Tzeng Tzu-Ning1, Chien-Hung Chen1, Tsung-Hui Hu1, Jing-Houng Wang1, Chao-Hung Hung1, Sheng-Nan Lu1

1Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Memorial Hospital, Chang Gung University College of Medicine, Taiwan

Background/Aims: The HBsAg changes after cessation of entecavir or tenofovir disoproxil fumarate in chronic hepatitis B patients who achieved virological suppression after transient virological relapse without clinical relapse remains unclear.We investigated the HBsAg changes after virological relapse without clinical relapse in HBeAg-negative CHB patients who discontinued ETV or TDF.

Methods: This study included 472 HBeAg-negative CHB patients without cirrhosis who received entecavir or TDF treatment.All patients enrolled had post-treatment follow-up for at least 24 months.Of the 472 patients,72 experienced virological relapse but no clinical relapse and 124 had a persistent virological suppression (Group I) during follow-up after cessation of entecavir or TDF therapy.

Results: Of the 72 patients who experienced virological relapse without clinical relapse,25 had a virological suppression(HBV DNA<2000IU/mL at least 1.5 years until last visit after transient virological relapse)(Group II)and 47 had a persistent or intermittent HBV DNA>2000 IU/mL(Group III) after virological relapse. Only HBsAg decline from the first virological relapse to end of treatment was an independent factor for virological suppression after virological relapse(OR: 25.47, 95% CI: 2.10-309.3,P=0.011).Patients in Groups I (P<0.001)and II (P=0.011)experienced a larger drop in post-treatment HBsAg levels than patients in Group III.Patients in Group I experienced a larger drop in HBsAg levels than patients in Group II (P<0.001).Patients in Groups I and II exhibited a greater post-treatment HBsAg decline than patients in Group III(both,P<0.001).However,the HBsAg decline was compatible between patients in Groups I and II(P=0.846).Of the 124 patients in Group I and 25 patients in Group II,43 and 9 experienced post-treatment HBsAg loss,respectively.The 6-year cumulative rates of HBsAg loss in the Groups I and II was 43.5% and 31.7%,respectively(P=0.285) .

Conclusion: Patients who had a virological suppression after transient virological relapse(Group II)exhibited a similar HBsAg decline and HBsAg loss rate compared with patients who had a persistent virological suppression(Group I)after cessation of entecavir or TDF therapy.

Keywords: hepatitis B, clinical relapse