Extended valganciclovir prophylaxis in D+/R- kidney transplant recipients is associated with long-term reduction in cytomegalovirus disease: two-year results of the IMPACT study

Transplantation. 2010 Dec 27;90(12):1427-31. doi: 10.1097/tp.0b013e3181ff1493.


Background: Whether the early reduction in cytomegalovirus (CMV) disease seen at 1 year with prolongation of antiviral prophylaxis (up to 200 days) persists in the long term is unknown.

Methods: This international, randomized, prospective, double-blind study, compared 318 CMV D+/R- kidney transplant recipients receiving valganciclovir (900 mg) once daily for up to 200 days vs. 100 days. Long-term outcomes including CMV disease, acute rejection, graft loss, patient survival, and seroconversion were assessed.

Results: At 2 years posttransplant, CMV disease occurred in significantly less patients in the 200- vs. the 100-day group: 21.3% vs. 38.7%, respectively (P<0.001). Between year 1 and 2, there were only 10 new cases of CMV disease; 7 in the 200-day group and 3 in the 100-day group. Patient survival was 100% in the 200-day group and 97% in the 100-day group (p=not significant). Biopsy-proven acute rejection and graft loss rates were comparable in both groups (11.6% vs. 17.2%, P=0.16, and 1.9% vs. 4.3%, P=0.22, in the 200-day vs. 100-day groups, respectively). Seroconversion was delayed in the 200-day group but was similar to the 100-day group by 2 years posttransplant (IgM or IgG seroconversion; 55.5% in the 200-day group vs. 62.0% in the 100-day group at 2-years; P=0.26). Assessment of seroconversion at the end of prophylaxis was of limited utility for predicting late-onset CMV disease.

Conclusion: Extending valganciclovir prophylaxis from 100 to 200 days is associated with a sustained reduction in CMV disease up to 2 years posttransplant.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antiviral Agents / administration & dosage
  • Antiviral Agents / therapeutic use*
  • Cytomegalovirus Infections / epidemiology
  • Cytomegalovirus Infections / prevention & control*
  • Double-Blind Method
  • Follow-Up Studies
  • Ganciclovir / administration & dosage
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / therapeutic use
  • Graft Survival
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Kidney Transplantation / adverse effects
  • Kidney Transplantation / mortality
  • Kidney Transplantation / physiology*
  • Likelihood Functions
  • Predictive Value of Tests
  • Prospective Studies
  • Serologic Tests / statistics & numerical data
  • Survival Rate
  • Time Factors
  • Valganciclovir


  • Antiviral Agents
  • Immunoglobulin G
  • Immunoglobulin M
  • Valganciclovir
  • Ganciclovir