HCV-1: PRoD efficacy high with advanced fibrosis in TOPAZ-III

  • Pessoa MG & al.
  • Ann Hepatol
  • 16 Oct 2018

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • Ritonavir-boosted paritaprevir/ombitasvir+dasabuvir (PrOD; Viekira Pak) ± ribavirin (RBV) safely achieves high HCV-1 clearance rates in patients with advanced fibrosis.    

Why this matters

  • Findings support use in this population, which included patients with cirrhosis, thrombocytopenia (to 25,000/mm3), hypoalbuminemia, and moderate renal dysfunction (creatinine clearance to 30 mL/minute).

Study design

  • Brazilian multicenter phase 3b TOPAZ-III trial of 222 patients (55.4% male, median age, 57.0 years) with HCV-1a (49.5%) or HCV-1b (50.5%) and advanced fibrosis (METAVIR-F3/F4); 59.9% had cirrhosis.
  • 54.1% had previously failed peginterferon/ribavirin (pegIFN/RBV) therapy.
  • HCV-1a: PrOD + RBV for 12 weeks, extended to 24 weeks for prior pegIFN/RBV nonresponders.
  • HCV-1b: PrOD (F3 fibrosis) or PrOD + RBV (F4 fibrosis) for 12 weeks.
  • Funding: AbbVie.

Key results

  • Sustained virologic response at 12 weeks (SVR12) was 96.4% (95% CI, 93.1%-98.2%).
    • Of 8 non-SVR12, there were 6 cases of relapse and 1 case of virologic breakthrough (all HCV-1a); 1 patient lost to follow-up.
  • HCV-1a:
    • SVR12, 93.6%.
    • SVR12 in cirrhotic and noncirrhotic patients was 92.2% and 95.7%, respectively.
  • HCV-1b:
    • SVR12, 99.1%.
    • SVR12 in cirrhotic and noncirrhotic patients was 100% and 97.7%, respectively.
  • SVR12 was similar in treatment-naive and -experienced patients (96.1% vs 96.6%).
  • 1 treatment-related serious adverse event potentially related to PrOD (decompensation) was reported.

Limitations

  • Open-label design.

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