Safety profile of standard- vs. high-dose peginterferon alfa-2a plus standard-dose ribavirin in HCV genotype 1/4 patients: pooled analysis from 5 randomized studies.
Expert Opin Drug Saf
; 11(6): 901-9, 2012 Nov.
Article
em En
| MEDLINE
| ID: mdl-22943161
ABSTRACT
OBJECTIVE:
This analysis examines the safety profile of standard- versus high-dose peginterferon alfa-2a.METHODS:
Data were pooled from five trials including HCV genotype 1- or 4-infected naive and treatment-experienced patients (n = 2,940). Patients were randomized to receive peginterferon alfa-2a at 180 µg/week (standard-dose; n = 1,672) or 360 µg/week (high-dose; n = 1,268) plus ribavirin 1,000/1,200 mg/day for 12 weeks; after 12 weeks, all received standard dose. This safety analysis was restricted to the first 12 weeks.RESULTS:
In standard and high-dose groups, similar frequencies of serious adverse events (SAEs, 3.2 and 4.2%, respectively) and treatment discontinuations for safety reasons (2.8 and 2.9%) were reported. More patients reported weight decrease as an adverse event (AE) in the 360 µg/week group (7.7 vs. 3.3%). Significant (p < 0.05) independent predictors for discontinuation due to safety were older age, male gender, lower albumin and low neutrophil count, but not the starting dose of peginterferon alfa-2a. Although more laboratory abnormalities were reported in patients receiving high-dose peginterferon alfa-2a, this was not reflected in AEs or discontinuations, suggesting these are adequately managed by dose modification.CONCLUSIONS:
High-dose peginterferon alfa-2a for 12 weeks does not significantly increase the incidence of SAEs or discontinuations for safety reasons, beyond that of a standard dose regimen.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Antivirais
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Polietilenoglicóis
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Ribavirina
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Interferon-alfa
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Hepatite C Crônica
Tipo de estudo:
Clinical_trials
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Etiology_studies
/
Prognostic_studies
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Risk_factors_studies
/
Systematic_reviews
Limite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Expert Opin Drug Saf
Ano de publicação:
2012
Tipo de documento:
Article