İstemihan Zülal, Kemeç Gamze, Cebeci Timurhan, Çetin Okan, Genç Uluçeçen Sezen, Rüstemzade Aynure, Nuriyev Kanan, Çavuş Bilger, Çifcibaşi Örmeci Asli, Akyüz Filiz, Demir Kadir, Beşişik Fatih, Kaymakoğlu Sabahattin
Department of Internal Medicine, Division of Gastroenterohepatology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Türkiye.
Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Türkiye.
Medicine (Baltimore). 2025 Jun 6;104(23):e42766. doi: 10.1097/MD.0000000000042766.
This study aims to investigate antiviral effectiveness, side effects, and disease outcomes in patients who have been using entecavir (ETV) and tenofovir disoproxil fumarate (TDF) for a long-term in chronic hepatitis B. Patients with chronic hepatitis B who had been using TDF or ETV for at least 10 years were included in this retrospective study. Co-infected patients, those receiving immunosuppressive therapy, and transplant patients were excluded. Of the study's total 173 patients (baseline mean age 43.4 ± 11.7 years), 110 (63.6%) were men. Thirty-three (19.1%) patients were cirrhotic, and hepatitis B e-antigen was negative in 131 (75.7%) patients at the baseline. Ninety-two (53.2%) patients used TDF and 81 (46.8%) used ETV for a mean of 156.76 ± 21.60 (120-204) months. Hepatitis B virus (HBV)-DNA negativity (<10 IU/mL) was achieved in 97.7% of all patients. Biochemical remission was achieved in 98.3% of all patients at the last visit. HBsAg became negative in only 5 (2.9%). Hepatocellular carcinoma (HCC) developed in 9 (5.2%) patients. All HCCs occurred after the 5th year of treatment. The age at HBV diagnosis was higher in HCC patients (P = .023), but the most important risk factor for the development of HCC was to have cirrhosis at baseline. Eight (4.6%) patients died in the follow-up, and 2 were due to liver disease and the remaining non-liver disease. At the end of follow-up, HBV-DNA negativity was achieved in almost all patients, and HBsAg sero-clearance was rarely achieved. Very few patients developed HCC and the long-term mortality rate was similar to the general population.
本研究旨在调查长期使用恩替卡韦（ETV）和替诺福韦酯（TDF）治疗慢性乙型肝炎患者的抗病毒疗效、副作用及疾病转归。本项回顾性研究纳入了使用TDF或ETV至少10年的慢性乙型肝炎患者。排除合并感染患者、接受免疫抑制治疗的患者以及移植患者。在该研究纳入的全部173例患者中（基线平均年龄43.4±11.7岁），110例（63.6%）为男性。33例（19.1%）患者为肝硬化患者，基线时131例（75.7%）患者乙肝e抗原阴性。92例（53.2%）患者使用TDF，81例（46.8%）患者使用ETV，平均用药时间为156.76±21.60（120 - 204）个月。所有患者中97.7%实现了乙肝病毒（HBV）DNA转阴（<10 IU/mL）。末次随访时所有患者中98.3%实现了生化缓解。仅5例（2.9%）患者HBsAg转阴。9例（5.2%）患者发生肝细胞癌（HCC）。所有HCC均在治疗5年后发生。HCC患者的HBV诊断年龄较高（P = 0.023），但发生HCC的最重要危险因素是基线时存在肝硬化。8例（4.6%）患者在随访期间死亡，其中2例死于肝脏疾病，其余死于非肝脏疾病。随访结束时，几乎所有患者均实现了HBV - DNA转阴，很少实现HBsAg血清学清除。很少有患者发生HCC，长期死亡率与普通人群相似。
