A controlled, comparative study of two regimens (750 mg bid and 500 mg bid) of oral ganciclovir in the prevention of cytomegalovirus infection in post-kidney transplant "CMV at risk"
ASN 30th Annual Meeting, San Antonio
J Am Soc Nephrol (Oct) 8:671A 1997
Cytomegalovirus infection continues to be one of the major causes of morbidity in the months following renal transplantation. Those at highest risk are patients without CMV antibody receiving a CMV+ kidney (D+R-), however recipients with antibody (R+) may have reactivation of latent infection or superinfection with a new strain if they receive a kidney from a CMV+ donor (D+R+). In addition, treatment with anti-lymphocyte preparations such as OKT3 or ATGAM greatly increases the risk of infection. Strategies to prevent CMV have included administration of acyclovir, CMV hyperimmune globulin, and ganciclovir. The drawbacks of most of these regimens include cost and, for most of these regimens, the need for parenteral therapy.
Ahsan et al. conducted a prospective controlled trial comparing administration of ganciclovir 500 mg bid or 750 mg bid to no prophylactic therapy in patients undergoing renal transplant. 51 patients, consisting of 16 D+R-, and the remainder D+R+ or D-R+ were randomized. The groups were well matched for relevant variables. Patients were treated for three months and followed for a total of six months. Of the control group, 37.5% developed CMV infection, compared to only 1 in the higher dose group and none in the lower dose group. Of interest, of the 51 patients, 41 received cytolytic induction, although the exact protocol is not described. The incidence of rejection was remarkably low in all groups: 6% vs. 6.6% vs 0%.
Comment: This report suggests that administration of relatively low doses of oral ganciclovir as prophylaxis confers substantial protection from CMV infection. Because of the small study size, and especially the small number of patients at the highest risk (D+R-), this finding will need to be confirmed in larger numbers of patients. In addition, as few patients experienced rejection, the efficacy of this protocol in patients reciving more intense immunosuppression is not established. Nevertheless, it is of interest that this regimen is effective and safe in transplant patients on maintenance immunosuppression, and it is likely that the use of prophylactic oral ganciclovir will continue to grow. (Judith Benstein, M.D., NYU University Hospital, New York, NY)
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ASN 30th Annual Meeting, San Antonio
Transplant : Transplantation