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Glecaprevir/pibrentasvir for HCV genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase III clinical trial

Hepatology Sep 23, 2017

Wyles D, et al. - The efficacy and safety of ribavirin (RBV)-free coformulated glecaprevir/pibrentasvir (G/P) were evaluated in patients with hepatitis C virus (HCV) genotype (GT) 3 infection with either prior treatment experience and/or compensated cirrhosis, a patient population with limited treatment options. The researchers achieved high sustained virologic response at post-treatment week 12 (SVR12) rates following 12 or 16 weeks of treatment with G/P in these patients. As per the outcomes, the regimen was well tolerated.

Methods
  • SURVEYOR-II, Part 3 was a partially-randomized, open-label, multicenter, phase 3 study.
  • The researchers randomized treatment-experienced (prior interferon (IFN) or pegIFN ± ribavirin or SOF plus ribavirin ± pegIFN therapy) patients without cirrhosis 1:1 to receive 12 or 16 weeks of G/P (300 mg/120 mg) once daily.
  • They treated treatment-naïve or treatment-experienced patients with compensated cirrhosis with G/P for 12 or 16 weeks, respectively.
  • The percentage of patients with sustained virologic response at post-treatment week 12 (SVR12) was the primary efficacy endpoint.
  • They evaluated safety throughout the study.

Results
  • The researchers enrolled and treated 131 patients.
  • SVR12 was achieved by 91% (20/22; CI 72-97) and 95% (21/22; CI 78-99) of patients treated with G/P for 12 or 16 weeks, respectively, among treatment-experienced patients without cirrhosis.
  • SVR12 was achieved by 98% (39/40; CI 87-99) of treatment-naïve patients treated for 12 weeks, and 96% (45/47; CI 86-99) of patients with prior treatment experience treated for 16 weeks among those with cirrhosis.
  • No adverse events (AEs) led to discontinuation of study drug.
  • They found no serious AEs related to study drug.
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