- A 24-wk regimen of daclatasvir (DCV; Daklinza) + sofosbuvir (SOF; Sovaldi) with ribavirin (RBV) achieves a high HCV-1 clearance rate in treatment-experienced patients with decompensated cirrhosis.
Why this matters
- This population is typically excluded from clinical trials.
- 249 patients (median age, 56 y) received DCV as part of an early-access Named Patient Program in Austria, Denmark, Spain, Sweden, Switzerland, and the UK.
- All had a life expectancy <12 mo, and no other treatment options.
- Almost all (n=246) received DCV+SOF, for 24 wks (98.7%); 26.5% received RBV.
- Primary endpoint was sustained virologic response at 12 wks post-therapy (SVR12).
- Funding: Bristol-Myers Squibb.
- 78% of patients were male, 75% had HCV-1, 65% were treatment-experienced, 49% had decompensated cirrhosis, and 40% were liver transplant recipients.
- Intent-to-treat (ITT) analysis included 242 patients, of whom 13 died, 1 was lost to follow-up, and 3 had missing data.
- ITT and as-treated (AT) analysis revealed SVR12 rates of 90% and 97%, respectively.
- In treatment-experienced patients with HCV-1 and decompensated cirrhosis, estimated ITT and AT SVR12 rates were 87% and 97%, respectively.
- ITT SVR12 was higher with vs without RBV (92% vs 85%) in this subpopulation.
- Retrospective design, missing data.