Department of Gastroenterology, Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Clin Mol Hepatol. 2024 Jan;30(1):49-63. doi: 10.3350/cmh.2023.0328. Epub 2023 Nov 20.
BACKGROUND/AIMS: Tenofovir disoproxil fumarate (TDF) is known to have a lipid-lowering effect. This is in contrast to tenofovir alafenamide (TAF), which has a lipid-neutral effect. Therefore, concerns have been raised as to whether these differences affect long-term cardiovascular risk. Here, we aimed to evaluate the long-term risk of cardiovascular events in chronic hepatitis B (CHB) patients treated with TAF or TDF.
We retrospectively analyzed 4,124 treatment-naïve CHB patients treated with TDF (n=3,186) or TAF (n=938) between 2012 and 2022. The primary outcome was a composite endpoint of major adverse cardiovascular events (MACE), including myocardial infarction, ischemic stroke, and hospitalization for unstable angina or heart failure. Serial changes in lipid profiles between two treatments were also explored.
The median age of the patients was 50.6 years, and 60.6% of the patients were male. At baseline, 486 (11.8%) and 637 (15.4%) of the patients had dyslipidemia and fatty liver, respectively. A total of 42 MACE occurred, with an annual incidence of 0.2%/100 person-years (PYs). At 1, 3, and 5 years, the cumulative risk of MACE was 0.4%, 0.8%, and 1.2% in patients treated with TDF, and 0.2%, 0.7%, and 0.7% in patients treated with TAF, respectively (p=0.538). No significant differences in the risk of MACE were observed between TDF and TAF. A multivariable analysis found that current smoker and a history of cardiovascular events were risk factors associated with an increased risk of MACE.
Patients treated with TAF had comparable risks of cardiovascular outcomes, defined as MACE, as patients treated with TDF.
背景/目的：富马酸替诺福韦二吡呋酯（TDF）已知具有降低血脂的作用。这与替诺福韦艾拉酚胺（TAF）形成对比，后者对血脂没有影响。因此，人们担心这些差异是否会影响长期心血管风险。在这里，我们旨在评估接受 TAF 或 TDF 治疗的慢性乙型肝炎（CHB）患者的长期心血管事件风险。
我们回顾性分析了 2012 年至 2022 年间接受 TDF（n=3186）或 TAF（n=938）治疗的 4124 例初治 CHB 患者。主要结局是主要不良心血管事件（MACE）的复合终点，包括心肌梗死、缺血性卒中和不稳定型心绞痛或心力衰竭住院。还探讨了两种治疗方法之间血脂谱的变化。
患者的中位年龄为 50.6 岁，60.6%的患者为男性。基线时，分别有 486（11.8%）和 637（15.4%）例患者存在血脂异常和脂肪肝。共发生 42 例 MACE，年发生率为 0.2%/100 人年（PYs）。在 1、3 和 5 年时，接受 TDF 治疗的患者的 MACE 累积风险分别为 0.4%、0.8%和 1.2%，而接受 TAF 治疗的患者分别为 0.2%、0.7%和 0.7%（p=0.538）。TDF 和 TAF 治疗的患者的 MACE 风险无显著差异。多变量分析发现，当前吸烟者和心血管事件史是与 MACE 风险增加相关的危险因素。
接受 TAF 治疗的患者发生心血管结局（定义为 MACE）的风险与接受 TDF 治疗的患者相当。
