title: Effectiveness and tolerability of simeprevir and sofosbuvir in nontransplant and post-liver transplant patients with hepatitis C genotype 1.
abstract: Hepatitis C virus genotype 1a (HCV-1a), prior treatment, cirrhosis and post-transplant status are historically associated with poor treatment responses. The new oral direct-acting agents appear to be effective and safe in these patients.
  
  
  
  To evaluate the effectiveness and tolerability of simeprevir and sofosbuvir in a diverse real-life cohort of patients, including difficult-to-treat patients.
  
  
  
  We conducted a retrospective cohort study in 198 consecutive patients with hepatitis C genotype 1 (148 nontransplant, 50 post transplant), who were treated with simeprevir and sofosbuvir for 12 weeks between December 2013 and December 2014. Primary outcome was sustained virological response with undetectable HCV RNA 12 weeks after completion of therapy (SVR12). Risk factors evaluated for lack of SVR12 included HCV 1a (vs. 1b), prior treatment (vs. none), and cirrhosis (vs. no cirrhosis).
  
  
  
  SVR12 rates were similar in non- and post-transplant settings, 82% and 88%, respectively. There were no significant differences in adverse events in patients regardless of cirrhosis or transplant status. On multivariate analysis also inclusive of gender and liver transplant status, negative predictors of SVR12 were having at least 2 or 3 risk factors (OR 0.30, 95% CI 0.10-0.87, P = 0.027 or 0.29, 95% CI 0.09-0.85, P = 0.025, respectively).
  
  
  
  Simeprevir and sofosbuvir combination is a safe and effective regimen for the treatment of non- and post-transplant patients with traditional risk factors for poor treatment response, unless more than 2 difficult-to-treat risk factors are present.
authors: Gastroenterology and Hepatology, Liver Transplant Program, Stanford University Medical Center, Palo Alto, CA, USA.
authors: G
authors: G
authors: Lutchman
authors: School of Medicine, University of California, San Diego, La Jolla, CA, USA.
authors: N H
authors: NH
authors: Nguyen
authors: Gastroenterology and Hepatology, Liver Transplant Program, Stanford University Medical Center, Palo Alto, CA, USA.
authors: C Y
authors: CY
authors: Chang
authors: Gastroenterology and Hepatology, Liver Transplant Program, Stanford University Medical Center, Palo Alto, CA, USA.
authors: A
authors: A
authors: Ahmed
authors: Gastroenterology and Hepatology, Liver Transplant Program, Stanford University Medical Center, Palo Alto, CA, USA.
authors: T
authors: T
authors: Daugherty
authors: Gastroenterology and Hepatology, Liver Transplant Program, Stanford University Medical Center, Palo Alto, CA, USA.
authors: G
authors: G
authors: Garcia
authors: Gastroenterology and Hepatology, Liver Transplant Program, Stanford University Medical Center, Palo Alto, CA, USA.
authors: R
authors: R
authors: Kumari
authors: Medical Affairs, Janssen Scientific Affairs, Titusville, NJ, USA.
authors: S
authors: S
authors: Gupta
authors: Health Economics & Outcomes Research, Janssen Scientific Affairs, Titusville, NJ, USA.
authors: D
authors: D
authors: Doshi
authors: Gastroenterology and Hepatology, Liver Transplant Program, Stanford University Medical Center, Palo Alto, CA, USA.
authors: M H
authors: MH
authors: Nguyen
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000069616:Simeprevir / Q000008:administration & dosage*; D000069474:Sofosbuvir / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000069616:Simeprevir; D000069474:Sofosbuvir