Anemia in Patients with Chronic Hepatitis C Infection during Triple Therapy with Telaprevir or Boceprevir - A Controlled Study

Abstract

Introduction: Triple therapy with protease inhibitors, telaprevir and boceprevir, is the new standard of treatment for hepatitis C virus (HCV) genotype 1 infection. In this study, we investigated the natural history of anemia in patients treated with triple therapy compared to those treated with pegylated-interferon and ribavirin (PEG/RBV) in the real-life setting. Methods: Anemia was monitored in 72 consecutive patients treated with telaprevir- (46) or boceprevir-based triple therapy (26) for 16 weeks. These patients were statistically matched to 72 controls with respect to age, sex, race, and fibrosis that were treated previously with PEG/RBV. Anemia was treated by dose RBV dose reduction, red blood cell (RBC) transfusions, or epoetin alfa injections (EPO). Results: The mean age for the study population was 52.1 years, 58.3% were male, 41.4% were treatment naive, and 30.3% were cirrhotic. The control group was similar in terms of age, sex, race, and fibrosis. The mean baseline hemoglobin was 14.8 ± 1.3 g/dL. Incidence of grade 2-4 anemia (hemoglobin<10g/dL) in patients was 50% for those treated with telaprevir, 50% for those treated with boceprevir, and 27.5% treated with PEG/RBV (p<0.005). Lowest mean hemoglobin was 10.3 ± 1.8 g/dL, 10.4 ± 1.8 g/dL, and 11.0 ± 1.8 g/dL for telaprevir, boceprevir, and controls respectively (p<0.061). Hemoglobin nadir was reached between treatment weeks 6-10 in all treatment arms. Anemia required RBV dose reduction in 60% of those on telaprevir, 57.1% of those on boceprevir and 17.9% of the controls (p<0.001). PEG dose reduction, use of EPO, and/or RBC transfusion was not significantly different between the three groups. None of the patients had to discontinue HCV therapy due to anemia. Conclusion: Using protease inhibitors such as telaprevir or boceprevir to treat patients with hepatitis C results in more significant anemia when compared to treatment with PEG/RBV alone. Ribavirin dose reduction was used more frequently in patients treated with protease inhibitors compared to controls; however, the need for RBC transfusions, EPO injections, and PEG dose reduction was similar in both groups.