Objective: Assess the safety and efficacy of 24 or 48 weeks of treatment with peginterferon α-2a (40 KD) plus ribavirin in treatment-naive patients with chronic hepatitis C.
Methods: All patients in this open-label multinational study were assigned at the investigator's discretion to receive peginterferon α-2a (40 KD) 180 µg/week plus ribavirin (800 mg/day) for a total of 24 weeks or peginterferon α-2a (40 KD) 180 µg/week plus ribavirin (1000/1200 mg/day) for a total of 48 weeks. Treatment success was defined as sustained virological response [sustained virological response (SVR); hepatitis C virus RNA less than 50 IU/ml after completion of untreated follow-up].
Results: A total of 789 treatment-naive patients were enrolled, of whom 91% (138 of 152) of nongenotype 1 patients and 77% (490 of 637) of genotype 1 patients completed 24 and 48 weeks of treatment, respectively. The overall SVR rate was 58% (459 of 789), and was 70 and 55% in nongenotype 1 and genotype 1 patients, respectively. Age (per 10-year decrement) and baseline hepatitis C virus RNA level (≤ 400 000 vs. >4 00 000 IU/ml) were significantly associated with SVR by multiple logistic regression analysis. The safety profile of peginterferon α-2a (40 KD) plus ribavirin was similar to that reported in pivotal trials, with no new or unexpected safety signals.
Conclusion: The combination of peginterferon α-2a (40 KD) plus ribavirin was well tolerated and produced an overall SVR rate of 58% in treatment-naive patients. This study confirms that SVR rates achieved in pivotal clinical trials in Western Europe and the USA can be achieved in routine clinical practice in Central and Eastern Europe.