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BROWSE SLIDES

Design

* Randomisation was stratified on HCV ge notype
** Metavir F4 or Ishak 5-6 or Fibroscan > 12.5 kPa or Fibrotest > 0.75 and APRI > 2

• RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or = 75 kg)

Objective

• SVR₁₂ (HCV RNA < 15 UI/ml) with 2-sided 95% CI , by ITT, 99% power to detect a SVR 12 = 41% ; not powered to detect significant differences in SVR among the treatment groups
• Changes in MELD and CPT scores

Baseline characteristics and patient disposition

SVR₁₂, % (95% CI)

*Patient with non-detectable drug levels at time of virological failure, LTFU, lost to follow-up

Characteristics of patients with virologic failure

CPT score change : baseline to follow-up W12 (% of patients)

17/267patients had no follow-up W12 assessment

MELD change: baseline to follow-up W12 (% of patients)

17/267patients had no follow-up W12 assessment

Adverse events, N (%)

* RBV discontinuation : 17%, dose reduction : 37%

Hematologic abnormalities, N (%)

* RBV discontinuation : 17%, dose reduction : 37%

Summary

• Treatment with SOF/VEL for 12 or 24 weeks or SOF/VEL + RBV for 12 weeks resulted in high SVR₁₂ rates in HCV patients with decompensated cirrhosis caused by HCV of all genotypes
• SOF/VEL + RBV resulted in the highest overall SVR₁₂ rates, with the lowest rates of virologic failure in HCV genotype 3 patients
• Treatment was associated with improved MELD and CPT scores largely due to decreased bilirubin and improvement in synthetic function (albumin)
• SOF/VEL for 12 or 24 weeks or SOF/VEL + RBV for 12 weeks was safe and well tolerated, with adverse events consistent with clinical sequelae of advanced liver disease and RBV toxicity
• Limitations
  • Study not powered to detect significant differences among the 3 treatment groups
  • Only patients with moderate hepatic decompensation were enrolled
  • The numbers of patients with HCV genotype 2, 4, or 6 were small
  • Limited number of black patients