title: Real-life experience with first generation HCV protease inhibitor therapy in Germany: The prospective, non-interventional PAN cohort.
abstract: OBJECTIVE
  The efficacy and safety of peginterferon alfa-2a (PEG-IFN) plus ribavirin (RBV) and either boceprevir (BOC) or telaprevir (TVR), and physician adherence to treatment algorithms were evaluated in patients included in an ongoing non-interventional study (PAN) enrolling adults with chronic hepatitis C virus (HCV) infection managed in German office-based practices.
  
  
  METHODS
  The analysis included HCV genotype 1-infected, treatment-naïve and treatment-experienced patients treated with BOC or TVR. Demographic, treatment history, virological response, safety, and patient management data were collected.
  
  
  RESULTS
  Of a total 1087 patients, 58.1 % achieved sustained virological responses (SVR). Response rates were higher in treatment-naïve (BOC 55 %; TVR 63.4 %) and prior relapse patients (BOC 63.2 %; TVR 74.5 %) versus previous null-responders (BOC 14.3 %; TVR 25 %). The most commonly reported adverse event overall was fatigue (60.6 %); 45.8 % patients experienced hemoglobin < 10 g/dL. Patients with cirrhosis had lower rates of SVR versus those without (42.9 % vs. 60.7 %, respectively), and had a higher incidence of serious adverse events (SAEs) (16.7 % vs. 8.6 %, respectively) and treatment discontinuation (44.6 % vs. 25.2 %, respectively). According to recommended response-guided treatment algorithms, about 70 % of patients were managed appropriately, 11/10 % (BOC/TVR) received unnecessarily extended therapy, and 19/7 % (BOC/TVR) received inappropriately shortened therapy.
  
  
  CONCLUSIONS
  The efficacy and safety of BOC- and TVR-based triple therapy in this large, "real-world" cohort were largely comparable to that reported in pivotal clinical trials, although SVR rates were lower overall. Recommended futility or treatment extension rules were violated in a substantial proportion of patients with potential implications for response, adverse events and costs.
authors.affiliation: Center for HIV and Hepatogastroenterology, Duesseldorf, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Mauss
authors.affiliation: Center for Hepatology, Hannover, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Böker
authors.affiliation: ifi -Institute for Interdisciplinary Medicine, Hamburg, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Buggisch
authors.affiliation: Center for Interdisciplinary Medicine, Muenster, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Christensen
authors.affiliation: Polikum Institute, Berlin, Germany.
authors.forename: W P
authors.initials: WP
authors.lastname: Hofmann
authors.affiliation: Department of Hepatology and Gastroenterology, Charité, CVK, Berlin, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Schott
authors.affiliation: Institute for Clinical Research and Statistics, Offenbach, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Pfeiffer-Vornkahl
authors.affiliation: Roche Pharma AG, Grenzach-Wyhlen, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Alshuth
authors.affiliation: Center of Gastroenterology, Herne, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Hüppe
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage; D015331:Cohort Studies; D004359:Drug Therapy, Combination / Q000379:methods; D019317:Evidence-Based Medicine; D005260:Female; D005858:Germany; D016174:Hepacivirus / Q000187:drug effects / Q000201:enzymology*; D006526:Hepatitis C / Q000175:diagnosis* / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D009842:Oligopeptides / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives; D011446:Prospective Studies; D011480:Protease Inhibitors / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D011480:Protease Inhibitors; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; C100416:peginterferon alfa-2a