Hepatitis C virus treatment-related anemia is associated with higher sustained virologic response rate.

Authors

• Mark S Sulkowski
• Mitchell L Shiffman
• Nezam H Afdhal
• K Rajender Reddy
• Jonathan McCone
• William M Lee
• Steven K Herrine
• Stephen A Harrison
• F Fred Poordad
• Kenneth Koury
• Weiping Deng
• Stephanie Noviello
• Lisa D Pedicone
• Clifford A Brass
• Janice K Albrecht
• John G McHutchison

Publication/Presentation Date

11-1-2010

Abstract

BACKGROUND & AIMS: Hepatitis C virus (HCV) treatment is frequently complicated by anemia from ribavirin (RBV)-related hemolysis and peginterferon-alfa (PEG-IFN)-related bone marrow suppression. We investigated the relationships among treatment outcomes, anemia, and their management with RBV dose reduction and/or erythropoiesis-stimulating agents (ESAs).

METHODS: We analyzed data from a trial conducted at 118 United States academic and community centers in treatment-naïve patients with HCV genotype 1. Patients were treated for as many as 48 weeks with 1 of 3 PEG-IFN/RBV regimens. ESAs were permitted for anemic patients (hemoglobin [Hb] < 10 g/dL) after RBV dose reduction. Sustained virologic responses (SVR) were assessed based on decreases in Hb, anemia, and ESA use.

RESULTS: While patients received treatment, 3023 had their Hb levels measured at least once. An SVR was associated with the magnitude of Hb decrease: >3 g/dL, 43.7%; ≤3 g/dL, 29.9% (P < .001). Anemia occurred in 865 patients (28.6%); 449 of these (51.9%) used ESAs. In patients with early-onset anemia (≤ 8 weeks of treatment), ESAs were associated with higher SVR rate (45.0% vs 25.9%; P < .001) and reduced discontinuation of treatment because of adverse events (12.6% vs 30.1%, P < .001). ESAs did not affect SVR or discontinuation rates among patients with late-stage anemia.

CONCLUSIONS: Among HCV genotype 1-infected patients treated with PEG-IFN/RBV, anemia was associated with higher rates of SVR. The effect of ESAs varied by time to anemia; patients with early-onset anemia had higher rates of SVR with ESA use, whereas no effect was observed in those with late-onset anemia. Prospective trials are needed to assess the role of ESAs in HCV treatment.

Volume

139

Issue

5

First Page

1602

Last Page

1611

ISSN

1528-0012

Published In/Presented At

Sulkowski, M. S., Shiffman, M. L., Afdhal, N. H., Reddy, K. R., McCone, J., Lee, W. M., Herrine, S. K., Harrison, S. A., Poordad, F. F., Koury, K., Deng, W., Noviello, S., Pedicone, L. D., Brass, C. A., Albrecht, J. K., McHutchison, J. G., & IDEAL Study Team (2010). Hepatitis C virus treatment-related anemia is associated with higher sustained virologic response rate. Gastroenterology, 139(5), 1602–1611.e1. https://doi.org/10.1053/j.gastro.2010.07.059

Disciplines

Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods

PubMedID

20723545

Department(s)

Administration and Leadership

Document Type

Article