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784
CHANGES OF HBsAg QUANTITY AND ITS RELATION
WITH HBEAG SEROCONVERSION FOLLOWING 48 WEEKS
PEGYLATED-INTERFERON-ALPHA TREATMENT IN PATIENTS
WITH HBEAG POSITIVE CHRONIC HEPATITIS B AFTER LONG
TERM NUCLEOS(T)IDE ANALOGUE MAINTENANCE THERAPY;
ROLL OVER TRIAL
Hyun Young Woo1, Jeong Heo1, Won-Young Tak2, Heon
Ju Lee3, Woo Jin Chung4, Soo Young Park2 and Young-Oh
Kweon2, (1)Internal Medicine, Pusan National University
Hospital, (2)Department of Internal Medicine, Kyungpook
National University Hospital, Daegu, Republic of Korea, (3)
Internal Medicine, College of Medicine, Yeungnam University,
(4)Internal Medicine, Keimyung University
Background: Durable post-treatment response is uncommon
in patients with chronic hepatitis B (CHB) on nucleos(t)
ide analogue (NA) therapy The aim of this study is to
investigate pegylated interferon (PegIFN) after long term
NA therapy might enhance the antiviral efficacy leading to
HBeAg seroconversion and eventually HBsAg loss and/or
seroconversion Methods: The patient with HBeAg-positive
CHB who had been treated with any NA except telbivudine at
least 72 weeks, who have an undetectable HBV DNA (<400
copies/mL) at least 48 weeks, were randomised 1:1 to receive
PegIFN alfa-2a 180 ug/week or previous NA for 48 weeks
The primary endpoint was change in log10 HBsAg titer during
antiviral therapy (ClinicalTrials gov: NCT01769833) Post
treatment HBsAg titer analysis was performed at every 12
weeks until 96 weeks after end of 48 weeks of PegIFN alfa-2a
or NA therapy Results: Total 150 patients were randomized;
75 received PegIFN alfa-2a On treatment HBsAg decline
from 24 to 48 weeks and was significantly higher in patients
who switched to PegIFN alfa-2a than those who continued
NA and maximal difference of HBsAg titer was shown at 36
weeks (mean log HBsAg ±SD, 0 378±0 572 vs 0 013±0 241;
p < 0 001) However, during follow-up period, this difference in
HBsAg titer was disappeared and HBsAg titer became similar
between two groups (HBsAg titer at 144 weeks: mean log
HBsAg ±SD, 0 221±0 526 vs 0 196±0 163; p = 0 243) HBeAg
seroconversion was significantly higher in patients receiving
PegIFN alfa-2a during [21 2% (14/66) vs 9 7% (5/69) at 48
weeks; p = 0 026] and after treatment [28 4% (19/67) vs 8 5%
(5/59) at 144 weeks; p = 0 006] HBsAg loss was observed in
one patient receiving PegIFN alfa-2a during follow-up period
HBV DNA level <2000 IU/ml was maintained in 94 6% until
week 12, 73 6% until week 24, 58 6% until week 36, 46 8%
until week 48, 8 15% until week 96 and 6 12% until week 144
in PegIFN alfa-2a group and 97 8% until week 48, 95 4% until
week 96 and week 144 in NA group For this viral rebound, NA
was restarted in 52 3% of patients until week 48, in 88 1% of
patients until week 96 and in 95 1% of patients until week 144
in PegIFN group There are total 101 cases of ALT elevation
Of these, 29 cases of ALT elevation appeared to be temporally
associated with viral rebound (HBV DNA≥2000 IU/mL). Other
72 cases of ALT elevation occurred within 3 months after
switching to PegIFN alfa-2a On-treatment change of HBsAg
was significantly associated with HBeAg seroconversion at
144 weeks (p=0 004) PegIFN alfa-2a was well-tolerated
Conclusion: This final analysis showed that, for patients who
achieve virological suppression with oral NA, switching to a
48 weeks PegIFN alfa-2a treatment significantly decrease
HBsAg titer and increases rates of HBeAg seroconversion
However, HBV DNA elevation was developed frequently
during and after PegIFN alfa-2a treatment and decrease in
HBsAg titer was not maintained during post-treatment followup.
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发表于 2020-10-25 16:26