Letermovir was shown to be just as effective as valganciclovir in preventing CMV in kidney transplant recipients in new study published in JAMA; results prompt additional FDA approval for this indication.
, according to the editorialists, leading patients to potentially stop taking the drug early or lower the dosage. November 2021 for the treatment of post-transplant CMV that is resistant to other drugs in transplant recipients aged 12 years or older who weigh at least 35 kg .The new study was a phase 3, randomized, active-controlled, double masked, double-dummy, noninferiority trial comparing letermovir with valganciclovir and included 589 participants across 94 international locations.
Patients in the letermovir group were also less likely to develop early disease: the letermovir group had no cases of CMV disease compared with 1.7%, or five cases, developing in the valganciclovir group, at week 28. "The surprising absence of resistance sequence variants or breakthrough disease in this prevention trial is a critical and somewhat unexpected finding," Raglow and Kaul write in their editorial. in the letermovir group compared with the valganciclovir group , meaning drug discontinuation due to adverse events is less likely with letermovir.
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