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Effects of Ribavirin Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A Randomized Trial

Fred F. Poordad 1 Eric Lawitz 1 K. Rajender Reddy 2 Nezam Afdhal 3 Christophe Hézode 4 Stefan Zeuzem 5 Samuel Lee 6 Jose Luis Calleja 7 Robert Brown 8 Antonio Craxi 9 Heiner Wedemeyer 10 L. M. Nyberg 11 David R. Nelson 12 Lorenzo Rossaro 13 Luis Balart 14 Timothy R. Morgan 15 Bruce R. Bacon 16 Steven L. Flamm 17 Kris V. Kowdley 18 Weiping Deng 19 Kenneth J. Koury 19 Lisa D. Pedicone 19 Frank J. Dutko 19 Margaret H. Burroughs 19 Katia Alves 19 Janice Wahl 19 Clifford A. Brass 19 Janice K. Albrecht 19 Mark S. Sulkowski 20 R. Bailey C. Cooper S.V. Feinman P. Marotta E. Tam F. Wong Marc Bourlière Jean-Pierre Bronowicki 21 Christophe Hezode A. Tran Tobias Goeser D. Klass R. Schmid M. Pirisi M. Zuin M. Bennett D. Bernstein T. Box T. Boyer D. Clain J. Crippin M. Davis Franco Felizarta Bradley Freilich Joseph Galati G. Galler Reem Ghalib A. Gibas E. Godofsky F. Gordon S. Gordon J. Gross S. Harrison J. Herrera S. Herrine R. Herring I. Jacobson S. Joshi A. Kilby J. King A. Koch Kris V Kowdley P. Kwo E. Lebovics W. Lee J. Levin Xiaojian Li Velimir Luketic M. Mailliard Jonathan Mccone D. Mikolich A. Muir K. Mullen F. Nunes A. Nyberg P. Pandya M. Pauly C. Peine Gary Poleynard J. Poulos D. Pound M. Rabinovitz Natarajan Ravendhran R. Reddy Robert Reindollar A. Reuben T. Riley R. Rubin M. Russo M. Ryan S. Saab J. Santoro W. Schmidt T. Sepe K. Sherman Marketa Sjögren J. Slim C. Smith L. Stein R. Strauss H. Vargas John Vierling D. Witt G. Wu Z. Younes 
Abstract : Background & Aims Treatment of hepatitis C virus (HCV) infection with boceprevir, peginterferon, and ribavirin can lead to anemia, which has been managed by reducing ribavirin dose and/or erythropoietin therapy. We assessed the effects of these anemia management strategies on rates of sustained virologic response (SVR) and safety. Methods Patients (n = 687) received 4 weeks of peginterferon and ribavirin followed by 24 or 44 weeks of boceprevir (800 mg, 3 times each day) plus peginterferon and ribavirin. Patients who became anemic (levels of hemoglobin approximately ≤10 g/dL) during the study treatment period (n = 500) were assigned to groups that were managed by ribavirin dosage reduction (n = 249) or erythropoietin therapy (n = 251). Results Rates of SVR were comparable between patients whose anemia was managed by ribavirin dosage reduction (71.5%) vs erythropoietin therapy (70.9%), regardless of the timing of the first intervention to manage anemia or the magnitude of ribavirin dosage reduction. There was a threshold for the effect on rate of SVR: patients who received <50% of the total milligrams of ribavirin assigned by the protocol had a significantly lower rate of SVR (P < .0001) than those who received ≥50%. Among patients who did not develop anemia, the rate of SVR was 40.1%. Eleven thromboembolic adverse events were reported in 9 of 295 patients who received erythropoietin, compared with 1 of 392 patients who did not receive erythropoietin. Conclusions Reduction of ribavirin dosage can be the primary approach for management of anemia in patients receiving peginterferon, ribavirin, and boceprevir for HCV infection. Reduction in ribavirin dosage throughout the course of triple therapy does not affect rates of SVR. However, it is important that the patient receives at least 50% of the total amount (milligrams) of ribavirin assigned by response-guided therapy.
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Fred F. Poordad, Eric Lawitz, K. Rajender Reddy, Nezam Afdhal, Christophe Hézode, et al.. Effects of Ribavirin Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A Randomized Trial. Gastroenterology, Elsevier, 2013, 145 (5), pp.1035 - 1044.e5. ⟨10.1053/j.gastro.2013.07.051⟩. ⟨hal-01707324⟩



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