Published online Nov 12, 2017. doi: 10.5501/wjv.v6.i4.59
Peer-review started: June 12, 2017
First decision: July 20, 2017
Revised: August 3, 2017
Accepted: September 16, 2017
Article in press: September 17, 2017
Published online: November 12, 2017
To assess the real-world effectiveness and cost of simeprevir (SMV), and/or sofosbuvir (SOF)-based therapy for chronic hepatitis C virus (HCV) infection.
The real-world performance of patients treated with SMV/SOF ± ribavirin (RBV), SOF/RBV, and SOF/RBV with pegylated-interferon (PEG) were analyzed in a consecutive series of 508 patients with chronic HCV infection treated at a single academic medical center. Patients with genotypes 1 through 4 were included. Rates of sustained virological response - the absence of a detectable serum HCV RNA 12 wk after the end of treatment [sustained virological response (SVR) 12] - were calculated on an intention-to-treat basis. Costs were calculated from the payer’s perspective using Medicare/Medicaid fees and Redbook Wholesale Acquisition Costs. Patient-related factors associated with SVR12 were identified using multivariable logistic regression.
SVR12 rates were as follows: 86% (95%CI: 80%-91%) among 178 patients on SMV/SOF ± RBV; 62% (95%CI: 55%-68%) among 234 patients on SOF/RBV; and 78% (95%CI: 68%-86%) among 96 patients on SOF/PEG/RBV. Mean costs-per-SVR12 were $174442 (standard deviation: ± $18588) for SMV/SOF ± RBV; $223003 (± $77946) for SOF/RBV; and $126496 (± $31052) for SOF/PEG/RBV. Among patients on SMV/SOF ± RBV, SVR12 was less likely in patients previously treated with a protease inhibitor [odds ratio (OR): 0.20, 95%CI: 0.06-0.56]. Higher bilirubin (OR: 0.47, 95%CI: 0.30-0.69) reduced the likelihood of SVR12 among patients on SOF/RBV, while FIB-4 score ≥ 3.25 reduced the likelihood of SVR12 (OR: 0.18, 95%CI: 0.05-0.59) among those on SOF/PEG/RBV.
SVR12 rates for SMV and/or SOF-based regimens in a diverse real-world population are comparable to those in clinical trials. Treatment failure accounts for 27% of costs.
Core tip: To our knowledge, this study is the largest real-world investigation of outcomes in patients with chronic hepatitis C virus infection with genotypes 1-4 being treated with simeprevir and/or sofosbuvir-containing regimens that has been conducted in a single center. We provide compelling real-world data in a large (n = 508), diverse population of patients, showing that the effectiveness of these regimens is comparable to that seen in multicenter clinical trials. Further, our unique cost analysis reveals that the cost-per-sustained virological response of simeprevir- and/or sofosbuvir-based therapy is lower than telaprevir-based triple therapy, likely due to higher rates of cure and lower rates of adverse events.