HCV: PrOD equal to LDV/SOF after failure of IFN-based triple therapy

  • Janczewska E & al.
  • BMC Infect Dis
  • 16 Nov 2018

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • Efficacy of ritonavir-boosted paritaprevir/ombitasvir+dasabuvir (PrOD) ± ribavirin (RBV) rivals that of ledipasvir/sofosbuvir (LDV/SOF) ± RBV in HCV-infected patients who have previously failed interferon (IFN)-based triple therapy with first-generation protease inhibitors.

Why this matters

  • PrOD is not among the treatment options recommended by the American Association for the Study of Liver Disease in this population with or without cirrhosis.

Study design

  • Real-world Polish nationwide study of 335 HCV-infected patients (HCV-1b, 93%) in the EpiTer-2 database who had previously failed IFN-based triple therapy with telaprevir (TVR; 62%) or boceprevir (BOC; 38%).
  • Most had F3 (BOC, 28.4%; TVR, 18.8%) or F4 fibrosis (BOC, 61.4%; TVR, 64.4%).
  • Participants were randomly assigned to receive PrOD±RBV (BOC, 50.4%; TVR, 49.5%) or LDV/SOF±RBV (BOC, 49.6%; TVR, 50.5%).
  • Primary endpoint: sustained virologic response at ≥12 weeks posttherapy (SVR12).
  • Funding: None.       

Key results

  • In intent-to-treat (ITT) analysis, SVR12 rates were similar with PrOD±RBV vs LDV/SOF±RBV in:
    • TVR-experienced patients (97% vs 96%).
    • BOC-experienced patients (100% vs 98%).
  • Modified ITT analysis (excluding patients lost to follow-up) supported these findings in:
    • TVR-experienced patients (99% vs 98%).
    • BOC-experienced patients (100% vs 99%).
  • Most adverse events were mild-moderate.
  • Patients who stopped treatment for adverse events (PrOD±RBV, n=3; LDV/SOF±RBV, n=2) all achieved SVR12.

Limitations

  • Clinician-determined RBV use, treatment duration.

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