Correlation between HCV core Ag and HCV-RNA levels using different commercial assay

Category 6: Viral hepatitis: clinical aspects Results: All “YMDD”-mutants determined by sequencing were also detected by the INNO-LiPA HBV-DR. However, the INNO-LiPA HBV-DR was less time and labour consuming. In six cases the YMDD mutants were detected by the INNO-LiPA HBV-DR only. Interestingly, four of those intermittently showed a reactivity for the M2041 mutant in the INNO-LiPA but not by conventional sequencing. which was lost in the subsequent sera. The M2041 mutant has been completely substituted by the M204V mutant, when clinical resistance to lamivudine emerged. More importantly in two patients YMDD mutants were detected by the INNO-LiPA HBV-DR only as minor population at the time of transplantation. Subsequently one of this patients developed HBV recurrence, while reccurence could be prevented by carefully monitoring of anti-HBs Titers in the second. Conclusion: The INNO-LiPA HBV-DR accurately detects YMDD mutants. Besides being less time consuming it is more sensitive in detecting YMDD mutants as a minor population.

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CORRELATION LEVELS

H. L. Tillmann’, ‘Dept.

.I. Andreas’,

Gastroenterology,

Hochschule

BETWEEN

HCV CORE AG AND HCV-RNA

USING DIFFERENT

Hannoves

COMMERCIAL

I. Glomb’,

Hepatology Hannoves

ASSAY

G. Picchio2, M.P. Manns’.

& Endocrinology,

Germany;

20rtho

Medizinische

Clinical Diagnostics,

Raritan, NJ, USA

Background: Recently, a new test for the detection and quantification of total HCV core Ag has been introduced. We were interested to determine the correlation between HCV core Ag levels in paired samples of serum and plasma, as well as the correlation between HCV core Ag and HCV-RNA levels using different commercial HCV-RNA quantification methods. Methods: Samples from 87 untreated patients previously tested for HCVRNA by three different commercially available assays (Superquant, NGI; HCV-Monitor 1.0, Roche Molecular Systems; Quantiplex, Bayer Diagnostics) were tested for total HCV core antigen using the Ortho tral-C assay (Ortho Clinical Diagnostics, Raritan, NJ, USA). In addition, in 38 patients both serum and plasma samples were analysed. Correlation was tested using Pearson’s method. Results: We observed good correlation between total HCV core antigen and HCV-RNA levels ranging from i-=0.565 to 0.710. Only 2/87 (2.3%) samples tested showed negative results with the &-al-C assay. One of these patients also resulted negative with all three HCV-RNA tests. The remaining patient had a very low viral load level (aprox. 100 (Superquant) or 5000 (HCV-Monitor) copies/ml.) Liver histology did not correlate with either HCV-RNA levels, total HCV core antigen levelsor the ratio between these two markers. Conclusion: The total HCV core antigen test is useful for quantification of HCV viremia. As only few samples with very low RNA results tested negative for HCV core Ag using tral-C, this assay may represent an alternative to HCV-NAT in the confirmation of viremia in anti-HCV+ samples. In the future, NAT may only be required in subjects with very low viral load levels.

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BITRIPEG ALFA-2B

STUDY: TRIPLE THERAPY PLUS RIBAVIRIN

STANDARD

THERAPY

WITH PEGINTERFERON

PLUS AMANTADINE

IN NON-RESPONDERS

VERSUS -AN

INTERIM

177

with PegIntron+Ribavirin+Placebo in non-responders to standard interferon+Ribavirin therapy. Methods: Multicenter, comparative, prospective, randomized, double blind study. Inclusion criteria were: elevated ALT, detectable HCV-RNA, and non-response to a previous cycle of IFN+Ribavirin therapy. Patients were randomized to receive PEG-IFN l.$g/kg/week, Ribavirin 800.1200mg/day and either amantadine 200mglday or placebo during 48 weeks. The primary endpoint of the study was HCV-RNA negativity 24 weeks after treatment discontinuation. Secondary endpoints included: histological benefit, ALT normalization, tolerability and compliance. Results: Results are given for the whole population because the study is still ongoing. The 204 enrolled patients were predominantly males (73%), infected by genotype 1 (79%), and had a fibrosis score
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611

PREDICTIVE

VALUE OF EARLY HCV RNA QUANTIFICATION

FOR SUSTAINED RECEIVING

RESPONSE

IN NON RESPONDERS

DAILY INTERFERON

AND RIBAVIRIN THERAPY

F! Trimoulet’,

V. de Ledinghen2,

P. Couzigou2.

‘Lab. de Virologie, H p. Pellegtin,

d’Hepatogastroenterologie,

.I. Foucher2,

L. Castera2, H. Fleury’,

H p. Haul Leveque,

Bordeaux,

2Service

Pessac, France

Aim: We evaluated the prognostic value of early HCV-RNA load among non responders (NR) to previous interferon (IFN) therapy treated with daily IFN and ribavirin. Methods: 106 NR (83 men), mean age 44.8&11 yrs, were treated with II+-2b 3MU daily during 24W followed by 3MUx3/W during 24W plus ribavirin 1 to 1.2 g/day during 48W. HCV-RNA was quantified by Versant HCV RNA 3.0 assay (Bayer Diagnostics; sensitivity 615 IU/ml) at baseline, Wl, W4 and W12. The predictive values of the baseline and the change in viral load at Wl, 4, and 12 for sustained virological responses (SVR) were analyzed using ROC curves as well as predictive values of HCV-RNA<615 IU/ml or >2-log10 drop from baseline by Wl, 4, and 12 for SVR. Results: 32 patients (30.2%) were SVR (qualitative HCV-RNA<50 IU/ml at W72). The highest area under the curve was obtained at W4. Patients with more than 334, 173 IU/ml at Wl or more than 77,738 IU/ml at W12 had no chance (negative predictive value (NPV) 100%) to achieve a SVR. HCV-RNA level > 615 IU/ml had a NPV of 74%, 84% and 97% at Wl, W4 and W12, respectively. The NPV of <2-log10 drop in combination with HCV-RNA > 615 IU/ml by Wl, W4 and W12 were 73%, 96% and 97%, respectively. Conclusion: Non response might be predicted as early as W4 or W12 in NR treated with daily IFN and ribavirin. This information may be useful for the management of previous NR patients retreated with PEG-IFN (kinetics similar to daily IFN).

ANALYSIS

M. Maynard, S.N. Si Ahmed, F. Rozier, N. Benmakhlouf, V. Boume-Branchu, C. Trepo. French Multicenter Group; Department Hepatology,

Hotel-Dieu,

Of

Lyon, France

Background and Aims: Triple antiviral therapy with interferonalfa+ribavirin+amantadine was suggested to increase sustained virological response rates in HCV non-reponder patients. This study was designed to evaluate the efficacy, side effects, quality of life (QoL) and safety of triple therapy with PegIntron+Ribavirin+Amantadine vs. double therapy

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CHRONIC

HEPATITIS DELTA VIRUS INFECTION

IN EASTERN

TURKEY

M.K. Turkdoean’, H. Bozkurt2, I. Tuncer’, I. Uygan’, H. Irmak3, T. Buzgan3, H. Akdeniz3. ‘Gastroenterology, 2Micicrobiology, ‘Infectious Diseases,

Yuzuncu Yil University, Van, Turkey,

Background and Aims: Hepatitis Delta virus (HDV) infection is an important cause of chronic liver diseases associated with Hepatitis B virus