The Effectiveness of Peginterferon and Ribavirin Combination Therapy for Chronic HCV in an Urban Clinic Setting Compared to Pivotal Clinical Trials

Nearly a half of patients with chronic hepatitis C (HCV) treated with combined pegylated interferon (PEG-IFN) and ribavirin fail to achieve the sustained viral response despite improved efficacy of antiviral therapy over the past decade. Furthermore, effectiveness of therapy in a clinic setting may not be as good as those obtained in a controlled clinical-trial.

Thus, using the early viral response (EVR) at 3 months as a marker, researchers at Beth Israel Medical Center, NYC, tried to compare their experience with PEG-IFN/ribavirin therapy to those obtained in the two registration trials.

All charts of patients consecutively treated with PEG-IFN/ribavirin from June 2002 to October 2003 at the GI/Liver clinics at Beth Israel Medical Center

were retrospectively reviewed. None of the patients were involved in clinical trials, and were previously treatment-naive.

Patient demographics, liver chemistries, HCV genotype, histology, EVR (achieving at least a 2 log drop from baseline at 3 months), PEG-IFN used, were recorded.

EVR at 3 months in the registration trials was approximately 80% (86% and 74% for PEG-IFN alfa-2a (Pegasys) and 2b (PEG-Intron), respectively). Data were examined using Chi-Square, Fishers exact test, t test analysis.

Results

There were 90 patients (57M:33F) in the study cohort. Mean age was 50 years (range 34-73). Distribution of HCV genotypes showed 74% type 1, 25% type 2/3.

Sixty-nine (77%) had liver biopsies (30% bridging fibrosis and 13% cirrhosis).

Mean pre-treatment HCV RNA was 1,570,000 IU/mL with mean ALT of 97 U/L. Forty (44%) patients were treated with PEG-IFN alfa-2a, while 50 (56%) with PEG-IFN alfa-2b.

Mean pretreatment HCV RNA for genotype 1 patients treated with PEG-IFN alfa-2a and 2b were 1,640,000 IU/ml and 1,730,000 IU/mL (p=0.88).

Overall, EVR at 3 months in our clinic setting was 60% (63% and 58% for PEG-IFN alfa-2a and 2b, respectively (p=0.67).

EVR at 3 months for genotype 1 patients in our clinic for PEG-IFN alfa-2a and 2b were 63% and 51%, respectively (p=0.36). In contrast, EVR at 3 months for the patients with genotype 2/3 treated with PEG-IFN alfa-2a and 2b were 70% and 78% (p=1.0). None of our patients discontinued treatment at 3 months.

THe authors conclude, “There was a decrease in the proportion of patients achieving an EVR in our clinic setting compared to those seen in the registration trials. However, type of pegylated interferon used in the combination treatment with ribavirin did not affect EVR in our previously untreated HCV patients managed in a non-clinical trial setting.”

05/21/04

Reference
T C Johnson and others. The Effectiveness of Pegylated-Interferon and Ribavirin Combination Therapy for Chronic Hepatitis C in an Urban Clinic Setting Compared to Pivotal Clinical Trials. Abstract 1242 (poster). Digestive Disease Week 2004. May 15-20, 2004. New Orleans, LA.