Document Detail

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.
MedLine Citation:
PMID:  21197713     Owner:  NLM     Status:  MEDLINE    
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.
Atul Humar; Ajit P Limaye; Emily A Blumberg; Ingeborg A Hauser; Flavio Vincenti; Alan G Jardine; Daniel Abramowicz; Jane A L Ives; Mahdi Farhan; Patrick Peeters
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Transplantation     Volume:  90     ISSN:  1534-6080     ISO Abbreviation:  Transplantation     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-12-30     Completed Date:  2011-01-28     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0132144     Medline TA:  Transplantation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1427-31     Citation Subset:  IM    
Transplant Infectious Diseases, University of Alberta, Edmonton, AB, Canada.
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MeSH Terms
Antiviral Agents / administration & dosage,  therapeutic use*
Cytomegalovirus Infections / epidemiology,  prevention & control*
Double-Blind Method
Follow-Up Studies
Ganciclovir / administration & dosage,  analogs & derivatives*,  therapeutic use
Graft Survival
Immunoglobulin G / blood
Immunoglobulin M / blood
Kidney Transplantation / adverse effects,  mortality,  physiology*
Likelihood Functions
Predictive Value of Tests
Prospective Studies
Serologic Tests / statistics & numerical data
Survival Rate
Time Factors
Reg. No./Substance:
0/Antiviral Agents; 0/Immunoglobulin G; 0/Immunoglobulin M; 0/valganciclovir; 82410-32-0/Ganciclovir

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