SOF/VEL Liver Transplant

Sofosbuvir/velpatasvir for 12 weeks in liver transplant recipients with genotype 1-4

Agarwal K. AASLD 2017, Abs. 1069

Anti-HCV
Velpatasvir (GS-5816)
Sofosbuvir
Genotype
1
3
Treatment history
IFN-Experienced
Cirrhosis
No

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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