Evaluation of Efficacy and Safety of Different Treatment Regimens in Treatment-Naïve High Viral Load Chronic Hepatitis B Patients: A Real-World Study

Abstract

Background: Evaluate the real-world effectiveness and safety of different treatment regimens for treatment-naïve high viral load chronic hepatitis B (CHB) patients. Methods: Prospective cohort study. Between January 2021 and August 2022, CHB patients with HBV DNA ≥10⁷ IU/mL were collected from four medical centers in Shenzhen. Patients treated with mono or combine antiviral therapy. The primary endpoint was the cumulative incidence of virological response at 48 weeks, and other endpoints included changes in HBsAg, HBeAg, ALT, and eGFR at 48 weeks. We used propensity score-based inverse probability of treatment weighting (IPTW) to balance the bias. Weighted logistics regression was used to estimate the factors affecting virological response. Results: A total of 391 patients were included in the study, with 296 patients undergoing statistical analysis using IPTW. The patients were distributed into four groups: ETV (n=62), TDF (n=89), TAF (n=36), TDF+LdT/ETV (n=109). The 48-week cumulative incidence of virological response was significantly lower in ETV group (52.3%) compared to TDF (71.7%), TAF (74.2%), and TDF+LdT/ETV groups (77.9%) (P<0.05). There were no significant differences in HBsAg loss among the four groups, but the HBeAg seroconversion rate was significantly higher in the TAF group. The ALT normalization rate was significantly higher in the TAF group (72.2%) compared to the others at 48 weeks (P<0.05). Conclusions: In treatment-naïve CHB patients with high viral load, combination therapy did not show superiority over monotherapy in term of antiviral efficacy at 48 weeks. TAF group exhibited superiority in HBeAg seroconversion and ALT normalization.