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Rapid and early virological response to chronic hepatitis C treatment with IFN 2b or PEG-IFN 2b plus ribavirin in HIV/HCV co-infected patients

¹ Département de Microbiologie-EA3882, CHU-Hôpital Morvan, Brest, France
² Laboratoire de Bactériologie-Virologie-Hygiène Hospitalière, CHU Angers, France
³ Laboratoire de Virologie, CHU Grenoble, France
⁴ INSERM U707, Faculté de Médecine St Antoine, Paris, France
⁵ Service d’Hépatologie, Hôpital Cochin, INSERM U567, Université René Descartes, Paris, France
⁶ Service de Médecine Interne, Hôpital Pitié-Salpétrière, Paris, France
⁷ Service des Maladies Infectieuses et Tropicales, Hôpital Raymond Poincaré, Paris, France

Correspondence to:
Correspondence to:
Professor Françoise Lunel
Laboratoire de Bactériologie-Virologie-Hygiène Hospitalière, CHU Angers, 4 rue Larrey, 49933 Angers Cedex, France; frlunel-fabiani{at}chu-angers.fr

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 2b 3 MU x3/week with pegylated interferon 2b 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.

Abbreviations: 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

Keywords: HIV/HCV co-infection; hepatitis C therapy; HCV viral load; rapid and early viral decline; prediction of response