Anemia and decreased health-related quality of life (HRQL) are common in patients receiving combination therapy of interferon alfa (IFN) and ribavirin (RBV) for chronic hepatitis C virus (HCV) infection. In a randomized, prospective study evaluating the effectiveness of epoetin alfa in maintaining RBV dose, alleviating anemia, and improving HRQL in anemic (Hb < 12 g/dL) HCV-infected patients receiving combination therapy, patients receiving epoetin alfa had significant improvements in HRQL compared with placebo. In this study, 185 patients were randomized to 40,000 units of epoetin alfa subcutaneously weekly or placebo for an 8-week double-blind phase (DBP), followed by an 8-week open-label phase during which all patients received epoetin alfa. To further assess the impact of epoetin alfa on HRQL, post hoc analyses were conducted in the same patient population to compare the HRQL of these patients at randomization with norms of other populations, and to determine the critical relationship between hemoglobin (Hb) levels and HRQL. Mean HRQL scores of anemic HCV-infected patients receiving combination therapy at randomization were significantly lower than those of both the general population and patients who had other chronic conditions. Patients receiving epoetin alfa who had the greatest Hb increases from randomization to the end of the DBP also had the largest improvements in HRQL. Hb improvement was an independent predictor of HRQL improvement in these patients. In conclusion, epoetin alfa provided clinically significant HRQL improvement in HCV-infected patients receiving IFN/RBV therapy. (HEPATOLOGY 2004;40: 1450-1458.) H ealth-related quality of life (HRQL) is impaired in many disease states ranging from diabetes mellitus 1 to cancer. 2 Until recently, a common perception among treating physicians was that most pa-tients infected with hepatitis C virus (HCV) did not experience a reduction in HRQL. 3 However, published data have suggested that HCV-infected patients have a decreased HRQL compared with the general population. 4 Studies have shown that HCV-infected patients who did not have cirrhosis but who were receiving treatment had a decreased HRQL when compared with groups of healthy individuals and patients infected with hepatitis B virus. 5,6 Similar decreases in HRQL have been demonstrated in cancer patients receiving chemotherapy, in whom HRQL was shown to correlate directly with hemoglobin (Hb) levels. 2,7 In these studies, patients receiving epoetin alfa treatment for their anemia not only experienced an increase in Hb but also exhibited clinically significant improvements in HRQL domains such as energy, activity, and overall quality of life.
Decreased Hb levels represent a common side effect of the interferon alfa (IFN) and ribavirin (RBV) combination or the pegylated interferon alfa (PEG-IFN) and RBV combination used to treat HCV infection, with 29% to 36% of treated patients developing anemia. 8 In a recent study, 54% of patients on this regimen experienced Hb decreases of 3 g/dL or more from pretreatment levels. 9 In