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EASL2015 TREATMENT INDIVIDUALIZATION BY HBsAg LEVELS AND MiR-B-INDEX KINETICS

P0635
CHRONIC HEPATITIS B TREATMENT INDIVIDUALIZATION BY
MEANS OF SERUM HBsAg AND MiR-B-INDEX KINETICS
D. Cavallone1, F. Oliveri1, P. Colombatto1, B. Coco1, P. Ciccorossi1,
V. Romagnoli1, B. Cherubini1, F. Moriconi1, B. Ferruccio2,
M.R. Brunetto1. 1Hepatology Unit, Reference Center of the Tuscany
Region for Chronic Liver Disease and Cancer, 2Digestive and Liver
Disease, General Medicine II Unit, University Hospital Pisa, Pisa, Italy
E-mail: [email protected]
Background and Aims: Non-viral biomarkers of sustained control
of HBV infection are an unmet need for treatment individualization
in Chronic Hepatitis B (CHB). We recently reported that Inactive
Carriers (IC) and patients with sustained-virologic-response (SVR)
to Peg-IFN share a common serum miRNA signature (MiR-B-Index,
MBI). We studied the kinetics of MBI and HBsAg during and after
Peg-IFN.
Methods: 46 CHB patients (11 HBeAg pos, 29 males, median age
48.6 y, range 22.4–64.1 y; genotypes: A 5, D 39, F 2) were treated
with Peg-IFN2a 180 mg/w (median 13.2 months, 8–24 mo): 20 SVR;
17 relapsers (REL) and 9 non-responders (NR). Single RT-q-PCR
for miR-122-5p, miR-99a-5p, miR-192-5p, miR-126-3p, miR-335-5p
and miR-320a were performed using miRCURY RNA Isolation kit,
miRCURY-LNA™ Universal-RT-cDNA-Synthesis and RT-miRNA-PCR
(Exiqon-A/S). HBV-DNA and HBsAg were quantified by COBAS
TaqMan (Roche) and Architect (Abbott). HBsAg and MBI were tested
at baseline (BL), 24–48 wks and end of therapy (EOT) and 24 wks
post treatment (PTFU).
Results: Median HBsAg and MBI values at the different time points
in overall patients, HBeAg pos and neg are reported in the table. MBI
values >−1.7 were found: at BL in 5 HBeAg neg pts (4 SVR, 1 NR);
at EOT in 14/19 (73.7%) SVR (4 HBeAg pos, 10 HBeAg neg) and at
PTFU in all SVR, but in 1 NR and 1 REL only. In HBeAg neg pts at
EOT MBI values ≥−3.0 and HBsAg <1000 IU/mL had 100–93.3% sens.,
94.7–85.0% spec., 93.3–82.4% PPV, 100–94.4% NPV and 97.0–88.6%
DA in identification of SVR (AUROC 0.988 and 0.951 respectively).
Conclusions: Both HBsAg and MBI show good performances in
SVR prediction overall. In HBeAg neg CHB MBI predicts SVR since
therapy beginning and identifies all SVR at EOT qualifying as the
best biomarker for individual therapy monitoring.
7 Responses
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Avatar universal
I am hbeag neg, so I am very interested on this news, Please keep us informed Steff. I am sure you will,as always
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Avatar universal
this is also an increadible test, i guess hbeag neg patients may try peg for about 4 weeks and stop it or keep it according to this test
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this is a discovery of dr brunetto team about immune system signature of hbsag loss, this test is able to predict response before hbsag decline and according to this new data it is able to predict hbsag loss on hbeag negative even at start of therapy

at my next appointment there i will ask if and when this test will be available, i am very interested in it because it may tell me if i need another round of peg or if i will clear on the followup of my previous pegintf add on therapy
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So basing on mbi you may predict is it makes sense to prolong peginf therapy for more than 12m ?
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Thank you for the information stef2011 & hope all of us 'll be cured as soon as possible.
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Avatar universal
In HBeAg neg MBI predicts SVR since
therapy beginning and identifies all SVR at EOT qualifying as the
best biomarker for individual therapy monitoring.
Helpful - 0
Avatar universal
this is extremely interesting, dr brunetto (pisa cisanello hospital researchers) and are already applying the discovery of serum miRNA signature to make personalized treatment
Helpful - 0
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