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What's it Worth? A Journal Club PodcastAuthor: Diana Langworthy
Get into the weeds with us as we take deep dives into clinical trials and build the essential skills of evidence critique! This podcast is a tool for healthcare professions students and practitioners to sharpen their science sleuth skills, learn key concepts about study design, biostatistics, and application of evidence to clinical practice. Language: en Genres: Health & Fitness, Medicine Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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S4E11 - Letermovir vs Valganciclovir: A Noninferiority Trial in Kidney Transplant CMV
Episode 11
Wednesday, 23 September, 2026
Cytomegalovirus — or CMV — is one of those transplant complications that sits at the intersection of infectious diseases, immunosuppression, medication access, monitoring, and toxicity. In high-risk kidney transplant recipients, valganciclovir has long been a standard prophylaxis option, but its use can be limited by myelosuppression, renal dose adjustments, and real-world logistics. In this episode, host Dr. Diana Langworthy is joined by Erin Hellickson, PharmD and Alyson Prom, PharmD, inpatient solid organ transplant pharmacists at Fairview – East Bank Hospital. Together, they decode a 2023 JAMA randomized, noninferiority clinical trial comparing letermovir with valganciclovir for CMV prophylaxis in high-risk kidney transplant recipients. The clinical question: can letermovir provide similar CMV protection with less myelosuppression — and where might it fit in a complex transplant prophylaxis toolbox? Key Points CMV risk is highest in donor-positive/recipient-negative transplant recipients. Universal prophylaxis and preemptive monitoring each come with tradeoffs. Valganciclovir works, but myelosuppression and renal dose changes can complicate use. Letermovir offers a different CMV mechanism without the same renal dosing burden. Letermovir does not cover HSV or VZV, so prophylaxis decisions do not disappear. This trial used a double-masked, double-dummy noninferiority design. The 10% noninferiority margin, adherence patterns, and missing data approach are worth a closer look. Leukopenia, neutropenia, G-CSF use, resistance, and discontinuation rates shape the safety story. Does letermovir move from "alternative" to a future first-line prophylaxis option in kidney transplant — or is the answer still "it depends"? ----> Tune in to find out! Featured Study Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023;330(1):33-42. doi:10.1001/jama.2023.9106. Host & Guest Information Diana Langworthy, PharmD, BCPS | Associate Professor, University of Minnesota College of Pharmacy | Clinical Pharmacist, Inpatient Internal Medicine, M Health Fairview East Bank Hospital Erin Hellickson, PharmD | Inpatient Solid Organ Transplant Pharmacist, Fairview – East Bank Hospital Alyson Prom, PharmD | Inpatient Solid Organ Transplant Pharmacist, Fairview – East Bank Hospital Join the Conversation Have a study you'd like us to decode on a future episode? Email whatsitworthpodcast@gmail.com or share how you're navigating evidence in practice — I love hearing how clinicians and learners think through uncertainty. Or you can find me on my socials — check out my Beacons for links to my TikTok and LinkedIn: https://beacons.ai/diana.the.pharm.d.etective Additional References Kotton CN, Kumar D, Manuel O, Chou S, Hayden RT, Danziger-Isakov L, Asberg A, Tedesco-Silva H, Humar A; Transplantation Society International CMV Consensus Group. The Fourth International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2025;109(7):1066-1110. doi:10.1097/TP.0000000000005374. Kotton CN, Kumar D, Caliendo AM, et al.; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018;102(6):900-931. doi:10.1097/TP.0000000000002191. Humar A, Lebranchu Y, Vincenti F, et al. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. American Journal of Transplantation. 2010;10(5):1228-1237. doi:10.1111/j.1600-6143.2010.03074.x. Paya C, Humar A, Dominguez E, et al.; Valganciclovir Solid Organ Transplant Study Group. Efficacy and safety of valganciclovir vs oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. American Journal of Transplantation. 2004;4(4):611-620. doi:10.1111/j.1600-6143.2004.00382.x. Rissling O, Naik M, Brakemeier S, et al. High frequency of valganciclovir underdosing for cytomegalovirus prophylaxis after renal transplantation. Clinical Kidney Journal. 2018;11(4):564-573. doi:10.1093/ckj/sfx145.
