Toronto Centre for Liver Disease, Toronto General Hospital, University Health Network, Toronto, Canada.
Canadian Hepatitis B Network, Vancouver, Canada.
J Viral Hepat. 2021 Jun;28(6):942-950. doi: 10.1111/jvh.13500. Epub 2021 Apr 1.
Tenofovir alafenamide fumarate (TAF) has high plasma stability resulting in fewer renal adverse events compared to tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB) patients. We aimed to study the effectiveness and renal safety of TAF in a real-world setting, in patients with or without compromised kidney function. CHB patients (Nucleos(t)ide Analogue [NA]-naïve or experienced) who received TAF >1 year from 11 academic institutions as part of the Canadian Hepatitis B Network (CanHepB) were included. Kidney function was measured by estimated glomerular filtration rate (eGFR) as per Cockcroft-Gault. Patients were followed for up to 160 weeks. Of 176 patients receiving TAF, 143 switched from NA (88% TDF), and 33(19%) were NA naïve. Majority of NA-naïve patients (75%) achieved undetectable HBV DNA after one year of TAF treatment. Majority of patients with eGFR <60 mL/min who had renal deterioration during TDF (76%) reversed to eGFR increase after one year of TAF (p=0.009). Among patients with stage 2 chronic kidney disease (CKD) (eGFR 60-89), the estimated eGFR decline during TDF was halted after switching to TAF (p=0.09). NA-experienced patients with abnormal ALT before TAF showed a significant decline after switching to TAF: -0.005 [-0.006 - -0.004] log ULN U/L/month, p<0.001). In CHB patients, TAF was safe, well-tolerated and effective in this real-world cohort. Switching to TAF led to improved kidney function, particularly in those with stage 2 CKD, which suggests that the indication for TAF in the guidelines could be extended to patients with an eGFR higher than 60 mL/min.
富马酸替诺福韦艾拉酚胺（TAF）与富马酸替诺福韦二吡呋酯（TDF）相比，具有更高的血浆稳定性，因此在慢性乙型肝炎（CHB）患者中导致更少的肾脏不良事件。我们旨在研究 TAF 在真实环境中的有效性和肾脏安全性，包括肾功能受损和未受损的患者。该研究纳入了 11 家学术机构的加拿大乙型肝炎网络（CanHepB）的 CHB 患者（核苷类似物[NA]-初治或经治），他们在接受 TAF 治疗>1 年。通过 Cockcroft-Gault 法估算肾小球滤过率（eGFR）来评估肾功能。患者的随访时间最长为 160 周。在接受 TAF 治疗的 176 名患者中，143 名患者从 NA（88% TDF）转换而来，33 名（19%）为 NA 初治患者。大多数 NA 初治患者（75%）在接受 TAF 治疗 1 年后实现了 HBV DNA 不可检测。在 TDF 治疗期间肾功能恶化的 eGFR<60 mL/min 的大多数患者（76%）在转为 TAF 治疗 1 年后 eGFR 增加（p=0.009）。在 eGFR 为 60-89 的 2 期慢性肾脏病（CKD）患者中，在转为 TAF 后，TDF 期间的估算 eGFR 下降停止（p=0.09）。在开始 TAF 治疗前 ALT 异常的 NA 经治患者在转为 TAF 治疗后 ALT 显著下降：-0.005 [-0.006 - -0.004] log ULN U/L/月，p<0.001）。在 CHB 患者中，TAF 在本真实队列中安全、耐受良好且有效。转为 TAF 治疗可改善肾功能，特别是在 2 期 CKD 患者中，这表明 TAF 的适应证可扩大到 eGFR 高于 60 mL/min 的患者。
