[Is it possible to stop treatment with nucleos(t)ide analogs in patients with e-antigen negative chronic hepatitis B? Experience and new expectations]

Abstract

Background: Treatment of HBeAg-negative chronic hepatitis B (CHB) with nucleos(t)ide analogues (NA) is usually indefinite, since the loss of HBsAg, as a criterion for its discontinuation, is a rare event. Recent evidence suggests that discontinuing NA therapy may be feasible in selected patients.

Objectives: To analyze the rate of virological relapse in patients with HBeAg-negative CHB who discontinued treatment with NAs.

Methods: We performed a single-center observational study that included 140 patients with HBsAg-negative CHB. Twenty-two patients, who received only NAs, discontinued treatment for different reasons and were subsequently monitored. All had normal ALT and AST, undetectable DNA and absence of cirrhosis or significant comorbidities before stopping treatment.

Results: Twelve patients showed virologic relapse (54.54%). The mean interval between discontinuation and relapse was 6.38 months (± 1.9) (75% relapsed during the first 12 months after discontinuation). Five received adefovir, 1 lamivudine and adefovir, 1 tenofovir and 5 lamivudine alone. The mean treatment duration in this group was 38.5 months (± 4.5). The sustained response group had a higher mean age and longer treatment duration than patients with virologic relapse but these differences were not statistically significant.

Conclusions: The results suggest that NA treatment can be stopped in selected patients with CHB as long as they are not cirrhotic, have completed a minimum period of treatment, have normal ALT and sustained undetectable DNA. These patients should be closely monitored during the first year and then indefinitely.

Keywords: Antivirales orales; HBeAg-negative chronic hepatitis B; Hepatitis crónica B; Nucleos(t)ide analogues; Rebote virológico; virological relapse.