Abstract
Chronic hepatitis B (CHB) with severe acute exacerbation (SAE) is an urgent problem requiring nucleos(t)ide analogue (NA) therapy. We aim to evaluate the clinical relapse (CR) risk after discontinuing NA in patients with prior SAE. Methods: In this retrospective cohort study, CHB patients who discontinued NA therapy were screened between October, 2003 and January, 2019. A total of 78 non-cirrhotic patients who had received NA therapy for CHB with SAE, i.e., bilirubin ≥ 2 mg/dL and/or prothrombin time prolongation ≥3 s, (SAE group) were matched 1:2 with 156 controls without SAE (non-SAE group) by means of propensity scores (age, gender, NA categories, NA therapy duration, and HBeAg status). Results: The 5-year cumulative incidences of severe CR, i.e., ALT > 10X ULN, (42.78%, 95% CI: 27.84–57.73% vs. 25.42%, 95% CI: 16.26–34.58%; p = 0.045) and SAE recurrence (25.91%, 95% CI: 10.91–40.91% vs. 1.04%, 95% CI: 0–3.07%; p < 0.001) were significantly higher in the SAE group. Prior SAE history (HR 1.79, 95% CI: 1.04–3.06) was an independent factor for severe CR. The 5-year cumulative incidence of HBsAg seroclearance was significantly higher in the SAE group than that in the non-SAE group (16.82%, 95% CI: 2.34–31.30% vs. 6.02%, 95% CI: 0–13.23%; p = 0.049). Conclusions: Even though it creates a greater chance of HBsAg seroclearance, NA therapy cessation may result in a high risk of severe CR in non-cirrhotic CHB patients with prior SAE.
Highlights
There are more than 250 million people worldwide chronically infected with hepatitisB virus (HBV); the treatment of chronic hepatitis B (CHB) is a huge burden on public health [1]
Nucleos(t)ide analogue (NA) therapy can reduce the risk of HBVrelated cirrhosis and/or hepatocellular carcinoma [2], the ideal endpoint of nucleos(t)ide analogue (NA) therapy, i.e., hepatitis B surface antigen (HBsAg) seroclearance or seroconversion, is rarely achieved [3]
The alternative endpoints for discontinuing NA therapy in non-cirrhotic patients have been suggested in the current practice guidelines: persistent undetectable serum hepatitisB virus (HBV) DNA in hepatitis B e antigen (HBeAg)-negative patients or
Summary
B virus (HBV); the treatment of chronic hepatitis B (CHB) is a huge burden on public health [1]. Without an effective therapy to eradicate HBV, NA therapy currently remains the standard treatment for patients with CHB. With a concern regarding virological relapse (VR; defined as serum HBV viral load > 2000 IU/mL) or clinical relapse (CR; defined as VR with alanine aminotransferase (ALT) > 2X upper limit of normal (ULN)) after NA therapy cessation, indefinite NA therapy for cirrhotic patients has been recommended in the clinical guidelines [4,5,6]. The alternative endpoints for discontinuing NA therapy in non-cirrhotic patients have been suggested in the current practice guidelines: persistent undetectable serum HBV DNA in hepatitis B e antigen (HBeAg)-negative patients or HBeAg seroconversion in HBeAg-positive patients. Most patients will experience a VR, so NA therapy retreatment for CR is common after cessation of NA therapy [7,8]
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