Tanaka Yasuhito, Nakamoto Daisuke, Piao Yi, Mizutani Hajime, Wakabayashi Ryozo, Saito Yoshiyuki, Kwon Kyung Min, Dickinson Harriet
Department of Gastroenterology and Hepatology, Faculty of Life Sciences, Kumamoto University, 1-1-1 Honjo Chuo-ku, Kumamoto-shi, Kumamoto, Japan.
Gilead Sciences K.K., 1-9-2 Marunochi Gran Tokyo South Tower 16F, Chiyoda-ku, Tokyo, 100-6616, Japan.
Infect Dis Ther. 2024 Jul;13(7):1607-1620. doi: 10.1007/s40121-024-00997-0. Epub 2024 May 29.
Although patients with HBV have a risk of reactivation after immunosuppressive therapy (IST), the status of their risk management is unclear in Japan. This study aims to describe the proportion of patients who received preventive management of HBV reactivation during ISTs in patients with chronic HBV infection of HBsAg or resolved HBV infection.
A retrospective cohort study was conducted using the JMDC Japanese claims database from April 2011 to June 2021. Patients with HBV infections of HbsAg who received ISTs or patients who had resolved HBV infections who received ISTs were identified from the database and evaluated for appropriate management to prevent HBV reactivation.
In total, 6242 eligible patients were identified. The proportions of patients with appropriate HBV reactivation management, stratified by the HBV reactivation risk level of IST, was 43.1% (276/641) for high-risk, 40.2% (223/555) for intermediate-risk and 14.9% (741/4965) for low-risk patients. When the evaluation period for the outcome calculation was shortened from 360 to 180 days, the proportion for high risk increased to 52.7%. The odds ratios of large hospitals for receiving appropriate management were 2.16 (95% CI 1.12-4.44) in the high-risk, 4.63 (95% CI 2.34-10.25) in the intermediate-risk and 3.60 (95% CI 3.07-4.24) in the low-risk patients.
HBV reactivation management was tailored according to the reactivation risk associated with IST. However, adherence to HBV reactivation management guidelines was sub-optimal, even among high-risk patients. This is especially the case for ensuring smaller-sized medical institutions, highlighting the need for further educational activities.
尽管乙肝病毒(HBV)感染者在免疫抑制治疗(IST)后有再激活的风险,但在日本,其风险管理状况尚不清楚。本研究旨在描述在HBsAg慢性HBV感染或已治愈HBV感染患者接受IST期间接受HBV再激活预防性管理的患者比例。
使用JMDC日本索赔数据库进行了一项回顾性队列研究,时间跨度为2011年4月至2021年6月。从数据库中识别出接受IST的HBsAg HBV感染者或接受IST的已治愈HBV感染患者,并评估其预防HBV再激活的适当管理情况。
总共识别出6242名符合条件的患者。根据IST的HBV再激活风险水平分层,接受适当HBV再激活管理的患者比例为:高风险患者43.1%(276/641),中风险患者40.2%(223/555),低风险患者14.9%(741/4965)。当计算结果的评估期从360天缩短至180天时,高风险患者的比例增加到52.7%。大型医院接受适当管理的优势比在高风险患者中为2.16(95%CI 1.12 - 4.44),中风险患者中为4.63(95%CI 2.34 - 10.25),低风险患者中为3.60(95%CI 3.07 - 4.24)。
HBV再激活管理是根据与IST相关的再激活风险进行调整的。然而,即使在高风险患者中,对HBV再激活管理指南的遵守情况也不理想。在小型医疗机构中尤其如此,这突出了进一步开展教育活动的必要性。