In:
Liver International, Wiley, Vol. 32, No. 8 ( 2012-09), p. 1270-1277
Abstract:
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 ( SAE s) 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 AE s, defined as SAE s and non‐ SAE s of special interest, were recorded during treatment and for 12 weeks thereafter. Non‐ SAE s of special interest included those leading to dose reduction/discontinuation, neutropenia, thrombocytopenia, anaemia, ALT elevations leading to dose modification and unknown/unexpected AE s. 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 AE s. 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 SAE s and 35.2 and 44.0% reported non‐ SAE s 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 AE s.
Type of Medium:
Online Resource
ISSN:
1478-3223
,
1478-3231
DOI:
10.1111/liv.2012.32.issue-8
DOI:
10.1111/j.1478-3231.2012.02819.x
Language:
English
Publisher:
Wiley
Publication Date:
2012
detail.hit.zdb_id:
2124684-1
