Efficacy Of Extended Antiviral Indication Therapy In Chronic HBV Infected Patients

Background and Aims:More and more studies have shown that a significant proportion of patients with chronic HBV infection do not meet the criteria for antiviral therapy according to current regional guidelines and may be at risk of liver histological changes and disease progression that exacerbate the burde n on patients,making it clinically important to explore the efficacy of antiviral therapy in this group of patients.In this study,we evaluated the disease stages of patients with chronic HBV infection,selected patients who were unable to stage accordin g to current guidelines and other patients who did not meet treatment standards,and administered nucleos(t)ide analogues(NAs)antiviral treatment to these patients.Patients who should be treated according to the guidelines were used as a control group to evaluate the efficacy.This paper examines the clinical outcomes of patients who exceeded the criteria for antiviral treatment and explores the feasibility and effectiveness of treatment for these patients,providing a basis for expanding or simplifying the indications for antiviral treatment of chronic hepatitis B.Methods:Patients with primary chronic HBV infection attending the outpatient clinic of the Department of Hepatobiliary Medicine at JUH from October 2020 to March 2023 were selected.The demographic information,liver biochemistry,hepatitis B serology and virology,liver stiffness,blood routine,alpha fetoprotein and imaging of patients were collected,and the results of quantitative detection of HBV DNA and HBs Ag and other serological and liver biochemical tests rechecked every 3-6 months after treatment.To evaluate the effectiveness of antiviral therapy in 1092 newly diagnosed chronic HBV infected patients,compare the virological response rates of chronic HBV infected patients with cirrhosis and non cirrhosis.Then,to stage 949 non cirrhosis chronic HBV infected patients by immunization and observe the clinical efficacy after treatment with NAs,select chronic HBV infected patients with uncertain stages and other conditions that do not meet the treatment criteria and compare them with patients who should be treated according to the guidelines,Analyze the impact of age(≤ 30 years or>30 years),ALT level(<ULN or ≥ ULN),HBe Ag serology,and immune staging on the effectiveness of antiviral therapy.The patients were then divided into a low viral load group(HBV DNA < 2 x 103 IU/m L)and a high viral load group(HBV DNA ≧ 2 x 103 IU/m L)according to baseline HBV DNA levels,and virological response was compared between the two groups.Results:Among 1092 patients with primary chronic HBV infection,within 6 months of treatment with NAs,the rate of virological response was higher in patients with cirrhosis than in those without cirrhosis,with HBe Ag negative patients more likely to achieve virological response.Of the 949 non-cirrhotic patients,up to 45.8%-57.0% could not be definitively staged according to currently accepted guidelines,and up to 74.6%-83.7% of patients in the indeterminate phase who did not rely on liver biopsy as a basis for diagnosis could not be staged.Within 6 months of treatment duration,patients aged >30 years,with ALT < ULN and indeterminate stage by AASLD guideline criteria had faster HBV D NA regression than those aged ≤30 years,with ALT ≧ ULN and active stage,and there was no difference in virological response rates when treatment duration was extended to 12 months and beyond.In addition,lowering the ALT threshold for initiating antiviral therapy still resulted in similar virological response rates.Viral response rates,as defined by the 2019 and 2022 CASL guideline criteria,increased with increasing treatment duration in patients in indeterminate phase,but were both slightly lower than in patients in active phase during treatment.In addition,both the AASLD and CASL guideline criteria have similar virological response rates for a higher proportion of patients in the custom indeterminate phase compared to the classical indeterminate phase.In 131 patients with normal ALT,HBe Ag negative and anti HBe antibody positive selected in a period of uncertainty defined by the AASLD guideline criteria,91.2% of patients had a satisfactory virological response after 12 months of treatment with NA s.Overall,in the subgroup divided by the threshold of HBV DNA level of 2000 IU/m L,patients with low viral load were more likely to achieve virological response within 12 months of treatment,but as the duration of treatment increased,the virological response rate was similar between the two groups.Conclusion:Outpatients with primary chronic HBV infection are predominantly non-cirrhotic,with up to 45.8%-83.7% of these patients unable to be staged definitively.Chronic HBV infected patients treated wit h NAs for extended antiviral indications can achieve a satisfactory virological response.