Letermovir Versus Valganciclovir for 90 Days in CMV Seropositive Kidney Transplant Recipients: Results of a Single-center Experience.
Elisabeth Kincaide
Summary
The purpose of this study is to find out whether letermovir can help prevent cytomegalovirus (CMV) infection in kidney transplant recipients who are CMV seropositive. To do this, researchers will compare patients who received letermovir with a group of historical patients who received valganciclovir ("mini dose"). Both groups will be on CMV prophylaxis drug for 90 days post-transplant. The main question the study wants to answer is: • Does letermovir work as well as valganciclovir in preventing CMV infections during the first 12 months after a kidney transplant? The study will also look at other important questions: * Is letermovir easier for patients to tolerate than valganciclovir? * How long does it take for a CMV infection to appear in each group? * Are there differences in "breakthrough" CMV infections between the two medications? * For patients who develop CMV that becomes resistant to treatment, are the resistance patterns different between the two groups
Description
The purpose of this study is to evaluate the efficacy and tolerability of letermovir compared to standard-of-care, valganciclovir, for the prevention of clinically significant cytomegalovirus (CMV) infection in CMV moderate risk adult kidney transplant recipients. A 3:1 match of historical valganciclvoir:letermovir arm • Matching criteria: * Induction agent: lymphocyte-depleting (rabbit anti-thymocyte globulin or alemtuzumab) versus non-lymphocyte depleting (basiliximab) * Delayed graft function (dialysis within one week of kidney transplant) * MMF dose at de novo discharge (weight-based vs…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (both arms): * ≥18 years old * Kidney transplant recipient with documented CMV IgG seropositive status (R+) within 90 days prior to transplant Inclusion Criteria (letermovir arm): * Males agree to use contraception and refraining from donating sperm for 290 days post-treatment initiation * Females of child-bearing potential agree to follow contraception guidance for 290 days post-treatment initiation Exclusion Criteria (both arms): * Multiorgan organ transplant * Received previous solid organ transplant or HSCT * Unable to take oral medications * Uncontrolled infections…
Interventions
- DrugLetermovir
Letermovir 480 mg PO daily or 240 mg PO daily (if on cyclosporine) for 90 days post kidney transplant
- DrugValganciclovir CMV Prophylaxis
Valganciclovir 450 mg PO daily for 90 days post kidney transplant (Historical Control)
Location
- University HospitalSan Antonio, Texas