Cytomegalovirus prophylaxis with letermovir in pediatric (birth to <18 years of age) hematopoietic cell transplant recipients: pharmacokinetics, efficacy, and safety results of a Phase 2b study. (PubMed, Antimicrob Agents Chemother) - Aug 18, 2025 - P2 | "In AG3, the initial cohort (letermovir with cyclosporin A) achieved exposures trending lower than the median exposure target; the letermovir dose was increased for the remaining participants. At exposures achieved, letermovir was efficacious and safe in preventing clinically significant CMV infection in pediatric allogeneic HCT recipients. The observed concentration data informed a pediatric PopPK model to optimize final letermovir dose recommendations in this population.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT03940586."
Journal • P2b data • PK/PD data • Bone Marrow Transplantation • Cytomegalovirus Infection • Infectious Disease • Pediatrics • Transplantation
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Aharon Gefen; Andreas H Groll; Barbara Haber; Bella Bielorai; Christopher J Fraser; Christopher L Gilbert; Cyrus Badshah; David Bueno; Jacqueline B McCrea; Johannes H Schulte; Lara Danziger-Isakov; Mayankbhai Patel; Natalya Broyde; Nicole A Karras; Peter J Shaw
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