ASSESSING HEALTH-RELATED QUALITY-OF-LIFE IN CHRONIC HEPATITIS-C USINGTHE SICKNESS IMPACT PROFILE

In a randomized, controlled trial that demonstrated the efficacy of in terferon alfa-2b 3 million units three times a week for 24 weeks in co ntrolling chronic hepatitis C (non-A, non-B), the Sickness Impact Prof ile (SIP) was used to evaluate the impact of disease and treatment on health-related quality of life (HRQOL). The SIP was self-administered by 160 patients before treatment, at the end of treatment, and at the study endpoint. Before treatment, patients with chronic hepatitis C sc ored significantly (P < 0.05) higher (worse) than an historical contro l group of the general population in mean total SIP score and in all c ategories except eating. The highest degree of impairment was observed in the work, sleep and rest, and recreation and pastimes categories. After treatment, patients who received interferon alfa-2b had signific ant (P less-than-or-equal-to 0.05) improvement in work, sleep and rest , and recreation and pastimes scores. Numerical improvement was observ ed in total score, physical and psychosocial dimension scores, and mos t-individual category scores. Mean SIP scores were unchanged or slight ly worsened in untreated control patients. In responders (patients wit h improvement in serum alanine aminotransferase levels), the largest i mprovement was seen in work scores. The SIP appears to be a reliable a nd valid instrument for describing the impact of chronic hepatitis C o n HRQOL but lacks disease-specificity and the ability to reflect clini cally relevant changes. Thus the SIP is not the best instrument to eva luate the HRQOL effects of treatment with interferon alfa-2b in patien ts with chronic hepatitis C.