- 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.
- 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.
- 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.
- Single-arm study, reliance on FibroScan.