Simeprevir plus sofosbuvir yields real-life HCV-1 clearance rate of 86%

Takeaway

• Real-life studies show that the hepatitis C virus-1 (HCV-1) clearance rate for simeprevir (SIM) plus sofosbuvir (SOF) with or without ribavirin (RBV) is about 86%.
• The clearance rate was 84% in 13 observational studies, compared with 94% in 2 randomized controlled trials (RCTs).
• The lower rate may reflect increased patient diversity in routine clinical settings.

Study Design

• This was a meta-analysis of 15 studies involving 1389 HCV-1-infected patients receiving SIM + SOF ± RBV for 12 wk.
• 2 RCTs and 13 observational studies were included (7 prospective, 2 retrospective).
• The primary endpoint was pooled rate of sustained virologic response at 12 wk after therapy (SVR12).

Key results

• SIM + SOF ± RBV achieved an overall SVR12 rate of 85.6% (95% CI, 81.3%-89.0%).
• Subanalysis by study design showed an SVR12 rate of 83.9% (95% CI, 79.4%-87.5%) for the 13 observational studies, compared with 93.5% (95% CI, 85.7%-97.2%) for the 2 RCTs.
• There was a trend toward higher SVR12 in mild vs advanced fibrosis (93.0% [95% CI, 86.2%-96.6%] vs 81.5% [95