| Objective Hepatitis B virus（HBV）infection is a serious challenge to global public health,and there are about 20-30 million patients with chronic hepatitis B（CHB）in China.Chronic HBV infection can lead to serious complications such as cirrhosis and hepatocellular carcinoma（HCC）,and it is particularly important to initiate antiviral therapy and select appropriate antiviral regimens at the right time.As a new antiviral drug,Tenofovir alafenamide fumarate（TAF）has been recommended by major guidelines as the first-line antiviral therapy.Since TAF has not been available in China for a long time,this study aims to evaluate the antiviral efficacy and safety of TAF with na（?）ve and NAs-treated CHB patients in real-world,and to compare the efficacy of TAF with entecavir（ETV）in patients with primary CHB to provide real-world clinical data for follow-up studies.To provide real-world clinical data for follow-up studies.Materials and methods The clinical data of 214 patients diagnosed with chronic hepatitis B who attended the outpatient of the First Affiliated Hospital of Anhui Medical University from January 2020 to June 2021 were collected.According to the patients’ treatment stage and medication,we divided patients into the na（?）ve CHB patient group（including TAF group and ETV group）and the NAs-treated CHB patients group（who switched from other antiviral treatment regimens to TAF monotherapy）.And we collected their general data（gender,age,previous medication history,reasons for switching drug in NAs-treated patients）and clinical data during treatment（alanine transaminase（ALT）,HBVDNA,hepatitis B virus surface antigen（HBs Ag）,hepatitis B virus e antigen（HBe Ag）,creatinine,estimated glomerular filtration rate（e GFR）,total cholesterol（TC）triglyceride（TG）,and blood phosphorus levels）and statistically analyzed data to assess their antiviral efficacy and safety.Results In this study,data were collected from 214 patients with CHB,including 57 cases in the TAF group,56 cases in the ETV group,and 101 cases in the NAs-treated patients group.There was no statistically significant difference between the TAF and ETV groups at baseline,except for serum HBVDNA level.The results of the study were as follows.1.At 24 weeks,the ALT normalization rates in the TAF group and ETV group were85.96% and 82.14%,respectively,which were significantly higher than their respective baselines（P < 0.01）,and there was no significant difference between the two groups（P > 0.05）.The virological response rates（< 20 IU/m L）of the TAF group and the ETV group were 45.61% and 21.43%,respectively,which were significantly higher than their respective baselines（P < 0.05）,and the difference was statistically significant（P <0.05）.At 24 weeks,the HBs Ag of TAF group and ETV group were 1054.50（380.30,2416.50）IU/m L and 909.10（265.55,1781.50）IU/m L,which were significantly lower than their respective baselines（P < 0.01）,and there was no statistical difference between the two groups Academic significance（P > 0.05）.The HBe Ag values in the TAF group and ETV group were 0.10（0.08,6.37）COI and 0.11（0.08,0.29）COI,respectively.The TAF group was significantly lower than the baseline（P < 0.05）,but there was no significant difference between the ETV group and the baseline（P > 0.05）,there was no significant difference between the two groups（P > 0.05）.There were 25 patients in the TAF group and 34 patients in the ETV group with complete data at baseline,24 weeks,and 48 weeks.At 48 weeks,the ALT normalization rates in the TAF group and ETV group were 96.00% and 88.24%,respectively,which were significantly higher than their respective baselines（P < 0.01）,and there was no significant difference between the two groups（P > 0.05）.The virological response rates（< 20 IU/m L）in the TAF group and ETV group were 64.00% and 55.90% at 48 weeks,respectively,which were significantly higher than their respective baselines（P < 0.05）,and there was no statistical difference between the two groups.Significance（P > 0.05）.The HBs Ag in TAF group and ETV group were 1056.00（255.20,2238.00）IU/m L and 808.40（349.38,1360.75）IU/m L,which were significantly lower than their respective baselines（P <0.05）.There was no significant difference between the two groups.（P > 0.05）.The HBe Ag values of TAF group and ETV group were 0.11（0.09,4.24）COI and0.09（0.08,0.47）COI respectively at 48 weeks,which were significantly lower than their respective baselines（P < 0.05）.There was no significant difference between the two groups（P > 0.05）.2.Among the reasons for switching to TAF in the NAs-treated patients,23.76% of the patients were switched due to low-level viraemia alone.20.79% of the patients were switched due to renal impairment or combined renal disease.13.86% of patients had ALT abnormalization.The number of patients switching for reasons such as patient request,combined multiple reasons,poor viral response,and drug resistance was less.3.NAs-treated patients with LLV at baseline had a virological response rate（< 20IU/m L）of 64.52% at 24 weeks,and 17 of them were followed up to 48 weeks,with a virological response rate of 76.47%;Among the 11 treated patients with poor response,the virological response rate（< 300 IU/m L）at 24 weeks was 81.82%（9/11）,and 6 of them were followed up to 48 weeks,and the virological response rate was 100.00 %（6/6）.4.The ALT normalization rate of 101 treated patients was 87.13% at 24 weeks,which was significantly higher than the baseline（P < 0.01）.HBs Ag was 1452.00（430.35,3764.00）IU/m L at 24 weeks,which was significantly lower than baseline（P <0.01）.HBe Ag was 0.84（0.09,26.09）COI at 24 weeks,a significant decrease from baseline（P < 0.01）.With 20 IU/m L as the detection limit,the virological response rate at 24 weeks was 78.22 %,significantly higher than baseline（P < 0.01）.A total of 57 patients had complete data at baseline,24 weeks and 48 weeks.At 48 weeks,the ALT normalization rate was 89.47%,which was significantly higher than baseline（P < 0.05）;HBs Ag was 1455.00（409.25,3555.00）IU/m L at 48 weeks,significantly decreased from baseline（P < 0.05）.HBe Ag was 1.35（0.10,24.34）COI,significantly decreased from baseline（P < 0.05）.Virological response rate at 48 weeks（< 20 IU /m L）was 89.47%,which was significantly higher than the baseline（P < 0.01）.5.e GFR,creatinine,TC and TG were not significantly changed（P > 0.05）at 24 weeks from baseline in primary patients with TAF.In NAs-treated patients with renal impairment,e GFR was elevated at 24 weeks from baseline and the creatinine was reduced from baseline,with statistically significant differences（P < 0.05）.Conclusions 1.Both TAF and ETV have high ALT normalization rate and potent viral suppressive effect on na（?）ve CHB patients,and can reduce serum HBs Ag and HBe Ag levels.2.In the research,LLV and renal impairment are the most frequent problems in the course of antiviral therapy in CHB patients,and are the main reasons for switching to TAF.3.Switching to TAF in NAs-treated CHB patients who are in LLV status and poor virological response and resistant to the original drugs can further inhibit HBVDNA replication and improve virological response rate.4.For NAs-treated CHB patients switching to TAF treatment,TAF can further improve ALT normalization rate and viral response rate,and reduce serum HBs Ag and HBe Ag levels.5.TAF showed a good safety profile in CHB patients and could further improve the renal function of patients. |
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