From Trials to a Real Hospital Setting: Effectiveness of Pegylated Interferon-α-2b/Ribavirin Combination Therapy for Naïve Chronic Hepatitis C Patients

Abstract

Registration trials regarding pegylated interferon treatment of hepatitis C have created great expectations for improved results, but there is little information on actual outcomes in everyday hospital practice. We aimed to define the effectiveness of this treatment in a hospital setting. Seventy-four naïve patients with hepatitis C treated with 12 kD-pegylated-interferon-alpha-2-b/ribavirin (PEG-IFN) were retrospectively analyzed in comparison with 54 patients treated with IFN-alpha-2-b/ribavirin (STANDARD IFN) and with results of three main registration trials. Overall sustained viral response rates were 46% in the STANDARD IFN group and 54% in PEG-IFN group, ranging from 48-61% in similar arms of the registration trials considered, although more of our patients presented comorbidity and high-grade fibrosis, and our dosages at outset of PEG-IFN were lower than optimal (mean 1.18 microg/kg BW). In our hospital setting, the effectiveness of PEG-IFN/ribavirin therapy appeared similar to that reported in large registration trials.

Efficacy of combined pegylated interferon and ribavirin therapy in Jewish patients of Israel suffering from chronic hepatitis C

“…1). These findings support the results of other worldwide studies, that combination antiviral therapy can be safely and successfully used in clinical practice outside the setting of strict clinical trials [10][11][12][13][14]. Pegylated interferon and ribavirin have been established as the gold standard therapy for patients with CHC based on data from randomized controlled trial (RCT) performed mostly in Caucasian populations [5][6][7].…”

Gaps in the achievement of effectiveness of HCV treatment in national VA practice

“…However, these studies did not incorporate the uptake of treatment among all patients presenting to these setting. In addition, the treated patients had favorable features for achieving SVR (e.g., predominantly Caucasian with a high prevalence of HCV genotypes 2 or 3) [9][10][11][12][13]. On the other hand, studies of drug users and racial and ethnic minorities have shown substantially lower SVR rates in clinical practice settings [14,15].…”

Zebrafish as a Potential Model Organism for Drug Test Against Hepatitis C Virus

“…Current therapy for HCV infection is the combination of Pegylated-interferon (PEG-IFN) with ribavirin [1], [2]. This regimen has only suboptimal clinical efficacy and is with side-effects [3], [4].…”