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