Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong Special Administrative Region; Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.
Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong Special Administrative Region; Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong Special Administrative Region; State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong Special Administrative Region.
J Hepatol. 2019 Mar;70(3):361-370. doi: 10.1016/j.jhep.2018.10.014. Epub 2018 Oct 25.
BACKGROUND & AIMS: In treated patients with chronic hepatitis B (CHB) who have achieved complete viral suppression, it is unclear if functional cure as indicated by hepatitis B surface antigen (HBsAg) seroclearance confers additional clinical benefit. We compared the risk of hepatocellular carcinoma (HCC) and hepatic events in nucleos(t)ide analogue (NA)-treated patients with and without HBsAg seroclearance.
We performed a territory-wide retrospective cohort study on all patients with CHB who had received entecavir and/or tenofovir disoproxil fumarate (TDF) for at least 6 months between 2005 and 2016 from Hospital Authority, Hong Kong. Patients' demographics, comorbidities, and laboratory parameters were analyzed. The primary outcome was HCC. The secondary outcomes were hepatic events including cirrhotic complications, liver transplantation, and liver-related mortality.
A total of 20,263 entecavir/TDF-treated patients with CHB were identified; 17,499 (86.4%) patients had complete viral suppression; 376 (2.1%) achieved HBsAg seroclearance. At a median (interquartile range) follow-up of 4.8 (2.8-7.0) years, 603 (3.5%) and 121 (4.4%) patients with and without complete viral suppression developed HCC; 2 (0.5%) patients with HBsAg seroclearance developed HCC. Compared to complete viral suppression, lack of complete viral suppression was associated with a higher risk of HCC (7.8% vs. 5.6% at 8 years, Gray's test, p <0.001) (adjusted hazard ratio [aHR] 1.69; 95% CI 1.36-2.09; p <0.001); patients who achieved functional cure had a lower risk of HCC (0.6% vs. 5.6% at 8 years, Gray's test, p <0.001) (aHR 0.24; 95% CI 0.06-0.97; p = 0.045) but not hepatic events (aHR 0.99; 95% CI 0.30-3.26; p = 0.991).
Patients who achieved HBsAg seroclearance on top of complete viral suppression with entecavir/TDF treatment may have a lower risk of HCC but not hepatic events.
We investigated 20,263 nucleos(t)ide analogue (NA)-treated patients with chronic hepatitis B. Patients with NA-induced hepatitis B surface antigen seroclearance on top of complete viral suppression have a lower risk of hepatocellular carcinoma but not hepatic events than those only achieving complete viral suppression under prolonged NA treatment.
在接受核苷（酸）类似物（NA）治疗并实现完全病毒抑制的慢性乙型肝炎（CHB）患者中，HBsAg 血清学清除（功能性治愈）是否能带来额外的临床获益尚不清楚。我们比较了 HBsAg 血清学清除患者和未清除患者发生肝细胞癌（HCC）和肝脏事件的风险。
我们对香港医院管理局在 2005 年至 2016 年间接受恩替卡韦和/或替诺福韦酯（TDF）治疗至少 6 个月的所有 CHB 患者进行了一项全港范围的回顾性队列研究。分析了患者的人口统计学、合并症和实验室参数。主要结局为 HCC。次要结局包括肝硬化并发症、肝移植和与肝脏相关的死亡率。
共纳入 20263 例接受恩替卡韦/TDF 治疗的 CHB 患者；17499 例（86.4%）患者实现了完全病毒抑制；376 例（2.1%）患者实现了 HBsAg 血清学清除。中位（四分位距）随访 4.8（2.8-7.0）年后，603 例（3.5%）和 121 例（4.4%）完全病毒抑制患者和未完全病毒抑制患者发生 HCC；2 例（0.5%）HBsAg 血清学清除患者发生 HCC。与完全病毒抑制相比，未完全病毒抑制与 HCC 风险增加相关（8 年时的 7.8%比 5.6%，Gray 检验，p<0.001）（调整后危险比[aHR] 1.69；95%CI 1.36-2.09；p<0.001）；实现功能性治愈的患者 HCC 风险较低（8 年时的 0.6%比 5.6%，Gray 检验，p<0.001）（aHR 0.24；95%CI 0.06-0.97；p=0.045），但肝脏事件风险无差异（aHR 0.99；95%CI 0.30-3.26；p=0.991）。
在接受恩替卡韦/TDF 治疗的患者中，在实现完全病毒抑制的基础上实现 HBsAg 血清学清除的患者可能 HCC 风险较低，但肝脏事件风险无差异。
医脉通
