title: Futility rules for telaprevir combination treatment for patients with hepatitis C virus infection.
abstract: For patients treated with telaprevir, peginterferon, and ribavirin, futility rules have been developed to prevent needless drug exposure and minimize development of drug-resistant variants for patients who have little or no chance of achieving a sustained virologic response. We performed retrospective analyses of data from phase 3 trials and validated the current futility rule. All therapy should be stopped for treatment-naive and treatment-experienced patients if hepatitis C virus RNA levels are greater than 1000 IU/mL at weeks 4 or 12, or if hepatitis C virus RNA is detectable at week 24.
authors.affiliation: Vertex Pharmaceuticals, Incorporated, Cambridge, Massachusetts, USA.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Adda
authors.forename: Doug J
authors.initials: DJ
authors.lastname: Bartels
authors.forename: Linda
authors.initials: L
authors.lastname: Gritz
authors.forename: Tara L
authors.initials: TL
authors.lastname: Kieffer
authors.forename: Frank
authors.initials: F
authors.lastname: Tomaka
authors.forename: Leif
authors.initials: L
authors.lastname: Bengtsson
authors.forename: Don
authors.initials: D
authors.lastname: Luo
authors.forename: Ira M
authors.initials: IM
authors.lastname: Jacobson
authors.forename: Robert S
authors.initials: RS
authors.lastname: Kauffman
authors.forename: Gaston
authors.initials: G
authors.lastname: Picchio
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D004359:Drug Therapy, Combination / Q000379:methods; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use; D018447:Medical Futility; D009842:Oligopeptides / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D012189:Retrospective Studies; D012254:Ribavirin / Q000627:therapeutic use; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D009842:Oligopeptides; D012367:RNA, Viral; D012254:Ribavirin; C486464:telaprevir; D007372:Interferons