Table 7.

Randomized trials of preemptive therapy in solid-organ transplant recipientsd

Type of transplantReferenceType of studyNo. of patients studied (no. of D+/Rpatients)aProphylactic regimenbOutcome(s)CMV diseasecMortalityc
Kidney447Secondary prophylaxis, >6 days of prophylactic treatment posttransplant with ALG or OKT3 or treatment within first 2 weeks for acute rejection16 (0)Immunoglobulin (Sandoglobulin; Novartis Pharmaceuticals Corp., East Hanover, N.J.) 500 mg/kg i.v. on day 0 and wk 2 and 4; 250 mg/kg at wk 6 and 8Reduction in severity of symptomatic CMV illness and incidence of CMV complications13% vs. 39%Not reported
18 (0)untreated controls
300Primary and secondary prophylaxis of patients receiving ATG for rejection, double-blind, placebo controlled19 (5)CMV immunoglobulin (Cytogam; Medimmune Inc., Gaithersburg, Md.) 100 mg/kg/day on day of ATG therapy and days 7, 14, 35, 56, and 77 thereafterPrevented fatal CMV disease; should be targeted to D+/R group37% vs. 30%0% vs. 20%
20 (4)placebo (albumin)
197Secondary prophylaxis of patients receiving OKT3 or ALG, non-placebo controlled, prospective64 (0)Ganciclovir 2.5 mg/kg i.v. twice a day till termination of antilymphocyte therapyGanciclovir reduced excessive occurrence of CMV disease14% vs. 33%2% vs. 4%
49 (0)untreated controls
76Primary and secondary prophylaxis of patients on OKT3, prospective, non-placebo controlled22 (0)Ganciclovir 2.5 mg/kg i.v. on day that antilymphocyte antibody therapy was givenReduction in CMV disease0% vs. 17%100% vs. 100%
18 (0)no prophylaxis
Liver453Secondary prophylaxis of patients on antilymphocyte antibody preparations, prospective, non-placebo controlled50 (14)Immunoglobulin (Gammagard; Baxter Healthcare Corp., Glendale, Calif.) 0.5 g/kg i.v. on days 1, 3, 5, then each wk for 3 wk with acyclovir 400 mg p.o. 5 times a day for 3 monthsNo benefitNot shown10% vs. 22%
50 (3)no prophylaxis
423Primary and secondary prophylaxis; stratified by donor and recipient CMV serostatus24 (2)Acyclovir 800 mg p.o. 4 times a day for 24 wkGanciclovir provided effective prophylaxis against CMV disease29% vs. 4%13% vs. 13%
23 (2)ganciclovir 5 mg/kg i.v. twice a day for 7 days if surveillance cultures (buffy coat, urine) yield CMV
  • a If known, the number of CMV-negative patients given donor-positive organs (D+/R) is shown in parentheses.

  • b ALG, antilymphocyte globulin; ATG, antithymocyte globulin; i.v., intravenous; p.o., peroral.

  • c Among patients given the drug, the percentage refers to the first versus the second listed regimen.

  • d Modified from references 334a and 336a with permission of the publisher.