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Observational Study
. 2018 Apr;47(8):1170-1180.
doi: 10.1111/apt.14560. Epub 2018 Mar 2.

Stopping nucleos(t)ide analogue treatment in Caucasian hepatitis B patients after HBeAg seroconversion is associated with high relapse rates and fatal outcomes

S Van Hees  1   2 , S Bourgeois  1 , H Van Vlierberghe  3 , T Sersté  4 , S Francque  1 , P Michielsen  1 , D Sprengers  1 , H Reynaert  4 , J Henrion  5 , S Negrin Dastis  6 , J Delwaide  7 , L Lasser  4 , J Decaestecker  8 , H Orlent  9 , F Janssens  10 , G Robaeys  11 , I Colle  12 , P Stärkel  4 , C Moreno  4 , F Nevens  13 , T Vanwolleghem  1   2 ; Belgian NA Stop Study Group
Collaborators, Affiliations
Observational Study

Stopping nucleos(t)ide analogue treatment in Caucasian hepatitis B patients after HBeAg seroconversion is associated with high relapse rates and fatal outcomes

S Van Hees et al. Aliment Pharmacol Ther. 2018 Apr.

Abstract

Background: Stopping nucleos(t)ide analogues (NA) after hepatitis B e antigen (HBeAg) seroconversion is associated with high relapse rates in Asian patients, but data in Caucasian cohorts are scarce. Clinical course, outcomes and immunological aspects of chronic hepatitis B infections differ substantially between distinct ethnicities.

Aim: The aim of this study was to determine relapse rates, factors predicting relapse and clinical outcomes after nucleos(t)ide analogue cessation in a large, predominantly Caucasian cohort of chronic hepatitis B patients with nucleos(t)ide analogue-induced HBeAg seroconversion.

Methods: This is a nationwide observational cohort study including HBeAg positive, mono-infected chronic hepatitis B patients with nucleos(t)ide analogue-induced HBeAg seroconversion from 18 centres in Belgium.

Results: A total of 98 patients with nucleo(s)tide analogue-induced HBeAg seroconversion were included in the study. Of the 62 patients who stopped treatment after a median consolidation treatment of 8 months, 30 relapsed. Higher gamma-glutamyl transferase levels at both treatment initiation (HR 1.004; P = 0.001 per unit increment) and HBeAg seroconversion (HR 1.006; P = 0.013 per unit increment) were associated with an increased risk of clinically significant relapse in a multivariate Cox regression model. Treatment cessation led to liver-related death in 2 patients, of whom one showed a severe flare. Of the patients who continued treatment after HBeAg seroconversion, none relapsed or developed severe hepatic outcomes.

Conclusion: Treatment withdrawal in Caucasian chronic hepatitis B patients after nucleos(t)ide analogue-induced HBeAg seroconversion results in viral relapses in more than half of patients with potential fatal outcomes. These real-world data further lend support to preferentially continue NA treatment after HBeAg seroconversion until HBsAg loss.

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Figures

Figure 1
Figure 1
Flowchart of the patients included in the study. NA, nucleos(t)ide analogues; HBsAg, hepatitis B surface antigen; HBeAg, hepatitis B e antigen; SC, seroconversion; HIV, human immunodeficiency virus; HDV, hepatitis delta virus; HCV, hepatitis C virus; LTFU, loss‐to‐follow‐up
Figure 2
Figure 2
Cumulative rates of clinically significant relapse after treatment cessation. *Clinically significant = persistent or immediately retreated relapse
See this image and copyright information in PMC

Comment in

References

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