Factors associated with success of telaprevir-and boceprevir-based triple therapy for hepatitis C virus infection

作     者：Kian Bichoupan Neeta Tandon Valerie Martel-Laferriere Neal M Patel David Sachs Michel Ng Emily A Schonfeld Alexis Pappas James Crismale Alicia Stivala Viktoriya Khaitova Donald Gardenier Michael Linderman William Olson Ponni V Perumalswami Thomas D Schiano Joseph A Odin Lawrence U Liu Douglas T Dieterich Andrea D Branch 

作者机构：Division of Liver Diseases Icahn School of Medicine at Mount Sinai Icahn Medical Instititute Janssen Pharmaceuticals Com-panies Division of Janssen Scientific Affairs Inc. Genetics and Genomics Icahn School of Medicine at Mount Sinai 

出 版 物：《World Journal of Hepatology》 (世界肝病学杂志（英文版）（电子版）)

年 卷 期：2017年第9卷第11期

页      面：551-561页

学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 100401[医学-流行病与卫生统计学] 10[医学] 

基　　金：Supported by Janssen Scientific Affairs,LLC(partially)to Andrea D Branch to conduct the study National Institute of Health(NIH),Nos.DK090317 and DA031095(partially)to Andrea D Branch to conduct the study 

主　　题：Sustained virologic response Hepatitis C virus Relapse Telaprevir Boceprevir Triple-therapy Classification and regression Adverse event Real-world 

摘      要：To evaluate new therapies for hepatitis C virus (HCV), data about real-world outcomes are needed. METHODSOutcomes of 223 patients with genotype 1 HCV who started telaprevir- or boceprevir-based triple therapy (May 2011-March 2012) at the Mount Sinai Medical Center were analyzed. Human immunodeficiency virus-positive patients and patients who received a liver transplant were excluded. Factors associated with sustained virological response (SVR24) and relapse were analyzed by univariable and multivariable logistic regression as well as classification and regression trees. Fast virological response (FVR) was defined as undetectable HCV RNA at week-4 (telaprevir) or week-8 (boceprevir). RESULTSThe median age was 57 years, 18% were black, 44% had advanced fibrosis/cirrhosis (FIB-4 ≥ 3.25). Only 42% (94/223) of patients achieved SVR24 on an intention-to-treat basis. In a model that included platelets, SVR24 was associated with white race [odds ratio (OR) = 5.92, 95% confidence interval (CI): 2.34-14.96], HCV sub-genotype 1b (OR = 2.81, 95%CI: 1.45-5.44), platelet count (OR = 1.10, per x 104 cells/μL, 95%CI: 1.05-1.16), and IL28B CC genotype (OR = 3.54, 95%CI: 1.19-10.53). Platelet counts 135 x 103/μL were the strongest predictor of SVR by classification and regression tree. Relapse occurred in 25% (27/104) of patients with an end-of-treatment response and was associated with non-FVR (OR = 4.77, 95%CI: 1.68-13.56), HCV sub-genotype 1a (OR = 5.20; 95%CI: 1.40-18.97), and FIB-4 ≥ 3.25 (OR = 2.77; 95%CI: 1.07-7.22). CONCLUSIONThe SVR rate was 42% with telaprevir- or boceprevir-based triple therapy in real-world practice. Low platelets and advanced fibrosis were associated with treatment failure and relapse.