Literature DB >> 27917084

Sofosbuvir and Simeprevir Combination Therapy for HCV Genotype 1 Infection: Results of a Single-Center VA Experience.

Seth N Sclair1, Maria Del Pilar Hernandez1, Evan Vance1, Dani Gilinski1, Helen Youtseff1, Maribel Toro1, Marie Antoine1, Lennox J Jeffers1, Adam Peyton1.   

Abstract

Treatment of chronic hepatitis C virus (HCV) infection remains a priority in the veterans affairs (VA) health care system nationwide, as there is a high burden of liver disease due to HCV infection among US veterans. The combination of sofosbuvir and simeprevir was the first all-oral antiviral regimen used in clinical practice to treat veterans with HCV infection. In this study, we report a single-center experience showing both the feasibility and effectiveness of this all-oral combination to treat HCV genotype 1 infection. One hundred patients with HCV genotype 1 infection were treated between December 2013 and June 2014. Eighty-six patients were treated with sofosbuvir and simeprevir, with or without ribavirin, for 12 weeks; 12 patients were treated with sofosbuvir, pegylated interferon, and ribavirin for 12 weeks; and 2 patients were treated with sofosbuvir and ribavirin for 24 weeks. Overall, treatment was well tolerated and feasible, with compliance rates over 95% in patients treated with all-oral therapy. The sustained virologic response (SVR) rate for sofosbuvir and simeprevir (88.4%) was superior to the rate for sofosbuvir, pegylated interferon, and ribavirin (50.0%). Subgroup analysis showed diminished SVR rates in cirrhotic patients vs noncirrhotic patients. There were no significant differences in SVR when comparing treatment with or without ribavirin or among genotype subtypes. In conclusion, this study demonstrated excellent completion rates for all-oral treatment of veterans with chronic HCV infection. Additionally, treatment was highly effective, nearing a 90% cure rate. Thus, we recommend that the VA health care system continue to incorporate new HCV medications into its formulary so as to expand HCV treatment for US veterans.

Entities:  

Keywords:  Hepatitis C virus; direct-acting antiviral agents; ribavirin; simeprevir; sofosbuvir

Year:  2016        PMID: 27917084      PMCID: PMC5114495     

Source DB:  PubMed          Journal:  Gastroenterol Hepatol (N Y)        ISSN: 1554-7914


  14 in total

1.  Comparative effectiveness of the hepatitis C virus protease inhibitors boceprevir and telaprevir in a large U.S. cohort.

Authors:  L I Backus; P S Belperio; T A Shahoumian; R Cheung; L A Mole
Journal:  Aliment Pharmacol Ther       Date:  2013-11-10       Impact factor: 8.171

2.  A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C.

Authors:  Lisa I Backus; Derek B Boothroyd; Barbara R Phillips; Pamela Belperio; James Halloran; Larry A Mole
Journal:  Clin Gastroenterol Hepatol       Date:  2011-03-11       Impact factor: 11.382

3.  Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial.

Authors:  Michael Manns; Patrick Marcellin; Fred Poordad; Evaldo Stanislau Affonso de Araujo; Maria Buti; Yves Horsmans; Ewa Janczewska; Federico Villamil; Jane Scott; Monika Peeters; Oliver Lenz; Sivi Ouwerkerk-Mahadevan; Guy De La Rosa; Ronald Kalmeijer; Rekha Sinha; Maria Beumont-Mauviel
Journal:  Lancet       Date:  2014-06-04       Impact factor: 79.321

4.  Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial.

Authors:  Ira M Jacobson; Gregory J Dore; Graham R Foster; Michael W Fried; Monica Radu; Vladimir V Rafalsky; Larysa Moroz; Antonio Craxi; Monika Peeters; Oliver Lenz; Sivi Ouwerkerk-Mahadevan; Guy De La Rosa; Ronald Kalmeijer; Jane Scott; Rekha Sinha; Maria Beumont-Mauviel
Journal:  Lancet       Date:  2014-06-04       Impact factor: 79.321

5.  Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 U.S. Veterans.

Authors:  L I Backus; P S Belperio; T A Shahoumian; T P Loomis; L A Mole
Journal:  Aliment Pharmacol Ther       Date:  2015-06-26       Impact factor: 8.171

6.  Similar effectiveness of boceprevir and telaprevir treatment regimens for hepatitis C virus infection on the basis of a nationwide study of veterans.

Authors:  George N Ioannou; Lauren A Beste; Pamela K Green
Journal:  Clin Gastroenterol Hepatol       Date:  2013-12-17       Impact factor: 11.382

7.  Sofosbuvir for previously untreated chronic hepatitis C infection.

Authors:  Eric Lawitz; Alessandra Mangia; David Wyles; Maribel Rodriguez-Torres; Tarek Hassanein; Stuart C Gordon; Michael Schultz; Mitchell N Davis; Zeid Kayali; K Rajender Reddy; Ira M Jacobson; Kris V Kowdley; Lisa Nyberg; G Mani Subramanian; Robert H Hyland; Sarah Arterburn; Deyuan Jiang; John McNally; Diana Brainard; William T Symonds; John G McHutchison; Aasim M Sheikh; Zobair Younossi; Edward J Gane
Journal:  N Engl J Med       Date:  2013-04-23       Impact factor: 91.245

8.  Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.

Authors:  Anuoluwapo Osinusi; Eric G Meissner; Yu-Jin Lee; Dimitra Bon; Laura Heytens; Amy Nelson; Michael Sneller; Anita Kohli; Lisa Barrett; Michael Proschan; Eva Herrmann; Bhavana Shivakumar; Wenjuan Gu; Richard Kwan; Geb Teferi; Rohit Talwani; Rachel Silk; Colleen Kotb; Susan Wroblewski; Dawn Fishbein; Robin Dewar; Helene Highbarger; Xiao Zhang; David Kleiner; Brad J Wood; Jose Chavez; William T Symonds; Mani Subramanian; John McHutchison; Michael A Polis; Anthony S Fauci; Henry Masur; Shyamasundaran Kottilil
Journal:  JAMA       Date:  2013-08-28       Impact factor: 56.272

9.  Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis.

Authors:  Adriaan J van der Meer; Bart J Veldt; Jordan J Feld; Heiner Wedemeyer; Jean-François Dufour; Frank Lammert; Andres Duarte-Rojo; E Jenny Heathcote; Michael P Manns; Lorenz Kuske; Stefan Zeuzem; W Peter Hofmann; Robert J de Knegt; Bettina E Hansen; Harry L A Janssen
Journal:  JAMA       Date:  2012-12-26       Impact factor: 56.272

10.  Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study.

Authors:  Eric Lawitz; Mark S Sulkowski; Reem Ghalib; Maribel Rodriguez-Torres; Zobair M Younossi; Ana Corregidor; Edwin DeJesus; Brian Pearlman; Mordechai Rabinovitz; Norman Gitlin; Joseph K Lim; Paul J Pockros; John D Scott; Bart Fevery; Tom Lambrecht; Sivi Ouwerkerk-Mahadevan; Katleen Callewaert; William T Symonds; Gaston Picchio; Karen L Lindsay; Maria Beumont; Ira M Jacobson
Journal:  Lancet       Date:  2014-07-28       Impact factor: 79.321

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