Peginterferon alpha-2a (40kD) [Pegasys] improves HR-QOL outcomes compared with unmodified interferon alpha-2a [Roferon-A]: in patients with chronic hepatitis C.
BACKGROUND
Use of unmodified interferon alpha-2a in chronic hepatitis C is associated with impaired health-related quality of life during therapy. Treatment with peginterferon alpha-2a (40kD) provides an improved sustained response over unmodified interferon alpha-2a.


OBJECTIVE
To compare health-related quality of life during treatment for patients receiving peginterferon alpha-2a (40kD) [Pegasys] versus unmodified interferon alpha-2a [Roferon].


METHODS
A randomised, international, multicentre, open-label, parallel group study.


METHODS
36 centres worldwide.


METHODS
Interferon-naïve patients (n = 531) with chronic hepatitis C.


METHODS
Peginterferon alpha-2a (40kD) 180 mirog once a week (n = 267) for 48 weeks or unmodified interferon alpha-2a 6 million IU three times a week for 12 weeks followed by 36 weeks of 3 million IU three times a week (n = 264).


METHODS
Fatigue Severity Scale and 36-item Short-Form Health Survey (SF-36).


RESULTS
At weeks 2 and 12, differences favouring peginterferon alpha-2a (40kD) were seen on seven of eight domains and both summary scores of the SF-36 (p < 0.05 to p < 0.01). At weeks 2, 12 and 24, patients receiving peginterferon alpha-2a (40kD) had less disabling fatigue (p < 0.01) than those receiving unmodified interferon alpha-2a.


CONCLUSIONS
Treatment with peginterferon alpha-2a (40kD) is associated with less disabling fatigue and less impairment in patient functioning and well-being during treatment than unmodified interferon alpha-2a. In addition to safety and efficacy, the impact on health-related quality of life may be an important consideration for physicians when selecting an optimal treatment regimen.
Rasenack
Jens
J
Klinikum der Albert-Ludwigs-Universität, Freiburg, Germany. rasenack@mm21.ukl.uni-freiburg.de
Zeuzem
Stefan
S
Feinman
S Victor
SV
Heathcote
E Jenny
EJ
Manns
Michael
M
Yoshida
Eric M
EM
Swain
Mark G
MG
Gane
Edward
E
Diago
Moises
M
Revicki
Dennis A
DA
Lin
Amy
A
Wintfeld
Neil
N
Green
Jesse
J
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D006304:Health Status; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols; D011788:Quality of Life; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a