title: Sofosbuvir and Simeprevir Combination Therapy for HCV Genotype 1 Infection: Results of a Single-Center VA Experience.
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.
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Seth N
authors.initials: SN
authors.lastname: Sclair
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Maria Del Pilar
authors.initials: MD
authors.lastname: Hernandez
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Evan
authors.initials: E
authors.lastname: Vance
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Dani
authors.initials: D
authors.lastname: Gilinski
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Helen
authors.initials: H
authors.lastname: Youtseff
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Maribel
authors.initials: M
authors.lastname: Toro
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Marie
authors.initials: M
authors.lastname: Antoine
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Lennox J
authors.initials: LJ
authors.lastname: Jeffers
authors.affiliation: Dr Sclair is a transplant hepatology fellow at the University of Miami Miller School of Medicine in Miami, Florida. Drs Hernandez and Peyton are assistant professors of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and staff physicians in the Hepatology Section of the Miami VA Healthcare System in Miami, Florida. Ms Vance is a research associate in the Miami VA Healthcare System. Dr Gilinski is an internal medicine resident at the University of Miami Miller School of Medicine. Drs Youtseff and Toro are clinical pharmacists in the Pharmacy Service of the Miami VA Healthcare System. Ms Antoine is a nurse practitioner in the Medicine Service of the Miami VA Healthcare System. Dr Jeffers is a professor of medicine in the Division of Hepatology at the University of Miami Miller School of Medicine and chief of the Hepatology Section of the Miami VA Healthcare System.
authors.forename: Adam
authors.initials: A
authors.lastname: Peyton
keywords: Hepatitis C virus; direct-acting antiviral agents; ribavirin; simeprevir; sofosbuvir