytomegalovirus infection and disease without affecting the survival rate of either grafts or patients.