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

Humar, A., Limaye, A.P., Blumberg, E.A., Hauser, I.A., Vincenti, F., Jardine, A.G. , Abramowicz, D., Ives, J.A.L., Farhan, M. and Peeters, P. (2010) 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, 90(12), pp. 1427-1431. (doi: 10.1097/TP.0b013e3181ff1493)

Abstract

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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Jardine, Professor Alan
• Authors: Humar, A., Limaye, A.P., Blumberg, E.A., Hauser, I.A., Vincenti, F., Jardine, A.G., Abramowicz, D., Ives, J.A.L., Farhan, M., and Peeters, P.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences
• Journal Name: Transplantation
• ISSN: 0041-1337