CMV INFECTION

A. Humar¹, Y. Lebranchu², F. Vincenti³, E. Blumberg⁴, J.D. Punch⁵, A.P. Limaye⁶, D. Abramowicz⁷, A.G. Jardine⁸, I.A. Hauser⁹, M. Farhan¹⁰, P. Peeters^11
1Department Of Transplant Infectious Diseases, University of Alberta, Edmonton/AB/CANADA, ²Nephrology And Transplantation, Hopial Bretenneau, Tours/FRANCE, ³, UCSF, San Francisco/UNITED STATES OF AMERICA, ⁴, Uni of Pennsylvania Medical Center, Philadelphia/UNITED STATES OF AMERICA, ⁵, Uni of Michigan Medical Center, Ann Arbor/UNITED STATES OF AMERICA, ⁶, University of Washington Medical Center, Seattle/UNITED STATES OF AMERICA, ⁷, Hopital Erasme, Anderlecht/BELGIUM, ⁸, Western Infirmary, Glasgow/UNITED KINGDOM, ⁹Nephrology, University Hospital Frankfurt/M, Frankfurt/M/GERMANY, ¹⁰Virology, Roche Products Ltd, Welwyn Garden City/UNITED KINGDOM, ¹¹, University of Ghent, Ghent/BELGIUM

Body: Introduction: The impact study demonstrated that valganciclovir prophylaxis up to 200 days vs. 100 days was associated with a significant reduction of CMV disease by 12 months post transplant. However, it remains to be confirmed that these benefits seen at 12 months are sustained over time. Methods: In this international, randomized, prospective, double-blind study, 318 CMV D+R- kidney transplant recipients received prophylaxis with valganciclovir 900 mg once daily for up to 200 days, compared to valganciclovir 900 mg once daily for up to 100 days, then placebo until day 200 post transplant, (doses adjusted for renal function). In this report, long-term (2 years post-transplant) outcomes were analyzed including CMV disease, acute rejection, graft loss, patient survival and seroconversion to investigate if the benefits of extending valganciclovir prophylaxis are sustained.
Results: At 2 years post-transplant, confirmed CMV disease (CMV syndrome and/or tissue invasive ) occurred in significantly less patients in the 200-day prophylaxis group vs. the 100-day prophylaxis group: 33/155 (21.3 %) vs. 63/163 (38.7 %); p<0.001, respectively (Figure 1). Between year 1 and 2 there were only 10 additional cases of CMV disease; 7 in the 200 day group and 3 in the 100 day group. There were 2 cases of tissue invasive disease beyond 12 months (1 case in each group). At 2 years, there was a non-significant trend towards less biopsy-proven acute rejection in the 200 day group: (11.6 % vs. 17.2%; p=0.16). Similarly, the rate of graft loss was low and occurred in 1.9% of patients in the 200 day group vs. 4.3% in the 100 day group; p=0.22). Patient survival was100% and 97% in the 200 vs. 100 day group respectively. The rates of seroconversion were comparable between the 200-day and 100-day prophylaxis groups: 53% vs. 59% at 2-years; p=0.31, respectively. No new differences in safety profile were observed with long-term follow-up.
Conclusion: Extending valganciclovir prophylaxis to 200 days compared with 100 days is associated with sustained reduction in the incidence of CMV disease up to 24 months post transplant. Only few cases of CMV disease occurred after 12 months indicating that extended prophylaxis did not simply postpone CMV disease.

Disclosure: All authors have declared no conflicts of interest.