HCV-3: 24-week course of DCV+SOF with RBV does well in ALLY-3C

  • Poordad F & al.
  • Antivir Ther (Lond)
  • 1 Nov 2018

  • curated by Yael Waknine
  • Clinical Essentials
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Takeaway

  • A 24-week course of daclatasvir (DCV) + sofosbuvir (SOF) with ribavirin (RBV) achieved an HCV-3 clearance rate of 88% in the ALLY-3C study of patients with compensated cirrhosis.

Why this matters

  • Results were comparable vs 12-16 weeks of DCV+SOF+RBV, or 24 weeks of DCV+SOF.
  • Patients with baseline NS5A-Y93H resistance-associated substitutions (RAS) may benefit from both RBV and extended treatment.

Study design

  • US/Canadian phase 3 study of DCV+SOF+RBV given for 24 weeks in 78 patients with HCV-3 and compensated cirrhosis; all but 1 had genotype (GT) 3a.
  • 24 patients (30.8%) were treatment-experienced, including 8 with SOF exposure.
  • Primary endpoint: sustained virologic response at 12 weeks posttreatment (SVR12).
  • Funding: Bristol-Myers Squibb.

Key results

  • SVR12 rate was 87% (68/78; 95% CI, 77.7%-93.7%) with centralized testing, rising to 88% (95% CI, 79.2%-94.6%) with 1 local testing result; the lower bound exceeded the 79.0% threshold from ALLY-3.
  • SVR12 in treatment-naive and -experienced patients was 93% and 79%, respectively.
  • Per-protocol SVR12, 94% (95% CI, 86.2%-98.4%).
  • All treatment-naive patients with NS5A-A30K (n=6) and NS5A-Y93H (n=6) RAS achieved SVR12.
  • 9 non-SVR12:
    • 2 relapses in SOF-experienced patients.
    • 2 virologic failures (including 1 with GT3b and NS5A RAS).
    • 1 early discontinuation for worsening depression.
    • 4 losses to follow-up.

Limitations

  • Single-arm study, reliance on FibroScan.

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