BACKGROUND/AIMS: Ledipasvir (LDV) and sofosbuvir (SOF) as single-tablet regimen (STR) has been approved for treatment of chronic HCV infection (CHC) for treatment-naïve or experienced cirrhotic or non-cirrhotic patients. Our aim was to analyse the effectiveness and safety of 12-24 weeks treatment of LDV/SOF (90mg/400 mg)±ribavirin in a real-life setting in Turkey. MATERIALS AND METHODS: Between May-Dec 2016, 104 treatment-naïve or experienced adult patients with CHC and with or without cirrhosis (including decompensated cirrhosis) were included in this observational study. Patients were administered LDV/SOF STR± ribavirin once daily for 12 -24 weeks. SVR12 rates and effects of the baseline characteristics on SVR12 rates were assessed. RESULTS: Out of 104 enrolled patients (61.5% female, mean age 62.0 years); 60.6% were cirrhotic, 76.0% previously used peg-IFN, 94.2% had GT1. At the end of the treatment, 77.8% (77/99, no data for 21 patients) had undetectable HCV-RNA and 98.9% (94/95) had SVR12. In the baseline characteristics subgroups, the SVR12 rates varied between 94.4% and 100%, and none of the baseline characteristics had a significant effect on the SVR12 rates. During the study, 6 (5.8%) patients died and none of the deaths was suspected to be related to the LDV/SOF. No treatment-emergent adverse event was reported. CONCLUSION: In conclusion, LDV/SOF±ribavirin yielded very high SVR12 rates, without any safety or tolerability concern in Turkey. The effectiveness of the LDV/SOF treatment was not affected by the patient demographics or medical characteristics such as fibrosis level, cirrhosis status, previous treatment status, HCV-RNA level or HCV genotype.
BACKGROUND/AIMS: Ledipasvir (LDV) and sofosbuvir (SOF) as single-tablet regimen (STR) has been approved for treatment of chronic HCV infection (CHC) for treatment-naïve or experienced cirrhotic or non-cirrhotic patients. Our aim was to analyse the effectiveness and safety of 12-24 weeks treatment of LDV/SOF (90mg/400 mg)±ribavirin in a real-life setting in Turkey. MATERIALS AND METHODS: Between May-Dec 2016, 104 treatment-naïve or experienced adult patients with CHC and with or without cirrhosis (including decompensated cirrhosis) were included in this observational study. Patients were administered LDV/SOF STR± ribavirin once daily for 12 -24 weeks. SVR12 rates and effects of the baseline characteristics on SVR12 rates were assessed. RESULTS: Out of 104 enrolled patients (61.5% female, mean age 62.0 years); 60.6% were cirrhotic, 76.0% previously used peg-IFN, 94.2% had GT1. At the end of the treatment, 77.8% (77/99, no data for 21 patients) had undetectable HCV-RNA and 98.9% (94/95) had SVR12. In the baseline characteristics subgroups, the SVR12 rates varied between 94.4% and 100%, and none of the baseline characteristics had a significant effect on the SVR12 rates. During the study, 6 (5.8%) patientsdied and none of the deaths was suspected to be related to the LDV/SOF. No treatment-emergent adverse event was reported. CONCLUSION: In conclusion, LDV/SOF±ribavirin yielded very high SVR12 rates, without any safety or tolerability concern in Turkey. The effectiveness of the LDV/SOF treatment was not affected by the patient demographics or medical characteristics such as fibrosis level, cirrhosis status, previous treatment status, HCV-RNA level or HCV genotype.
Authors: Joseph K Lim; Ann Marie Liapakis; Mitchell L Shiffman; Anna S Lok; Stefan Zeuzem; Norah A Terrault; James S Park; Charles S Landis; Mohamed Hassan; Joel Gallant; Alexander Kuo; Paul J Pockros; Monika Vainorius; Lucy Akushevich; Larry Michael; Michael W Fried; David R Nelson; Ziv Ben-Ari Journal: Clin Gastroenterol Hepatol Date: 2018-01-03 Impact factor: 11.382
Authors: Michael Manns; Didier Samuel; Edward J Gane; David Mutimer; Geoff McCaughan; Maria Buti; Martín Prieto; José Luis Calleja; Markus Peck-Radosavljevic; Beat Müllhaupt; Kosh Agarwal; Peter Angus; Eric M Yoshida; Massimo Colombo; Mario Rizzetto; Hadas Dvory-Sobol; Jill Denning; Sarah Arterburn; Phillip S Pang; Diana Brainard; John G McHutchison; Jean-François Dufour; Hans Van Vlierberghe; Bart van Hoek; Xavier Forns Journal: Lancet Infect Dis Date: 2016-02-18 Impact factor: 25.071
Authors: E B Tapper; B R Bacon; M P Curry; D T Dieterich; S L Flamm; L E Guest; K V Kowdley; Y Lee; N C Tsai; Z M Younossi; N H Afdhal Journal: J Viral Hepat Date: 2016-10-11 Impact factor: 3.728
Authors: N Tozun; O Ozdogan; Y Cakaloglu; R Idilman; Z Karasu; U Akarca; S Kaymakoglu; O Ergonul Journal: Clin Microbiol Infect Date: 2015-07-08 Impact factor: 8.067
Authors: Kris V Kowdley; Stuart C Gordon; K Rajender Reddy; Lorenzo Rossaro; David E Bernstein; Eric Lawitz; Mitchell L Shiffman; Eugene Schiff; Reem Ghalib; Michael Ryan; Vinod Rustgi; Mario Chojkier; Robert Herring; Adrian M Di Bisceglie; Paul J Pockros; G Mani Subramanian; Di An; Evguenia Svarovskaia; Robert H Hyland; Phillip S Pang; William T Symonds; John G McHutchison; Andrew J Muir; David Pound; Michael W Fried Journal: N Engl J Med Date: 2014-04-10 Impact factor: 91.245
Authors: Nezam Afdhal; Stefan Zeuzem; Paul Kwo; Mario Chojkier; Norman Gitlin; Massimo Puoti; Manuel Romero-Gomez; Jean-Pierre Zarski; Kosh Agarwal; Peter Buggisch; Graham R Foster; Norbert Bräu; Maria Buti; Ira M Jacobson; G Mani Subramanian; Xiao Ding; Hongmei Mo; Jenny C Yang; Phillip S Pang; William T Symonds; John G McHutchison; Andrew J Muir; Alessandra Mangia; Patrick Marcellin Journal: N Engl J Med Date: 2014-04-11 Impact factor: 91.245
Authors: Lisa I Backus; Pamela S Belperio; Troy A Shahoumian; Timothy P Loomis; Larry A Mole Journal: Hepatology Date: 2016-06-07 Impact factor: 17.425
Authors: Nezam Afdhal; K Rajender Reddy; David R Nelson; Eric Lawitz; Stuart C Gordon; Eugene Schiff; Ronald Nahass; Reem Ghalib; Norman Gitlin; Robert Herring; Jacob Lalezari; Ziad H Younes; Paul J Pockros; Adrian M Di Bisceglie; Sanjeev Arora; G Mani Subramanian; Yanni Zhu; Hadas Dvory-Sobol; Jenny C Yang; Phillip S Pang; William T Symonds; John G McHutchison; Andrew J Muir; Mark Sulkowski; Paul Kwo Journal: N Engl J Med Date: 2014-04-11 Impact factor: 91.245