Sa1014 Meta-Analysis and Systematic Review of Chronic Hepatitis B Patients With Minimally Elevated Alanine Aminotransferase (ALT): Nearly Half With ALT 1-2x Upper Limit of Normal Have Significant Fibrosis

Abstract

Background and Aim: Entecavir (ETV) is a potent antiviral drug to treat chronic hepatitis B (CHB) patients with high genetic barrier. Aim of this study was to assess the effectiveness, safety, and rate of antiviral resistance of ETV monotherapy in nucleos(t)ide analogues (NUC) naive CHB patients in clinical practice. Methods: Charts of CHB patients were reviewed. CHB patients who were treated with ETV at least one year were included in this study. Clinical symptoms, liver function test and HBV DNA were monitored every 3-6 months. Virological breakthrough was defined as . 1 log IU/mL increase from nadir. Antiviral resistance testing was performed in patients who had confirmed virological breakthrough. Imaging studies using ultrasonography or CT of liver was monitored every 6 months for hepatocellular carcinoma (HCC) screening. Results: 535 patients were included. At baseline, mean age was 51.8 years, 58.5% was male, 35.1% was HBeAg positive, mean HBV DNA was 6.8 log IU/mL, 87% had elevation of ALT, and 37.1% was cirrhosis. Mean of follow up was 40 months. The rates of undetectable HBV DNA progressively increased to more than 90% in both HBeAg positive and negative patients at year 5. HBeAg seroconversion and HBsAg loss was found in 10.5% and 1.7% at year 5, respectively. No virological breakthrough or antiviral resistance mutations was found in 5 years. Among 337 noncirrhotic patients, 20 patients (5.9%) developed cirrhosis using imaging criteria during follow up; however, no patients in this group developed clinical decompensation. Of 198 cirrhotic patients, clinical decompensation was developed in 5 patients (2.5%). HCC occurred 12 patients (2.2%) in 5 years. No serious adverse event was demonstrated. Serum creatinine remained unchanged during ETV treatment. Conclusion: ETV was safe and effectively suppressed hepatitis B virus without virological breakthrough throughout 5 years of treatment.