title: Simeprevir and Sofosbuvir (SMV-SOF) for 12 Weeks for the Treatment of Chronic Hepatitis C Genotype 1 Infection: A Real World (Transplant) Hepatology Practice Experience.
abstract: OBJECTIVE
  The combination of simeprevir (SMV) and sofosbuvir (SOF) was found to be well-tolerated with high sustained virologic response (SVR) rates in patients with genotype 1 chronic hepatitis C in clinical trials. Previous experience with hepatitis C virus (HCV) therapy has shown that patient tolerability and treatment efficacy described in controlled clinical trials did not necessarily mirror the "real world" experience. The goal of this study was to define SVR rates in a "real world" analysis and to explore predictors of treatment response with SMV and SOF.
  
  
  METHODS
  This is a retrospective study examining the "real world" treatment of 170 patients with chronic HCV genotype 1 using the combination of SMV and SOF with or without ribavirin (RBV) for a fixed 12-week duration irrespective of prior interferon therapy, transplant status or fibrosis stage. Differences between SVR cohorts were analyzed by both intention-to-treat (ITT) and per protocol.
  
  
  RESULTS
  The vast majority of patients were genotype 1a, 77% were cirrhotic in the non-LT group, and 35% of the entire cohort was African-American. Combination treatment with SMV and SOF in genotype 1 chronic HCV patients achieved an overall SVR rate at 12 weeks after completion of therapy (SVR12) of 78% by ITT and 86% by per protocol (84% in non-liver transplant (LT) patients and 89% in post-LT recipients). The presence of hepatocellular carcinoma was found to be a significant negative predictor of SVR12, whereas an undetectable week eight VL was a significant positive predictor of SVR in the entire cohort.
  
  
  CONCLUSIONS
  Our data confirm excellent SVR outcomes with favorable safety and tolerability profiles in patients who carry many traditional high-risk features for non-response, including post-LT recipients and patients with advanced liver disease.
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: Anjana A
authors.initials: AA
authors.lastname: Pillai
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Wedd
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Norvell
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: Samir
authors.initials: S
authors.lastname: Parekh
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Cheng
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: Nikita
authors.initials: N
authors.lastname: Young
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: James R
authors.initials: JR
authors.lastname: Spivey
authors.affiliation: Emory University Hospital, Section of Hepatology, Division of Digestive Diseases and The Emory Transplant Center, Atlanta, Georgia, USA.
authors.forename: Ryan
authors.initials: R
authors.lastname: Ford
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000150:complications / Q000601:surgery; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D005762:Gastroenterology; D005838:Genotype; D006086:Graft vs Host Disease / Q000517:prevention & control; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000150:complications / Q000601:surgery; D008113:Liver Neoplasms / Q000150:complications / Q000601:surgery; D016031:Liver Transplantation; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use*; D000069616:Simeprevir / Q000627:therapeutic use*; D000069474:Sofosbuvir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D012367:RNA, Viral; D012254:Ribavirin; D000069616:Simeprevir; D000069474:Sofosbuvir
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