BACKGROUND: Anemia is a complication of therapy for hepatitis C virus (HCV) infection, necessitating dose reductions or therapy abandonment. Administration of an erythropoiesis-stimulating agent (ESA) is a common strategy to manage this complication. Clinical data in other patient populations demonstrate increased rates of cardiovascular events, thrombosis, malignancy, and death among ESA recipients. Event rates in the context of HCV treatment are unknown. METHODS: All recipients of interferon-ribavirin-based HCV therapy at the Ottawa Hospital Viral Hepatitis Clinic from October 2003 through October 2006 were identified. Predictors of ESA use were assessed by regression analysis. Adverse events during and after treatment were evaluated. RESULTS: A total of 174 courses of HCV therapy were initiated. Predictors of ESA use included older age, lower weight, lower baseline hemoglobin level, and infection with HCV genotype 1 or 4. Targeted hemoglobin levels of >110 g/L were achieved in 88% of ESA recipients. Although not statistically significant, sustained virological responses were obtained in more recipients of ESA (54%) than nonrecipients (45%). In the period after HCV treatment, no myocardial infarctions, deep vein thromboses, or pulmonary embolisms occurred; the frequency of stroke and cancer events were low; and rates of adverse events appeared to be similar between groups. CONCLUSIONS: ESA use is not associated with increased risk of cardiovascular events, malignancy, thrombosis, or death in HCV-infected patients during receipt of HCV therapy or in the period after completion. Given the inherent differences in patient populations, practitioners should exercise caution when extrapolating the results of studies of other diseases to HCV infection. Our efficacy and safety analysis suggests against the withholding of ESAs in the management of anemia induced by HCV treatment.
BACKGROUND:Anemia is a complication of therapy for hepatitis C virus (HCV) infection, necessitating dose reductions or therapy abandonment. Administration of an erythropoiesis-stimulating agent (ESA) is a common strategy to manage this complication. Clinical data in other patient populations demonstrate increased rates of cardiovascular events, thrombosis, malignancy, and death among ESA recipients. Event rates in the context of HCV treatment are unknown. METHODS: All recipients of interferon-ribavirin-based HCV therapy at the Ottawa Hospital Viral Hepatitis Clinic from October 2003 through October 2006 were identified. Predictors of ESA use were assessed by regression analysis. Adverse events during and after treatment were evaluated. RESULTS: A total of 174 courses of HCV therapy were initiated. Predictors of ESA use included older age, lower weight, lower baseline hemoglobin level, and infection with HCV genotype 1 or 4. Targeted hemoglobin levels of >110 g/L were achieved in 88% of ESA recipients. Although not statistically significant, sustained virological responses were obtained in more recipients of ESA (54%) than nonrecipients (45%). In the period after HCV treatment, no myocardial infarctions, deep vein thromboses, or pulmonary embolisms occurred; the frequency of stroke and cancer events were low; and rates of adverse events appeared to be similar between groups. CONCLUSIONS: ESA use is not associated with increased risk of cardiovascular events, malignancy, thrombosis, or death in HCV-infectedpatients during receipt of HCV therapy or in the period after completion. Given the inherent differences in patient populations, practitioners should exercise caution when extrapolating the results of studies of other diseases to HCV infection. Our efficacy and safety analysis suggests against the withholding of ESAs in the management of anemia induced by HCV treatment.