Negative HCV-RNA 2 weeks after initiation of treatment predicts sustained virological response to pegylated interferon alfa-2a and ribavirin in patients with chronic hepatitis C

Abstract

Objective. The aim of this study was to examine the early viral kinetics as predictor for sustained virological response (SVR) during hepatitis C treatment. Materials and methods. We included patients with biopsy-proven chronic hepatitis C and ALT above the upper limit of normal, who received a standard treatment of pegylated interferon alfa-2a and ribavirin. The HCV–RNA concentration (limit of detection 20 IU/mL) was determined at days 0, 1, 2, 3, 4, 7, 14, 21 and monthly thereafter. Results. Among 46 patients who completed the trial, 30 (65%) had SVR. Low baseline viral load, IL28B genotype CC and absence of cirrhosis were statistically associated with SVR. In multivariate analysis only absence of cirrhosis and HCV–RNA negativity at day 14 were independent predictors for SVR. Eight patients who became HCV–RNA negative on day 14 as well as 13 of 14 patients (93%) with HCV–RNA levels of <1000 IU/mL at day 7 obtained a SVR. Among 8 of 18 (44%) genotype 1 and 4 patients with more than a one log drop in HCV–RNA titer at day 7, 75% achieved SVR. Conclusions. We observed a correlation between low HCV–RNA titers in week 2 and SVR during pegylated interferon/ribavirin-based treatment. This may help identify a group of patients for whom SVR may be obtained without the addition of directly acting antivirals, and thereby save the patients for unnecessary side effects and the health care system for additional costs.

Key Words::

• hepatitis C
• pegylated interferon alfa-2a
• ribavirin concentration
• treatment
• viral kinetics

Acknowledgments

The study was supported by an unrestricted grant from Roche a/s, Denmark. We thank Axel Møller, Department of Internal Medicine, Kolding Hospital, Kolding, Mads Buhl, Department of Infectious Diseases, Skejby University Hospital, Aarhus, Lars Mathiesen, Department of Infectious Diseases, Hvidovre University Hospital, Copenhagen. Ulrik Tage-Jensen, Department of Medical Gastroenterology, Aalborg University Hospital, for participating as investigators in the study.

Declaration of interest: Peer Brehm Christensen has been a member of the advisory board for Roche a/s and has received research grants from Roche and Scheering Plough a/s. The authors alone are responsible for the content and writing of the paper.