DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

* Cirrhosis : Fibrotest ® >0.75 + APRI >2 or Fibroscan ® >12.5 kPa or liver biopsy

• SOF/VEL: 400/100 mg 1 tablet QD

Objective

• SVR₁₂ (HCV RNA < 15 IU/mL)

Baseline characteristics

Primary Endpoint (SRV₁₂)

* 1 patient stopped treatment after 7 days for hyperglycemia (GT1b)
** 2 patients relapsed after treatment cessation (GT1a and GT3)

SVR₁₂ by fibrosis stage (Fibrotest ®)

2 patients had missing Fibrotest ® scores

RAS and SVR₁₂

• The 2 virological relapses occurred in patients with baseline NS5A RAS:
  • GT3b-infected patient with A30K+L31M at baseline
  • GT1a-infected patient with K24R at baseline

Adverse events and laboratory abnormalities, %

* Joint swelling, pneumonia and hepatocellular carcinoma, all unrelated to treatment
** Hyperglycemia (treatment-related)

Summary

• 12 weeks of SOF/VEL achieved high cure rate (SVR₁₂ of 96%) in liver transplantation recipients with relapse of HCV infection with genotypes 1-4
• Good safety profile
• No rejection episode