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740
USEFULNESS OF HEPATITIS B CORE-RELATED ANTIGEN
AND SURFACE ANTIGEN USING ULTRA-HIGHLY SENSITIVE
IMMUNOASSAYS FOR PREDICTING HEPATOCELLULAR
CARCINOMA IN PATIENTS TREATED WITH ENTECAVIR
Tetsuya Hosaka1, Fumitaka Suzuki1, Mariko Kobayashi2,
Shunichiro Fujiyama1, Yusuke Kawamura1, Hitomi Sezaki1,
Norio Akuta1, Masahiro Kobayashi1, Yoshiyuki Suzuki1,
Satoshi Saitoh1, Yasuji Arase1, Kenji Ikeda1 and Hiromitsu
Kumada1, (1)Hepatology, Toranomon Hospital, (2)Research
Institute for Hepatology, Toranomon Hospital
Background: Serum hepatitis B core-related antigen
(HBcrAg) and surface antigen (HBsAg) have been known as
surrogate markers of intrahepatic covalently closed circular
DNA (cccDNA) and transcriptional activity Some studies
recently reported that patients with high HBcrAg levels were
likely to develop hepatocellular carcinoma (HCC) despite
of long-term nucleos(t)ide analogues (NA) treatment The
measurement range of current HBcrAg assay is relatively
narrow We examined the potential of HBcrAg and HBsAg
measured by the ultra-highly sensitive assays for predicting
HCC development in chronic hepatitis B (CHB) patients
treated with entecavir (ETV) Methods: We conducted a
retrospective cohort study of 180 patients who received ETV
for more than one year in our institute All of these patients
had HBeAg negativity at baseline, and no prior history of
HCC Serum HBcrAg and HBsAg levels at baseline and year 1
were measured in all patients by ultra-highly sensitive assays
using “immunoassay for total antigen including complex
via pretreatment (iTACT)” technology (Fujirebio Inc, Tokyo,
Japan) from their stored serum samples The iTACT-HBcrAg
assay has about 8 times higher sensitivity (sensitivity: 2 1
Log U/mL) than the current assay The sensitivity of iTACTHBsAg
is about 100 times higher (sensitivity: 0 0005 IU/mL)
than that of the conventional HBsAg assays Patients were
followed until any confirmed HCC diagnosis 1 year after the
start of ETV treatment (primary outcome) Results: During
follow-ups of median 10 5 years, 21 patients had developed
HCC (11 8/1,000 person-years) Median baseline iTACTHBcrAg
and -HBsAg levels were 4 2 log U/mL (IQR: 3 3-5 2),
and 1752 62 IU/mL (IQR: 417 84-4876 15) Unfortunately,
baseline HBsAg levels were not associated with HCC
development during ETV treatment However, high HBcrAg
levels at baseline and year 1 were significantly associated
with HCC development (log-rank test; P < 0 001) (cut-off
values; 4 7 log U/mL at baseline and 4 0 at year 1) The time-dependent
areas under receiver operating characteristic
curves (AUROCs) of baseline HBcrAg for discriminating the
5- and 10-year incidence of HCC are 0 721 and 0 748 The
AUROCs of on-treatment HBcrAg at 1 year for 5- and 10-year
incidence of HCC are 0 650 and 0 747 110 of 160 patients
(61.1%) had ≥ 4.0 log U/mL at baseline (High HBcrAg cohort).
HBcrAg declined to ≤ 2.9 at year 1 in 25 patients (22.7%), and
to 3 0-3 9 in 41 (37 3%) of high HBcrAg cohort Cumulative
HCC incidence rate was significantly lower in patients with
HBcrAg at year 1 ≤ 2.9 than the others in high HBcrAg cohort
(P = 0 019) No patients without the detection of HBcrAg at
year 1 experienced HCC development Conclusion: The
results may suggest that the measurement of HBcrAg by
the ultra-highly sensitive assay has the better potential for
predicting HCC during NA treatment than the current assay |
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发表于 2020-10-23 16:50