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469
THE OPTIMAL DURATION OF CONSOLIDATION TREATMENT
PRIOR TO CESSATION OF NUC THERAPY IN HBEAG-NEGATIVE
PATIENTS
Wen-Juei Jeng1,2, Yi-Cheng Chen2,3, I-Shyan Sheen1,4,
Rong-Nan Chien1,2 and Yun-Fan Liaw3,4, (1)College of
Medicine, Chang Gung University, Taiwan, (2)Department
of Gastroenterology and Hepatology, Chang Gung Memorial
Hospital, Linkou Branch, Taiwan, (3)College of Medicine,
Chang Gung University, (4)Department of Gastroenterology
and Hepatology, Chang Gung Memorial Hospital, Linkou
Branch
Background: In finite Nuc therapy in HBeAg negative
chronic hepatitis B (CHB) patients, the consolidation duration
proposed by APASL stopping rule is ≥ 1year. However, the
duration proposed in Western studies and EASL guidelines
was 2-3 years Aim: To investigate the optimal length of
consolidation treatment in terms of 1-year clinical relapse (CR:
HBV DNA ≥ 2000IU/ml + ALT ≥2X ULN) rate in a large number
of patients Methods: HBeAg negative CHB patients received
monotherapy with Nuc and stop therapy by APASL guidelines
(undetectable HBV DNA for more than 1 year) and had been
followed-up ≥ 1 year were recruited. The 1-year CR rate was
compared among patients with consolidation therapy of 1-2
year vs. 2-3 and ≥ 3 years. Baseline demographic features,
Nuc used, HBV DNA, qHBsAg level, treatment duration, ontreatment
early rapid qHBsAg decline, qHBsAg reduction > 1
log10IU/ml during treatment, time to ALT normalization, time to
undetectable DNA, consolidation treatment duration, end-oftreatment
(EOT) qHBsAg were compared between patients
with and without 1-year CR Logistic regression was applied to
investigate the predictors for 1-year clinical relapse Results:
A total of 902 patients were included, 719 were treated with
entecavir (ETV), 84.%% were males, mean age was 52.7
years, 42 7% were cirrhotics and 54 3% were treatment
experienced During 1-year follow-up, 72 4% patients
encountered virologic relapse and 44 6% CR Multivariate
analysis showed older age [aOR: 1.02 (1.01-1.04), P=0.0013],
cirrhotic [aOR: 1.35 (1.02-1.79), P=0.0375], ETV therapy
[ETV vs. non-ETV: aOR: 0.49 (0.35-0.68), P<0.0001], ALT
normalization > 6 months [aOR: 1.81 (1.28-2.55, P=0.0008)
and EOT qHBsAg level [aOR: 1.54 (1.21-1.95), P=0.0004]
were independent predictors for off-Nuc 1-year CR The
duration of consolidation therapy was not a factors for relapse
[1-2 year as referent, 2-3years: crude OR (95%CI): 1.01
(0.77-1.33) P=0.9478, ≥3 years: 0.96 (0.57-1.61) P=0.8716
respectively] (Figure) nor duration of total treatment [< 2
years as referent, 2-3, 3-4, ≥4: crude OR (95%CI): 0.98
(0 64-1 48), P=0 9075, 1 43 (0 94-2 18), P=0 0927, 0 8 (0 41-
1 55), P=0 5066, respectively] Conclusion: The results have
demonstrated that a consolidation duration > 1 year was not
inferior to those > 2 or > 3 years in terms of 1-year CR rate,
hence is more cost-effective in clinical practice. |
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