Abstract: Objective To investigate the incidence and predictive factors of hepatitis B virus (HBV) relapse in patients with chronic hepatitis B (CHB) after discontinuation of tenofovir (TDF). Methods A total of 197 patients with CHB admitted to our hospital from January 2015 to June 2017 were selected as the study subjects. The Cox model was used to analyze the factors affecting viral relapse at week 96. The best cut-off value was calculated by the receiver operating characteristic (ROC) curve. Results There were correlations between the age, HBV deoxyribonucleic acid, HBV genotype, baseline hepatitis B surface antigen (HBsAg), treatment time, HBsAg level at 12 months of treatment and HBsAg level at the end of treatment in CHB patients (P<0.05). There was no significant difference in sex, baseline ALT level and total bilirubin level between the hepatitis B envelope antigen (HBeAg) positive and negative CHB patients (P>0.05). The viral relapse rates of HBeAg positive patients at week 12, 24, 48, 72 and 96 were 26.23% (16/61), 45.90% (28/61), 55.74% (34/61), 57.38% (35/61) and 72.13 (44/61), respectively, and the clinical relapse rates were 13.11% (8/61), 27.87% (17/61), 40.98% (25/61), 44.26% (27/61) and 57.38% (35/61), respectively. The viral relapse rates of HBeAg negative patients at week 12, 24, 48, 72 and 96 were 18.38% (25/136), 43.38% (59/136), 61.03% (83/136), 67.65% (92/136) and 72.06% (98/136), respectively, and the clinical relapse rates were 11.03% (15/136), 27.94% (38/136), 40.44% (55/136), 53.68% (73/136) and 58.09% (79/136), respectively. Besides, the multivariate analysis showed that HBsAg level at the end of treatment was an independent risk factor for viral relapse within 96 weeks after TDF withdrawal for both HBeAg positive and negative CHB patients. ROC curve showed that the best cut-off value of HBsAg at the end of treatment was 92 IU/mL for HBeAg negative patients. Conclusion The relapse rate of CHB patients within 48 weeks after termination of TDF treatment is high. The level of HBsAg at the end of treatment is related to the relapse rate, which may be an effective factor for predicting the relapse in CHB patients after discontinuation of TDF treatment.

Key words: Chronic hepatitis B, Tenofovir, Relapse, Predictive factors