Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin

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http://www3.interscience.wiley.com/journal/123191081/abstract

Hepatology

Early View (Articles online in advance of print)

Published Online: 30 Nov 2009

Copyright © 2005 American Association for the Study of Liver Diseases

Viral Hepatitis

Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the

sustained virologic response in patients with hepatitis C virus receiving

pegylated interferon and ribavirin

ot-Peignoux 1 *, Christiane Stern 1, Maylin 1, Marie-Pierre

Ripault 2, Nathalie Boyer 2, ce Leclere 1, Corinne Castelnau 2, Nathalie

Giuily 2, Ahmed El Ray 2, Ana-Carolina Cardoso 1, Rami Moucari 1 2, Tarik

Asselah 1 2, Marcellin 1 2

1Institut National de la Santé et de la Recherche Médicale, U-773, Centre de

Recherche Biomédicale Bichat-Beaujon CRB3, Université Paris VII, Paris, France

2Service d'Hépatologie, Hpital Beaujon, Clichy, France

email: ot-Peignoux (michelle.martinot@...)

*Correspondence to ot-Peignoux, ot-Peignoux,

INSERM, U-773, Centre de Recherche Biomédicale Bichat-Beaujon CRB3; Université

Paris VII, and Service d'Hépatologie, Hpital Beaujon, 92110 Clichy, France

Potential conflict of interest: Nothing to report.

fax: (33)-1-4730-9440

Abstract

A sustained virologic response (SVR) in patients with chronic hepatitis C

receiving pegylated interferon (PEG-IFN) plus ribavirin is defined as

undetectable serum HCV-RNA at 24 weeks (W+24) posttreatment follow-up. Viral

load outcome in patients with virological relapse (VR) has not been explored.

This study evaluated whether the assessment of serum HCV-RNA 12 weeks (W+12)

after the end of treatment was as relevant as W+24 to evaluate SVR in 573

patients who received combination PEG-IFN and ribavirin and had a virological

response at the end of treatment. Serum HCV-RNA was measured, using a new assay

based on transcription-mediated amplification (TMA) with a lowest detection

limit of 5-10 IU/mL, at W+12 and W+24 after the end of treatment. VR was defined

as reappearance of detectable HCV-RNA at W+24 posttreatment follow-up. The

positive predictive value (PPV) of undetectable serum HCV-RNA at W+12 was

evaluated to identify patients with SVR, and the viral load outcome was measured

in relapse patients. At the W+24 posttreatment follow-up, 408 (71%) patients had

an SVR, 181 (71.2%) were treated with PEG-IFN-2a and ribavirin, and 227 (71.1%)

were treated with PEG-IFN-2b and ribavirin. At W+12, serum HCV-RNA was

undetectable in 409 patients, and 408 patients were SVR (PPV 99.7%, 95%

confidence interval 99.1-100). In relapse patients, serum HCV-RNA levels were

5.623 ± 0.748, 4.979 ± 0.870, and 5.216 ± 0.758 log10 IU/mL at baseline, W+12,

and W+24, respectively. Conclusion: Our results show that the assessment of

serum HCV-RNA 12 weeks after the end of treatment, using the highly sensitive

TMA assay (PPV 99.7%), is as relevant as after 24 weeks to predict SVR and make

decisions on the management of treated patients, suggesting a new definition for

SVR. (HEPATOLOGY 2010.)

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Received: 28 September 2009