Safety, tolerability and efficacy of peginterferon alpha‐2a and ribavirin in chronic hepatitis C in clinical practice: The German Open Safety Trial

Abstract

OnlineOpen: This article is available free online at www.blackwell-synergy.com SUMMARY. The combination treatment of peginterferon alpha-2a (PEG-IFN alpha-2a; Pegasys Ò ) plus ribavirin (RBV) is recommended as a standard care for HCV infections. Side effects and aspects of efficacy and safety have to be balanced. This study evaluates clinical practice data on safety and efficacy of HCV treatment with PEG-IFN in combination with RBV over 24 and 48 weeks. This study was a phase III, multi-centre, open-label study with two treatment groups: PEG-IFN in combination with RBV for 24 or 48 weeks. The allocation to the treatment groups was at the discretion of the investigator; 309 patients entered active treatment: 90 patients received PEG-IFN plus RBV for 24 weeks and 219 patients PEG-IFN plus RBV for 48 weeks. A sustained virological response (SVR) was achieved in 48.9% of all patients. Genotype 1 patients with a 48-week combination treatment achieved an SVR of 39.9%. In the 48-week group a low baseline viral load was associated with a higher SVR rate (47.0% vs. 32.4%). For genotype 2 or 3 patients, the SVR was 67.9%. For these patients there was no relevant difference between patients with low and high viral loads; 97.7% of the patients experienced at least one adverse event. The incidence of serious adverse events was distinctly lower in the 24-week group (4.4% vs. 10.5%). This investigation confirms the well-known risk-benefit ratio found in controlled studies in a clinical practice setting. The safety profile is similar and shows the highest incidence of adverse events in the first 12 weeks of treatment.

Comparison of adverse effects related to pegylated interferon-based therapy for patients with chronic hepatitis B and chronic hepatitis C in Taiwan

“…In another randomized controlled trial [22] comparing the efficacy and safety of Peg-IFN-a-2a 135 lg/ week, Peg-IFN-a-2a 180 lg/week, and IFN-a-2a in patients with CHC, the overall safety profiles were similar for the three different treatments. According to our analysis, we agree with these previous reports [22,39] that the dosage and duration of IFN therapy seem to have no significant effect on the safety profile.…”

“…In a study for evaluating clinical practice data on safety and efficacy of HCV treatment with Peg-IFN in combination with ribavirin over 24 and 48 weeks, the safety profile was similar and showed the highest incidence of AEs in the first 12 weeks of treatment [39]. In another randomized controlled trial [22] comparing the efficacy and safety of Peg-IFN-a-2a 135 lg/ week, Peg-IFN-a-2a 180 lg/week, and IFN-a-2a in patients with CHC, the overall safety profiles were similar for the three different treatments.…”

Efficacy of Treatment With Pegylated Interferon and Ribavirin in Patients With Chronic HCV Infection “Under Real Life“ Conditions

“…Our results regarding genotypes as the strong predictors of SVR correspond to the data of the majority of other investigators obtained in RCT and in "real life" studies [10,24,25,28,31,32,33,40,42,46,[48][49][50].…”

“…Danish nationwide cohort study [38], presented the data obtained in a routine clinical practice and found them comparable to those observed in controlled clinical trials: overall 57.9 % of patients achieved SVR: it was 46.5 % in patients with genotype 1/4 infection and 77.3 % in those with genotype 2/3 infection. Some other authors [39][40][41][42][43][44][45] and community based studies in Germany, Canada, France and Australia [46][47][48][49][50][51] reported SVR data comparable with those in RCT too. Conversely, results of other investigators were lower [52,53].…”

“…Majority of RCT and community based studies found that high pretreatment viral load and presence of advanced fibrosis or cirrhosis are strong independent negative predictors of SVR in combined antiviral treatment [15,24,25,40,44,[45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62].…”