Zhang Dongmu, Weiss Thomas, Feng Yu, Finelli Lynn
Center for Observational and Real-World Evidence, Merck and Co., Inc., Kenilworth, NJ, USA.
Biostatistics and Research Decision Sciences, Merck and Co., Inc., Kenilworth, NJ, USA.
Adv Ther. 2017 Jul;34(7):1610-1621. doi: 10.1007/s12325-017-0553-4. Epub 2017 May 15.
There are no real-world data on antiviral prophylaxis (AP) duration and risk of herpes zoster (HZ) given AP duration in patients receiving autologous hematopoietic stem cell transplants (auto-HSCT). The objectives of this study are to describe the duration of AP and to compare incidence of HZ by AP duration in auto-HSCT patients.
This is a retrospective, observational database (Marketscan) study. This study included patients ≥18 years old who had auto-HSCT during 2009-2013, had chemotherapy within 60 days prior to auto-HSCT (latest chemotherapy date within the 60 days was the study enrollment date), and had continuous health plan enrollment for at least 365 days before and after the study enrollment date. AP duration was the sum of days supply of all AP prescriptions from 30 days before to 365 days after the study enrollment date. Patients were followed from the study enrollment date to the end of continuous health plan enrollment, death, or December 31, 2014 to assess HZ incidence. The Cox proportional hazards model was used to examine the association between the risk of HZ and AP duration.
This study identified 1959 eligible auto-HSCT patients, of whom 93.0% were prescribed AP. Average AP duration was 220 days (SD = 122), while 200 (11%) patients had AP for ≥1 year. HZ incidence was 42.4/1000 person-years (PY) (95% CI 36.5, 49.0) for the overall auto-HSCT cohort. Among patients who received AP, duration of AP prescriptions and HZ incidence were inversely related. Compared with patients who were on AP for 1-89 days, patients with AP duration of 180-269 days [hazard ratio (HR) = 0.576, p = 0.019], 270-359 days (HR = 0.594, p = 0.023), and ≥360 days (HR = 0.309, p < 0.001) had significantly lower risk of HZ.
Auto-HSCT patients are at increased risk for HZ, even when prescribed AP. A safe and effective vaccine against HZ for auto-HSCT patients could be a useful adjunctive prevention strategy.
对于接受自体造血干细胞移植（auto-HSCT）的患者，目前尚无关于抗病毒预防（AP）持续时间以及基于AP持续时间的带状疱疹（HZ）风险的真实世界数据。本研究的目的是描述AP的持续时间，并比较auto-HSCT患者中按AP持续时间划分的HZ发病率。
这是一项回顾性观察数据库（Marketscan）研究。本研究纳入了年龄≥18岁、在2009年至2013年期间接受auto-HSCT、在auto-HSCT前60天内接受过化疗（60天内的最新化疗日期为研究入组日期）且在研究入组日期前后至少连续参加健康计划365天的患者。AP持续时间是从研究入组日期前30天至入组日期后365天内所有AP处方的供应天数总和。从研究入组日期开始对患者进行随访，直至连续健康计划参保结束、死亡或2014年12月31日，以评估HZ发病率。采用Cox比例风险模型来检验HZ风险与AP持续时间之间的关联。
本研究确定了1959例符合条件的auto-HSCT患者，其中93.0%的患者开具了AP。AP的平均持续时间为220天（标准差=122），而200例（11%）患者接受AP的时间≥1年。整个auto-HSCT队列的HZ发病率为42.4/1000人年（95%置信区间36.5，49.0）。在接受AP的患者中，AP处方的持续时间与HZ发病率呈负相关。与接受AP 1 - 89天的患者相比，AP持续时间为180 - 269天[风险比（HR）=0.576，p = 0.019]、270 - 359天（HR = 0.594，p = 0.023）和≥360天（HR = 0.309，p < 0.001）的患者患HZ的风险显著较低。
即使开具了AP，auto-HSCT患者患HZ的风险仍会增加。一种针对auto-HSCT患者的安全有效的HZ疫苗可能是一种有用的辅助预防策略。
