Comparison of Quality of Life, Work Productivity
Comparison of Quality of Life, Work Productivity
Summary: The on-treatment impact of interferon-based therapies on quality of life (QOL), work productivity, and medical resource utilization has not been systematically studied. We evaluated the effects of treatment with peginterferon alpha (pegIFNα) 2a monotherapy and the combination of interferon alpha (IFNα) 2b plus ribavirin (RBV) on health-related QOL, work productivity and resource utilization. A total of 412 patients with hepatitis C infection were randomized to open-label treatment with either pegIFNα 2a (n = 206) or IFNα 2b/RBV (n = 206). PegIFNα 2a was administered subcutaneously at a dose of 180 µg once weekly for 48 weeks; and IFNα 2b/RBV at doses of 3 MU thrice weekly subcutaneously and 1000-1200 mg/day orally. Outcome measures included the SF-36 Health Survey Questionnaire and additional generic and specific scales. During treatment, for all SF-36 summary and Hepatitis Quality of Life Questionnaire (HQLQ)-specific scales, the pegIFNα 2a group experienced less impairment than did the IFNα 2b/RBV patients. The between-treatment differences were significant for many of the scores particularly in the first 24 weeks of treatment. Across all measures of work functioning and productivity at each visit, patients randomized to pegIFNα 2a treatment showed less impairment relative to the group treated with IFNα 2b/RBV. Hence treatment with pegIFNα 2a relative to IFNα 2b/RBV minimizes the adverse impact of therapy on health-related QOL. Patients randomized to pegIFNα 2a had improved work productivity, less activity impairment, decreased need for prescription drugs to treat adverse effects, and better adherence to therapy.
Several drugs are currently available for the treatment of patients with chronic hepatitis C infection, including interferon α (IFNα) 2a/2b, polyethylene glycol-modified interferon α (pegIFNα) 2a; pegIFNα 2b; combination IFNα 2b plus ribavirin (RBV); and combination pegIFNα 2b plus RBV. IFNs produce various adverse effects, such as fatigue, myalgia, influenza like symptoms, and alterations in mood, inability to concentrate and decreased libido, which may negatively affect a patient's vitality, social interaction, and ability to perform work and other activities. An understanding of the extent to which the recommended year-long course of treatment is likely to impact patient quality of life (QOL) as well as work productivity is important when considering a personalized approach to treatment planning. However, most QOL studies in patients undergoing IFN-based therapy have focused on the influence of treatment response on health-related QOL, and few studies have carefully assessed these issues during therapy. In view of the burgeoning population of patients with chronic hepatitis C in the US, there is a need for additional information on the on-treatment effect of anti-hepatitis C virus (HCV) therapies on health-related QOL.
The present study was designed before the combination of a pegIFNα plus RBV became the standard of care. Nevertheless, as the adverse event profile of the combination of IFNα 2b plus RBV is similar to that of 12 kDa pegIFNα 2b/RBV, the results of the drug comparison herein still provide data useful in guiding clinical decision-making for some patients. The aim of this study was to compare the effects of treatment with 40 kDa pegIFNα 2a monotherapy and the combination of IFNα 2b plus RBV on health-related QOL, work productivity and resource utilization in patients with chronic hepatitis C.
Summary: The on-treatment impact of interferon-based therapies on quality of life (QOL), work productivity, and medical resource utilization has not been systematically studied. We evaluated the effects of treatment with peginterferon alpha (pegIFNα) 2a monotherapy and the combination of interferon alpha (IFNα) 2b plus ribavirin (RBV) on health-related QOL, work productivity and resource utilization. A total of 412 patients with hepatitis C infection were randomized to open-label treatment with either pegIFNα 2a (n = 206) or IFNα 2b/RBV (n = 206). PegIFNα 2a was administered subcutaneously at a dose of 180 µg once weekly for 48 weeks; and IFNα 2b/RBV at doses of 3 MU thrice weekly subcutaneously and 1000-1200 mg/day orally. Outcome measures included the SF-36 Health Survey Questionnaire and additional generic and specific scales. During treatment, for all SF-36 summary and Hepatitis Quality of Life Questionnaire (HQLQ)-specific scales, the pegIFNα 2a group experienced less impairment than did the IFNα 2b/RBV patients. The between-treatment differences were significant for many of the scores particularly in the first 24 weeks of treatment. Across all measures of work functioning and productivity at each visit, patients randomized to pegIFNα 2a treatment showed less impairment relative to the group treated with IFNα 2b/RBV. Hence treatment with pegIFNα 2a relative to IFNα 2b/RBV minimizes the adverse impact of therapy on health-related QOL. Patients randomized to pegIFNα 2a had improved work productivity, less activity impairment, decreased need for prescription drugs to treat adverse effects, and better adherence to therapy.
Several drugs are currently available for the treatment of patients with chronic hepatitis C infection, including interferon α (IFNα) 2a/2b, polyethylene glycol-modified interferon α (pegIFNα) 2a; pegIFNα 2b; combination IFNα 2b plus ribavirin (RBV); and combination pegIFNα 2b plus RBV. IFNs produce various adverse effects, such as fatigue, myalgia, influenza like symptoms, and alterations in mood, inability to concentrate and decreased libido, which may negatively affect a patient's vitality, social interaction, and ability to perform work and other activities. An understanding of the extent to which the recommended year-long course of treatment is likely to impact patient quality of life (QOL) as well as work productivity is important when considering a personalized approach to treatment planning. However, most QOL studies in patients undergoing IFN-based therapy have focused on the influence of treatment response on health-related QOL, and few studies have carefully assessed these issues during therapy. In view of the burgeoning population of patients with chronic hepatitis C in the US, there is a need for additional information on the on-treatment effect of anti-hepatitis C virus (HCV) therapies on health-related QOL.
The present study was designed before the combination of a pegIFNα plus RBV became the standard of care. Nevertheless, as the adverse event profile of the combination of IFNα 2b plus RBV is similar to that of 12 kDa pegIFNα 2b/RBV, the results of the drug comparison herein still provide data useful in guiding clinical decision-making for some patients. The aim of this study was to compare the effects of treatment with 40 kDa pegIFNα 2a monotherapy and the combination of IFNα 2b plus RBV on health-related QOL, work productivity and resource utilization in patients with chronic hepatitis C.