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Quality of Life of Pegasys+Ribavirin vs Interferon+Ribavirin (48 Week Results)
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BRIEF STUDY SUMMARY: This study was reported by T.I. Hassanien et al and Roche. The purpose was to evaluate the quality of life during Pegasys+ribavirin therapy comparing it to standard interferon + ribavirin therapy for about 900 patients. Patients received 1000 or 1200 mg per day of ribavirin. They examined patients taking therapy for 48 weeks. The study found that after the first two weeks on therapy body pains, fatigue, vitality, and social functioning appeared better for patients receiving Pegasys/RBV compared to patients taking IFN/RBV. This is important because the degree of side effects during the early stages of therapy can influence whether patients discontinue or stay on therapy. In this study the discontinuation rate was higher in patients receiving IFN/RBV than those receiving Pegasys/RBV. This could be due to better tolerability of Pegasys or due to a better antiviral response due to Pegasys/RBV. The study reported less fatigue and less degree of fatigue was experienced for patients receiving Pegasys/RBV. The authors said these lower rates of side effects were consistent with less flu-like symptoms and depression being experienced by patients receiving Pegasys/RBV. The authors also concluded Pegasys/RBV offered a more favorable quality of life on therapy compared to that on IFN/RBV.
Patients with hepatitis C can experience a diminshed health-related quality of life (QOL). Treatments for hepatitis C also have a negative impact on health related QOL during the course of treatment. Declines in quality of life increases the risk that patients will prematurely discontinue treatment. This study was reported at the EASL (European liver conference) in Madrid in april 2002.
The purpose of this study was to examine and compare the quality of life while on Pegasys/RBV vs standard IFN/RBV during treatment.
This study examines 3 phase 3 randomized studies in which patients received either Pegasys plus ribavirin (RBV) or standard interferon (3 times per week) plus ribavirin. Patients received 1000 or 1200 mg perday of RBV based on their body weight. Overall 56% of patients receiving pegasys+RBV achieved a sustained virologic response (SVR) and 45% of patients receiving standard interferon+RBV achieved an SVR. 444 patients received IFN/RBV vs 453 receiving Pegasys/RBV.
Significantly lower rates of fever (56% vs 43%), rigors (35% vs 24%), depression (30% vs 21%), and hair loss (35% vs 28%) were seen in patients receiving Pegasys/RBV vs those receiving IFN/RBV. 31% of patients receiving PegIntron/RBV reported depression in the large phase 3 study of PegIntron 1.5 mcg/RBV. Rigors is shivering or chills as in flu-like symptoms. Injection site reactions were about 11% in both arms. There was less myalgia (muscular aches & pains) in patients receiving Pegasys/RBV but the difference was not significant (50% vs 42%).
Quality of life was assessed before starting therapy and at weeks 2, 12, 24, 48, and 72 weeks. They used several test instruments:
SF-36 Health Survey (SF-36)
This test looks at the physical and mental experience during therapy. The physical experience includes evaluating physical functioning, bodily pain, general health. The mental aspect evaluates vitality, social functioning, emotions, and mental health.
Fatugue Severity Score
This is a self-administered 10-item questionaireevaluating the impact of fatigue on daily living and the degree of fatigue.
RESULTS
The patients were about the same in the 2 groups. Premature discontinuation was 6.9% in the Pegasys/RBV group and 9.4% in the IFN/RBV group.
Overall, patients receiving Pegasys/RBV experienced significantly less bodily pain, more vitality, better social functioning, and had better overall physical feelings.
The overall SF score at weeks 2 and 24 were significantly better for patients taking Pegasys/RBV. At weeks 12 and 48 they were better also but it wasn't significant.
The SF-36 vitality score was significantly better at week 2 for patients taking Pegasys/RBV. For the remainder of the 48 weeks there was no significant difference but there was a trend (p=0.06) for more vitality for patients receiving Pegasys/RBV.
The SF-36 social functioning test showed similar results: a trend towards being better for Pegasys/RBV patients.
The FSS fatigue score was significantly better at week 2 for Pegasys/RBV patients, no difference at week 12, but appeared better throughot the remainder of the 48 weeks for Pegasys/RBV patients. Overall the study authors reported significantly less fatigue and degree of fatigue for patients receiving Pegasys/RBV.
You can review adverse events profile in study comparing IFN/RBV to PegIntron 1.5/RBV at:
www.natap.org/2001/slideShows/slide.htm
www.natap.org/2001/36theasl/part5easl050101.htm
www.natap.org/2001/sum01/adverseEvents.html
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