s 458A
Validation of End-of-Treatment HBsAg Cut-Off
Level As 200 IU/Ml in Off-Nuc Therapy Hbeag
Negative Chronic Hepatitis B Patients
Wen-Juei Jeng1,2, Yi-Cheng Chen1,2, Rong-Nan Chien1,2,
I-Shyan Sheen1,2 and Yun-Fan Liaw1,3, (1)College of Medicine,
Chang Gung University, (2)Department of Gastroenterology
and Hepatology, Chang Gung Memorial Hospital, Linkou, (3)
Liver Research Unit, Chang Gung Memorial Hospital
Background: Recent ILC-2018 congress has proposed that
HBeAg negative chronic hepatitis B (CHB) patients treated
with Nuc and whose end of treatment (EOT) HBsAg level had
achieved a level < 200IU/ml might consider stopping therapy.
However, the EOT HBsAg < 200IU/ml was achieved only in
< 30% patients during Nuc therapy. The aim of this study
is to vailidate the outcome of patients whose EOT HBsAg
≥ 200IU/ml. Methods: HBeAg negative CHB patients who
discontinued Nuc by the APASL stopping rule (consecutive
HBV DNA undetectable > 1 year) with an EOT HBsAg ≥200IU/
ml and had already followed-up ≥ 1 year were recruited. The
scheduled follow-up protocol after stopping Nuc was monthly
in the first 3 months, then every 1-3 months. Baseline age,
gender, cirrhosis, prior treatment history, HBV genotype,
pretherapy serum ALT, HBsAg and HBV DNA levels, duration
of therapy, consolidation duration, on-treatment viral kinetics,
and EOT HBsAg level were analyzed Serum HBV DNA was
assayed by Cobas Amplicor HBV Monitor (Roche Diagnostics,
negative < 20IU/ml). Serum HBsAg was measured by Roche
Elecsys II kit (negative < 0.05 IU/ml). Results: Of these 430
patients, (age: 50.9, male: 84.9%, cirrhosis: 41.9%), the
independent predictors for clinical relapse was age older than
55 (aHR: 1.319 (1.035-1.680), P=0.025), cirrhosis (aHR: 1.275
(95%CI: 1.012-1.605), P=0.0394), male (aHR: 1.524 (1.066-
2.180), P=0.0210), non-ETV Nuc therapy (aHR: 1.646 (1.232-
2.199), P=0.0007), and time to ALT normalization (aHR: 1.005
(1.000-1.009), P=0.0416). Off-therapy HBsAg loss rate in the
430 patients was 0.8% per year, 0%/year in 216 patients with
clinical relapse who were retreated, 0.8%/year in 73 patients
with viral relapse and not retreated. 1.5%/year in 102 patients
with clinical relapse without retreatment, and 3.7%/year in 39
patients with sustained response. Conclusion: There are still
26% of the patients whose EOT HBsAg ≥200IU/ml maintained
sustained response off Nuc therapy. In addition, the overall
off-Nuc HBsAg loss rate was 0.8% per year, while patients
with sustained response or relapse remained untreated had
HBsAg loss rate up to 3.72% per year. Therefore, patients
with EOT HBsAg ≥200IU/ml still have options considering
finite Nuc therapy. 作者: StephenW 时间: 2018-10-23 15:19