Serum Fibrosis Markers in Chronic Hepatitis C

Investigators:

Principal Investigator: Robert Fontana

Co-Investigators: Anna Lok; Zachary Goodman; Mitchell Shiffman; Jules Dienstag; Herb Bonkovsky, and Savant Mehta

Hypotheses/Aims

The aim of this ancillary study is to evaluate the reliability of a panel of serum markers: N-terminal propetide collagen III (PIIINP), hyaluronic acid (HA), YKL-40, TIMP-1 (refer to Amendment # 1 and # 2), and TGF-β1 in predicting hepatic fibrosis in chronic hepatitis C. In addition, we will determine the effects of long-term IFN therapy on these markers and if changes in these serum markers correlate with changes in hepatic fibrosis.

The hypotheses to be tested in this study are:

1. Serum levels of PIIINP, HA, and TGF-β1, singly or in combination, correlate well with hepatic fibrosis in patients with chronic hepatitis C.
2. Changes in serum levels of PIIINP, HA, and TGF-β1 during the course of the HALT-C trial correlate with changes in hepatic fibrosis in patients with chronic hepatitis C.
3. Long-term IFN therapy induces significant decrease in hepatic fibrosis as well as serum levels of PIIINP, HA, and TGF-β1 in patients with chronic hepatitis C even in the absence of a virologic response.