Department of Medicine, Division of Infectious Diseases, Ruth and Raymond Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Antimicrob Agents Chemother. 2022 Sep 20;66(9):e0240521. doi: 10.1128/aac.02405-21. Epub 2022 Aug 2.
Maribavir was approved by the U.S. Food and Drug Administration in November 2021 for the treatment of adult and pediatric patients with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet. Maribavir is an oral benzimidazole riboside with potent and selective multimodal anti-CMV activity. It utilizes a novel mechanism of action which confers activity against CMV strains that are resistant to traditional anti-CMV agents, and also offers a more favorable safety profile relative to the dose-limiting side effects of previously available therapies. Maribavir was initially studied as an agent for CMV prophylaxis in solid organ and hematopoietic stem cell recipients, but initial phase III trials failed to meet clinical efficacy endpoints. It has been more recently studied as a therapeutic agent at higher doses for refractory-resistant (R-R) CMV infections with favorable outcomes. After an overview of maribavir's chemistry and clinical pharmacology, this review will summarize clinical efficacy, safety, tolerability, and resistance data associated with maribavir therapy.
马拉韦罗于 2021 年 11 月获得美国食品药品监督管理局批准，用于治疗成人和儿科患者的移植后巨细胞病毒（CMV）感染/疾病，这些患者对更昔洛韦、缬更昔洛韦、西多福韦或膦甲酸钠治疗（有或无基因型耐药）无反应。马拉韦罗是一种口服苯并咪唑核苷，具有强大且选择性的多模式抗 CMV 活性。它采用了一种新颖的作用机制，对传统抗 CMV 药物耐药的 CMV 株具有活性，并且与先前可用疗法的剂量限制副作用相比，具有更有利的安全性特征。马拉韦罗最初被研究作为实体器官和造血干细胞受者的 CMV 预防药物，但最初的 III 期试验未能达到临床疗效终点。最近，它在更高剂量下被研究为治疗难治性/耐药性（R-R）CMV 感染的药物，结果良好。在概述马拉韦罗的化学和临床药理学后，本文将总结与马拉韦罗治疗相关的临床疗效、安全性、耐受性和耐药性数据。
