C-SURGE

C-SURGE: uprifosbuvir/grazoprevir/ruzasvir for genotype 1 with prior DAA-failure

Wyles D. Hepatology 2017 (ePub ahead of print)

Anti-HCV
Grazoprevir
Ruzasvir (MK-8408)
Uprifosbuvir (MK-3682)
Genotype
1a
Treatment history
NS5A experienced
SOF-experienced
Cirrhosis
Yes
No

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Design


* Randomisation stratified by genotype (1a vs 1b), prior DAA regimen and cirrhosis
** Liver biopsy or Fibroscan® > 12.5 kPa or Fibrotest® ≥ 0.75 + APRI ≥ 2

  • MK3: Uprifosbuvir 225 mg/GZR 50 mg/RZR 30 mg FDC (MK3) = 2 tablets QD
  • RBV dose based on body weight (< 65 kg = 800 mg/d ; 65-85 kg = 1000 mg/d ; > 85-105 kg = 1200 mg/d ; > 105 kg = 1400 mg/d)

Objective

  • SVR12 (HCV RNA < 15 IU/mL), full analysis set (≥ 1 dose of study medication)

Baseline characteristics


* Exclusion of a participant who withdrew prior to beginning treatment

SVR12 (HCV RNA <15 IU/mL)


* One patient from the 16W + RBV arm withdrew from the study after taking 3 doses of study medication (this patient was excluded in the mFAS analysis)

Adverse events, %


* N = 5 (hospitalization for cervical spine disc herniation ; hospitalization for chest pain ; hospitalization for dizziness ; pancreatitis without hospitalization ; and hospitalization for shoulder cyst surgery)

Summary

  • MK3 (uprifosbuvir/grazoprevir/ruzasvir) ± ribavirin was highly effective in cirrhotic and non-cirrhotic genotype 1 patients who previously failed an NS5A inhibitor-containing antiviral regimen
  • 98% (43/44) of patients receiving MK3 + RBV for 16 weeks achieved SVR12
    • One patient withdrew from the study after receiving 3 doses
  • 100% (49/49) of patients receiving MK3 alone for 24 weeks have achieved SVR12
  • High efficacy was observed despite a high prevalence of baseline NS3 and NS5A RAVs in this population
  • Treatment was generally safe and well-tolerated