Observational Study
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Virol. Nov 12, 2017; 6(4): 59-72
Published online Nov 12, 2017. doi: 10.5501/wjv.v6.i4.59
Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results
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
Kian Bichoupan, James F Crismale, Joshua Hartman, David Del Bello, Neal Patel, Sweta Chekuri, Alyson Harty, Michel Ng, 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, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States
Neeta Tandon, Janssen Scientific Affairs, LLC, Titusville, NJ 08560, United States
Keith M Sigel, Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States
Author contributions: Bichoupan K, Dieterich DT and Branch AD contributed to study conception and design; Hartman J, Del Bello D, Patel N and Chekuri S gathered and analyzed patient data; Harty A, Ng M, Sigel KM, Bansal MB, Grewal P, Chang CY, Leong J, Im GY, Liu LU, Odin JA, Bach N, Schiano TD and Perumalswami PV contributed patient data for analysis and assisted in editing the manuscript; Friedman SL assisted in editing the manuscript; Bichoupan K performed the statistical analysis; Bichoupan K, Tandon N, Crismale JF and Branch AD contributed to the final writing of the manuscript; all authors had final approval of the article to be published.
Supported by Janssen Scientific Affairs and National Institutes of Health, Nos. DA031095 and DK090317.
Institutional review board statement: The study was conducted in accordance with the Helsinki agreement, with approval of the Mount Sinai Institutional Review Board (GCO 10-0032).
Informed consent statement: Study participants did not provide informed consent prior to study enrollment as the Icahn School of Medicine at Mount Sinai Institutional Review Board provided a waiver of authorization to release de-identified patient data for research purposes.
Conflict-of-interest statement: Dr. Kian Bichoupan is a paid consultant for Gilead Sciences and Janssen Pharmaceuticals, Inc. Neeta Tandon is an employee of Johnson and Johnson. Dr. Andrea D Branch received research support from Gilead Sciences and Janssen Pharmaceuticals, Inc. Dr. Douglas T Dieterich serves as a paid lecturer, consultant and is a member on scientific advisory boards of companies which either develop or assess medicines used for the treatment of viral hepatitis. These companies include Gilead Sciences, Abbvie, Achillion, Bristol-Myers Squibb, Merck, and Janssen Pharmaceuticals, Inc. Dr. Thomas D Schiano is a paid consultant for Salix, Merck, Gilead, BMS, Novartis and Janssen and received research support from Mass biologics, Gilead, Merck, Biotest and Genentech. Michel Ng is a paid member of AbbVie’s Speakers bureau. Dr. Ponni V Perumalswami receives research support from Gilead Sciences. Dr. Keith M Sigel has served on an advisory board for Gilead Sciences. Dr. James Crismale, Dr Meena B Bansal, Dr. Joshua Hartman, Dr. Sweta Chekuri, Alyson Harty, Dr. Joseph A Odin, Dr. Priya Grewal, Dr. Nancy Bach, Dr. Lawrence Liu, Dr. Charissa Y Chang, Dr. Gene Y Im, Dr. Jennifer Leong, Dr. David Del Bello, Dr. Neal M Patel and Dr. Scott L Friedman do not have any relevant disclosures.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at andrea.branch@mssm.edu. Consent was not obtained but the presented data are anonymized and risk of identification is low.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Andrea D Branch, PhD, Professor of Medicine, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, NY 10029, United States. andrea.branch@mssm.edu
Telephone: +1-212-6598371 Fax: +1-212-3483517
Received: June 11, 2017
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
Processing time: 144 Days and 13.9 Hours
Abstract
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

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.

Keywords: Cirrhosis; Cost; Sustained virological response; Protease inhibitor; Polymerase inhibitor

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.