Long-term outcomes after nucleos(t)ide analogues discontinuation in chronic hepatitis B patients with HBeAg-negative

Abstract

BackgroundHepatitis B e Antigen (HBeAg)-negative chronic hepatitis B (CHB) patients have an active liver disease with a high risk of progression to decompensated cirrhosis and hepatocellular carcinoma. The management strategy for HBeAg-negative CHB patients treated with nucleos(t)ide analogues (NUCs) is a topic of concern. To observe the outcomes for this population after NUCs withdrawal, HBeAg-negative CHB patients with loss of hepatitis B surface antigen (HBsAg) or sustained undetectable HBV DNA levels who had discontinued NUCs therapy were included in the study.MethodsA total of 66 patients (2 patients with HBsAg loss and 64 patients with sustained undetectable HBV DNA levels) were examined. HBV DNA levels and alanine aminotransferase (ALT) levels were monitored regularly after discontinuation of NUCs therapy. Relapse was defined as HBV DNA levels >2,000 IU/mL while off therapy in at least two determinations more than 4 weeks apart.ResultsThe time to achieve undetectable HBV DNA levels was 14 weeks (interquartile range (IQR): 12–24 weeks). The time until consolidation therapy was 144 weeks (IQR: 96–168 weeks). No relapses occurred in either of the HBsAg loss patients. Among the 64 patients with undetectable HBV DNA levels, 19 (29.7%) patients demonstrated evidence of relapse. All the relapses occurred within 96 weeks after discontinuation. The median duration of relapse was 36 weeks (IQR: 12–48 weeks). Elevation of HBV DNA and ALT levels over baseline was only observed in 10% of the relapse patients. There were no significant differences among the baseline characteristics (sex, HBV genotype, age, or ALT level) or the time until consolidation therapy between relapse and sustained-response patients.ConclusionsNUC discontinuation is feasible after achieving undetectable HBV DNA levels in HBeAg-negative CHB patients. Prolonging the time until consolidation therapy may be a good strategy to decrease the rate of relapse. More than 96 weeks of sustained response is a predictive marker of long-term sustained response.

Discontinuation of oral antivirals in chronic hepatitis B: A systematic review

“…The literature search initially identified 972 papers; of those, 25 fulfilled the inclusion and exclusion criteria for this review (http://onlinelibrary.wiley.com/doi/10.1002/hep.28438/suppinfo). The main characteristics of the included studies and patients are presented in Tables and .…”

“…In total, 2332 (each study contribution from 11 to 401) patients were included in the 25 studies. All but one were cohort studies (three prospective, one retrospective‐prospective, and 20 retrospective, while one was a randomized study comparing the effects of 12 versus 24 months of additional therapy after response to lamivudine in HBeAg‐negative CHB . One study was found to have high quality, 14 to have acceptable quality, and 10 to have low quality based on their risk of bias assessments (http://onlinelibrary.wiley.com/doi/10.1002/hep.28438/suppinfo).…”

“…Eight studies included only HBeAg‐positive, 11 only HBeAg‐negative, and six both HBeAg‐positive and HBeAg‐negative patients. There were 1217 (52.2%) HBeAg‐positive and 1115 (47.8%) HBeAg‐negative patients.…”

“…The majority of studies included patients from East Asia, two studies included Caucasian patients, and one study had a mixed patient population . The majority of patients in all studies were males.…”

Long-term outcomes after nucleos(t)ide analogue discontinuation in HBeAg-positive chronic hepatitis B patients

“…In similar studies on patients with HBsAg loss, relapse did not occur during the follow-up period, irrespective of whether the patient was HBeAg positive or HBeAg negative [8][9][10][11][12]. In similar studies on patients with HBsAg loss, relapse did not occur during the follow-up period, irrespective of whether the patient was HBeAg positive or HBeAg negative [8][9][10][11][12].…”