Early Hepatitis C Virus-RNA Responses Predict Interferon Treatment Outcomes in Chronic Hepatitis C

Hepatology, November 1998, p. 1411-1415, Vol. 28, No. 5

     William M. Lee1, K. Rajender Reddy2, Myron J. Tong3, Martin Black4, Dirk J. van Leeuwen5, F. Blaine Hollinger6, Kevin D. Mullen7, Neville Pimstone8, Donald Albert9, Sheila Gardner9, and the Consensus Interferon Study Group* >From the 1University of Texas Southwestern Medical Center at Dallas, Dallas, TX; 2University of Miami, Miami, FL; 3Huntington Memorial Hospital, Pasadena, CA; 4Temple University Hospital, Philadelphia, PA; 5University of Alabama at Birmingham, Birmingham, AL; 6Baylor College of Medicine, Houston, TX; 7MetroHealth Medical Center, Cleveland, OH; 8University of California, Davis, Sacramento, CA; and 9Amgen, Boulder, CO.

In previous studies employing interferons (IFNs) in the treatment of chronic hepatitis C, there have been few reliable predictors of sustained responses. We retrospectively evaluated the predictive value of hepatitis C virus (HCV)-RNA measurements in the first few months during consensus interferon (CIFN) treatment using a sensitive reverse-transcriptase polymerase chain reaction assay to determine sustained responses. Data from two large treatment trials, one of IFN-naive patients and one of retreated relapsers and nonresponders, were used, including serum samples at 2-week intervals in the naive study and 8-week intervals in the retreatment study. Patients received initial CIFN (9 µg) treatment for 6 months and were assessed 6 months after treatment. There were 28 sustained viral responders of 232 CIFN-treated patients. Of the sustained responders, 48% had already cleared HCV RNA from serum (<100 copies/mL) by week 2, 78% by week 4, 81% by week 6, and 96% by week 12. Patients with early HCV-RNA clearance were more likely to have sustained responses than those who responded later. Early clearance of HCV from serum was also associated with greater likelihood of a sustained response to 48 weeks of retreatment with 15 µg CIFN. Ninety-five percent of the sustained responders were HCV-RNA-negative by week 8 of retreatment. Early assessment of HCV RNA may help in the prediction of sustained responses to IFN and allow the value of continued treatment to be determined early in the course of IFN therapy.