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Valacyclovir for CMV Prophylaxis in Renal Transplantation

Cytomegalovirus (CMV) disease is the principal infectious-disease complication of organ transplantation and has also been linked to graft rejection. Although prophylactic acyclovir prevents CMV disease in the transplant setting, its poor oral absorption and low intrinsic activity against CMV has limited its utility. This international, double-blind, controlled trial now demonstrates that the more bioavailable prodrug valacyclovir is highly effective for CMV prophylaxis in renal transplant recipients.

Six hundred eighteen renal transplant recipients were randomized to receive 2 g of oral valacyclovir or placebo four times daily, beginning within 72 hours of transplantation and continuing for 90 days, with dose adjustments for renal function. Valacyclovir significantly reduced the incidence of CMV disease in both CMV seropositive and seronegative recipients. For seronegative recipients, the incidence of CMV disease at 90 days was 45% in the placebo group and 3% in the valacyclovir group; for seropositive recipients, the respective rates were 6% and 0%. Valacyclovir therapy was associated with a 57% reduction at six months in biopsy-confirmed acute graft rejection in seronegative recipients, and significant reductions in rates of herpes simplex disease and nonherpesvirus infections. Valacyclovir recipients also had significantly fewer hospitalizations and hospitalized days. Adverse events associated with valacyclovir were hallucinations (8% of recipients) and confusion (7% of recipients).

Comment: Valacyclovir prophylaxis still must be investigated for other types of organ transplantation but, as demonstrated in this study, is an important advance for the field of transplantation.

— R Ellison

Published in Journal Watch Infectious Diseases July 1, 1999

Citation(s):

Lowance D et al. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. N Engl J Med 1999 May 13 340 1462-1470.

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