Efficacy and safety of tenofovir alafenamide in patients with chronic hepatitis B exhibiting suboptimal response to entecavir
作者机构：Department of Infectious DiseasesYichun University Second Affiliated HospitalYichun 336000Jiangxi ProvinceChina
出 版 物：《World Journal of Clinical Cases》 (世界临床病例杂志)
年 卷 期：2023年第11卷第34期
页 面：8139-8146页
核心收录：
学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 100401[医学-流行病与卫生统计学] 10[医学]
基 金：Study on the efficacy and safety of tenofovir alafenamide in treating chronic hepatitis B patients with poor entecavir response No.SKJP22020201008
主 题：Entecavir Tenofovir alafenamide Chronic hepatitis B Virologic response Renal and bone toxicity Suboptimal response
摘 要：BACKGROUND Entecavir(ETV)is a potent and safe antiviral agent for patients with chronic hepatitis B(CHB);however,some patients may exhibit suboptimal response or resistance to *** alafenamide(TAF)is a novel tenofovir prodrug with improved pharmacokinetics and reduced renal and bone toxicity compared with tenofovir disoproxil *** To evaluate the efficacy and safety of switching from ETV to TAF in patients with CHB exhibiting suboptimal response to *** A total of 60 patients with CHB who had been treated with ETV for at least 12 mo and had persistent or recurrent viremia[Hepatitis B virus(HBV)DNA≥20 IU/mL]or partial virologic response(HBV DNA20 IU/mL,but detectable)were enrolled in the *** patients were randomly assigned to either continue ETV(0.5 mg)daily or switch to TAF(25 mg)daily for 48 *** primary endpoint was the proportion of patients who achieved a virologic response(HBV DNA level20 IU/mL)at week *** endpoints included changes in serum alanine aminotransferase(ALT),hepatitis B surface antigen(HBsAg),hepatitis B e antigen(HBeAg),and anti-HBe levels,and renal and bone safety *** At week 48,the proportion of patients who achieved a virologic response was significantly higher in the TAF group than in the ETV group(93.3%vs 66.7%,P=0.012).The mean reduction in HBV DNA from baseline was also significantly greater in the TAF group than in the ETV group(-3.8 vs-2.4 Log10 IU/mL,P0.001).The rates of ALT normalization,HBeAg loss,HBeAg seroconversion,and HBsAg loss were not found to significantly differ between the two *** of the patients developed genotypic resistance to ETV or *** drugs were well tolerated,with no serious adverse events or discontinuations caused by adverse *** significant changes were observed in the estimated glomerular filtration rate,serum creatinine level,or urine protein-to-creatinine ratio in either *** TAF group had a significantly lower decrease in bone mine
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