HCV-1/4: 8 weeks of EBR/GZR effective for acute infection

  • Boerekamps A & al.
  • Lancet Gastroenterol Hepatol
  • 16 Jan 2019

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • An 8-week course of elbasvir/grazoprevir (EBR/GZR; Zepatier) is highly effective for clearing acute HCV genotype 1 or 4 infection.

Why this matters

  • This is the first study with sufficient statistical power to determine efficacy.
  • The eradication rate is similar to that reported (99%) with a 12-week regimen in chronic HCV.
  • Immediate treatment can reduce transmission in high-risk populations.

Study design

  • Multicenter phase 3b Dutch Acute HCV in HIV study number 2 (DAHHS2) involving 80 men who have sex with men (MSM; mean age, 47 years) with acute (≤26 weeks) HCV-1a (64%) or HCV-4 (36%) receiving 8 weeks of EBR/GZR.
  • 91% had HIV coinfection.
  • Primary outcome: sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: MSD, Health-Holland.

Key results

  • All patients completed treatment and follow-up.
  • SVR12 was achieved by 79/80 patients (99%; 95% CI, 93%-100%), including all 14 patients with NS5A resistance-associated substitutions.
  • 4 patients with HIV experienced reinfection.
    • SVR12 considering these as failures: 94% (95% CI, 86%-98%).
  • The most common adverse event (AE) was sexually transmitted infection (24%).
  • AEs potentially related to treatment were mild and included fatigue (14%), headache (9%), insomnia (9%), mood changes (6%), dyspepsia (6%), impaired concentration (5%), and dizziness (5%).

Limitations

  • Open-label design, homogeneous population.

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