Title |
Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results
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Published in |
World Journal of Virology, November 2017
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DOI | 10.5501/wjv.v6.i4.59 |
Pubmed ID | |
Authors |
Kian Bichoupan, Neeta Tandon, James F Crismale, Joshua Hartman, David Del Bello, Neal Patel, Sweta Chekuri, Alyson Harty, Michel Ng, Keith M Sigel, Meena B Bansal, Priya Grewal, Charissa Y Chang, Jennifer Leong, Gene Y Im, Lawrence U Liu, Joseph A Odin, Nancy Bach, Scott L Friedman, Thomas D Schiano, Ponni V Perumalswami, Douglas T Dieterich, Andrea D Branch |
Abstract |
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. |
X Demographics
Geographical breakdown
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United States | 3 | 100% |
Demographic breakdown
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Members of the public | 2 | 67% |
Scientists | 1 | 33% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 8 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 3 | 38% |
Student > Ph. D. Student | 1 | 13% |
Other | 1 | 13% |
Researcher | 1 | 13% |
Unknown | 2 | 25% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 2 | 25% |
Immunology and Microbiology | 2 | 25% |
Pharmacology, Toxicology and Pharmaceutical Science | 1 | 13% |
Biochemistry, Genetics and Molecular Biology | 1 | 13% |
Unknown | 2 | 25% |