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Long-Term Follow-Up of Patients in a Prospective Study of NA Discontinuation Identifies Different Patterns of HBsAg

Simon J Hume1,2,3, Samuel Hall1,2, Gareth Burns4

  • 1St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia.

Alimentary Pharmacology & Therapeutics
|August 22, 2025
PubMed

Insights

Discontinuing nucleos(t)ide analogues (NAs) can lead to functional cure (HBsAg loss) in chronic hepatitis B (CHB) patients. Lower end-of-treatment HBsAg levels predict successful HBsAg loss, though flares may occur.

Area of Science:

  • Hepatology
  • Virology
  • Immunology

Background:

  • Nucleos(t)ide analogues (NAs) are standard treatment for chronic hepatitis B (CHB).
  • Discontinuation of NAs may offer a chance for functional cure, defined as hepatitis B surface antigen (HBsAg) loss.
  • Predicting successful NA discontinuation and functional cure is crucial for patient management.

Purpose of the Study:

  • To evaluate the long-term rates of HBsAg loss after stopping NAs in CHB patients.
  • To identify predictors of HBsAg loss and assess safety outcomes, including hepatitis flares and hepatocellular carcinoma (HCC).

Main Methods:

  • A real-world extension study followed 97 participants with HBeAg-negative CHB without cirrhosis after NA discontinuation.
  • Efficacy outcomes (HBsAg loss/decline) and safety outcomes (hepatitis flares, HCC) were monitored over a median of 7 years.
  • Statistical analyses identified predictors of HBsAg loss.

Main Results:

  • Cumulative incidence of HBsAg loss reached 22% at 9 years post-NA cessation.
  • Lower end-of-treatment (EOT) HBsAg levels (≤10 IU/mL) predicted early HBsAg loss without flares.
  • Higher EOT HBsAg levels (≥10 IU/mL) were associated with later HBsAg loss, sometimes following ALT flares. Older age and peak off-treatment HBV DNA also predicted HBsAg loss.
  • No hepatic decompensation, transplantation, or death occurred. HCC incidence was 4.4/1000 person-years.

Conclusions:

  • Functional cure rates increase over long-term follow-up but remain low.
  • EOT HBsAg level is a strong predictor of HBsAg loss likelihood and timing.
  • ALT flares are linked to HBsAg decline and can influence the timing of HBsAg loss.
Abstract

Keywords:
alt flarechronic hepatitis bfunctional curehbsag levelhbsag losshepatitis flarelong‐term follow‐upnucleos(t)ide analogue discontinuation

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