Usefulness of viral kinetics for early prediction of a sustained virological response in HCV-1 non-responders re-treated with pegylated interferon and ribavirin

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J Hepatol. 2011 Feb 24. [Epub ahead of print]

Usefulness of viral kinetics for early prediction of a sustained virological

response in HCV-1 non-responders re-treated with pegylated interferon and

ribavirin.

Deltenre P, Corouge M, Canva V, Castel H, Wartel F, Dharancy S, Louvet A, Lazrek

M, Moreno C, Henrion J, Mathurin P.

Service d'Hépato-Gastroentérologie, Hôpital Huriez, CHRU Lille, Lille, France;

Service d'Hépato-Gastroentérologie, Hôpital de Jolimont, Haine-Saint-,

Belgium.

Abstract

INTRODUCTION: Undetectable HCV RNA at 12 weeks is the stopping rule recommended

in HCV patients in whom previous treatment has failed. Whether earlier

virological criteria may be useful for deciding treatment discontinuation

remains subjects to debate.

AIM: To identify, in HCV-1 non-responders and relapsers to IFN or Peg-IFN and

ribavirin, the earliest and most accurate predictor of failure to respond to a

new treatment combining Peg-IFN and ribavirin.

METHODS: Prediction of SVR was assessed using the area under the ROC (AUROC)

curve of reduction in viral load at different time points.

RESULTS: This study included 151 patients (32% with extensive fibrosis or

cirrhosis). A SVR was reached in 34% (21% in non-responders and 59% in

relapsers). In non-responders, 1 month was the most accurate time point for

predicting SVR (AUROC: 0.787±0.075, p=0.0001). Thirty-seven percent of

non-responders did not have a 1-log drop in viral load at 1 month. All these

patients had detectable HCV RNA at 3 months (p<0.0001) and only 4% attained a

SVR (p=0.004). The same high negative predictive value for SVR was found in

sensitivity analysis restricted to non-responders to Peg-IFN and ribavirin. In

contrast, in relapsers, undetectable HCV RNA at 3 months was the earliest

criterion with high negative predictive value (92%, p<0.0001).

CONCLUSION: All HCV-1 non-responders who did not have a 1-log drop in viral load

at 1 month remained HCV-RNA-detectable at 3 months, and only 4% attained a SVR.

This new criterion can be used early on as a first stopping rule.

Copyright © 2011. Published by Elsevier B.V.

PMID: 21354445 [PubMed - as supplied by publisher]

[Guest guest]

J Hepatol. 2011 Feb 24. [Epub ahead of print]

Usefulness of viral kinetics for early prediction of a sustained virological

response in HCV-1 non-responders re-treated with pegylated interferon and

ribavirin.

Deltenre P, Corouge M, Canva V, Castel H, Wartel F, Dharancy S, Louvet A, Lazrek

M, Moreno C, Henrion J, Mathurin P.

Service d'Hépato-Gastroentérologie, Hôpital Huriez, CHRU Lille, Lille, France;

Service d'Hépato-Gastroentérologie, Hôpital de Jolimont, Haine-Saint-,

Belgium.

Abstract

INTRODUCTION: Undetectable HCV RNA at 12 weeks is the stopping rule recommended

in HCV patients in whom previous treatment has failed. Whether earlier

virological criteria may be useful for deciding treatment discontinuation

remains subjects to debate.

AIM: To identify, in HCV-1 non-responders and relapsers to IFN or Peg-IFN and

ribavirin, the earliest and most accurate predictor of failure to respond to a

new treatment combining Peg-IFN and ribavirin.

METHODS: Prediction of SVR was assessed using the area under the ROC (AUROC)

curve of reduction in viral load at different time points.

RESULTS: This study included 151 patients (32% with extensive fibrosis or

cirrhosis). A SVR was reached in 34% (21% in non-responders and 59% in

relapsers). In non-responders, 1 month was the most accurate time point for

predicting SVR (AUROC: 0.787±0.075, p=0.0001). Thirty-seven percent of

non-responders did not have a 1-log drop in viral load at 1 month. All these

patients had detectable HCV RNA at 3 months (p<0.0001) and only 4% attained a

SVR (p=0.004). The same high negative predictive value for SVR was found in

sensitivity analysis restricted to non-responders to Peg-IFN and ribavirin. In

contrast, in relapsers, undetectable HCV RNA at 3 months was the earliest

criterion with high negative predictive value (92%, p<0.0001).

CONCLUSION: All HCV-1 non-responders who did not have a 1-log drop in viral load

at 1 month remained HCV-RNA-detectable at 3 months, and only 4% attained a SVR.

This new criterion can be used early on as a first stopping rule.

Copyright © 2011. Published by Elsevier B.V.

PMID: 21354445 [PubMed - as supplied by publisher]