Long-term nucleoside analogue therapy can lead effective HBV DNA inhibition in patients with chronic HBV infection in immune tolerate phase

Background and Aims The efficacy and safety of long-term antiviral therapy with nucleoside analogues (NAs) for chronic hepatitis B (CHB) patients in immune tolerate (IT) phase is uncertain.We retrospectively evaluated the efficacy and safety of 61 CHB patients in IT phase receiving NAs therapy from 2013 through 2018. Methods We performed a retrospective study of CHB patients who had high HBV DNA, normal or minimum alanine aminotransferase (ALT), liver biopsy confirmed light necro-inflammation and received NAs therapy from 2012 through 2018.All patients received NAs at least 12 months. Patients on-treatment monitoring were in accordance with the roadmap concept and were followed after their treatment start date to the treatment end date (if any) or 6 years at least once every 6 months. The median follow-up time was 36(16; 52) months. We assessed the virological response (the proportions of patients with plasma HBV DNA loads less than the limit of quantification,100IU/ml) and serological endpoints (HBeAg loss and seroconcersion to anti-HBe, and HBsAg loss and seroconversion to anti-HBs). Safety and tolerability, including serious events, were regularly assessed. Results At 48 weeks on treatment, 55.6%(95%confidence interval(CI):37.0-70.0%) patients with CHB in IT phase achieved HBV DNA less than quantitative limit(<100IU/ml), and the accumulate proportion of patients who achieved HBV DNA less than quantitative limit was 76.7%(95%CI: 58-90.0%) and 95.8%(95%CI: 79-100%) at 96 weeks and ≥144weeks on treatment, respectively. The HBeAg loss or seroconversion rate in patients with CHB in IT phase on NAs treatment at 48, 96 and ≥144weeks was 2.7%(95%CI: 0-14.0%), 13.3% (95%CI: 4-31.0%) and 29.2%(95%CI: 13-51%), respectively. During the study only one patient achieved HBsAg seroconversion after 3years NAs therapy and only one patient experienced drug-related breakthrough during the study. Conclusion Patients with CHB in IT phase have relatively preferable safety and HBV DNA inhibition efficacy on long-term NAs treatment.