Efficacy and safety of peginterferon alpha-2a (40 kD) plus
ribavirin in treatment-naive chronic hepatitis C patients in
Central and Eastern Europe

J 2011

Efficacy and safety of peginterferon alpha-2a (40 kD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe

URBÁNEK, Petr; Marian OLTMAN; Ljubomir IVANOVSKI; Vratislav ŘEHÁK; Diethelm MESSINGER et al.

Základní údaje

Originální název

Efficacy and safety of peginterferon alpha-2a (40 kD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe

Název česky

Účinnost a bezpečnost léčby pygylovaným interferonem alfa-2a (40kD) a ribavirinem u dosud neléčených osob s hepatitidou C ve střední a východní Evropě

Autoři

URBÁNEK, Petr; Marian OLTMAN; Ljubomir IVANOVSKI; Vratislav ŘEHÁK; Diethelm MESSINGER; Andreas TIETZ a Petr HUSA

Vydání

European Journal of Gastroenterology and Hepatology, Philadelphia, Lippincott, Williams and Wilkins, 2011, 0954-691X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30300 3.3 Health sciences

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 1.757

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/11:00054147

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1097/MEG.0b013e32834b326b

UT WoS

000295831900006

Klíčová slova anglicky

hepatitis C; peginterferon alpha-2a; sustained virological response

Příznaky

Mezinárodní význam

Změněno: 20. 4. 2012 12:07, Mgr. Michal Petr

Anotace

V originále

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.

Citovat

URBÁNEK, Petr; Marian OLTMAN; Ljubomir IVANOVSKI; Vratislav ŘEHÁK; Diethelm MESSINGER; Andreas TIETZ a 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, roč. 23, č. 11, s. 1004-1010. ISSN 0954-691X. Dostupné z: https://doi.org/10.1097/MEG.0b013e32834b326b.

@article{960063,
   author = {Urbánek, Petr and Oltman, Marian and Ivanovski, Ljubomir and Řehák, Vratislav and Messinger, Diethelm and Tietz, Andreas and Husa, Petr},
   article_location = {Philadelphia},
   article_number = {11},
   doi = {https://doi.org/10.1097/MEG.0b013e32834b326b},
   keywords = {hepatitis C; peginterferon alpha-2a; sustained virological response},
   language = {eng},
   issn = {0954-691X},
   journal = {European Journal of Gastroenterology and Hepatology},
   title = {Efficacy and safety of peginterferon alpha-2a (40 kD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe},
   volume = {23},
   year = {2011}
}

TY  - JOUR
ID  - 960063
AU  - Urbánek, Petr - Oltman, Marian - Ivanovski, Ljubomir - Řehák, Vratislav - Messinger, Diethelm - Tietz, Andreas - Husa, Petr
PY  - 2011
TI  - Efficacy and safety of peginterferon alpha-2a (40 kD) plus ribavirin in treatment-naive chronic hepatitis C patients in Central and Eastern Europe
JF  - European Journal of Gastroenterology and Hepatology
VL  - 23
IS  - 11
SP  - 1004-1010
EP  - 1004-1010
PB  - Lippincott, Williams and Wilkins
SN  - 0954691X
KW  - hepatitis C
KW  - peginterferon alpha-2a
KW  - sustained virological response
N2  - 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.
ER  -

URBÁNEK, Petr; Marian OLTMAN; Ljubomir IVANOVSKI; Vratislav ŘEHÁK; Diethelm MESSINGER; Andreas TIETZ a 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. \textit{European Journal of Gastroenterology and Hepatology}. Philadelphia: Lippincott, Williams and Wilkins, 2011, roč.~23, č.~11, s.~1004-1010. ISSN~0954-691X. Dostupné z: https://doi.org/10.1097/MEG.0b013e32834b326b.

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