A Real-world Study Of The Efficacy And Safety Analysis Of Tenofovir Alafenamide Fumarate In Chronic Hepatitis B

Background & Objective: The new generation of antiviral drug tenofovir alafenamide fumarate(TAF)was approved for application in China in 2018,and there are few studies on the efficacy and safety of taking TAF in patients with chronic hepatitis B in China in the real world,and this study aims to evaluate the efficacy and safety of Chinese groups in the treatment of chronic hepatitis B virus in the real world.Method:This study selected patients with chronic hepatitis B virus(HBV)infection who were treated with tenofovir alafenamide fumarate antiviral therapy between September 2019 and February 2023 in Zhenjiang Third People’s Hospital,Affiliated Hospital of Jiangsu University.According to the inclusion exclusion criteria,the clinical data of 202 patients with chronic hepatitis B in the included studies were collected,and they were divided into treatment-na(?)ve group(chronic hepatitis B patients who were antiviral for the first time and chose TAF antiviral therapy)and treatment group(chronic hepatitis B patients who switched to TAF for continued antiviral therapy after having a history of other drugs antiviral),according to the different disease conditions of the patients when TAF was used,they were divided into hepatitis B with cirrhosis group and hepatitis B without cirrhosis group(hereinafter referred to as cirrhosis group with cirrhosis and non-cirrhosis group),and according to the qualitative analysis of HBe Ag of patients,they were divided into HBe Ag-positive group and HBe Ag-negative group,General data(sex,age,height,weight,history of antivirals,reason for dressing changes,chronic history,smoking,alcohol consumption,etc.)and clinical data(ALT、HBV DNA、HBs Ag、HBe Ag、e GFR、TC、TG、HDL、LDL)were statistically analyzed to evaluate the clinical efficacy and safety of TAF antiviral in patients with different types of chronic hepatitis B.Results: 1.Effectiveness of the drug :(1)The treatment-na(?)ve group(n=100)was treated with TAF antiviral for 48 weeks: the undetected rate of HBV DNA increased from 0% to 99% at baseline,and the difference between the two was statistically significant(P<0.05),and the negative rate of HBe Ag increased from 46.00% at baseline to 64.00%,and the difference was statistically significant(P <0.05).(2)Treatment group(n=102)with TAF antiviral for 48 weeks: compared with baseline,HBV DNA undetected rate was increased(98.04% vs.80.39%),and median HBs Ag and HBe Ag levels decreased(521.00(IU/m L)vs.706.80(IU/m L),0.11(COI)vs.0.17(COI),the differences were statistically significant(P<0.05),and the levels of Compared with baseline,HBs Ag and HBe Ag levels were 570.9(130.63,1853.55)(IU/m L)vs.954.30(310.30,3344.00)(IU/m L),0.12(0.08,8.42)(COI)vs.1.11(0.11,515.93)(COI),with statistically significant differences before and after treatment(P<0.05).2.Safety of the drug:(1)The treatment-na(?)ve group(n=100):BMI was elevated from baseline,and the difference was not statistically significant(23.18±1.70(kg/m2)vs.23.12±1.78(kg/m2),t=-0.979,P=0.330),TC,TG,HDL and LDL were increased from baseline,among which the differences before and after TC,HDL and LDL treatment were statistically significant,with 4.04±1.11(mmol/L)vs.4.14±1.02(mmol/L),t=-2.151,P=0.034,1.21±0.49(mmol/L)vs.1.25±0.41(mmol/L),t=-2.089,P=0.039,2.40±0.93 vs.2.43±0.90(mmol/L),t=-2.064,P=0.038.(2)Treatment group(n=102): BMI,TC,TG,HDL and LDL were increased,respectively:23.30±1.74(kg/m2)vs.23.27± 1.75(kg/m2),4.07±0.96(mmol/L)vs.4.06±1.10(mmol/L),1.51±0.75(mmol/L)vs.1.50±0.82(mmol/L),1.22±0.44(mmol/L)vs.1.20±0.49(mmol/L),2.67±0.76(mmol/L)vs.2.65±0.99(mmol/L),but there was no statistically significant difference before and after treatment(P> 0.05).After 48 weeks of antiviral TAF in the treatment-na(?)ve group and the treated group,the recurrence rate of ALT was 93.33% and 80.77%,but there was no significant difference between the two groups(P>0.05),and only the difference between the two groups was statistically significant(P<0.05).After removing confounding factors and using1:1 preference matching,there was a statistically difference between the treatment-na(?)ve group and the treated group that had a lower level of HBe Ag at 48 weeks of TAF antiviral(0.08(0.07,0.19)(COI)vs.0.14(0.09,1.31)(COI),P<0.05).(3)In 202 patients treated with TAF antiviral therapy for 48 weeks,the e GRF changed from94.40±20.20(ml/min/L)to 95.92±18.03(ml/min/L),the difference between the two was not statistically significant(t=-1.844,P=0.067),and the BMI before and after treatment was23.20±1.76(kg/m2),23.29±1.72(kg/m2),the difference was statistically significant(t=-2.353,P=0.020),and TC,TG,HDL,and LDL increased from baseline at 48 weeks of TAF treatment,4.10±0.99(mmol/L)vs.4.05±1.11(mmol/L),1.55±0.86(mmol/L)vs.1.53±1.10(mmol/L),1.24±0.42(mmol/L)vs.1.21± 0.49(mmol/L),2.58±0.84(mmol/L)vs.2.53±0.97(mmol/L),but there was no significant difference between before and after treatment(P>0.05).Conclusion:1.TAF can increase the recurrence rate of ALT and have good HBV DNA inhibition effect in different chronic hepatitis B people,which can significantly reduce the levels of HBs Ag and HBe Ag.2.This study found that some treated patients who switched to TAF to continue antiviral therapy had a low glomerular filtration rate at baseline,and the glomerular filtration rate recovered after 48 weeks of switching to TAF treatment,and no worsening renal function was found.It is recommended that patients with poor renal function should continue antiviral therapy with TAF as soon as possible.3.During the treatment of TAF,some patients have significant fluctuations in weight and blood lipids,and it is recommended to monitor blood lipids regularly and,if necessary,combine blood lipid-lowering drugs.