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a 195
ADDITION OF PEGINTERFERON ALFA-2a INCREASES
HBsAg DECLINE IN HBEAG-NEGATIVE CHRONIC HEPATITIS
B PATIENTS TREATED WITH LONG-TERM NUCLEOS(T)IDE
ANALOGUE THERAPY: RESULTS FROM A MULTICENTER
RANDOMIZED CONTROLLED TRIAL. (PAS STUDY)
Mina S. Farag1,2, Scott K Fung1, Margo Van Campenhout3,
Karel J. Van Erpecum4, David KH Wong1, Andre Boonstra5,
Elke Verhey3, Robert A. De Man3, Kin Seng Liem1,3, Bettina
E. Hansen1,6 and Harry L. A. Janssen1, (1)Toronto Centre
for Liver Disease, Toronto General Hospital, University
Health Network, (2)Institute of Medical Science, University of
Toronto, (3)Department of Gastroenterology & Hepatology,
Erasmus Medical Centre Rotterdam, (4)Department of
Gastroenterology and Hepatology, University Medical Center
Utrecht, (5)Department of Gastroenterology & Hepatology,
Erasmus University Medical Center Rotterdam, (6)Institute
of Health Policy, Management and Evaluation, University of
Toronto
Background: Pegylated-interferon (PEG-IFN) treatment
has been associated with higher Hepatitis B surface antigen
(HBsAg) decline rates in chronic hepatitis B (CHB) It is
essential to assess this decline as PEG-IFN add-on to NA
is increasingly used in new regimens aiming for a functional
cure In addition, PEG-IFN add-on therapy may help to reach
HBsAg loss allowing to stop NA Therefore, we investigated
in a randomized, controlled trial the dynamics of HBsAg in
HBeAg-negative CHB patients on long-term NA therapy who
received add-on PEG-IFN Methods: In this investigatorinitiated
randomized controlled trial conducted in Europe and
Canada, HBeAg-negative patients with compensated liver
disease treated with NA therapy > 12 months and had HBV
DNA <200 IU/mL were enrolled. Patients were randomized 2:1
(baseline) to 48 weeks of add-on PEG-IFN alfa-2a (180 μg per
week) or continued NA monotherapy with subsequent followup
to week 72. The primary endpoint was HBsAg decline >
1 log IU/ml at week 48 from baseline and HBsAg loss was a
secondary endpoint. Week 48 interim results are presented
here, and final results from week 72 will be presented during
the meeting Results: Of the 89 patients in the modified
intention-to-treat analysis, 58 patients received PEG-IFN
add-on, and 31 continued NA monotherapy At present, 71
patients have reached week 72 At baseline, the mean age
was 48 years, 86% male, 66% Asian, and 25% Caucasian
Median baseline HBsAg level was 2 9 log10 IU/mL At week
48, 6 (10%) patients achieved HBsAg > 1 log10 decline in
the add-on arm compared to none on NA monotherapy
(P<0 0001) Compared to NA monotherapy, PEG-IFN add-on
resulted in significant HBsAg decline at week 48 (mean [SD]:
-0.84 [1.1] vs. -0.2 [0.3] log10, P=0.001; see Figure). At week
48, HBsAg clearance was observed in 5 (8 6%) of patients
who received PEG-IFN add-on therapy versus none of the
NA monotherapy patients (P<0 0001) PEG-IFN was safe
and well-tolerated in the majority of patients Severe adverse
events were reported in three patients Conclusion: At week
48, the addition of PEG-IFN to long term NA is associated
with substantial HBsAg decline and limited HBsAg clearance
in HBeAg-negative CHB patients Therefore, the future role
of PEG-IFN add-on appears to be mainly in new regimens
aiming for a functional cure of CHB
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发表于 2019-10-24 20:10
