Efficacy and safety of peginterferon α-2a (40 kD) plus ribavirin among patients with chronic hepatitis C and earlier treatment failure to interferon and ribavirin: An open-label study in central and Eastern Europe
Department of Infectious Diseases, Faculty Hospital and Faculty of Medicine, Masaryk University Brno, Brno, Czech Republic. European journal of gastroenterology & hepatology
(Impact Factor: 2.25).
05/2011; 23(5):375-81. DOI: 10.1097/MEG.0b013e3283458407
To assess the safety and efficacy of 48 weeks of re-treatment with peginterferon α-2a (40 kD) plus ribavirin in previously treated hepatitis C virus (HCV) genotype 1 patients.
HCV genotype 1 patients previously treated with conventional interferon with or without ribavirin were assigned to 48 weeks of treatment with peginterferon α-2a (40 kD; 180 μg/week) plus ribavirin (recommended dose: 1000/1200 mg/day) in this open-label trial conducted in central and Eastern Europe. The primary efficacy endpoint was sustained virological response (SVR, HCV RNA <50 IU/ml) after 24 weeks of untreated follow-up. Early virological response (EVR) was defined as an undetectable HCV RNA or at least 2-log drop at week 12.
A total of 154 of the 203 (76%) treatment-experienced genotype 1 patients completed the treatment. Overall, 113 patients (56%) achieved an EVR, 107 (53%) had an end-of-treatment response and 63 patients (31%) achieved an SVR [including 38% (40/105) of those with an earlier breakthrough or relapse and 24% (21/88) of those with earlier nonresponse]. Among patients with an EVR, 47% (53/113) achieved an SVR (positive predictive value=47%), compared with 3% (1/34) of patients without an EVR (negative predictive value=97.1%). Rates of SVR were higher in patients without cirrhosis (54/169, 32%), with a baseline viral load of 800 000 IU/ml or less (29/68, 43%) and younger than 40 years of age (36/77, 47%).
The combination of peginterferon α-2a (40 kD) plus ribavirin produced an overall SVR rate of 31% in difficult-to-treat genotype 1 patients who had not responded to the previous treatment with conventional interferon plus ribavirin.
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