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Quality of Life at week 24 in Study of Pegasys + Ribavirin Compared to
Standard Interferon + Ribavirin
Reported by Jules Levin
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This study looks at the quality of life in the pivotol trial of Pegasys. The
investigators used the SF-36 Heath Survey which are questionaires
self-administered by patients about physical and mental functioning while on
therapy. The investigators also used the Fatigue Severity Questionaire. Both
tests have been reportedly validated for use in Hepatitis C. Treatment-naive
patients received 1000-1200 mg of ribavirin per day plus either standard
interferon 3 times per week or once weekly Pegasys. Treatment was for 48
weeks with a 24 week follow-up. At the end of follow-up 45% (n=444) receiving
IFN+RBV compared to 56% (n=453) receiving Pegasys+RBV achieved a sustained
virologic response (p=0.001). Previously, Mike Fried reported depression (30%
vs 21%, p=0.006), fever (56% vs 43%, p=0.001), rigors (35% vs 24%, p=0.001),
myalgia 50% vs 42%, NS) were experienced less by patients receiving Pegasys.
12% had cirrhosis in each arm. HCV-RNA was 6 million copies/ml in each arm.
Age, gender, weight, and genotype were about the same in each arm. The
primary outcome of the study was quality of life during 24 weeks of study.
Evaluation by questionaires showed non-significant differences between arms
in a number of measures favoring Pegasys. But, the differences were
significant in 3 measures: bodily pain (p<0.001), vitality p<0.01), and
social functioning (p<0.05). Questionaires were filled out at weeks 2, 12,
and 24 of the study. Although 55% and 54% of patients reported fatigue in the
standard IFN vs PegIFN arms, patients receiving standard IFN reported a
greater degree of fatigue (p=0.01). In the chart of degree of fatigue over 24
weeks, the difference between the two arms continued through all 24 weeks
favoring the Pegasys arm but was significant only at week 2 (p=0.001), not at
weeks 12 and 24. For bodily pain score, the differences were significant
favoring Pegasys at weeks 2 (p=0.01) and 24 (p=0.001). Although there was a
difference favoring Pegasys at week 12 it was not significant (p=0.1). The
vitality score was significantly greater favoring Pegasys at week 2
(p=0.001). At weeks 12 and 24, there was a slight difference favoring Pegasys
but it was not significant. This data suggests tolerability was much better
in the early weeks of treatment.
17% in the IFN arm vs 10% in the PegIFN arm reported moderate to severe
bodily pain and bodily pain interfered with work. 22% in IFN arm vs 10%
PegIFN arm reported little and no energy or tired most of the time. 18% in
the IFN arm vs 7% in the PegIFN arm reported physical health interfered with
social activities. These evaluations were not reported by week.
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