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New Antiviral Drug Licensed by the FDA Shows Promise for Kidney Transplant Recipients

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Emedinexus    09 June 2023

According to the findings of the phase III clinical trial, the recently authorized antiviral Letermovir for the treatment of cytomegalovirus infections (CMV) showed promise in kidney transplant patients, who are more sensitive to the virus. The results published in the Journal of the American Medical Association (JAMA) revealed that letermovir has a lower potential to generate low levels of infection-fighting white blood cells.

Letermovir, developed by US drug major Merck, has shown similar efficacy to valganciclovir in preventing CMV disease in recipients of kidneys from CMV-positive donors. It was initially approved by the US Food and Drug Administration (FDA) in 2017.

Oral valganciclovir, administered for 200 days following transplant, is standard therapy to prevent problems in high-risk kidney transplants from CMV-positive donors to CMV-negative recipients, although it suppresses the immune system.

Additionally, it requires dose adjustments because of fluctuating kidney function after transplant and can lead to valganciclovir resistance. However, letermovir does not require dose adjustment because of fluctuating kidney function after the transplant.

In the clinical trial, the researchers from the University of Washington compared the effectiveness of two antiviral drugs in 586 adult kidney transplant recipients who were randomly assigned to receive either letermovir (480 milligrams) or valganciclovir (900 mg) for up to 200 days after transplant.

The findings of the study showed that letermovir was non-inferior to valganciclovir in preventing CMV illness. Also, letermovir was associated with lower rates of leukopenia or neutropenia. It was seen that 1.7% of the recipients in the valganciclovir group developed CMV illness through 28 weeks of treatment duration, while no recipient in the letermovir group developed CMV illness.

(Source:https://www.medscape.com/viewarticle/992878 )

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