论文部分内容阅读
AIM To assess the real-world effectiveness and cost of simeprevir(SMV), and/or sofosbuvir(SOF)-based therapy for chronic hepatitis C virus(HCV) infection.METHODS 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.RESULTS SVR 12 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-SVR 12 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 SVR 12(OR: 0.18, 95%CI: 0.05-0.59) among those on SOF/PEG/RBV. CONCLUSION SVR 12 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.
AIM To assess the real-world effectiveness and cost of simeprevir (SMV), and / or sofosbuvir (SOF) -based therapy for chronic hepatitis C virus (HCV) infection. METHODS 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 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 Patient-related factors associated with SVR12 were identified using multivariable logistic regression .RESULTS SVR 12 rates were as follows: 86% (95% CI: 80% -91%) among 178 patients on SMV / SOF ± RBV; 62% (95% C Of 95% -68%) among 234 patients on SOF / RBV; and 78% (95% CI: 68% -86%) among 96 patients on SOF / PEG / RBV. Mean costs-per-SVR 12 were $ 174442 of patients with SMV / SOF ± RBV; and $ 126496 (± $ 31052) for SOF / PEG / RBV. Among patients with 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 SVR 12 (OR: 0.18, 95% CI: 0.05-0.59) among those on SOF / PEG / RBV. CONCLUSION SVR 12 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.