Edward Tam1, Julie Tremblay2, Chris Fraser3, Brian Conway4, Alnoor Ramji5, Sergio Borgia6, Keith Tsoi7, Eric M Yoshida8, Bahe Rajendran9, Gisela Macphail10, Alexander Wong11, Curtis Cooper12, Keyur Patel13, Marco Puglia14, Kris Stewart15, Benoit Trottier16, Lucie Deshaies17, Karen Doucette18, Peter Ghali19, Samuel S Lee20, Jodi Halsey-Brandt21, Janie B Trepanier21. 1. LAIR Centre, Vancouver, British Columbia, Canada. 2. Centre Sida Amitié, Saint-Jérôme, Quebec, Canada. 3. The Cool Aid Community Health Centre, Victoria, British Columbia, Canada. 4. Vancouver Infectious Diseases Centre, Vancouver, British Columbia, Canada. 5. Gastroenterology Division, GI Research Institute (GIRI), Vancouver, British Columbia, Canada. 6. William Osler Health System, Brampton, Ontario, Canada. 7. St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada. 8. Vancouver General Hospital, Vancouver, British Columbia, Canada. 9. The Peterborough Clinic, Peterborough, Ontario, Canada. 10. Calgary Urban Project Society (CUPS), Calgary, Alberta, Canada. 11. Department of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. 12. The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 13. University Health Network, Toronto, Ontario, Canada. 14. Hamilton Health Sciences, Hamilton, Ontario, Canada. 15. Saskatchewan Infectious Disease Care Network, Saskatoon, Saskatchewan, Canada. 16. Clinique de Médecine Urbaine du Quartier Latin, Montreal, Quebec, Canada. 17. CIUSSS Capitale Nationale, Quebec, Quebec, Canada. 18. Division of Infectious Diseases, University of Alberta, Edmonton, Alberta, Canada. 19. McGill University Health Center, Montreal, Quebec, Canada. 20. Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada. 21. Merck Canada Inc., Kirkland, Quebec, Canada.
Abstract
Background: Canada was the first country to approve elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic HCV infection for genotypes 1 and 4 with or without ribavirin and genotype 3 with sofosbuvir, with no recommendation for baseline resistance testing. The aim of this study was to describe the effectiveness of EBR/GZR and the profile of patients selected for treatment in a Canadian real-world setting. Methods: This multicenter retrospective study of HCV-infected patients treated with EBR/GZR took place among selected Canadian health care providers, with no exclusion criteria. Primary outcome measures included parameters associated with patient profile and sustained virologic response at 12 weeks (SVR12) and 24 weeks after treatment. Results: A total of 408 patients were included; 244 had available SVR12 information (per-protocol population [PP]). Genotype distribution included 1a (54.7%), 1b (17.2%), 3 (11.8%), 4 (10.0%), and other (6.4%). The majority (88.7%) of participants were treated for 12 weeks without ribavirin. Fifty-nine (14.5%) participants, predominantly with genotype 1a (49/59) infection, were tested for baseline resistance-associated substitutions (bRAS). SVR12 was achieved by 95.9% of the PP. In an exploratory analysis assessing potential predictors of SVR12, participants who had undergone bRAS testing (OR 0.14, 95% CI 0.03-0.64) and participants who had undergone liver transplant (OR 0.05, 95% CI 0.00-0.68) had significantly lower odds of achieving SVR12. Conclusions: This study supports the real-world effectiveness of EBR/GZR-including a broad range of genotypes and diverse fibrosis stages-in the absence of bRAS testing and in special populations.
Background: Canada was the first country to approve elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic HCV infection for genotypes 1 and 4 with or without ribavirin and genotype 3 with sofosbuvir, with no recommendation for baseline resistance testing. The aim of this study was to describe the effectiveness of EBR/GZR and the profile of patients selected for treatment in a Canadian real-world setting. Methods: This multicenter retrospective study of HCV-infected patients treated with EBR/GZR took place among selected Canadian health care providers, with no exclusion criteria. Primary outcome measures included parameters associated with patient profile and sustained virologic response at 12 weeks (SVR12) and 24 weeks after treatment. Results: A total of 408 patients were included; 244 had available SVR12 information (per-protocol population [PP]). Genotype distribution included 1a (54.7%), 1b (17.2%), 3 (11.8%), 4 (10.0%), and other (6.4%). The majority (88.7%) of participants were treated for 12 weeks without ribavirin. Fifty-nine (14.5%) participants, predominantly with genotype 1a (49/59) infection, were tested for baseline resistance-associated substitutions (bRAS). SVR12 was achieved by 95.9% of the PP. In an exploratory analysis assessing potential predictors of SVR12, participants who had undergone bRAS testing (OR 0.14, 95% CI 0.03-0.64) and participants who had undergone liver transplant (OR 0.05, 95% CI 0.00-0.68) had significantly lower odds of achieving SVR12. Conclusions: This study supports the real-world effectiveness of EBR/GZR-including a broad range of genotypes and diverse fibrosis stages-in the absence of bRAS testing and in special populations.
Authors: G B Gaeta; D F Precone; F M Felaco; R Bruno; A Spadaro; G Stornaiuolo; M Stanzione; T Ascione; R De Sena; A Campanone; G Filice; F Piccinino Journal: Aliment Pharmacol Ther Date: 2002-09 Impact factor: 8.171
Authors: Mark Sulkowski; Christophe Hezode; Jan Gerstoft; John M Vierling; Josep Mallolas; Stanislas Pol; Marcelo Kugelmas; Abel Murillo; Nina Weis; Ronald Nahass; Oren Shibolet; Lawrence Serfaty; Marc Bourliere; Edwin DeJesus; Eli Zuckerman; Frank Dutko; Melissa Shaughnessy; Peggy Hwang; Anita Y M Howe; Janice Wahl; Michael Robertson; Eliav Barr; Barbara Haber Journal: Lancet Date: 2014-11-11 Impact factor: 202.731
Authors: Paul Kwo; Edward J Gane; Cheng-Yuan Peng; Brian Pearlman; John M Vierling; Lawrence Serfaty; Maria Buti; Stephen Shafran; Paul Stryszak; Li Lin; Jacqueline Gress; Stuart Black; Frank J Dutko; Michael Robertson; Janice Wahl; Lisa Lupinacci; Eliav Barr; Barbara Haber Journal: Gastroenterology Date: 2016-10-05 Impact factor: 33.883