HCV: ledipasvir/sofosbuvir real-world efficacy confirmed

Takeaway

• Real-world hepatitis C virus (HCV) clearance rates with ledipasvir/sofosbuvir (LDV/SOF) are similar to those achieved in clinical trials and were not associated with excess cost.

Study design

• Pooled analysis of data from a real-world, multicenter, prospective, observational study (HCV-TARGET; n=1270) and a retrospective database of HCV-treated patients (TRIO Network; n=895).
• ION-1 (n=1870) and ION-3 (n=647) clinical study data were used for comparison.
• Cost per sustained virologic response (SVR) included the regimen, adverse events, and monitoring cost for 1 y of treatment.

Key results

• After 12 wk, SVR rates obtained in real-world studies ranged from 94% to 98%, comparing favorably with SVR rates achieved in the ION-1 and ION-3 trials (94% and 95%-99% with 8 and 12 wk of ribavirin-free therapy, respectively).
• In ION-3, the mean cost of SVR was $84,989; cost was higher in patients with compensated vs no cirrhosis ($101,204 vs $81,668).
• In the pooled TARGET/TRIO popu...