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HBV-RNA IS A VERY USEFUL BIOMARKER FOR PREDICTION OF
HBEAG NEGATIVE SUBJECTS WITH SIGNIFICANT FIBROSIS
Adriana Palom1, Sara Sopena Santisteve2,3, Luisa Roade
Tato1,2, David Tabernero4, Maria Francesca Cortese2,3,
Francisco Rodriguez-Frías4,5, Rafael Esteban-Mur1,2, Mar
Riveiro Barciela2,6 and Maria Asuncion Buti Ferret1,2, (1)Liver
Unit, Internal Medicine Department. Hospital Universitari
Vall d’Hebron, Barcelona, Spain, (2)Ciberehd, Instituto
Carlos III, Madrid, (3)Liver Pathology Unit (Biochemistry and
Microbiology departments, Clinical Laboratories), Hospital
Universitari Vall d’Hebron, Barcelona, Spain, (4)Liver
Pathology Unit Departments of Biochemistry and Microbiology,
Vall d’ Hebron University Hospital and Universitat Autonoma
De Barcelona, Barcelona, Spain, University Hospital Vall
D’hebron, (5)Centro De Investigación Biomédica En Red,
Enfermedades Hepáticas y Digestvas (CIBERehd), Instituto
De Salud Carlos III, Madrid, Spain, (6)Liver Unit, Internal
Medicine Department. Hospital Universitari Vall d’Hebron,
Barcelona, Spain, University Hospital Vall D’hebron
Background: Chronic Hepatitis B (CHB) entails an important
healthcare burden. The appropriate classification of CHB
patients regarding therapy requirements and prognosis often
requires a liver biopsy The aim of the study was to assess
the usefulness of new HBV biomarkers (qHBsAg, HBcrAg
and HBV-RNA) to predict clinical events in patients with CHB
Methods: Prospective study including 111 HBeAg-negative
patients: 74 naïve subjects with HBV DNA>2000 IU/mL
who underwent a liver biopsy and 37 CHB on nucleos(t)ide
analogues (NAs) with viral suppression for ≥2 years. Primary
endpoints were: treatment criteria in naïve patients (HBVDNA>
2000 IU/mL plus significant fibrosis in liver biopsy); and
HBsAg loss, development of hepatocellular carcinoma (HCC)
or liver decompensation for patients on NAs HBV-DNA was
quantified by qPCR (LLOD 20IU/mL), HBV-RNA by in-house
one-step RT-qPCR (LLOD 10 copies/mL) and HBcrAg by
chemiluminiscent enzyme immunoassay (LLOD 2 logU/mL)
Results: The majority were male and Caucasian, mean age
49 ± SD 14 years, 32% liver cirrhosis Among naïve patients,
20 (27%) met criteria for antiviral therapy throughout a median
follow-up of 10 8 months (IQR, 0 6-15 6 months) Baseline
biomarkers were higher among those who met treatment
criteria after liver biopsy: HBV-RNA (log cop/mL 2 61 vs
0 85, p<0 001), HBcrAg (logU/mL 3 81 vs 2 52, p<0 001),
HBV-DNA (logUI/mL 4 98 vs 3 93, p=0 001) and APRI
(0 58 vs 0 38, p=0 004) HBV-RNA presented the greatest
AUROC for identification of patients with criteria for antiviral
therapy (R=0 897) (Figure 1), followed by HBcrAg (R=0 785),
APRI (R=0 755) and HBV-DNA (R=0 748) The cut-off with
the highest Youden’s index was HBV-RNA>2.0 (Positive
predictive value=90%, Negative predictive value=95%)
Among NAs-virological suppressed patients, progressive
decrease of HBsAg (logUI/mL 2 75 vs 2 49, p=0 046), HBVRNA
(log cop/mL 0 74 vs 0 43, p=0 061) and improvement
of MELD score (8 7 vs 6 7, p<0 05) was observed when
comparing baseline and last follow-up results To date, 5
(14%) NAs-viral suppressed patients developed HCC All
presented liver cirrhosis, but only higher age (>50 years) and
AST (>40 UI/mL) at baseline were independent predictors
of HCC development (OR=4 5 and OR=10 5, respectively)
Conclusion: HBV-RNA is a useful non-invasive biomarker for
identification of naive HBeAg negative patients with significant
liver fibrosis who benefit from antiviral therapy. This marker
could avoid the performance of liver biopsy These results
need to be confirmed in a larger number of patients.作者: StephenW 时间: 2020-10-23 15:59