Department of Gastroenterology, Medical School of National and Kapodistrian University of Athens, Laiko General Hospital, Athens, Greece.
Department of Internal Medicine, Thessalia University Medical School, Larissa, Greece.
J Hepatol. 2020 Nov;73(5):1037-1045. doi: 10.1016/j.jhep.2020.06.011. Epub 2020 Jun 16.
BACKGROUND & AIMS: A recent study in Asian patients with chronic hepatitis B (CHB) reported that the incidence of hepatocellular carcinoma (HCC) was lower in patients treated with tenofovir disoproxil fumarate (TDF) than entecavir (ETV), but this finding remains controversial. We aimed to identify any differences in HCC incidence, or other patient outcomes, between patients receiving TDF or ETV in the well monitored, multicenter European PAGE-B cohort.
We included 1,935 Caucasians with CHB, with or without compensated cirrhosis, treated with ETV (n = 772) or TDF (n = 1,163) monotherapy. Mean follow-up was 7.1 ± 3.0 years from ETV/TDF onset.
The 5-year cumulative HCC incidence was 5.4% in ETV- and 6.0% in TDF-treated patients (log-rank, p = 0.321), with no significant difference in any patient subgroup (with or without cirrhosis, naïve or experienced to oral antiviral(s) [total, with or without cirrhosis]). In multivariable Cox regression analyses, the hazard of HCC was similar between ETV- and TDF-treated patients after adjustment for several HCC risk factors. ETV- and TDF-treated patients had similar rates of on-therapy biochemical and virological remission, HBsAg loss, liver transplantation and/or death. Elastographic reversion of cirrhosis at year 5 (liver stiffness <12 kPa) was observed in 245/347 (70.6%) patients with pretreatment cirrhosis, being more frequent in TDF- than ETV- treated patients (73.8% vs. 61.5%, p = 0.038).
In Caucasian patients with CHB, with or without cirrhosis, long-term ETV or TDF monotherapy is associated with similar HCC risk, rates of biochemical/virological remission, HBsAg loss and liver transplantation or death, but elastographic reversion of cirrhosis at year 5 was more frequent with TDF.
In a large cohort of Caucasians with chronic hepatitis B treated with entecavir (ETV) or tenofovir disoproxil fumarate (TDF) monotherapy, cumulative rates of hepatocellular carcinoma did not differ (up to 12 years). Nor did rates of biochemical/virological remission, HBsAg loss and liver transplantation or death. However, elastographic reversion of cirrhosis at year 5 was more frequent in TDF- than ETV-treated patients with pretreatment cirrhosis.
最近一项针对亚洲慢性乙型肝炎（CHB）患者的研究报告称，替诺福韦酯（TDF）治疗患者的肝细胞癌（HCC）发生率低于恩替卡韦（ETV）治疗患者，但这一发现仍存在争议。我们旨在确定在经过良好监测的、多中心的欧洲 PAGE-B 队列中，接受 TDF 或 ETV 治疗的患者之间 HCC 发生率或其他患者结局是否存在差异。
我们纳入了 1935 名接受 ETV（n=772）或 TDF（n=1163）单药治疗的 CHB 白人患者，无论是否伴有代偿性肝硬化。ETV/TDF 起始后的中位随访时间为 7.1±3.0 年。
ETV 组和 TDF 组患者的 5 年 HCC 累积发生率分别为 5.4%和 6.0%（对数秩检验，p=0.321），各患者亚组（伴或不伴肝硬化、初治或经治口服抗病毒药物[总人群，伴或不伴肝硬化]）之间无显著差异。多变量 Cox 回归分析显示，调整多个 HCC 风险因素后，ETV 组和 TDF 组患者 HCC 的发生风险相似。ETV 组和 TDF 组患者治疗期间的生化和病毒学缓解率、HBsAg 丢失率、肝移植率和/或死亡率相似。在有预处理肝硬化的 347 例患者中，5 年时弹性成像逆转肝硬化（肝脏硬度<12kPa）的比例为 245/347（70.6%），TDF 组高于 ETV 组（73.8% vs. 61.5%，p=0.038）。
在白人 CHB 患者中，无论是否伴有肝硬化，长期应用 ETV 或 TDF 单药治疗与 HCC 风险相似，生化/病毒学缓解率、HBsAg 丢失率以及肝移植或死亡的发生率也相似，但 TDF 组 5 年时肝硬化的弹性成像逆转率更高。
在一项纳入接受恩替卡韦（ETV）或替诺福韦酯（TDF）单药治疗的白人慢性乙型肝炎（CHB）患者的大型队列研究中，直至 12 年，HCC 的累积发生率无差异。生化/病毒学缓解率、HBsAg 丢失率以及肝移植或死亡的发生率也无差异。然而，在有预处理肝硬化的患者中，TDF 组肝硬化的弹性成像逆转率高于 ETV 组。
