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

Christophe Hézode1, Massimo Colombo2, Marc Bourlière3

  • 1Henri Mondor Hospital, Paris, France.

Hepatology (Baltimore, Md.)
|March 4, 2017
PubMed

Insights

Direct-acting antiviral elbasvir/grazoprevir (EBR/GZR) demonstrated high efficacy and safety in patients with inherited blood disorders and hepatitis C virus (HCV) infection. The study confirmed favorable tolerability and a high sustained virological response rate (SVR12) in this population.

Area of Science:

  • Hepatology
  • Virology
  • Hematology

Background:

  • Direct-acting antiviral agents (DAAs) have shown efficacy against hepatitis C virus (HCV).
  • Limited data exist on DAA use in patients with inherited blood disorders and HCV coinfection.
  • Inherited bleeding disorders may influence treatment outcomes and safety profiles.

Purpose of the Study:

  • To evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) in adults with HCV infection and inherited bleeding disorders.
  • To assess the sustained virological response 12 weeks posttreatment (SVR12) in this specific patient group.
  • To compare the safety profiles of immediate versus deferred treatment with EBR/GZR.

Main Methods:

  • A randomized, placebo-controlled, phase III clinical trial (C-EDGE IBLD) was conducted.
  • 159 adults with HCV and conditions like sickle cell anemia, thalassemia, or hemophilia received EBR/GZR for 12 weeks.
  • Patients were randomized to immediate treatment or a deferred treatment group.

Main Results:

  • The immediate-treatment group achieved a 93.5% SVR12 rate (100/107 patients).
  • High SVR12 rates were observed across specific inherited blood disorders: 94.7% (sickle cell disease), 97.6% (β-thalassemia), and 89.4% (hemophilia).
  • Serious adverse events were low (2.8% in the immediate-treatment group) and comparable to placebo.

Conclusions:

  • Elbasvir/grazoprevir (EBR/GZR) is highly effective and well-tolerated in patients with HCV and inherited bleeding disorders.
  • The treatment regimen achieved high SVR12 rates across various hematological conditions.
  • These findings support the use of EBR/GZR in this coinfected population.

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