Monitoring of viral levels during therapy of hepatitis C

Authors

  • Gary L. Davis M.D.

    Corresponding author
    1. Division of Hepatology, Baylor University Medical Center, Dallas, TX. Dr. Davis has received clinical research support from Roche Laboratories, Schering Plough Research Institute, Human Genomic Sciences, Wyeth, and Bayer Laboratories
    • Hepatology Division, 4 Roberts Baylor University Medical Center, 3500 Gaston Ave., Dallas, TX 75246–2088. fax: 214–820–8168
    Search for more papers by this author

Abstract

Alpha interferon therapy of chronic hepatitis C is typically accompanied by a biphasic decrease in hepatitis C virus (HCV) RNA levels: an initial rapid decline during the first 24 to 48 hours, and a second more gradual decline during the following weeks. The rate of second-phase decline correlates with ultimate response to interferon treatment. Thus, assessment of early virological response (EVR) may predict outcome. Data from 2 large clinical trials of peginterferon and ribavirin were combined and analyzed to determine the optimal definition of an EVR which, if not achieved, was associated with a low likelihood of a sustained virological response (SVR). A fall in HCV RNA level to undetectable or by at least 2 log10 units after 12 weeks was found to be the optimal definition of an EVR. Among 965 patients, 778 (80%) achieved an EVR by week 12, including all except 1 patient with genotypes 2 or 3. Among 187 patients without an EVR, only 3 (1.6%) had an SVR. These findings suggest that patients with genotype 1 who do not achieve an EVR should stop treatment after 12 weeks. Use of an early stopping rule reduces treatment costs by at least 16% and avoids the inconvenience and side effects of treatment in the 19% of patients without an EVR who have little chance of a lasting virological response.

Ancillary