Division of Public Health, Infectious Diseases and Occupational Medicine, Mayo Clinic, Rochester, MN, USA.
William J von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, MN, USA.
Drug Des Devel Ther. 2024 Sep 6;18:3987-4001. doi: 10.2147/DDDT.S265644. eCollection 2024.
Cytomegalovirus (CMV) infection is arguably the most important infectious complication that negatively affects the outcome of solid organ transplantation. For decades, CMV management after transplantation has relied on antiviral drugs that inhibit viral DNA polymerase (ganciclovir, foscarnet, and cidofovir). However, their use has been complicated by myelosuppression, nephrotoxicity, and selection of drug-resistant viruses. During the past few years, the therapeutic armamentarium for the management of CMV in solid organ transplant recipients has expanded with the approval of letermovir for CMV prophylaxis in high-risk CMV D+/R- kidney recipients, and maribavir for the treatment of refractory and resistant CMV infection. Both drugs offer significant improvement when compared to standard anti-CMV therapies; letermovir was as efficacious for CMV prevention, whereas maribavir was more effective in treating refractory and resistant CMV infections. Both letermovir and maribavir have favorable safety profiles compared to CMV DNA polymerase inhibitors, without the risk of neutropenia and leukopenia associated with ganciclovir and renal toxicities associated with foscarnet and cidofovir. Moreover, letermovir and maribavir are orally bioavailable, which allows convenient outpatient treatment. However, letermovir and maribavir have a significant drug interaction potential in solid organ transplant recipients, resulting in higher levels of calcineurin inhibitors (cyclosporine and tacrolimus) and mTOR inhibitors (sirolimus and everolimus). Both letermovir and maribavir are CMV-specific and do not have clinical efficacy against other herpes viruses. Thus, there is a need for additional antiviral drugs to prevent herpes simplex and other herpes viruses when clinically indicated. This article provides a comprehensive review of the clinical data supporting the use of letermovir and maribavir in clinical practice. The author provides perspectives on the role of these newly approved drugs in the current management landscape of CMV infection in solid organ transplantation.
巨细胞病毒 (CMV) 感染可说是最重要的感染性并发症,会对实体器官移植的结果产生负面影响。几十年来,移植后的 CMV 管理依赖于抑制病毒 DNA 聚合酶的抗病毒药物(更昔洛韦、膦甲酸和缬更昔洛韦)。然而,它们的使用受到骨髓抑制、肾毒性和耐药病毒选择的影响。在过去的几年中,用于治疗实体器官移植受者 CMV 的治疗方法已经扩大,批准了来特莫韦用于高危 CMV D+/R-肾移植受者的 CMV 预防,以及马拉韦用于治疗难治性和耐药性 CMV 感染。与标准抗 CMV 疗法相比,这两种药物都有显著改善;来特莫韦在预防 CMV 方面同样有效,而马拉韦在治疗难治性和耐药性 CMV 感染方面更有效。与 CMV DNA 聚合酶抑制剂相比,来特莫韦和马拉韦的安全性更好,没有与更昔洛韦相关的中性粒细胞减少和白细胞减少以及与膦甲酸和缬更昔洛韦相关的肾毒性的风险。此外,来特莫韦和马拉韦具有口服生物利用度,允许方便的门诊治疗。然而,来特莫韦和马拉韦在实体器官移植受者中有显著的药物相互作用潜力,导致钙调神经磷酸酶抑制剂(环孢素和他克莫司)和 mTOR 抑制剂(西罗莫司和依维莫司)的水平升高。来特莫韦和马拉韦都是 CMV 特异性的,对其他疱疹病毒没有临床疗效。因此,当临床需要时,需要额外的抗病毒药物来预防单纯疱疹和其他疱疹病毒。本文全面回顾了支持来特莫韦和马拉韦在临床实践中应用的临床数据。作者提供了这些新批准药物在当前实体器官移植中 CMV 感染管理中的作用的观点。