Off-treatment efficacy of 3-year nucleos(t)ide analogues in chronic hepatitis B patients

Ching-Chung Lin1, Ming-Jong Bair2, Chih-Jen Chen3

  • 1Division of Gastroenterology, Department of Internal Medicine and Liver Medical Center, Mackay Memorial Hospital, Taipei, Taiwan; Mackay Medical College, New Taipei City, Taiwan.

Insights

Stopping nucleos(t)ide analogue therapy for chronic hepatitis B virus (HBV) after 3 years resulted in a 33.8% 1-year clinical relapse rate. No significant differences in relapse rates were observed among lamivudine, telbivudine, and entecavir treatments.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Chronic hepatitis B virus (HBV) infection is a global health concern.
  • Nucleos(t)ide analogues are first-line treatments for chronic HBV, with 3-year durations often covered by national health insurance.
  • Optimal treatment duration and post-treatment outcomes remain unclear for these agents.

Purpose of the Study:

  • To evaluate the durability of HBV treatment cessation after a 3-year course of nucleos(t)ide analogues.
  • To compare predictors of clinical relapse in patients with and without relapse after stopping therapy.
  • To assess the safety and efficacy of treatment withdrawal in a real-world setting.

Main Methods:

  • Retrospective cohort study of 210 patients with chronic HBV treated for 3 years with lamivudine, telbivudine, or entecavir.
  • Patients were stratified into those who continued therapy (n=102) and those who stopped (n=88) and were followed for 1 year.
  • Efficacy outcomes included alanine aminotransferase (ALT) normalization, HBV DNA clearance, viral breakthrough, clinical relapse, and liver decompensation.

Main Results:

  • Eighty patients (14 lamivudine, 19 telbivudine, 47 entecavir) were analyzed for off-treatment outcomes.
  • The overall 1-year clinical relapse rate after 3 years of treatment was 33.8%, with no significant difference among the three drugs (35.7% vs. 36.8% vs. 31.9%, p=0.916).
  • No liver decompensated hepatitis flare-ups were observed. Higher mean 3rd-year serum ALT levels were associated with clinical relapse (37.5 U/L vs. 27.7 U/L, p=0.044).

Conclusions:

  • Three years of nucleos(t)ide analogue therapy for chronic HBV followed by treatment cessation results in a substantial 1-year clinical relapse rate.
  • The choice of lamivudine, telbivudine, or entecavir did not influence the clinical relapse rate after stopping treatment.
  • Monitoring ALT levels may help predict relapse risk after treatment discontinuation.

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