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HBsAg loss rates remain low during 3-year follow-up of
HBeAg negative patients with chronic hepatitis B after
nucleos(t)ide analogue withdrawal: results of the Toronto
STOP Study
Kin Seng Liem1,2, Bahareh Moazen1, Scott K Fung1,3,
David KH Wong1, Jiayun Chen1, Colina K. Yim1, Seham
Noureldin1, Jordan J. Feld4,5, Bettina E. Hansen1,6 and Harry
L. A. Janssen1, (1)Toronto Centre for Liver Disease, Toronto
General Hospital, University Health Network, (2)Department
of Gastroenterology & Hepatology, Erasmus Medical Centre
Rotterdam, (3)University of Toronto, Toronto, on, Canada,
(4)Mclaughlin-Rotman Centre for Global Health, (5)Toronto
Centre for Liver Disease, University Health Network, (6)
Institute of Health Policy, Management and Evaluation,
University of Toronto
Background: Several studies have investigated the potential
of nucleos(t)ide analogues (NA) withdrawal in patients
with chronic hepatitis B (CHB), but have lacked long-term
follow-up (LTFU). We prospectively evaluated the long-term
outcomes during NA discontinuation in HBeAg negative
patients Methods: Patients who stopped or continued NA
therapy for 72 weeks in a single-center trial were eligible to
participate in this LTFU study Patients were retreated in case
of persistent HBV DNA>20,000IU/mL, HBeAg seroreversion
or HBV DNA>2,000 with ALT>5xULN. These criteria allowed
viral relapse, but not at the cost of severe and dangerous
flares. Retreatment, HBsAg loss and HBsAg decline were
evaluated Results: Out of 66 included patients (60% male,
97% Asian), 45 patients stopped and 21 continued NA therapy
The median (IQR) duration of follow-up was 132 (52) weeks,
and 17/45 (38%) stop patients received retreatment initially
At the end of LTFU, 23/45 (51%) stop patients received
retreatment, of which 6/45 (13%) had a sustained off-therapy
response until week 72 The probability of retreatment
increased linearly beyond week 12 (see Figure) Five of
the 22 (23%) patients randomized to treatment continuation
elected to stop therapy after week 72 and 2 (40%) of them
remained off therapy thus far Beyond week 72, no HBsAg
loss occurred Mean (SD) HBsAg decline from randomization
to LTFU was 0 4 (0 4) log IU/mL and did not differ according
to randomization or retreatment (p>0.05). HBsAg decline >1
log IU/mL was achieved in 4/23 (17%) retreated stop patients,
4/22 (18%) not retreated stop patients, and 1/21 (5%) continue
patient Eleven (17%) patients reached HBsAg <100 IU/mL
HBeAg seroreversion occurred in 9/45 (20%) stop patients
Although two stop patients developed a severe ALT flare
(864-1,610 IU/mL) with concurrent bilirubin increase (114-
68 umol/L), no patient experienced liver decompensation or
died Conclusion: During 3-year observation of an Asian
majority NA stop cohort, no further HBsAg loss occurred
beyond week 72 while the rate of HBsAg decline remained
low. These findings suggest that even during longer follow-up
and with liberal retreatment criteria, stop patients are at risk
of significant relapse and retreatment, although the odds of
achieving functional cure remain limited.
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