title: Interferon-free treatment of chronic hepatitis C with faldaprevir, deleobuvir and ribavirin: SOUND-C3, a Phase 2b study.
abstract: OBJECTIVE
  The safety and efficacy of the interferon-free combination of faldaprevir (NS3/A4 protease inhibitor), deleobuvir (BI 207127, non-nucleoside polymerase inhibitor), and ribavirin in treatment-naïve patients chronically infected with HCV genotype-1 was explored.
  
  
  METHODS
  SOUND-C3 was a multicenter, open-label Phase 2b study. Treatment-naïve patients chronically infected with HCV genotype-1a (IL28B CC genotype only; n = 12) and genotype-1b (n = 20) were assigned to 16 weeks of treatment with faldaprevir 120 mg once daily, deleobuvir 600 mg twice daily, and weight-based ribavirin. Patients with compensated liver disease, including cirrhosis, were eligible for inclusion in this study. The primary endpoint was sustained virological response 12 weeks after completion of therapy.
  
  
  RESULTS
  Sustained virological response rates 12 weeks after completion of therapy were 17% and 95% in patients infected with HCV genotype-1a and genotype-1b respectively. All four patients with cirrhosis achieved sustained virological response 12 weeks after completion of therapy. The most frequently reported adverse events of at least moderate intensity were anaemia (16%), nausea, vomiting and fatigue (9% each). Three (9%) patients discontinued because of adverse events.
  
  
  CONCLUSIONS
  The interferon-free regimen of faldaprevir, deleobuvir and ribavirin was efficacious in patients infected with genotype-1b and generally well tolerated.
authors.affiliation: J. W. Goethe University Hospital, Frankfurt am Main, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Zeuzem
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Dufour
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.forename: Vicente
authors.initials: V
authors.lastname: Soriano
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Buynak
authors.forename: Parvez
authors.initials: P
authors.lastname: Mantry
authors.forename: Jawahar
authors.initials: J
authors.lastname: Taunk
authors.forename: Jerry O
authors.initials: JO
authors.lastname: Stern
authors.forename: Richard
authors.initials: R
authors.lastname: Vinisko
authors.forename: John-Paul
authors.initials: JP
authors.lastname: Gallivan
authors.forename: Wulf
authors.initials: W
authors.lastname: Böcher
authors.forename: Federico J
authors.initials: FJ
authors.lastname: Mensa
mesh_terms: D000179:Acrylates / Q000009:adverse effects / Q000627:therapeutic use*; D000621:Aminoisobutyric Acids; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D007930:Leucine / Q000031:analogs & derivatives; D009842:Oligopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D011392:Proline / Q000031:analogs & derivatives; D011804:Quinolines; D012367:RNA, Viral / Q000097:blood; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000179:Acrylates; D000621:Aminoisobutyric Acids; D000998:Antiviral Agents; D001562:Benzimidazoles; D009842:Oligopeptides; D011804:Quinolines; D012367:RNA, Viral; D013844:Thiazoles; D012254:Ribavirin; C000592437:deleobuvir; C552340:faldaprevir; D011392:Proline; D007930:Leucine
keywords: SVR12; genotype-1; interferon-free; treatment-naïve