关键词: 慢性乙型肝炎, 抗病毒, 艾米替诺福韦, 恩替卡韦, 真实世界

Abstract: Objective To investigate the clinical effect and safety of Tenofovir amibufenamide (TMF) versus entecavir (ETV) in the treatment of previously untreated HBeAg-positive chronic hepatitis B (CHB) patients for 120 weeks. Methods A retrospective analysis was performed for the clinical data of 161 HBeAg-positive CHB patients who were first treated with ETV or TMF, and the patients were categorized into the TMF group (n=90) and the ETV group (n=71). The patients’ age, gender, HBV DNA, serum alanine aminotransferase (ALT), creatinine, blood calcium, and blood phosphorus were collected, and Fibrosis-4 (FIB-4) and aminotransferase-to-platelet ratio index (APRI) indices were calculated and followed up at 24th, 48th, 96th, and 120th weeks of the treatment. Follow-up and evaluated visits were performed at weeks 24, 48, 96, and 120 of treatment to compare the HBV DNA conversion rate, ALT normalization rate, HBeAg seroconversion, and changes in FIB-4 and APRI indices between the 2 groups at each time point. Results In the TMF group and the ETV group, 90 and 71 cases completed 96-week follow-up. After excluding patients with incomplete responses, 88 and 67 patients completed 120-week follow-up. The results of univariate analysis of the two groups showed no statistical significance for age, HBV DNA level, HBeAg, FIB-4, and APRI index at baseline (P>0.05). There were no statistically significant difference in complete virologic response rate between the TMF group and the ETV group at 24, 48, and 96 weeks of treatment, which were 56.67%/77.78%/97.78% vs 63.38%/80.28%/94.37% (P>0.05). There were also no statistically significant differences in ALT recovery rate between the TMF group and the ETV group at 24, 48, and 96 weeks of treatment, which were 78.9%/94.4%/97.78% vs 81.69%/94.37%/97.18% (P>0.05). The FIB-4 index and APRI index decreased from the baseline at 24, 48, 96, and 120 weeks in both groups, and there was no statistically significant difference in inter-group comparisons (P>0.05). Among the patients who completed the 120-week follow-up, the complete virologic response rate and ALT recovery rate at 120 weeks in the TMF group were 96.59% and 98.86%, and the differences were not statistically significant when compared with those in the ETV group, which were 92.54% and 97.01%, respectively (P>0.05). Among them, there were 44 cases in the TMF group and 27 cases in the ETV group with baseline HBV DNA >10⁸ IU/mL(which means CHB patient with a high viral load), with baseline HBV DNA values of 7.53±0.89 lg IU/mL vs. 7.43±0.87 lg IU/mL, after 96 weeks of treatment, the HBV DNA values were 2.05±0.26 lg IU/mL vs 2.12±0.48 lg IU/mL, and the conversion rate was 95.45% vs 88.89%, which means there were no statistically significant between the two groups. The HBV DNA value was significantly reduced after 96 weeks of treatment, and the TMF group’ descend range was greater than the ETV group. During the whole treatment period, no severe complications occurred in both two groups. Conclusion The antiviral efficacy of 120-week treatment of HBeAg-positive CHB patients with TMF and ETV is significant and also effective in patients with high viral loads, and there are no significant adverse reaction to either drug, with a favorable safety profile. TMF and ETV had similar significant antiviral effects on HBeAg-positive CHB patients in the 120-week-treatment and were also effective in patients with high viral loads, with few adverse reaction and a favorable safety profile.

Key words: Chronic hepatitis B, Antivirus, Tenofovir amibufenamide, Entecavir, Real world