Department of Pharmacy, University of Wisconsin Hospital and Clinics, Madison, WI, USA.
Department of Medicine, Division of Nephrology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Ann Pharmacother. 2023 May;57(5):597-608. doi: 10.1177/10600280221118959. Epub 2022 Aug 24.
To review the efficacy and safety of maribavir for management of cytomegalovirus (CMV) in solid organ transplant recipients.
A literature search of PubMed and the Cochrane Controlled Trials Register (1960 to early July 2022) was performed using the following search terms: , and .
All relevant English-language studies were reviewed and considered, with a focus on phase 3 trials.
Maribavir, an orally available benzimidazole riboside with minimal adverse effects, was originally studied for universal prophylaxis in phase 3 trials but failed to demonstrate noninferiority over placebo and oral ganciclovir. It was effective for preemptive treatment in a dose-finding Phase 2 study. Maribavir is FDA approved for treatment of refractory/resistant CMV infection based on improved response rate at 8 weeks compared with investigator-assigned therapy (IAT) when initiated at median viral loads less than approximately 10 000 IU/mL (55.7% vs 23.9%, < 0.001). Recurrence after 8-week treatment for refractory/resistant CMV was high (maribavir 50% vs IAT 39%). Significant drug interactions exist and must be managed by a pharmacotherapy expert to prevent harm.
The addition of maribavir to the antiviral armamentarium should improve the management of refractory/resistant CMV, allowing early transition from toxic, high-cost, intravenous agents such as foscarnet and outpatient management. Optimal timing of initiation, duration, and potential alternative uses are unclear.
Future studies are needed to fully elucidate the role of maribavir in the management of CMV after transplant.
回顾马拉韦罗治疗实体器官移植受者巨细胞病毒 (CMV) 的疗效和安全性。
使用以下搜索词在 PubMed 和 Cochrane 对照试验登记处(1960 年至 2022 年 7 月初)进行文献检索:, 和 。
综述了所有相关的英文研究,并重点关注了 3 期试验。
马拉韦罗是一种口服可用的苯并咪唑核苷,副作用极小,最初在 3 期试验中进行了广泛预防研究,但未能证明其非劣效性优于安慰剂和口服更昔洛韦。在一项剂量发现的 2 期研究中,它在抢先治疗方面是有效的。马拉韦罗基于与研究者指定治疗(IAT)相比,在中位数病毒载量低于约 10000IU/mL 时,8 周时改善反应率(分别为 55.7%和 23.9%,<0.001),被 FDA 批准用于治疗难治/耐药性 CMV 感染。在 8 周治疗后,难治/耐药性 CMV 的复发率很高(马拉韦罗 50%,IAT 39%)。存在显著的药物相互作用,必须由药物治疗学专家进行管理以防止伤害。
将马拉韦罗添加到抗病毒武器库中应改善难治/耐药性 CMV 的管理,允许尽早从毒性大、成本高、静脉内药物(如膦甲酸)过渡,并进行门诊管理。启动时机、持续时间和潜在替代用途尚不清楚。
需要进一步的研究来充分阐明马拉韦罗在移植后 CMV 管理中的作用。