HCV-1/4: 3D, 2D highly effective in pooled real-world studies

  • Ferenci P & al.
  • J Viral Hepat
  • 10 Feb 2019

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • Ritonavir-boosted paritaprevir/ombitasvir ± dasabuvir (Viekira [3D],Technivie [2D]) ± ribavirin (RBV) achieved high HCV-1 and HCV-4 clearance rates in pooled analysis of postmarketing data from 13 countries.

Why this matters

  • Real-world populations have diverse comorbidities and medication usage not generally captured in clinical trials.

Study design

  • Real-world data for 3850 adults (median age, 57 years) with HCV-1 (1b, 69%; 1a, 19%) or HCV-4 (12%) receiving 3D/2D ± RBV at 289 sites.
  • 35% had cirrhosis and 39% were treatment-experienced.
  • Primary endpoint: rate of sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: AbbVie.

Key results

  • Available data (n=3546) showed an SVR12 of 95.9% (95% CI, 95.2%-96.5%), not affected by cirrhosis.
  • SVR12 rates overall and in treatment-experienced patients:
    • HCV-1a: 92.6%, 91.8%;
    • HCV-1b: 97.1%, 97.2%;
    • HCV-4: 94.0%, 92.4%.
  • SVR12 was 96.3% with an 8-week course for HCV-1b.
  • SVR12 was 95.5% among patients with ≥1 comorbidity (67% of population).
  • Most patients (58%) received ≥1 comedication with little effect on SVR12; 92.1% of agents were continued during treatment.
    • SVR12 ranged from 90% to 95% with use of peptic ulcer/GERD medications, statins, antipsychotics, or antiepileptics.
    • 43% of users (n=53) maintained statins with no change.
  • Adverse events were common (26.2%) but serious events were rare (3.4%).
  • 5.0% discontinued treatment, most commonly for anemia.

Limitations

  • Observational design.

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