HCV: SOF/VEL and LDV/SOF yield excellent outcomes in real-world study

  • Buggisch P & al.
  • PLoS One
  • 1 Jan 2019

  • International Clinical Digest
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Takeaway

  • Sofosbuvir/velpatasvir (SOF/VEL, Epclusa) and ledipasvir/sofosbuvir (LDV/SOF; Harvoni) achieved high HCV clearance rates in a pangenotypic real-world population.

Why this matters

  • Rates of sustained virologic response at 12 weeks posttherapy (SVR12) were high regardless of treatment history or cirrhosis status.

Study design

  • German study of 364 patients (median age, 50-56 years) with HCV genotypes (GT) 1-6.
  • Regimens included:
    • 12 weeks of SOF/VEL (n=80; 63.8% GT3, 21.2% cirrhotic, 87.5% treatment-naive).
    • 12 weeks of SOF/VEL + ribavirin (n=35; 97.1% GT3, 94.3% cirrhotic, 74.3% treatment-naive).
    • 8 weeks of LDV/SOF (n=129; 98.5% GT1, 0% cirrhotic, 97.7% treatment-naive).
    • 12 or 24 weeks of LDV/SOF±ribavirin (n=120; 72.5% GT1, 46.7% cirrhotic, 63.3% treatment-experienced).
  • Funding: Gilead Sciences, Inc.

Key results

  • 99.1% SVR12 with 12 weeks of SOF/VEL±ribavirin for GT1-6.
  • 99.2% SVR12 with 8 weeks of LDV/SOF, 93.0% with 12 or 24 weeks of LDV/SOF±ribavirin.
  • Treatment-naive, noncirrhotic GT1: ≥99% SVR12 across SOF/VEL or LDV/SOF regimens.
  • GT3 with cirrhosis: 100% SVR12 with SOF/VEL±ribavirin.
  • 9 of 10 patients who had previously failed direct-acting antivirals (DAAs) achieved SVR12.
  • All 20 HIV-coinfected patients achieved SVR12.
  • Grade 3/4 adverse events were uncommon (SOF/VEL,

Limitations

  • Retrospective, monocentric, observational design.
  • Small subgroup sample sizes.

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