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. ClinicalTrials.gov number, NCT01023035.
RCT Entities:
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. ClinicalTrials.gov number, NCT01023035.
Authors: Christina Sølund; Henrik Krarup; Santseharay Ramirez; Peter Thielsen; Birgit T Røge; Suzanne Lunding; Toke S Barfod; Lone G Madsen; Britta Tarp; Peer B Christensen; Jan Gerstoft; Alex L Laursen; Jens Bukh; Nina Weis Journal: PLoS One Date: 2014-12-01 Impact factor: 3.240
Authors: John A Howe; Jianmin Long; Stuart Black; Robert Chase; Patricia McMonagle; Stephanie Curry; Seth Thompson; Mark J DiNubile; Anita Y M Howe Journal: Open Forum Infect Dis Date: 2014-09-16 Impact factor: 3.835
Authors: Christoph R Werner; Carolin Franz; Daniel P Egetemeyr; Robert Beck; Nisar P Malek; Ulrich M Lauer; Christoph P Berg Journal: Virol J Date: 2015-03-03 Impact factor: 4.099
Authors: Raoel Maan; Adriaan J van der Meer; Willem Pieter Brouwer; Elisabeth P C Plompen; Milan J Sonneveld; Robert Roomer; Annemiek A van der Eijk; Zwier M A Groothuismink; Bettina E Hansen; Bart J Veldt; Harry L A Janssen; Andre Boonstra; Robert J de Knegt Journal: PLoS One Date: 2015-10-06 Impact factor: 3.240
Authors: C Laouénan; J Guedj; G Peytavin; Th Tram Nguyen; M Lapalus; F Khelifa-Mouri; N Boyer; F Zoulim; L Serfaty; J-P Bronowicki; M Martinot-Peignoux; O Lada; T Asselah; C Dorival; C Hézode; F Carrat; F Nicot; P Marcellin; F Mentré Journal: CPT Pharmacometrics Syst Pharmacol Date: 2014-12-30
Authors: Fritz Klein; Ruth Neuhaus; Dennis Eurich; Jörg Hofmann; Sandra Bayraktar; Johann Pratschke; Marcus Bahra Journal: Hepat Res Treat Date: 2016-04-18