| Objective: The aim of this study was to investigate the efficacy of switching from entecavir（ETV）or tenofovir（TDF）to other different antiviral therapy in ETV-or TDF-treated chronic hepatitis B（CHB）patients with low-level viraemia（LLV）using a single-center retrospective study method.Methods: In this single-center retrospective study,a total of 197 patients with CHB who had been treated with ETV or TDF were enrolled in this study and were divided into group A（n=74）continuing ETV or TDF treatment,group B（n=63）switching to TAF therapy and group C（n=60）switching to ETV or TDF and peg-IFNα-2b combination therapy.The regimen lasted for（48±2）weeks.Results:1.Patient baseline characteristics: A total of 197 LLV patients treated with ETV or TDF were collected,all of which had good clinical compliance.There were 74 patients in group A,63 patients in group B and 60 patients in group C.Comparison of baseline characteristics among the three groups showed that the three groups had balanced demographic and clinical characteristics.2.To compare the complete virologic response（CVR）rates of patients in the three groups at mid-term observation（24±2w）and endpoint observation（48±2w）with different strategies treatment.The CVR rates of the A,B and C groups at mid-term observation（24±2w）were 6.8%,38.1% and 56.7%,respectively,with statistically significant differences（P＜0.001）;at endpoint observation（48±2w）,the CVR of group A,B and C were 16.2%,66.7% and 90.0%,respectively,The difference of CVR rate in the three groups was statistically significant（P=0.003,P=0.032,P<0.001）.3.The decline of HBV-DNA in the three groups: Compared with baseline,the decline of HBV-DNA at mid-term observation（24±2w）in groups A,B,and C by11.8%,27.0%,and 42.1%,respectively.The difference of serum HBV-DNA at mid-term observation（24±2w）in the three groups was statistically significant（P=0.003,P=0.032,P<0.001）.4.The decline of serum q HBe Ag and the rate of HBe Ag loss in the three groups.Compared with baseline,decline of q HBe Ag at endpoint observation（48±2w）by9.9% in group A,47.7% in group B and 64.5% in group C.Compared with baseline,the rate of HBe Ag loss at endpoint observation（48±2w）in group A,group B and group C were 8.2%,12.8% and 71.4%,respectively,There were statistically significant differences between group A and group C,group B and group C（P=0.006,P＜0.001）/（P＜0.001,P＜0.001）,but there was no difference in the rate of HBe Ag loss between group A and B.5.The decline of serum q HBs Ag in the three groups.Compared with baseline,decline of q HBe Ag at endpoint observation（48±2w）by 1.3% in group A,20.9% in group B and 45.6% in group C.There were statistically significant differences between group A and group C,group B and group C（P=0.017,P<0.001）,but there was no difference between group A and B（P=0.573）.6.Changes in CVR rates of patients in each subgroup at endpoint observation: At endpoint observation,the CVR in group A of HBe Ag-positive and HBe Ag-negative group was 8/49（16.3%）and 4/25（16.0%）,respectively,with no significant difference（P＞0.05）.The CVR in group B of HBe Ag-positive and HBe Ag-negative group were28/47（59.6%）and 14/16（87.5%）,respectively,with statistical significance（P=0.020）,the CVR in group C of HBe Ag-positive and HBe Ag-negative group were31/35（88.5%）and 23/25（92.0%）,respectively,with no significant difference（P=0.663）.7.The decline of HBV-DNA（lg）in each subgroup of the three groups at mid-term observation: the decline of HBV-DNA（lg）in group A in HBe Ag-positive group vs HBe Ag-negative group was not statistically significant（P＞0.05）;the decline of HBV-DNA（lg）of group B and Group B in HBe Ag-positive group vs HBe Ag negative group were statistically significant（P=0.004,P=0.022）.8.Changes in ALT: Compared with baseline,ALT decreased in all three groups at the endpoint observation（48±2w）under different treatment strategies,except for group A,group B and C had statistically significant differences（P<0.001,P=0.014）.The rate of ALT normalization was statistically significant difference（P=0.083）。.9.Changes in non-invasive liver fibrosis measurements: Compared with baseline,APRI and LSM decreased in all three groups at the endpoint observation（48±2w）under different treatment strategies,except for group A,group B and C had statistically significant differences（P＜0.001,P＜0.001）.10.There were no serious adverse effect events in this study.Conclusion:1.The CVR rate and HBV-DNA decline of LLV patients treated with ETV or TDF combined with PEG IFNα-2b were significantly better than those patients who switch to TAF treatment or those patients who continue ETV or TDF monotherapy,and CVR rate and HBV-DNA decline of patients who switch to TAF treatment were better than those patients who continue ETV or TDF monotherapy;2.For LLV patients treated with ETV or TDF combined with PEG IFNα-2b,the rate of HBe Ag loss or q HBe Ag and q HBe Ag decline after treatment were significantly better than switching to TAF and ETV or TDF maintenance treatment.There was no significant difference in the rate of HBe Ag loss or q HBe Ag and q HBe Ag decline between switching to TAF and continuing ETV or TDF monotherapy treatment.3.Switching to TAF treatment with HBe Ag-negative LLV patients treated with ETV or TDF showed better virological response than HBe Ag-positive LLV patients treated with ETV or TDF.Whether HBe Ag-positive and HBe Ag-negative LLV patients,the combination of PEG IFNα-2b showed higher virological response.4.In terms of improving liver inflammation and fibrosis,the combination of PEG IFNα-2b and switching to TAF was better than continuing ETV or TDF monotherapy treatment. |
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