Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders: A Phase III Study

on behalf of the C-EDGE IBLD Study Investigators

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

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).

Original languageEnglish (US)
Pages (from-to)736-745
Number of pages10
JournalHepatology
Volume66
Issue number3
DOIs
StatePublished - Sep 1 2017

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Virus Diseases
Hepacivirus
Placebos
Hemophilia B
von Willebrand Diseases
Thalassemia
Hemophilia A
Sickle Cell Anemia
Therapeutics
Hemoglobins
2-(pyrrolidin-2-yl)-5-(2-(4-(5-(pyrrolidin-2-yl)-1H-imidazol-2-yl)phenyl)benzofuran-5-yl)-1H-imidazole
MK-5172
Safety
Hemoglobinopathies
International Normalized Ratio
Lost to Follow-Up
Gastroenterology
Israel
Thailand
Canada

ASJC Scopus subject areas

  • Hepatology

Cite this

Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders : A Phase III Study. / on behalf of the C-EDGE IBLD Study Investigators.

In: Hepatology, Vol. 66, No. 3, 01.09.2017, p. 736-745.

Research output: Contribution to journalArticle

on behalf of the C-EDGE IBLD Study Investigators. / Elbasvir/Grazoprevir for Patients With Hepatitis C Virus Infection and Inherited Blood Disorders : A Phase III Study. In: Hepatology. 2017 ; Vol. 66, No. 3. pp. 736-745.
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abstract = "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).",
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T2 - A Phase III Study

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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

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