Treatment and Renal Outcomes Up to 96 Weeks After Tenofovir Alafenamide Switch From Tenofovir Disoproxil Fumarate in Routine Practice
Treatment and Renal Outcomes Up to 96 Weeks After Tenofovir Alafenamide Switch From Tenofovir Disoproxil Fumarate in Routine Practice
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DOI：
10.1002/hep.31793
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发表时间：
2021-05-22
期刊：
影响因子：
13.5
通讯作者：
Nguyen, Mindie H.
中科院分区：
文献类型：
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作者：
Toyoda, Hidenori;Leong, Jennifer;Nguyen, Mindie H.
背景和目标：从富马酸替诺福韦酯（TDF）转换为新的更安全的前药替诺福韦艾拉酚胺（TAF）的慢性B型肝炎（CH B）患者的治疗有效性和肾脏结局的真实数据有限。因此，我们的目的是评估该人群的治疗和肾脏结局。方法和结果：我们分析了834名既往接受TDF治疗>= 12个月的CHB患者，这些患者在13个美国和亚洲中心的常规实践中改用TAF，以观察病毒变化（HBV DNA < 20 IU/ml，），生化（男性/女性丙氨酸氨基转移酶[ALT] < 35/25 U/L），（病毒+生化）反应，以及估计的肾小球滤过率（eGFR;毫升/分钟/1.73平方米），直至转换后96周。病毒抑制（P < 0.001）和ALT正常化（P = 0.003）转换后，发生率显著增加，完全缓解率有增加的趋势（P趋势= 0.004），而eGFR趋势（P趋势> 0.44）或平均eGFR（P > 0.83，通过广义线性模型调整年龄、性别、基线eGFR以及糖尿病、高血压或肝硬化）保持稳定。然而，在基线eGFR < 90（慢性肾脏疾病[CKD]分期>= 2）的患者中，平均eGFR在TDF治疗期间显著降低（P = 0.029），但在TAF转换后则无显著降低（P = 0.90）。到第96周，21%（55/267）的CKD 2期患者在转换时改善为1期，3 - 5%（30/85）的CKD 3-5期患者改善为2期，1.2%（1/85）改善为1期。结论：总体而言，我们观察到病毒学应答持续改善，ALT正常化，从TDF转换为TAF后eGFR无显著变化。
BACKGROUND AND AIMS: 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.APPROACH AND RESULTS: 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/mI,), 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-trend = 0.004), while the eGFR trend (P-trend > 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.CONCLUSIONS: Overall, we observed continued improvement in virologic response, ALT normalization, and no significant changes in eGFR following switch to TAF from TDF.