TY - JOUR
T1 - Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders
T2 - A Phase III Study
AU - on behalf of the C-EDGE IBLD Study Investigators
AU - Hézode, Christophe
AU - Colombo, Massimo
AU - Bourlière, Marc
AU - Spengler, Ulrich
AU - Ben-Ari, Ziv
AU - Strasser, Simone I.
AU - Lee, William M.
AU - Morgan, Leslie
AU - Qiu, Jingjun
AU - Hwang, Peggy
AU - Robertson, Michael
AU - Nguyen, Bach Yen
AU - Barr, Eliav
AU - Wahl, Janice
AU - Haber, Barbara
AU - Chase, Robert
AU - Talwani, Rohit
AU - Marco, Vito Di
N1 - Funding Information:
Additional Supporting Information may be found at onlinelibrary.wiley.com/doi/10.1002/hep.29139/suppinfo. This study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Publisher Copyright:
© 2017 by the American Association for the Study of Liver Diseases.
PY - 2017/9
Y1 - 2017/9
N2 - Direct-acting antiviral agents have not been studied exclusively in patients with inherited blood disorders and hepatitis C virus (HCV) infection. The objective of the randomized, placebo-controlled, phase III C-EDGE IBLD study was to assess the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) in patients with inherited bleeding disorders and HCV infection. One hundred fifty-nine adults with HCV infection and sickle cell anemia, thalassemia, or hemophilia A/B or von Willebrand disease were enrolled at 31 study sites in the United States, Europe, Australia, Canada, Israel, and Thailand. Patients were given an oral, once-daily, fixed-dose combination of EBR/GZR 50 mg/100 mg for 12 weeks and randomized to the immediate-treatment group (ITG) or deferred-treatment group (DTG; placebo followed by active treatment). The primary endpoints were the proportion of patients in the ITG with unquantifiable HCV RNA 12 weeks posttreatment (sustained virological response 12 weeks after completion of study treatment; SVR12) and the comparison of safety in the ITG and DTG. In the ITG, 100 of 107 patients (93.5%) achieved SVR12, 6 relapsed, and 1 was lost to follow-up. SVR12 was achieved in 94.7% (18 of 19), 97.6% (40 of 41), and 89.4% (42 of 47) of patients with sickle cell disease, β-thalassemia, and hemophilia A/B or von Willebrand disease, respectively. Serious adverse events were reported by 2.8% (n = 3) and 11.5% (n = 6) of patients in the ITG and DTG, respectively. Hemoglobin levels and international normalized ratio values were similar in patients receiving EBR/GZR and placebo; among patients with hemoglobinopathies, change in mean hemoglobin levels was similar in those receiving EBR/GZR compared to those receiving placebo. Conclusion: These results add to the expanding pool of data available for EBR/GZR, indicating a high level of efficacy and favorable tolerability in patients with HCV infection. (Hepatology 2017;66:736–745).
AB - Direct-acting antiviral agents have not been studied exclusively in patients with inherited blood disorders and hepatitis C virus (HCV) infection. The objective of the randomized, placebo-controlled, phase III C-EDGE IBLD study was to assess the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) in patients with inherited bleeding disorders and HCV infection. One hundred fifty-nine adults with HCV infection and sickle cell anemia, thalassemia, or hemophilia A/B or von Willebrand disease were enrolled at 31 study sites in the United States, Europe, Australia, Canada, Israel, and Thailand. Patients were given an oral, once-daily, fixed-dose combination of EBR/GZR 50 mg/100 mg for 12 weeks and randomized to the immediate-treatment group (ITG) or deferred-treatment group (DTG; placebo followed by active treatment). The primary endpoints were the proportion of patients in the ITG with unquantifiable HCV RNA 12 weeks posttreatment (sustained virological response 12 weeks after completion of study treatment; SVR12) and the comparison of safety in the ITG and DTG. In the ITG, 100 of 107 patients (93.5%) achieved SVR12, 6 relapsed, and 1 was lost to follow-up. SVR12 was achieved in 94.7% (18 of 19), 97.6% (40 of 41), and 89.4% (42 of 47) of patients with sickle cell disease, β-thalassemia, and hemophilia A/B or von Willebrand disease, respectively. Serious adverse events were reported by 2.8% (n = 3) and 11.5% (n = 6) of patients in the ITG and DTG, respectively. Hemoglobin levels and international normalized ratio values were similar in patients receiving EBR/GZR and placebo; among patients with hemoglobinopathies, change in mean hemoglobin levels was similar in those receiving EBR/GZR compared to those receiving placebo. Conclusion: These results add to the expanding pool of data available for EBR/GZR, indicating a high level of efficacy and favorable tolerability in patients with HCV infection. (Hepatology 2017;66:736–745).
UR - http://www.scopus.com/inward/record.url?scp=85018230276&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85018230276&partnerID=8YFLogxK
U2 - 10.1002/hep.29139
DO - 10.1002/hep.29139
M3 - Article
C2 - 28256747
AN - SCOPUS:85018230276
SN - 0270-9139
VL - 66
SP - 736
EP - 745
JO - Hepatology
JF - Hepatology
IS - 3
ER -