URBÁNEK, Petr, Marian OLTMAN, Ljubomir IVANOVSKI, Vratislav ŘEHÁK, Diethelm MESSINGER, Andreas TIETZ and Petr HUSA. Efficacy and safety of peginterferon alpha-2a (40 kD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe. European Journal of Gastroenterology and Hepatology. Philadelphia: Lippincott, Williams and Wilkins, 2011, vol. 23, No 11, p. 1004-1010. ISSN 0954-691X. Available from: https://dx.doi.org/10.1097/MEG.0b013e32834b326b.
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Basic information
Original name Efficacy and safety of peginterferon alpha-2a (40 kD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe
Name in Czech Účinnost a bezpečnost léčby pygylovaným interferonem alfa-2a (40kD) a ribavirinem u dosud neléčených osob s hepatitidou C ve střední a východní Evropě
Authors URBÁNEK, Petr (203 Czech Republic, guarantor), Marian OLTMAN (703 Slovakia), Ljubomir IVANOVSKI (705 Slovenia), Vratislav ŘEHÁK (203 Czech Republic, belonging to the institution), Diethelm MESSINGER (276 Germany), Andreas TIETZ (276 Germany) and Petr HUSA (203 Czech Republic, belonging to the institution).
Edition European Journal of Gastroenterology and Hepatology, Philadelphia, Lippincott, Williams and Wilkins, 2011, 0954-691X.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30300 3.3 Health sciences
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
Impact factor Impact factor: 1.757
RIV identification code RIV/00216224:14110/11:00054147
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1097/MEG.0b013e32834b326b
UT WoS 000295831900006
Keywords in English hepatitis C; peginterferon alpha-2a; sustained virological response
Tags International impact
Changed by Changed by: Mgr. Michal Petr, učo 65024. Changed: 20/4/2012 12:07.
Abstract
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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