Are there studies supporting the use of anti-Cytomegalovirus (CMV) medication, such as Valganciclovir (valganciclovir), as prophylaxis in high-risk patients, including organ transplant recipients?

From the Guidelines

Yes, there is substantial evidence supporting the use of anti-CMV medications, particularly valganciclovir, as prophylaxis in high-risk patients such as organ transplant recipients, as recommended by the NCCN Guidelines panel 1. The use of valganciclovir as prophylaxis has been shown to significantly reduce the incidence of CMV disease, which can cause serious complications including organ rejection, opportunistic infections, and increased mortality in transplant recipients.

• The medication works by inhibiting viral DNA polymerase, preventing CMV replication.
• The typical duration of prophylaxis is 3-6 months post-transplantation, with dose adjustments required for patients with renal impairment.
• Patients should be monitored for neutropenia and thrombocytopenia, which are potential side effects of valganciclovir.
• Alternative medications include oral ganciclovir and intravenous ganciclovir, though valganciclovir is generally preferred due to better bioavailability and once-daily dosing.
• Prophylaxis is particularly important for CMV-seronegative recipients who receive organs from CMV-seropositive donors, as they are at highest risk for primary CMV infection. Some studies suggest that weekly monitoring of CMV replication by PCR or pp65 antigen detection is recommended to trigger antiviral therapy, as this approach lowers the rate of CMV infections and mortality 1. However, the most recent and highest quality study recommends routine surveillance for CMV reactivation after allogeneic HCT, consisting of weekly monitoring by PCR, especially during alemtuzumab therapy and at least 2 months after completion of treatment 1. The NCCN Guidelines panel recommends pre-emptive therapy with oral valganciclovir, intravenous ganciclovir or intravenous foscarnet for at least 2 weeks and until CMV is no longer detectable 1.

From the FDA Drug Label

A double-blind, placebo-controlled study was conducted in 326 kidney transplant patients at high risk for CMV disease (D+/R-) to assess the efficacy and safety of extending valganciclovir tablets CMV prophylaxis from 100 to 200 days post-transplant Extending CMV prophylaxis with valganciclovir tablets until Day 200 post-transplant demonstrated superiority in preventing CMV disease within the first 12 months post-transplant in high risk kidney transplant patients compared to the 100 day dosing regimen (primary endpoint)

Yes, there are studies supporting the use of anti-CMV medication, such as valganciclovir, as prophylaxis in high-risk patients, including organ transplant recipients.

• The study showed that extending CMV prophylaxis with valganciclovir until Day 200 post-transplant demonstrated superiority in preventing CMV disease within the first 12 months post-transplant in high-risk kidney transplant patients compared to the 100-day dosing regimen 2.
• The results suggest that valganciclovir can be effective in preventing CMV disease in high-risk patients, including organ transplant recipients.

From the Research

Studies on Anti-CMV Medication as Prophylaxis

• There are several studies that support the use of anti-Cytomegalovirus (CMV) medication, such as Valganciclovir, as prophylaxis in high-risk patients, including organ transplant recipients 3, 4, 5, 6, 7.
• A randomized clinical trial compared the efficacy and safety of letermovir with valganciclovir for prevention of CMV disease in CMV-seronegative kidney transplant recipients who receive an organ from a CMV-seropositive donor, and found that letermovir was noninferior to valganciclovir for prophylaxis of CMV disease over 52 weeks, with lower rates of leukopenia or neutropenia 3.
• Another study reviewed the use of valganciclovir in the management of CMV infection and disease in immunocompromised patients, and found that it is as effective as intravenous ganciclovir for the treatment of AIDS-related CMV retinitis, and oral ganciclovir for the prophylaxis of CMV infection and disease in high-risk solid organ transplant recipients 4.
• A prospective, comparative cohort study compared the efficacy of valganciclovir with intravenous ganciclovir for preemptive therapy or treatment of CMV disease in solid organ transplant recipients, and found that valganciclovir is safe and useful for preemptive therapy and treatment of CMV disease 5.
• However, a meta-analytic study found that valganciclovir shows no superior efficacy and significantly higher risk of absolute neutropenia, CMV late-onset disease, and CMV tissue-invasive disease compared to other standard therapies 6.
• A Cochrane review found that prophylaxis with antiviral medications, including valganciclovir, reduces CMV disease and CMV-associated mortality in solid organ transplant recipients, and should be used routinely in CMV positive recipients and in CMV negative recipients of CMV positive organ transplants 7.

Key Findings

• Valganciclovir is effective for prophylaxis of CMV infection and disease in high-risk solid organ transplant recipients 3, 4, 5.
• Letermovir is noninferior to valganciclovir for prophylaxis of CMV disease in CMV-seronegative kidney transplant recipients who receive an organ from a CMV-seropositive donor 3.
• Valganciclovir has a higher risk of absolute neutropenia, CMV late-onset disease, and CMV tissue-invasive disease compared to other standard therapies 6.
• Prophylaxis with antiviral medications reduces CMV disease and CMV-associated mortality in solid organ transplant recipients 7.