Treatment with PEG-Intron + Ribavirin Is Effective for Patients with Chronic Hepatitis C and Normal Liver Enzymes

Approximately 30% of patients with chronic HCV have persistently normal liver enzymes, some of whom have progressive liver disease. The efficacy of pegylated interferon alfa 2b (PEG-Intron) + ribavirin in HCV patients with normal liver enzymes is unknown.

The objective of the current study was to determine the efficacy of pegylated interferon alfa 2b + ribavirin in HCV patients with persistently normal liver enzymes.

Patients with chronic HCV (+HCV RNA) and persistently normal or abnormal ALT were evaluated within the context of a prospective, randomized, controlled, multicenter trial comparing pegylated interferon alfa 2b 1.0 mcg/kg/wk + ribavirin (800-1400mg/d) vs. pegylated interferon alfa 2b 1.5 mcg/kg/wk + ribavirin (800-1400mg/d).

Demographic, serological (ALT), virological (HCV viral load and genotype) and histological data were obtained.

Patients were randomized to one treatment group and were administered the medications for 24 weeks (genotypes 2,3) or 48 weeks (genotype 1,4).

Sustained response rate (HCV RNA negativity) will be assessed after a 24-week follow-up period. Preliminary 24-week response data in the patients with persistently normal ALT are reported.

Results

300 patients were enrolled including 76 with persistently normal ALT. 31/76 (41%) were men and 45/76 (59%) were women. 54/76 (71%) had fibrosis stage 0-1 and 22/76 (29%) had fibrosis stage 2-4. 53/76 (70%) of patients were GT 1 and 20/76 (26%) were GT 2,3.

75/76 patients have reached wk 24 of therapy. Of the 75 patients that reached wk 24, 46/75 (61%) are HCV RNA (-). 30/53 (57%) of HCV GT 1 were HCV RNA(-) at wk 24 and 14/20 (70%) of GT 2,3 were negative.

13/76 patients discontinued by wk 24. 5 discontinued due to AE/SAE.

Conclusions

·         PEG IFN alfa 2b + ribavirin are effective in GT 1 patients with chronic HCV and persistently normal ALT in regards to HCV RNA negativity at wk 24;

·         PEG IFN alfa 2b + ribavirin are effective in GT 2,3 patients with chronic HCV and persistently normal ALT in regards to HCV RNA negativity at wk 24; and

·         There was significant medication discontinuation due to AE/SAE in this population for unclear reasons.

05/19/04

Reference
S Flamm and others. Treatment of Patients with Chronic HCV Infection and Normal Liver Enzymes with PEG IFN alfa 2b + Ribavirin Is Effective: Results from a Prospective, Randomized, Controlled, Multicenter Trial. Abstract 1148 (poster). Digestive Disease Week. May 15-20, 2004. New Orleans, LA.