Fourth-year Results of HBeAg Negative Chronic Hepatitis B Patients Discontinuing Nucleos(t)ide Analogue Therapy

Abstract

Objective: There is not a definitive virological treatment for chronic hepatitis B . Withdrawal of nucleos(t)ide analogue (NA) therapy frequently results in viral recurrence, necessitating lifetime treatment. We aimed to look into the results of discontinuation of nucleos(t)ide analogue therapy in HBeAg negative patients. Methods: Treatment of HBeAg-negative patients without cirrhosis who had suppressed HBV DNA for a mean of ≥7 years and underwent nucleos(t)ide analogue therapy for a mean of ≥7 years were stopped according to the EASL guideline stopping rule. Standard laboratory tests, such as HBV DNA viral load, HBsAg, alanine aminotransferase, and adverse events, were monitored for more than four years during therapy and afterwards. Results: HBsAg loss was not observed in any of the patients during the four-year follow-up period. After the first 12 weeks, HBV-DNA was detected in all patients whose nucleos(t)ide analogue treatment was discontinued. The percentage of patients with HBV DNA >2000 IU/mL was 70% at 6 months, 74% at 12 months, 78% at 24 months, and 79.7% at 36 months, HBV DNA >2000 IU/mL was not detected in remaining patients over a four-year period. In the first year, 26% (n=18) of patients were started treatment for relapse, 46% (n=32) in the second year, 49% (n=34) in the third year, and 55% (n=38) in the fourth year. 45% (n=31) of the patients were still being followed without treatment at the end of the fourth year. Conclusion: Although the follow-up of hepatitis B e antigen-negative CHB patients on NA therapy was longer than in the literature, our recurrence rates were similar to other studies, and no patient lost HBsAg. The most significant benefit was that we were able to follow half of the patients without therapy for more than four years, eliminating the need for the patients to use drugs.