Your browser doesn't support javascript.
loading
Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent.
Forns, Xavier; Gordon, Stuart C; Zuckerman, Eli; Lawitz, Eric; Calleja, Jose L; Hofer, Harald; Gilbert, Christopher; Palcza, John; Howe, Anita Y M; DiNubile, Mark J; Robertson, Michael N; Wahl, Janice; Barr, Eliav; Buti, Maria.
Affiliation
  • Forns X; Liver Unit, Hospital Clinic, IDIBAPS and CIBEREHD, Barcelona, Spain. Electronic address: xforns@clinic.ub.es.
  • Gordon SC; Henry Ford Health System, Detroit, MI, USA.
  • Zuckerman E; Carmel Medical Center, Haifa, Israel.
  • Lawitz E; The Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, USA.
  • Calleja JL; Servicio de Gastroenterología y Hepatología, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid, Madrid, Spain.
  • Hofer H; Division of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
  • Gilbert C; Merck and Co., Inc., Kenilworth, NJ, USA.
  • Palcza J; Merck and Co., Inc., Kenilworth, NJ, USA.
  • Howe AY; Merck and Co., Inc., Kenilworth, NJ, USA.
  • DiNubile MJ; Merck and Co., Inc., Kenilworth, NJ, USA.
  • Robertson MN; Merck and Co., Inc., Kenilworth, NJ, USA.
  • Wahl J; Merck and Co., Inc., Kenilworth, NJ, USA.
  • Barr E; Merck and Co., Inc., Kenilworth, NJ, USA.
  • Buti M; Hospital Universitario Valle Hebron and Ciberehd, Barcelona, Spain.
J Hepatol ; 63(3): 564-72, 2015 Sep.
Article in En | MEDLINE | ID: mdl-25895428
BACKGROUND & AIMS: The Phase-2 C-SALVAGE study evaluated an investigational interferon-free combination of grazoprevir (a NS3/4A protease inhibitor) and elbasvir (a NS5A inhibitor) with ribavirin for patients with chronic HCV genotype-1 infection who had failed licensed DAA-containing therapy. METHODS: C-SALVAGE was an open-label study of grazoprevir 100 mg and elbasvir 50 mg QD with weight-based ribavirin BID for 12 weeks in cirrhotic and non-cirrhotic patients with chronic HCV genotype-1 infection who had not attained SVR after ⩾4 weeks of peginterferon and ribavirin plus either boceprevir, telaprevir, or simeprevir. Exclusion criteria included decompensated liver disease, hepatocellular carcinoma, and HIV or HBV co-infection. The primary efficacy outcome was SVR12 defined as a HCV RNA level below the assay limit of quantification 12 weeks after the end of treatment. RESULTS: Of the 79 patients treated with ⩾1 dose of study drug, 66 (84%) patients had a history of virologic failure on a regimen containing a NS3/4A protease inhibitor; 12 of the other 13 patients discontinued prior treatment because of adverse experiences. At entry, 34 (43.6%) of 78 evaluable patients harbored NS3 RAVs. SVR12 rates were 76/79 (96.2%) overall, including 28/30 (93.3%) patients with genotype 1a infection, 63/66 (95.5%) patients with prior virologic failure, 43/43 (100%) patients without baseline RAVs, 31/34 (91.2%) patients with baseline NS3 RAVs, 6/8 (75.0%) patients with baseline NS5A RAVs, 4/6 (66.7%) patients with both baseline NS3 and RAVs, and 32/34 (94.1%) cirrhotic patients. None of the five reported serious adverse events were considered drug-related. CONCLUSIONS: Grazoprevir and elbasvir plus ribavirin for 12 weeks provides a promising new treatment option for patients after failure of triple therapy containing an earlier-generation protease inhibitor.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antiviral Agents / Hepatitis C, Chronic Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: J Hepatol Journal subject: GASTROENTEROLOGIA Year: 2015 Document type: Article Country of publication: Netherlands

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antiviral Agents / Hepatitis C, Chronic Limits: Adult / Aged / Female / Humans / Male / Middle aged Language: En Journal: J Hepatol Journal subject: GASTROENTEROLOGIA Year: 2015 Document type: Article Country of publication: Netherlands