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@article{1071441,
author = {Lee, Samuel S. and Roberts, Stuart K. and Berak, Hanna and Dusheiko, Geoffrey M. and Harley, Hugh A. and Gane, Edward J. and Husa, Petr and Horsmans, Yves J. and Hadziyannis, Stephanos J. and Heathcote, Jenny E. and Messinger, Diethelm and Tatsch, Fernando and Han, KwangandHyub and Ferenci, Peter},
article_location = {Malden, MA},
article_number = {8},
doi = {http://dx.doi.org/10.1111/j.1478-3231.2012.02819.x},
keywords = {chronic hepatitis C; pegylated interferon; ribavirin; treatment},
language = {eng},
issn = {1478-3223},
journal = {Liver International},
title = {Safety of peginterferon alfa-2a plus ribavirin in a large multinational cohort of chronic hepatitis C patients},
volume = {32},
year = {2012}
}
TY - JOUR
ID - 1071441
AU - Lee, Samuel S. - Roberts, Stuart K. - Berak, Hanna - Dusheiko, Geoffrey M. - Harley, Hugh A. - Gane, Edward J. - Husa, Petr - Horsmans, Yves J. - Hadziyannis, Stephanos J. - Heathcote, Jenny E. - Messinger, Diethelm - Tatsch, Fernando - Han, Kwang-Hyub - Ferenci, Peter
PY - 2012
TI - Safety of peginterferon alfa-2a plus ribavirin in a large multinational cohort of chronic hepatitis C patients
JF - Liver International
VL - 32
IS - 8
SP - 1270-1277
EP - 1270-1277
PB - John Viley ans Sons
SN - 14783223
KW - chronic hepatitis C
KW - pegylated interferon
KW - ribavirin
KW - treatment
N2 - Background & Aims Peginterferon plus ribavirin has been the standard of care for chronic hepatitis C for a decade and an essential component of combination regimens for this disease. This large multinational open-label study aimed to better define the incidence of serious adverse events (SAEs) and non-serious adverse events of special interest in patients receiving peginterferon alfa-2a/ribavirin. Methods Patients were assigned at the investigator's discretion to 24- or 48-week treatment with peginterferon alfa-2a 180 mmg/week and ribavirin 800 mg/day or 1000/1200 mg/day. All AEs, defined as SAEs and non-SAEs of special interest, were recorded during treatment and for 12 weeks thereafter. Non-SAEs of special interest included those leading to dose reduction/discontinuation, neutropenia, thrombocytopenia, anaemia, ALT elevations leading to dose modification and unknown/unexpected AEs. Results Of 1675 and 7178 patients assigned to 24 and 48 weeks of treatment, respectively, 87.6 and 68.3% completed therapy, whereas 6.4 and 10.3% prematurely stopped peginterferon alfa-2a treatment because of AEs. Among patients assigned to 24 and 48 weeks, 37.4 and 46.9%, respectively, reported any AE (SAE or non-SAE of special interest); 4.2 and 6.6% reported SAEs and 35.2 and 44.0% reported non-SAEs of special interest. Female gender, increasing age and cirrhosis were significantly associated with dose reductions of either drug. Increasing age (and female gender in the case of ribavirin) was significantly associated with treatment discontinuation. Conclusion This study confirmed the safety and tolerability profile of peginterferon alfa-2a/ribavirin and identified patient subgroups at higher risk of dose reductions and discontinuations, thus allowing optimum management of AEs.
ER -
LEE, Samuel S., Stuart K. ROBERTS, Hanna BERAK, Geoffrey M. DUSHEIKO, Hugh A. HARLEY, Edward J. GANE, Petr HUSA, Yves J. HORSMANS, Stephanos J. HADZIYANNIS, Jenny E. HEATHCOTE, Diethelm MESSINGER, Fernando TATSCH, Kwang-Hyub HAN a Peter FERENCI. Safety of peginterferon alfa-2a plus ribavirin in a large multinational cohort of chronic hepatitis C patients. \textit{Liver International}. Malden, MA: John Viley ans Sons, 2012, roč.~32, č.~8, s.~1270-1277. ISSN~1478-3223. Dostupné z: https://dx.doi.org/10.1111/j.1478-3231.2012.02819.x.
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