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Risk of Cytomegalovirus Infection after 3 or 6 Months of Valganciclovir Prophylaxis among Donor-Seropositive,
Vincent Leclerc1, Nathalie Châteauvert2
1, BPharm, MSc, is with the Département de pharmacie, Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval, and the Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval, Québec, Quebec.
Insights
For heart transplant recipients with donor-positive, recipient-negative cytomegalovirus (CMV) status, 6 months of valganciclovir prophylaxis is associated with a lower risk of CMV infection and disease compared to 3 months.
Area of Science:
- Transplantation Medicine
- Infectious Diseases
- Virology
Background:
- Cytomegalovirus (CMV) disease is a common complication after heart transplantation, particularly in donor-positive, recipient-negative (D+/R-) patients.
- Current guidelines recommend 3 to 6 months of valganciclovir prophylaxis, but evidence favoring 6 months over 3 months in heart transplant recipients is limited.
Purpose of the Study:
- To compare the incidence of CMV infection and CMV disease in CMV D+/R- heart transplant recipients receiving 3 versus 6 months of valganciclovir prophylaxis.
- To evaluate the timing of CMV infection and disease occurrence in relation to prophylaxis duration.
Main Methods:
- Retrospective analysis of CMV D+/R- heart transplant recipients between October 2015 and October 2022.
- Inclusion criteria required a minimum of 1 year of follow-up post-transplant.
- Patients were stratified into two groups based on the duration of valganciclovir prophylaxis: 3 months (n=22) or 6 months (n=13).
Main Results:
- CMV infection occurred in 68.2% of patients receiving 3 months of prophylaxis versus 30.8% receiving 6 months (p=0.04).
- CMV disease occurred in 54.5% of the 3-month group compared to 23.1% in the 6-month group (p=0.09).
- The majority of CMV infections and diseases were diagnosed within 3 months after completing prophylaxis in both groups.
Conclusions:
- CMV D+/R- heart transplant recipients receiving 3 months of valganciclovir prophylaxis experienced a significantly higher risk of CMV infection compared to those receiving 6 months.
- While not statistically significant, a trend towards higher CMV disease incidence was observed with 3 months of prophylaxis.
- These findings suggest that a 6-month prophylaxis regimen may offer improved protection against CMV infection and disease in this high-risk population.
Background:
Cytomegalovirus (CMV) disease is frequent following heart transplant, especially among patients with donor-seropositive, recipient-seronegative (D+/R-) CMV status. Valganciclovir prophylaxis for 3 to 6 months is recommended, but few data support the use of 6 rather than 3 months of prophylaxis for patients who have undergone heart transplant.
Objective:
To compare the risk of CMV infection and a first occurrence of CMV disease after heart transplant among CMV D+/R- patients who received 3 or 6 months of prophylaxis in the first year after transplant.
Methods:
This retrospective analysis included every D+/R- heart transplant recipient at the study centre between October 2015 and October 2022. Patients had to have a minimum of 1 year of follow-up for inclusion.
Results:
Thirty-five patients met the inclusion criteria. The duration of valganciclovir prophylaxis (determined by the medical team) was 3 months for 22 patients and 6 months for 13 patients. CMV infection occurred in 68.2% (15/22) and 30.8% (4/13) of the 3-month and 6-month groups, respectively (risk difference 37.4%, 95% confidence interval [CI] 1.75 to 65.8, p = 0.04). CMV disease occurred in 54.5% (12/22) of patients who received 3 months of prophylaxis and 23.1% (3/13) of those who received 6 months of prophylaxis (risk difference 31.4%, 95% CI -3.7 to 59.4, p = 0.09). Most CMV infections and diseases occurred in the 3 months after the end of prophylaxis.
Conclusions:
After heart transplant, CMV D+/R- patients who received 3 months of prophylaxis had a higher risk of CMV infection and a non-statistically significant higher risk of CMV disease relative to those who received 6 months of prophylaxis.
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