Toyoda Hidenori, Leong Jennifer, Landis Charles, Atsukawa Masanori, Watanabe Tsunamasa, Huang Daniel Q, Liu Joanne, Quek Sabrina Xin Zi, Ishikawa Toru, Arai Taeang, Yokohama Keisuke, Chuma Makoto, Takaguchi Koichi, Uojima Haruki, Senoo Tomonori, Dang Hansen, Maeda Mayumi, Hoang Joseph, Le Richard H, Yasuda Satoshi, Thin Khin N, Tran Sally, Chien Nicholas, Henry Linda, Asai Akira, Fukunishi Shinya, Cheung Ramsey, Lim Seng Gee, Trinh Huy N, Nguyen Mindie H
Department of Gastroenterology and HepatologyOgaki Municipal HospitalOgakiJapan.
Henry D. Janowitz Division of GastroenterologyMt. Sinai Health SystemNew YorkNY.
Hepatology. 2021 Aug;74(2):656-666. doi: 10.1002/hep.31793. Epub 2021 May 22.
Real-world data for treatment effectiveness and renal outcomes in chronic hepatitis B (CHB) patients who were switched to the new and safer prodrug tenofovir alafenamide (TAF) from tenofovir disoproxil fumarate (TDF) are limited. Therefore, we aimed to evaluate treatment and renal outcomes of this population.
We analyzed 834 patients with CHB previously treated with TDF for ≥12 months who were switched to TAF in routine practice at 13 US and Asian centers for changes in viral (HBV DNA < 20 IU/mL), biochemical (alanine aminotransferase [ALT] < 35/25 U/L for male/female), and complete (viral+biochemical) responses, as well as estimated glomerular filtration rate (eGFR; milliliters per minute per 1.73 square meters) up to 96 weeks after switch. Viral suppression (P < 0.001) and ALT normalization (P = 0.003) rates increased significantly after switch, with a trend for increasing complete response (P = 0.004), while the eGFR trend (P > 0.44) or mean eGFR (P > 0.83, adjusted for age, sex, baseline eGFR, and diabetes, hypertension, or cirrhosis by generalized linear modeling) remained stable. However, among those with baseline eGFR < 90 (chronic kidney disease [CKD] stage ≥2), mean eGFR decreased significantly while on TDF (P = 0.029) but not after TAF switch (P = 0.90). By week 96, 21% (55/267) of patients with CKD stage 2 at switch improved to stage 1 and 35% (30/85) of CKD stage 3-5 patients improved to stage 2 and 1.2% (1/85) to stage 1.
Overall, we observed continued improvement in virologic response, ALT normalization, and no significant changes in eGFR following switch to TAF from TDF.
关于慢性乙型肝炎（CHB）患者从富马酸替诺福韦二吡呋酯（TDF）转换为新型更安全的前体药物替诺福韦艾拉酚胺（TAF）后的治疗效果及肾脏转归的真实世界数据有限。因此，我们旨在评估该人群的治疗及肾脏转归情况。
我们分析了834例先前接受TDF治疗≥12个月的CHB患者，这些患者在美国和亚洲的13个中心接受常规治疗时转换为TAF，观察其病毒学（乙肝病毒脱氧核糖核酸[HBV DNA]<20国际单位/毫升）、生化指标（男性/女性的丙氨酸转氨酶[ALT]<35/25单位/升）和完全（病毒学+生化）反应的变化，以及转换后长达96周的估计肾小球滤过率（eGFR；每分钟每1.73平方米的毫升数）。转换后病毒抑制率（P<0.001）和ALT正常化率（P = 0.003）显著增加，完全反应有增加趋势（P = 0.004），而eGFR趋势（P>0.44）或平均eGFR（通过广义线性模型对年龄、性别、基线eGFR以及糖尿病、高血压或肝硬化进行校正后，P>0.83）保持稳定。然而，在基线eGFR<90（慢性肾脏病[CKD]≥2期）的患者中，服用TDF时平均eGFR显著下降（P = 0.029），但转换为TAF后未出现下降（P = 0.90）。到96周时，转换时处于CKD 2期的患者中有21%（55/267）改善为1期，CKD 3 - 5期患者中有35%（30/85）改善为2期，1.2%（1/85）改善为1期。
总体而言，我们观察到从TDF转换为TAF后，病毒学反应持续改善，ALT正常化，且eGFR无显著变化。
