November 11, 2001
Patients infected with the hepatitis C virus have decreased quality of life when compared with those in non-infected cohorts. While effective therapy exists to treat chronic hepatitis C infection, during the treatment period, its use is associated with a significant decrease in quality of life. Newer, less toxic therapeutic agents that do not diminish quality of life during therapy are needed.
Two new types of long-acting (pegylated) interferon products have been recently developed. While these products have increased antiviral efficacy, it is not known if they are better tolerated than previously available antiviral therapy: interferon alfa-2b + ribavirin (Rebetron).
Dr. Tarek Hassanein, from the University of California in San Diego, presented a paper at the 52nd Annual Meeting of the American Association for the Study of Liver Diseases assessing quality of life during treatment with pegylated interferon.
A recent trial compared the efficacy of pegylated interferon alfa-2a (Pegasys) plus ribavirin versus the conventional treatment of interferon alfa-2b plus ribavirin. Patients were treated with either pegylated interferon alfa-2a 180µg weekly plus ribavirin 1,000 to 1,200mg daily or interferon alfa-2b 3 MU three times per week plus ribavirin 1,000-1,200mg daily. Dr. Hassanein analyzed quality of life data among the treatment groups for the first six months of therapy.
Quality of life was assessed using well-known instruments. The SF-36 (short form 36) assesses quality of life in terms of physical and mental domains. The Fatigue Severity Scale (FSS) measures the degree of fatigue and the impact of fatigue on daily life activities. Both of these instruments were used at week 2, 12 and 24 of therapy.
Side effects that were less common with Pegasys plus ribavirin compared to interferon alfa-2b plus ribavirin included fevers, rigors and depression. While other side effects occurred with equal frequency in both treatment groups, quality of life measures indicated that Pegasys plus ribavirin was better tolerated than Rebetron.
The Pegasys plus ribavirin group scored better in terms of amount of bodily pain, vitality and social functioning. Among physical components, the Pegasys plus ribavirin treatment group did much better than the Rebetron group. Fatigue, as assessed by the Fatigue Severity Scale, revealed less fatigue in the group receiving Pegasys plus ribavirin than in the Rebetron group. The difference among groups became evident by the second week of therapy and was maintained during treatment.
Comparisons between treatment groups were as follows:
|Rebetron||Pegasys plus Ribavirin|
|Moderate fever/body pain||17%||10%|
|Interference with work schedule||17%||10%|
|Little or no energy||22%||10%|
|Time spent as being very tired||21%||9%|
|Interference with social functions||18%||7%|
Dr. Hassanein concluded that this data indicates that Pegasys plus ribavirin is better tolerated than Rebetron. It should be noted that it is not clear if the patients in this study knew whether they had responded to treatment or not at the time of completing the quality of life questionnaires. It is known from prior studies that patients who respond to treatment score better in quality of life instruments. Whether this is due to the infection being under control or simply knowing that the treatment is working is not known.
Another drawback of this study is that the relationship between the time the injection was administered and the time when the questionnaires were completed is not known. Patients injecting interferon three times per week are more likely to have completed the questionnaire the day after an injection, at which time symptoms are worse and quality of life is less.
Despite these limitations, this research indicates that pegylated interferon alfa-2a not only increases the efficacy of prior therapy, but may actually be better tolerated.
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