Hepatic Fibrosis Influences Early Virological Response Rates in Chronic Hepatitis C

Early virological response (EVR), during HCV therapy is defined as undetectable HCV RNA or at least a 2-log decrease in HCV RNA at week 12. Failure to achieve this has been shown to accurately predict non-response.

The aim of the current study was to determine the influence of hepatic fibrosis on EVR rates.

138 genotype 1 CHC patients who had received either combination peginterferon alfa-2b (Peg-Intron) 1.5mcg/kg weekly or standard interferon alfa (3MU TIW) and ribavirin (1000-1200 mg/d) were retrospectively identified from the databases of 2 hospitals.

Serum HCV RNA was measured at baseline, week 12, and at 24 weeks after completion of therapy using a quantitative PCR assay with a lower limit of detection of 100 copies/ml (NGI, Los Angeles, CA).

Pre-treatment liver biopsies were scored for fibrosis by the METAVIR system.

Results

Of 138 patients, 95 (69%) were male, 81 (59%) were Caucasian, 47 (34%) were African American. 61 (44%) had Metavir stage F0-F1 and 77 (56%) had Metavir stage F2-F4.

Overall 67/138 (49%) patients achieved EVR and 33/138 (24%) achieved SVR.

Patients most likely to achieve an EVR were those with fibrosis stage F0-F1 compared with F2-F4 (62% vs 38%; p=0.006), male patients with lower grades of fibrosis (66% vs 40%; p=0.02) and Caucasian patients with fibrosis scores 0-1 (74% vs 42%; p=0.004).

Only 15/47 (32%) of African American patients achieved EVR and 9/47(19%) achieved SVR.

There was no difference in EVR between African American high and low-grade fibrosis groups.

In the low-grade fibrosis group, Caucasians were more likely to achieve EVR than African Americans (74% vs 32%; p=0.012).

The authors conclude, “In difficult to treat HCV genotype 1 infection, the negative predictive value of EVR still holds true irrespective of fibrosis score. Male and Caucasian patients with lower grades of fibrosis were more likely to achieve EVR compared to patients with higher grades of fibrosis. This study also confirms previously observed poor rates of response in African Americans.”

06/07/04

Reference
A T Dev and others. Hepatic Fibrosis Influences Early Virological Response Rates in Chronic Hepatitis C (CHC). Abstract 1159 (poster). Digestive Disease Week. May 15-20, 2004. New Orleans, LA.