title: Retreatment with telaprevir combination therapy in hepatitis C patients with well-characterized prior treatment response.
abstract: Retreatment with peginterferon alpha and ribavirin (PR) offers a limited chance of sustained virologic response (SVR) in patients who did not achieve SVR with prior PR treatment. This study evaluated the safety and efficacy of telaprevir-based treatment in combination with PR in well-characterized patients who did not achieve SVR in the control arms of three Phase II clinical trials. Patients eligible to enroll in this open-label nonrandomized study either met on-treatment criteria for nonresponse or relapsed after 48 weeks of treatment in the control arm of the three Phase II PROVE studies. The initial protocol was a 24-week regimen: 12 weeks of telaprevir and PR followed by an additional 12 weeks of PR. During the study the protocol was amended to extend PR to 48 weeks for patients with previous null response. All other patients with undetectable hepatitis C virus (HCV) RNA at weeks 4 and 12 received 24 weeks of therapy. Those with detectable HCV RNA at weeks 4 or 12 received a total of 48 weeks of therapy. The overall SVR rate was 59% (69/117). SVR rates with T12PR were 37% (19/51) in prior null responders, 55% (16/29) in prior partial responders, 75% (6/8) in prior breakthroughs, and 97% (28/29) in prior relapsers. The overall relapse rate was 16% (13/83). Adverse events were similar to those in previous trials with telaprevir, with 9% of patients discontinuing due to an adverse event (most commonly rash and anemia).
  
  
  CONCLUSIONS
  This study demonstrated the benefit of retreatment with a telaprevir-based regimen for patients with well-characterized nonresponse (null and partial) or relapse to a prior course of PR treatment.
authors: Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center, Durham, NC 27715, USA. muir0002@mc.duke.edu.
authors: Andrew J
authors: AJ
authors: Muir
authors: Fred F
authors: FF
authors: Poordad
authors: John G
authors: JG
authors: McHutchison
authors: Mitchell L
authors: ML
authors: Shiffman
authors: Thomas
authors: T
authors: Berg
authors: Peter
authors: P
authors: Ferenci
authors: E Jenny
authors: EJ
authors: Heathcote
authors: Jean-Michel
authors: JM
authors: Pawlotsky
authors: Stefan
authors: S
authors: Zeuzem
authors: Henk W
authors: HW
authors: Reesink
authors: Geoffrey
authors: G
authors: Dusheiko
authors: Emily C
authors: EC
authors: Martin
authors: Shelley
authors: S
authors: George
authors: Robert S
authors: RS
authors: Kauffman
authors: Nathalie
authors: N
authors: Adda
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage* / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D019233:Retreatment / Q000379:methods; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C100416:peginterferon alfa-2a