富马酸丙酚替诺福韦治疗失代偿期乙型肝炎肝硬化患者疗效和安全性

Effectiveness and safety of tenofovir alafenamide for chronic hepatitis B patients with decompensated cirrhosis

目的探讨富马酸丙酚替诺福韦(tenofovir alafenamide,TAF)治疗失代偿期乙型肝炎肝硬化患者的疗效和安全性。方法回顾性分析2022年6月至2023年6月就诊于甘肃省武威肿瘤医院的失代偿期乙型肝炎肝硬化患者41例,给予TAF 25 mg/d治疗24周。主要疗效终点为第24周达到病毒学应答(HBV DNA<20 IU/mL)的患者比例。其他疗效终点包括自基线至24周ALT、AST、TBIL、CTP评分和MELD评分的变化。安全性方面,观察自基线至24周Scr、e GFR的变化以及不良事件。结果41例患者中,男30例73.2%,年龄(53.49±9.27)岁,TAF治疗24周后,90.2%的患者HBV DNA均检测不到,基线时ALT、AST和TBil中位值分别为50.70、48.70 U/L和26.40μmol/L,治疗24周后,ALT、AST和TBil显著降低,分别为31.50、37.80 U/L和23.80μmol/L(P<0.05)。58.5%(n=24)和63.4%(n=26)的患者CTP评分和MELD评分改善。基线时中位Scr和e GFR分别为58.50μmol/L和106.15 mL/(min·1.73 m^(2)),治疗期间Scr和e GFR稳定,前后比较差异均无统计学意义(P>0.05)。治疗期间未发现药物相关不良事件或严重不良事件,也未发生肝移植、肝癌或死亡。结论TAF在真实世界中对失代偿期乙型肝炎肝硬化患者具有良好的有效性和安全性。

Objective To investigate the efficacy and safety of tenofovir alafenamide fumarate(TAF)in the treatment of patients with decompensated hepatitis B cirrhosis.Methods We retrospective analyzed 41 patients with decompensated hepatitis B cirrhosis receiving TAF antiviral therapy for 24 weeks at Wuwei Tumor Hospital in Gansu province from June 2022 to June 2023.Primary endpoint was proportion of patients achieving virologic response(HBV DNA<20 IU/mL).Other endpoints included changes in ALT,AST,TBIL,Child-Pugh score(CTP),and MELD score from baseline to week 24.In terms of safety,changes in Scr,eGFR and adverse events from baseline to week 24 were observed.Results Of 41 patients,73.2%were male(n=30),with mean age of 53.49 years.24 weeks after treatment with TAF,HBV DNA was undetectable in 90.2%of the patients.The median levels of ALT,AST and total bilirubin(TBIL)were 50.70 U/L,48.70 U/L and 26.40μmol/L respectively at base-line,and reduced significantly to 31.50 U/L,37.8 U/L and 23.8μmol/L(P<0.05)respectively after 24-week therapy with TAF.CTP score was improved in 58.6%of the patients(n=24),and so was MELD score in 63.4%of the patients(n=26)at week 24.The median serum creatinine and eGFR were 58.5μmol/L and 106.15 mL/(min·1.73 m^(2))respectively at baseline,and creatinine and eGFR were stable during treatment.No drug-related adverse events or severe adverse events occurred during treatment,neither did creatinine and eGFR liver transplan-tation,HCC or death.Conclusions Our clinical studies demonstrated better effectiveness and safety of TAF for decompensated CHB patients.