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.
RCT Entities:
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 anemicpatients (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-infectedpatients 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.
Authors: Gregory T Everson; Norah A Terrault; Anna S Lok; Del R Rodrigo; Robert S Brown; Sammy Saab; Mitchell L Shiffman; Abdullah M S Al-Osaimi; Laura M Kulik; Brenda W Gillespie; James E Everhart Journal: Hepatology Date: 2013-01-17 Impact factor: 17.425
Authors: Susanna Naggie; Norma I Rallon; José M Benito; Judith Morello; Sonia Rodriguez-Novoa; Paul J Clark; Alexander J Thompson; Kevin V Shianna; Eugenia Vispo; John G McHutchison; David B Goldstein; Vincent Soriano Journal: J Infect Dis Date: 2011-12-09 Impact factor: 5.226
Authors: Yaron Rotman; Mazen Noureddin; Jordan J Feld; Jeremie Guedj; Michael Witthaus; Hwalih Han; Yoon J Park; Su-Hyung Park; Theo Heller; Marc G Ghany; Edward Doo; Christopher Koh; Adil Abdalla; Naveen Gara; Souvik Sarkar; Emmanuel Thomas; Golo Ahlenstiel; Birgit Edlich; Rachel Titerence; Leah Hogdal; Barbara Rehermann; Harel Dahari; Alan S Perelson; Jay H Hoofnagle; T Jake Liang Journal: Gut Date: 2013-02-08 Impact factor: 23.059
Authors: Byung Chul You; Young Seok Kim; Hun il Kim; Se Hun Kim; Seung Sik Park; Yu Ri Seo; Sang Gyune Kim; Se Whan Lee; Hong Soo Kim; Soung Won Jeong; Jae Young Jang; Boo Sung Kim Journal: Clin Mol Hepatol Date: 2012-09-25