Adverse events in kidney transplant patients
In a Phase 3 clinical trial in adult high-risk CMV D+/R- kidney transplant recipients,
prophylaxis with PREVYMIS® (letermovir) was generally well-tolerated
Adverse events through Week 28 (~200 days) post-transplant in adults
- Diarrhea was reported in at least 10% of subjects in the PREVYMIS group and at a frequency greater than valganciclovir (PREVYMIS 32% vs valganciclovir 29%)
Fewer patients discontinued PREVYMIS vs valganciclovir due to an AE through Week 28 (~200 days) post-transplant
- 4% of patients receiving PREVYMIS discontinued due to an AE vs 14% of patients receiving valganciclovir
- Most frequently reported AEs leading to discontinuation were neutropenia (1% with PREVYMIS vs 2% with valganciclovir) and leukopenia (1% with PREVYMIS vs 5% with valganciclovir)
In a Phase 3 clinical trial in adult high-risk CMV D+/R- kidney transplant recipients,
Selected laboratory abnormalities through Week 28 (~200 days) post-transplant
Prespecified analysis of neutropenia or leukopenia events through Week 28 in adults1
- The proportion of participants with events of leukopenia or neutropenia (reported as an AE by an investigator or as laboratory criteria defined in protocol as total WBC count <3500 cells/μL or ANC <1000 cells/μL) through Week 28 post-transplant was significantly lower in the PREVYMIS group compared with the valganciclovir group (26% vs 64%); P<0.0011
- Limitation: This analysis captures both clinical AEs reported by investigators and reported laboratory abnormalities. Laboratory abnormalities are not consistently reported as clinical AEs and laboratory results are generally considered to be more objective
Pediatric information
Use of PREVYMIS in pediatric patients
The use of PREVYMIS for prophylaxis of CMV disease in high-risk [D+/R-] kidney transplant recipients 12 years of age and older and weighing at least 40 kg is supported by evidence from an adequate and well-controlled study in adults and safety data from pediatric HSCT recipients (Trial P030). Letermovir exposures are expected to be similar between adult and pediatric patients 12 years of age and older and weighing at least 40 kg.
The safety and effectiveness of PREVYMIS have not been established for kidney transplant recipients less than 12 years of age or weighing less than 40 kg.
Reference
- Limaye AP, Budde K, Humar A, et al. Letermovir vs valganciclovir for prophylaxis of cytomegalovirus in high-risk kidney transplant recipients: a randomized clinical trial. JAMA. 2023;e239106. doi:10.1001/jama.2023.9106