Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Liver Int. 2022 Jul;42(7):1517-1527. doi: 10.1111/liv.15261. Epub 2022 Apr 3.
We used real-world data to evaluate the efficacy and safety of tenofovir alafenamide (TAF) compared with tenofovir disoproxil fumarate (TDF) in treatment-naïve patients with CHB.
We analysed 2747 patients with CHB under TAF (n = 502) or TDF (n = 2245) treatments. Virological responses (VR: HBV DNA <15 IU/ml), on-treatment ALT normalization, the incidence of HCC, renal function and lipid profiles were compared between these groups. Propensity score matching of 495 pairs was conducted for these comparisons.
The mean age of the total cohort was 48.6 years and 58.2% of the subjects were male. Cirrhosis had a 33.3% prevalence in the population. VRs at 12, 24 and 36 months were achieved in 70.3%, 81.2% and 83.3% of the TAF and 67.9%, 84.3% and 86.1% in the TDF cases respectively (p > 0.05 for all). Normalized ALT, as determined by local laboratory criteria (<40 U/L), occurred in 79.7%, 90.6% and 86.2% of TAF the group and 78.2%, 85.8% and 85.7% of the TDF group at 12, 24 and 36 months respectively (p > 0.05 for all). The HCC risk did not statistically differ across the entire cohort or in the PS-matched cohort. The TAF group showed a lower median increase in serum creatinine from baseline during the early study period. Compared with the TAF, the TDF group showed significant decreases in total cholesterol, triglyceride and HDL, but not in LDL.
Real-word data indicate that TAF has comparable efficacies to TDF in terms of VR and ALT normalization, with no higher risk of HCC.
我们使用真实世界的数据评估了替诺福韦艾拉酚胺（TAF）与替诺福韦二吡呋酯（TDF）在初治慢性乙型肝炎（CHB）患者中的疗效和安全性。
我们分析了 2747 例接受 TAF（n=502）或 TDF（n=2245）治疗的 CHB 患者。比较了两组患者的病毒学应答（VR：HBV DNA <15IU/ml）、治疗期间丙氨酸氨基转移酶（ALT）正常化、肝癌（HCC）发生率、肾功能和血脂谱。对 495 对患者进行了倾向评分匹配。
总队列的平均年龄为 48.6 岁，58.2%的患者为男性。该人群中肝硬化的患病率为 33.3%。VR 在 12、24 和 36 个月时，TAF 组分别为 70.3%、81.2%和 83.3%，TDF 组分别为 67.9%、84.3%和 86.1%（所有 p>0.05）。根据当地实验室标准（<40U/L），TAF 组在 12、24 和 36 个月时分别有 79.7%、90.6%和 86.2%的患者 ALT 正常化，TDF 组分别有 78.2%、85.8%和 85.7%（所有 p>0.05）。整个队列或倾向评分匹配队列的 HCC 风险无统计学差异。在早期研究期间，TAF 组的血清肌酐从基线的中位数增加幅度较低。与 TAF 相比，TDF 组总胆固醇、甘油三酯和高密度脂蛋白显著降低，但低密度脂蛋白没有降低。
真实世界数据表明，TAF 在 VR 和 ALT 正常化方面与 TDF 疗效相当，HCC 风险没有增加。
