Efficacy and safety of peginterferon alpha-2a (40 kD) plusribavirin in treatment-naive chronic hepatitis C patients inCentral and Eastern Europe
2011
Objective Assess the safety and efficacy of 24 or 48 weeks of
treatment with peginterferon alpha-2a (40KD) 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
alpha-2a (40KD) 180 mu g/week plus ribavirin (800 mg/day) for a
total of 24 weeks or peginterferon alpha-2a (40KD) 180 mu
g/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 enroled, 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 a-2a (40KD) plus ribavirin was similar to that
reported in pivotal trials, with no new or unexpected safety
signals. Conclusion The combination of peginterferon alpha-2a
(40KD) 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.
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