title: Patient Characteristics, Safety, and Tolerability with Telaprevir Treatment for HCV in the Clinic: a Retrospective, Multicenter Study.
abstract: OBJECTIVE
  There is a paucity of information regarding similarities and differences between patients from the phase 3 studies of telaprevir and those receiving telaprevir in clinical practice.
  
  
  METHODS
  This retrospective chart review evaluated baseline characteristics and follow-up safety and tolerability data for patients with hepatitis C virus (HCV) infection treated with telaprevir and peginterferon alfa and ribavirin (PR) in clinical practice.
  
  
  RESULTS
  In total, 338 charts from patients at four academic and three community US treatment centers who received telaprevir and PR and had at least 12 weeks of follow-up data were included; 62% were from academic centers and 38% were from community centers. Of the 338 patients, 269 completed 12 weeks of telaprevir and PR; 32 discontinued due to adverse events. Mean age was 55 years; patients were predominantly white (79.3%) males (58.9%) with genotype 1a HCV infection (61.8%); 35.5% were reported to have cirrhosis at baseline; and 55.3% previously received PR. Hypertension and depression were the most common comorbidities. Patient characteristics outside the per-protocol minimum criteria used in the phase 3 studies of telaprevir were, e.g., hemoglobin, 9.2%; albumin, 5.3%; platelets, 11.5%; and neutrophil count, 5.6%. Adverse events occurred in 329/338 (97.3%) patients, with anemia, fatigue, nausea, and rash being the most common. Of 38 hospitalizations, 26 were deemed related to telaprevir and PR. Three patients died due to pneumonia, septic shock, and hepatorenal syndrome (n=1 each).
  
  
  CONCLUSIONS
  These findings complement those reported from rigorous, randomized controlled studies with telaprevir-based treatment and provide a general assessment of similarities and/or differences between patients from the phase 3 studies of telaprevir and those treated with telaprevir in clinical practice.
authors.affiliation: Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.
authors.forename: Steven L
authors.initials: SL
authors.lastname: Flamm
authors.affiliation: Scripps Clinic and Scripps Translational Science Institute, La Jolla, California, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Pockros
authors.affiliation: Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, USA.
authors.forename: Leif
authors.initials: L
authors.lastname: Bengtsson
authors.affiliation: Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Friedman
keywords: Combination drug therapy; Hepatitis C virus; Liver diseases; Protease inhibitors