Article Text
Abstract
Background and aims: An algorithm based on a 2 log10 decline in hepatitis C virus (HCV) RNA at week (W) 12 has been proposed in US and European recommendations for the management of patients with chronic hepatitis C treated with pegylated-interferon and ribavirin.
Methods: We examined rapid virological response (RVR; at W2 and W4 after the initiation of therapy) in HIV/HCV co-infected patients. Using HCV RNA measurements (Versant HCV RNA 3.0, Cobas Amplicor HCV 2.0), RVR was studied in 323 patients from the ANRS HC02 RIBAVIC trial, comparing interferon α2b 3 MU ×3/week with pegylated interferon α2b 1.5 μg/kg/week, each combined with ribavirin 800 mg/day over 48 weeks.
Results: The best positive and negative predictive values of sustained virological response (SVR) were obtained with an undetectable HCV RNA at W4 (97%) and with more than a 2 log10 decrease at W12 (99%), respectively. Prediction of non-SVR was obtained in all patients by using HCV RNA cut-off levels above 460 000 IU/ml at W4 and above 39 000 UI/ml at W12 irrespective of the HCV genotype and arm of treatment.
Conclusion: We propose a new algorithm based on RVR thresholds using HCV RNA that allows for excellent prediction of non-SVR as early as W4.
- EVR, early virological response
- HAART, highly active antiretroviral treatment
- HCV, hepatitis C virus
- IFN, interferon
- NPV, negative predictive value
- NR, non-responders
- PEG-IFN, pegylated interferon
- PPV, positive predictive value
- RB, responders with breakthrough
- ROC, receiver operating characteristics
- RR, responders with relapse
- RVR, rapid virological response
- SVR, sustained virological response/responders
- HIV/HCV co-infection
- hepatitis C therapy
- HCV viral load
- rapid and early viral decline
- prediction of response
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- EVR, early virological response
- HAART, highly active antiretroviral treatment
- HCV, hepatitis C virus
- IFN, interferon
- NPV, negative predictive value
- NR, non-responders
- PEG-IFN, pegylated interferon
- PPV, positive predictive value
- RB, responders with breakthrough
- ROC, receiver operating characteristics
- RR, responders with relapse
- RVR, rapid virological response
- SVR, sustained virological response/responders
Footnotes
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Published Online 22 March 2007
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Financial support: ANRS (the French National Agency for Research on AIDS and Viral Hepatitis) was the sponsor of the ANRS HC02 RIBAVIC study, which was conducted with the support of Schering Plough (C Lemonnier and A Rimailho).
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Competing interests: None.