Clinical and economic evaluation of a surveillance protocol to manage hepatitis B virus (HBV) reactivation among lymphoma patients with resolved HBV infection receiving rituximab
Clinical and economic evaluation of a surveillance protocol to manage hepatitis B virus (HBV) reactivation among lymphoma patients with resolved HBV infection receiving rituximab
复制标题
DOI：
10.1002/phar.2508
复制
发表时间：
2021-02-27
期刊：
影响因子：
4.1
通讯作者：
Tang, Tiffany
中科院分区：
文献类型：
--
作者：
Tan, Chia Jie;Kumar, Rajneesh;Tang, Tiffany
研究目的评价在接受利妥昔单抗治疗的淋巴瘤患者中控制乙肝病毒(乙肝病毒)再激活风险的监测方案。设计前瞻性单臂研究。设立新加坡国家癌症中心。利妥昔单抗治疗期间每4-6周，治疗后第一年每6-8周，治疗后第二年每3-4个月。通过评估再激活相关事件的发生率来评估监测方案的有效性。可行性是根据患者的依从性进行评估的。使用成本最小化方法进行经济学分析，以比较监测方案和普遍预防方案之间的成本，恩替卡韦每日0.5 mg，最长可达1年。主要结果：共有66名患者提供了可分析的数据，随访时间为966.6个月。没有检测到肝炎发作或与再激活相关的事件。监测方案依从率中位数为90.5%。在整个监测期间，如果采用监测方案，每个患者可节省946.40美元的成本，且受预防持续时间和抗病毒预防费用变化的影响最大。结论监测方案是一种有效、可行和节省成本的策略，可以管理接受利妥昔单抗治疗的乙肝病毒感染缓解的淋巴瘤患者的乙肝病毒再激活。
Study Objective To evaluate a surveillance protocol in managing the risk of hepatitis B virus (HBV) reactivation among lymphoma patients with resolved HBV infection receiving rituximab.Design Prospective, single-arm study.Setting National Cancer Centre, Singapore.Patients Lymphoma patients with resolved HBV infection and scheduled to receive rituximab-based treatment.Intervention Close monitoring of HBV DNA levels, ie. every 4-6 weeks during rituximab treatment, every 6-8 weeks in the first year post-treatment, and every 3-4 months in the second year post-treatment.Measurements The efficacy of the surveillance protocol was examined by evaluating the rates of reactivation-related events. Feasibility was evaluated based on patient adherence. An economic analysis using a cost-minimization approach was conducted to compare the costs between the surveillance protocol and universal prophylaxis with entecavir 0.5 mg daily up to 1 year after cessation of rituximab.Main Results: A total of 66 patients provided analyzable data with a follow-up period of 966.6 months. No hepatitis flare or reactivation-related events were detected. The median adherence rate to the surveillance protocol was 90.5%. Cost savings of US$946.40 per patient over the entire surveillance period were achieved if the surveillance protocol was adopted and was most affected by changes in prophylaxis duration and the cost of antiviral prophylaxis.Conclusions The surveillance protocol is an effective, feasible and cost-saving strategy to manage HBV reactivation among lymphoma patients with resolved HBV infection receiving rituximab.