HCV-1: PrOD efficacy tops 90% with IDU/OST in D3FEAT

  • Grebely J & al.
  • Int J Drug Policy
  • 29 Oct 2018

  • curated by Yael Waknine
  • Univadis Clinical Summaries
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Takeaway

  • A 12-week course of ombitasvir/paritaprevir+dasabuvir (PrOD)±ribavirin (RBV) achieves a >90% HCV-1 clearance rate among patients with recent/current injection drug use (IDU) and/or who are receiving opioid substitution therapy (OST).

Why this matters

  • Efficacy aligns with prior studies excluding patients with ongoing IDU/OST.

Study design

  • D3FEAT study of 87 treatment-naive patients (median age, 48 years; 23% female; cirrhosis, 8%) receiving 12 weeks of PrOD±RBV for HCV-1 in Switzerland, France, Norway, New Zealand, Canada, and Australia.
  • Patients with genotype 1a (90%) received RBV.
  • Primary endpoint: sustained virologic response at 12 weeks posttreatment (SVR12).
  • Funding: AbbVie.

Key results

  • OST use: 71%.
  • IDU: 61% in the prior 6 months, 45% in the prior month, 15% at least once daily.
  • Median adherence, 87%.
  • 97% (84/87) of patients completed treatment (1 each of nonadherence, incarceration, and loss to follow-up).
  • SVR12, 91% (79/87; 95% CI, 83%-96%).
  • 5 patients failed to achieve SVR12 despite treatment completion: 3 relapsed, 1 died, and 1 was lost to follow-up.
  • SVR12 was not affected by drug use before/during treatment.
  • Adverse events (up to 28 days posttherapy): 53% (grade 1-2, 51%; grade 3, 7%; grade 4, 0%).
  • 2 cases of reinfection identified (week 36).

Limitations

  • Open-label, noncontrolled design; small sample size.