HCV: SOF/VEL yields 99% clearance rate regardless of fibrosis stage

  • Mangia A & al.
  • PLoS One
  • 1 Jan 2019

  • International Clinical Digest
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Takeaway

  • In a real-world study, sofosbuvir/velpatasvir (SOF/VEL; Epclusa) generated HCV clearance rates similar to those observed in registration trials, reaching >99% regardless of fibrosis stage.

Why this matters

  • Few real-world data exist for this pangenotypic regimen.
  • People who inject drugs (PWID) may need closer monitoring.

Study design

  • Real-world study of 1319 patients (median age, 63.8 years; 58.8% men) treated with 12 weeks of SOF/VEL; 3.1% also received ribavirin.
  • Primary endpoint: sustained virologic response at 12 weeks posttreatment (SVR12).
  • Funding: None.

Key results

  • 80.2% were treatment-naive; 55.5% had F0-F2 fibrosis (F3, 23.1%; F4 [cirrhosis], 21.4%).
  • Overall SVR12, 98.5% (95% CI, 97.6%-99.0%).
    • Of 20 non-SVR12 participants, 6 were relapses and 2 were reinfections.
  • In sensitivity analysis excluding 12 patients who stopped treatment or were lost to follow-up, SVR12 was 99.1% (95% CI, 98.7%-99.7%).
    • SVR12 was identical in F3 and F4 fibrosis (99.3% [95% CI, 97.3%-99.8%] vs 99.3% [95% CI, 97.1%-99.8%]); SVR12 in F0-F2 fibrosis was 99.4% (95% CI, 98.4%-99.8%).
  • SVR12 by genotype (GT):  
    • GT1 (42.3%): 98.0%.
    • GT2 (38.8%): 99.4%.
    • GT3 (15.5%): 97.1%.
    • GT4 (3.3%): 100%.
  • Among PWID (n=218), SVR12 was 94.5%.
    • Discontinuation rates were higher for PWID vs non-PWID (3.7% vs 0.7%; P=.004).
  • SVR12 was similar with/without use of proton pump inhibitors (P=.48).

Limitations

  • Observational design.

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