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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Safety of peginterferon alfa-2a plus ribavirin in a large multinational cohort of chronic hepatitis C patients
Liver International, Volume 32, No. 8, Year 2012
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Description
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 μg/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. © 2012 John Wiley & Sons A/S.
Authors & Co-Authors
Lee, Samuel Lee
Canada, Calgary
University of Calgary
Roberts, Stuart Keith
Australia, Melbourne
The Alfred
Dusheiko, Geoffrey M.
United Kingdom, London
Ucl Medical School
Gane, Edward John
New Zealand, Auckland
Auckland City Hospital
Husa, Petr
Czech Republic, Brno
Masaryk University
Horsmans, Y.
Belgium, Brussels
Cliniques Universitaires Saint-luc
Hadziyannis, Stephanos J.
Greece, Athens
Henry Dunant Hospital
Messinger, Diethelm
Unknown Affiliation
Han, Kwanghyub
South Korea, Seoul
Yonsei University College of Medicine
Statistics
Citations: 14
Authors: 9
Affiliations: 13
Identifiers
Doi:
10.1111/j.1478-3231.2012.02819.x
ISSN:
14783231
Research Areas
Health System And Policy
Infectious Diseases
Study Design
Cohort Study
Participants Gender
Female