Hepatitis C Virus Treatment-Related Anemia Is Associated With Higher Sustained Virologic Response Rate

被引:92
作者
Sulkowski, Mark S. [1 ]
Shiffman, Mitchell L. [2 ]
Afdhal, Nezam H. [3 ]
Reddy, K. Rajender [4 ]
McCone, Jonathan [5 ]
Lee, William M. [6 ]
Herrine, Steven K. [7 ]
Harrison, Stephen A. [8 ]
Poordad, F. Fred [9 ]
Koury, Kenneth [10 ]
Deng, Weiping [10 ]
Noviello, Stephanie [10 ]
Pedicone, Lisa D. [10 ]
Brass, Clifford A. [10 ]
Albrecht, Janice K. [10 ]
McHutchison, John G. [11 ]
机构
[1] Johns Hopkins Univ, Sch Med, Baltimore, MD 21287 USA
[2] Liver Inst Virginia, Bon Secours Hlth Syst, Newport News, VA USA
[3] Beth Israel Liver Ctr, Boston, MA USA
[4] Univ Penn Hlth Syst, Philadelphia, PA USA
[5] Mt Vernon Endoscopy Ctr, Alexandria, VA USA
[6] Univ Texas SW Med Ctr Dallas, Dallas, TX 75390 USA
[7] Thomas Jefferson Univ, Philadelphia, PA 19107 USA
[8] Brooke Army Med Ctr, Ft Sam Houston, TX 78234 USA
[9] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA
[10] Merck & Co Inc, Whitehouse Stn, NJ USA
[11] Duke Clin Res Inst, Durham, NC USA
关键词
Adverse Effects of Hepatitis Therapy; Clinical Trial; Liver Disease; Blood Disorders; INTERFERON-ALPHA-2B PLUS RIBAVIRIN; HCV-INFECTED PATIENTS; RED-CELL APLASIA; EPOETIN-ALPHA; COMBINATION THERAPY; PEGYLATED INTERFERON-ALPHA-2B; PEGINTERFERON ALPHA-2A; GENOTYPE-1; PATIENTS; GROWTH-FACTORS; MANAGEMENT;
D O I
10.1053/j.gastro.2010.07.059
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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-naive 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.
引用
收藏
页码:1602 / +
页数:11
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