Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results

• 作者: Alyson Harty Andrea D Branch Charissa Y Chang David Del Bello Douglas T Dieterich Gene Y Im James F Crismale Jennifer Leong Joseph A Odin Joshua Hartman Keith M Sigel Kian Bichoupan Lawrence U Liu Meena B Bansal Michel Ng Nancy Bach Neal Patel Neeta Tandon Ponni V Perumalswami Priya Grewal Scott L Friedman Sweta Chekuri Thomas D Schiano
• 来源期刊: 世界病毒学杂志
• 学科: 医学
• 关键词: Cirrhosis Cost SUSTAINED virological response PROTEASE INHIBITOR POLYMERASE INHIBITOR
• 年，卷（期）: sjbdxzz_2017,（4）
• 页码范围: 59-72
• 页数: 14页
• 分类号: R

摘要

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.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.CONCLUSION 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.