Abstract
We report data from two similarly designed studies that evaluated the efficacy, safety, and optimal duration of ledipasvir/sofosbuvir (LDV/SOF) ± ribavirin (RBV) for retreatment of chronic hepatitis C virus (HCV) in individuals who failed to achieve sustained virological response (SVR) with prior SOF-based, non-NS5A inhibitor-containing regimens. The RESCUE study enrolled HCV mono-infected adults with genotype (GT) 1 or 4. Non-cirrhotic participants were randomized to 12 weeks of LDV/SOF or LDV/SOF + RBV. Compensated cirrhotic participants were randomized to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). The AIDS Clinical Trials Group A5348 study randomized genotype 1 adults with HCV/HIV co-infection to LDV/SOF + RBV (12 weeks) or LDV/SOF (24 weeks). Both studies used SVR at 12 weeks post-treatment (SVR12) as the primary endpoint. In the RESCUE study, 82 participants were randomized and treated, and all completed treatment. Overall, SVR12 was 88% (72/82); 81-100% in non-cirrhotic participants treated with LDV/SOF or LDV/SOF + RBV for 12 weeks and 80-92% in cirrhotic participants treated with LDV/SOF + RBV for 12 weeks or LDV/SOF for 24 weeks. Adverse events (AEs), mostly mild-to-moderate in severity, were experienced by 78% of...Continue Reading
References
Apr 15, 2006·International Journal of Medical Sciences·Stephen L Chen, Timothy R Morgan
Apr 9, 2009·The American Journal of Gastroenterology·Savino BrunoPatrick Maisonneuve
Apr 12, 2014·The New England Journal of Medicine·Kris V KowdleyUNKNOWN ION-3 Investigators
Apr 15, 2014·The New England Journal of Medicine·Nezam AfdhalUNKNOWN ION-2 Investigators
Apr 15, 2014·The New England Journal of Medicine·Nezam AfdhalUNKNOWN ION-1 Investigators
Nov 5, 2014·Annals of Internal Medicine·Anu OsinusiShyam Kottilil
Feb 28, 2015·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Surakit PungpapongAndrew P Keaveny
Mar 17, 2015·The Lancet Infectious Diseases·Marc BourlièreStanislas Pol
Apr 8, 2015·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·David WylesEric Lawitz
Apr 22, 2015·Infectious Diseases and Therapy·Kirpal KaurJudianne Slish
May 20, 2015·Gastroenterology·Michael CharltonUNKNOWN SOLAR-1 Investigators
Jul 22, 2015·The New England Journal of Medicine·Susanna NaggieUNKNOWN ION-4 Investigators
Oct 28, 2015·Alimentary Pharmacology & Therapeutics·C L LaiH L Y Chan
Feb 26, 2016·The Lancet Infectious Diseases·Michael MannsUNKNOWN SOLAR-2 investigators
Apr 27, 2016·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Lisa I BackusLarry A Mole
May 27, 2016·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Curtis CooperMark Sulkowski
Jun 29, 2016·Therapeutics and Clinical Risk Management·Marcel NkuizeJean-Pierre Mulkay
Aug 18, 2016·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Elliot B TapperNezam H Afdhal
Oct 25, 2016·Gastroenterology·Norah A TerraultUNKNOWN HCV-TARGET Study Group
Jun 1, 2017·The New England Journal of Medicine·Marc BourlièreUNKNOWN POLARIS-1 and POLARIS-4 Investigators
Mar 24, 2018·Alimentary Pharmacology & Therapeutics·A A ModiS A Gonzalez
Citations
Jan 31, 2018·Drugs·Lesley J Scott
May 23, 2019·Clinical Pharmacokinetics·Elise J SmoldersDavid M Burger
Apr 4, 2019·Canadian Journal of Gastroenterology & Hepatology·Dorota Zarębska-MichalukRobert Flisiak
Aug 16, 2019·World Journal of Gastroenterology : WJG·Massimo Giuseppe ColomboSanjay Hadigal
Nov 23, 2019·Wellcome Open Research·Christopher R JonesGraham S Cooke
Jan 28, 2021·Surgical Neurology International·Megan E CosgroveDavid A Chesler