Table 6.
Parameter | Commentsa |
|
---|---|---|
Preemptive therapy | Antiviral prophylaxis | |
Strategy | Monitor patients for CMV reactivation by using highly sensitive and predictive laboratory assays (such as nucleic acid amplification tests) | Administer antiviral drug (valganciclovir) for a defined duration to all patients at risk for CMV disease (duration varies depending on the organ transplant and the risk profile of patients) |
Laboratory monitoring is performed once weekly. More frequent monitoring may be considered for patients at very high risk of CMV disease | Laboratory monitoring (NAT) for CMV reactivation is not routinely recommended for patients receiving antiviral prophylaxis | |
Administer antiviral therapy (valganciclovir) only to patients who develop CMV reactivation above a predefined viral load threshold | ||
Monitor patients by use of CMV NAT once weekly to guide treatment duration; treatment is continued until the viral load falls to an undetectable level or below a predefined threshold | ||
Recommended populations | CMV-seropositive (CMV D+/R+ and CMV D−/R+) heart, liver, kidney, and pancreas transplant recipients | All CMV D+/R− solid organ transplant recipients |
Considered but less preferred for CMV D+/R− heart, liver, kidney, and pancreas transplant recipients due to potential risk of breakthrough disease as a result of rapid replication dynamics | All CMV D+/R− and CMV R+ lung, intestinal, and composite tissue allograft transplant recipients | |
Not recommended for lung, intestinal, and composite tissue allograft transplant recipients | All CMV-seropositive (CMV D+/R+ and CMV D−/R+) heart, liver, kidney, and pancreas transplant recipients | |
All transplant patients in centers that do not have an available assay for sensitive detection of CMV reactivation | ||
Advantages | Reduced no. of patients exposed to antiviral drugs | Prevents reactivation of other herpesviruses (i.e., herpes simplex virus, HHV-6) |
Reduced direct antiviral drug costs | Does not rely on a highly sensitive and predictive assay for CMV detection | |
Reduced duration of antiviral drug use | Reduces incidence of indirect CMV effects | |
Reduced toxicity related to antiviral drugs | ||
Lower risk of antiviral drug resistance | ||
Disadvantages | Requires a predictive test for early identification of patients at risk of CMV disease | Prolonged antiviral drug use may lead to emergence of antiviral drug resistance |
Requires patients to comply with stringent laboratory surveillance schedule | Prolonged antiviral drug use may lead to higher incidence of adverse drug effects | |
No widely accepted viral load threshold for initiation of antiviral therapy | Use of expensive drugs by all patients, including those who may not have viral reactivation | |
Increased cost of diagnostic surveillance testing | ||
May not identify all patients at risk of CMV disease (breakthrough infection may occur in high-risk CMV D+/R− patients between scheduled weekly testing) | ||
CMV-selective nature does not prevent reactivation of other herpesviruses | ||
Prolonged duration of preemptive antiviral therapy may be associated with drug resistance |
CMV, cytomegalovirus; HHV, human herpesvirus.