The Catholic University Liver Research Center, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Division of Hepatology, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon-si, Republic of Korea.
J Gastroenterol Hepatol. 2024 Aug;39(8):1673-1683. doi: 10.1111/jgh.16593. Epub 2024 May 1.
BACKGROUND AND AIM: Our study evaluated the outcomes of switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) in patients with chronic hepatitis B (CHB). We assessed viral and biochemical responses as well as changes in the estimated glomerular filtration rate (eGFR) and bone mineral density (BMD). METHODS: This retrospective multicenter study included CHB patients who achieved virologic response (VR) (HBV DNA < 20 IU/mL) while on TDF and were subsequently switched to TAF between April 2018 and October 2021. RESULTS: This study included 309 patients with a median age of 59 years, and 42.1% were male. The mean duration of TDF and TAF administration were 54.0 and 37.5 months, respectively. All patients maintained VR after switching to TAF. Alanine aminotransferase (ALT) normalization rate significantly increased 6 months after switching (74.8%-83.5%; P = 0.008). Adjusted eGFR significantly improved at 6 months (+5.55 ± 10.52 mL/min/1.73 m; P < 0.001) and 12 months (+6.02 ± 10.70 mL/min/1.73 m; P < 0.001) after switching. In the subgroup of patients with renal impairment (eGFR < 60 mL/min/1.73 m), significant improvement in renal function was observed at 6 months (+0.6 ± 10.5 mL/min/1.73 m; P < 0.001) and 12 months (+1.0 ± 10.7 mL/min/1.73 m; P < 0.001) after switching to TAF. In patients with osteoporosis (n = 182), switching to TAF resulted in significant improvement in spine and hip BMD at 12 months, with increases of 9.7% (95% CI: 7.0-12.5) and 9.4% (95% CI: 7.0-11.8), respectively. CONCLUSION: In this real-world study, switching to TAF was effective and safe in patients, with notable improvements in ALT levels, renal function, and BMD.
背景与目的:本研究评估了慢性乙型肝炎(CHB)患者从替诺福韦酯(TDF)转换为替诺福韦艾拉酚胺(TAF)的治疗效果。我们评估了病毒学和生化学应答以及估算肾小球滤过率(eGFR)和骨矿物质密度(BMD)的变化。
方法:这项回顾性多中心研究纳入了 309 例在接受 TDF 治疗时实现病毒学应答(HBV DNA < 20 IU/mL)的 CHB 患者,这些患者在 2018 年 4 月至 2021 年 10 月期间转换为 TAF。
结果:本研究共纳入 309 例中位年龄为 59 岁的患者,其中 42.1%为男性。TDF 和 TAF 的平均治疗时间分别为 54.0 个月和 37.5 个月。所有患者在转换为 TAF 后均维持病毒学应答。转换后 6 个月时,丙氨酸氨基转移酶(ALT)正常化率显著增加(74.8%-83.5%;P = 0.008)。调整后的 eGFR 在转换后 6 个月时(+5.55 ± 10.52 mL/min/1.73 m;P < 0.001)和 12 个月时(+6.02 ± 10.70 mL/min/1.73 m;P < 0.001)显著改善。在肾功能受损(eGFR < 60 mL/min/1.73 m)的患者亚组中,转换为 TAF 后 6 个月(+0.6 ± 10.5 mL/min/1.73 m;P < 0.001)和 12 个月(+1.0 ± 10.7 mL/min/1.73 m;P < 0.001)时肾功能显著改善。在 182 例骨质疏松症患者中,转换为 TAF 后 12 个月时脊柱和髋部 BMD 显著改善,分别增加了 9.7%(95%CI:7.0-12.5)和 9.4%(95%CI:7.0-11.8)。
结论:在这项真实世界研究中,转换为 TAF 对患者是有效且安全的,可显著改善 ALT 水平、肾功能和 BMD。
J Gastroenterol Hepatol. 2019-5-21