Medication side effects are one of the most difficult aspects of the treatment of hepatitis C virus (HCV) infected patients. HCV treatments, especially interferon, are well known for their adverse effects, including fatigue, myalgia, flu-like symptoms, and mood changes, among others.

These adverse effects negatively impact the patient's overall sense of well-being and quality of life. They are also important factors in the patient's decision to start, continue and be adherent while on therapy. Treatment with pegylated interferons have been shown in several studies to have improved sustained virologic response (SVR) relative to standard interferon, but whether pegylated interferons will improve side effects and quality of life is unknown.

In a study published in Hepatology, the objective was to (1) evaluate the effect of SVR on quality of life in patients with HCV and (2) determine whether impairment of quality of life during treatment contributes to early treatment discontinuation. The authors of the study used a pooled secondary analysis of 1,441 patients from across 3 international, multicenter, open-label, randomized studies that compared Pegasys (peginterferon alfa-2a) with interferon alfa-2a. Quality of life was evaluated using the SF-36 Health Survey and the Fatigue Severity Scale (FSS), both of which were completed by patients at baseline and at weeks 2, 12, 24, 48, and 72.

During treatment, patients receiving Pegasys had better scores on 7 of 8 SF-36 domains regarding quality of life, both SF-36 summary scores, and had less fatigue as measured by the FSS assessments. Baseline to 24-week changes in fatigue and mental and physical compromise significantly predicted treatment discontinuation.

Therapy was discontinued in 141 patients (10%) before 24 weeks of therapy, and worsening fatigue scores and declines in SF-36 mental and physical component summary scores were found to be significant predictors of treatment discontinuation. The authors found that SVR was associated with marked improvements from baseline to end of follow-up in all subjects, including patients with cirrhosis.

The authors conclude, "Sustained virologic response is associated with improvements in disabling fatigue and patient functioning and well-being in patients with [chronic HCV] with and without evidence of cirrhosis as measured by both the SF-36 and FSS scales…Maintaining an acceptable [quality of life] on therapy is vital to patient compliance and acceptance of these therapies. Minimizing the adverse impact of therapy on [quality of life] should help lessen the degree of early treatment discontinuation.

"Peginterferons seem to offer an advantage over standard therapies in maintaining an acceptable [quality of life]. [Quality of life] issues should be considered in conjunction with safety and efficacy concerns in choosing optimal therapy for the treatment of patients with [chronic HCV]."

04/01/02

Reference
D Bernstein and others. Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patients. Hepatology 2002; 35:704-708.

With permission from HIVANDHEPATITIS