Background: Everolimus is approved for treating breast, renal, and pancreatic neuroendocrine cancers but carries the risk of hepatitis B virus (HBV) reactivation (HBVr) and hepatitis. However, data on HBVr in everolimus-treated patients are limited. This study evaluates the risk of hepatitis and HBVr in cancer patients with current or past HBV infection. Methods: This retrospective study analyzed patients prescribed everolimus between 1 January 2011 and 31 May 2022, using a private healthcare system database in Taiwan. Patients with HBsAg positivity or HBsAg negativity and anti-HBs or anti-HBc results were included. The cumulative incidence function and risk of hepatitis from a competing risk model, which estimates Fine-Gray subdistribution hazard (SDH), were analyzed across different HBV serological subgroups. The risk of hepatitis B reactivation was also calculated. Results: Of 377 patients, 45% (36/80) of HBsAg-positive and 0.67% (2/297) of HBsAg-negative patients received nucleos(t)ide analogues (NUCs) prophylaxis. Hepatitis occurred in 28.75% of HBsAg-positive and 17.85% of HBsAg-negative patients. Baseline HBsAg positivity and exemestane use increased hepatitis risk. HBVr occurred in 11.36% (5/44) of HBsAg-positive patients without NUCs and 5.56% (2/36) with prophylaxis. Two HBsAg-negative, anti-HBc-positive patients developed severe HBVr-related hepatitis. Conclusion: Hepatitis occurred in 28.75% of HBsAg-positive and 17.85% of HBsAg-negative patients on everolimus. HBVr was common in HBsAg-positive patients but rare in HBsAg-negative individuals. HBV screening and liver function monitoring are critical for patients with past or current HBV infection receiving everolimus, especially in endemic areas.
背景：依维莫司被批准用于治疗乳腺、肾和胰腺神经内分泌肿瘤，但存在乙型肝炎病毒（HBV）再激活（HBVr）及肝炎风险。然而，关于依维莫司治疗患者中HBVr的数据有限。本研究旨在评估当前或既往感染HBV的癌症患者发生肝炎及HBVr的风险。 方法：这项回顾性研究利用台湾某私立医疗系统数据库，分析了2011年1月1日至2022年5月31日期间接受依维莫司处方的患者。纳入标准包括HBsAg阳性，或HBsAg阴性但具有抗-HBs或抗-HBc检测结果的患者。采用竞争风险模型分析不同HBV血清学亚组中肝炎的累积发生函数及风险，并估计Fine-Gray亚分布风险比（SDH）。同时计算了乙型肝炎再激活的风险。 结果：在377例患者中，45%（36/80）的HBsAg阳性患者和0.67%（2/297）的HBsAg阴性患者接受了核苷（酸）类似物（NUCs）预防治疗。肝炎发生率在HBsAg阳性患者中为28.75%，在HBsAg阴性患者中为17.85%。基线HBsAg阳性和依西美坦的使用增加了肝炎风险。在未接受NUCs预防的HBsAg阳性患者中，HBVr发生率为11.36%（5/44），而在接受预防的患者中为5.56%（2/36）。两名HBsAg阴性、抗-HBc阳性的患者出现了严重的HBVr相关肝炎。 结论：接受依维莫司治疗的患者中，HBsAg阳性者肝炎发生率为28.75%，HBsAg阴性者为17.85%。HBVr在HBsAg阳性患者中较为常见，但在HBsAg阴性个体中罕见。对于接受依维莫司治疗的当前或既往HBV感染患者，尤其是在流行地区，进行HBV筛查和肝功能监测至关重要。
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