Raffaella Lionetti1, Vincenza Calvaruso2, Paola Piccolo3,4, Rossella Letizia Mancusi5, Chiara Mazzarelli6, Stefano Fagiuoli7, Marzia Montalbano1, Ilaria Lenci4, Paola Carrai8, Giovanni Guaraldi9, Ubaldo Visco-Comandini1, Martina Milana4, Marco Biolato10, Laura Loiacono1, Giovanna Valente11, Antonio Craxì2, Mario Angelico4, Gianpiero D'offizi1. 1. Infectious and Liver Diseases, Lazzaro Spallanzani National Infectious Disease Institute, Rome, Italy. 2. Gastroenterology Unit, University of Palermo, Palermo, Italy. 3. Department of Internal Medicine, San Giovanni Calibita Fatebenefratelli Hospital, Rome, Italy. 4. Hepatology Unit, Tor Vergata University, Rome, Italy. 5. Consortium for Economic Research in Health (CREA Sanità), Tor Vergata University, Rome, Italy. 6. Gastroenterology and Liver Unit, Niguarda Ca' Granda Hospital, Milan, Italy. 7. Gastroenterology and Liver Unit, San Giovanni XXIII Hospital, Bergamo, Italy. 8. Liver Transplantation Unit, Pisa Hospital, Pisa, Italy. 9. Infectious Diseases Unit, University of Modena, Modena, Italy. 10. Liver Transplant Medicine, Fondazione Policlinico Gemelli Catholic University, Rome, Italy. 11. Gastroenterology Unit, San Sebastiano Hospital, Caserta, Italy.
Abstract
BACKGROUND: In 2012, an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. The aim of this "real-life" study was to assess treatment efficacy and safety with an extended course of daclatasvir (DCV) plus sofosbuvir (SOF) with or without ribavirin (RBV). METHODS: All HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOF±RBV for 24 weeks; sustained virological response was assessed at 12 weeks post-treatment (SVR12). RESULTS: Eighty-seven patients were enrolled (75.9% males, mean age 58.4 ± 7.2 years, 83.9% genotype 1, 81.6% cirrhosis); 52 (59.8%) received RBV. Overall, 79 obtained SVR12 (90.8%): 100% in F3 and 88.7% in cirrhotics (91.5% in Child-Pugh A, 83.3% in Child-Pugh B and C). According to the treatment group, SVR was 80% in DCV + SOF group and 98.1% in SOF + DCV + RBV. Two virological relapses occurred during follow-up in cirrhotic patients who received DCV + SOF. Four cirrhotic patients in DCV + SOF group and 1 in DCV + SOF + RBV group died on treatment. CONCLUSION: An extended course of SOF plus DCV for 24 weeks, with or without RBV, is effective and well tolerated for the treatment of post-LT HCV recurrence with severe fibrosis.
BACKGROUND: In 2012, an Italian Named Patient Program began for hepatitis C virus (HCV)-infected liver transplant (LT) recipients with advanced fibrosis, before approval of direct antiviral agents (DAA), to benefit severely ill patients. The aim of this "real-life" study was to assess treatment efficacy and safety with an extended course of daclatasvir (DCV) plus sofosbuvir (SOF) with or without ribavirin (RBV). METHODS: All HCV LT recipients with severe fibrosis in 15 Italian transplant centers were treated with DCV+SOF±RBV for 24 weeks; sustained virological response was assessed at 12 weeks post-treatment (SVR12). RESULTS: Eighty-seven patients were enrolled (75.9% males, mean age 58.4 ± 7.2 years, 83.9% genotype 1, 81.6% cirrhosis); 52 (59.8%) received RBV. Overall, 79 obtained SVR12 (90.8%): 100% in F3 and 88.7% in cirrhotics (91.5% in Child-Pugh A, 83.3% in Child-Pugh B and C). According to the treatment group, SVR was 80% in DCV + SOF group and 98.1% in SOF + DCV + RBV. Two virological relapses occurred during follow-up in cirrhotic patients who received DCV + SOF. Four cirrhotic patients in DCV + SOF group and 1 in DCV + SOF + RBV group died on treatment. CONCLUSION: An extended course of SOF plus DCV for 24 weeks, with or without RBV, is effective and well tolerated for the treatment of post-LT HCV recurrence with severe fibrosis.
Authors: Massimo Giuseppe Colombo; Erkin Isakovich Musabaev; Umed Yusupovich Ismailov; Igor A Zaytsev; Alexander V Nersesov; Igor Anatoliyevich Anastasiy; Igor Alexandrovich Karpov; Olga A Golubovska; Kulpash S Kaliaskarova; Ravishankar Ac; Sanjay Hadigal Journal: World J Gastroenterol Date: 2019-08-07 Impact factor: 5.742
Authors: Elise J Smolders; Anouk M E Jansen; Peter G J Ter Horst; Jürgen Rockstroh; David J Back; David M Burger Journal: Clin Pharmacokinet Date: 2019-10 Impact factor: 6.447
Authors: Barnaby Flower; Leanne McCabe; Chau Le Ngoc; Hung Le Manh; Phuong Le Thanh; Thuan Dang Trong; Thu Vo Thi; Hang Vu Thi Kim; Thanh Nguyen Tat; Dao Phan Thi Hong; An Nguyen Thi Chau; Tan Dinh Thi; Nga Tran Thi Tuyet; Joel Tarning; Cherry Kingsley; Evelyne Kestelyn; Sarah L Pett; Guy Thwaites; Vinh Chau Nguyen Van; David Smith; Eleanor Barnes; M Azim Ansari; Hugo Turner; Motiur Rahman; Ann Sarah Walker; Jeremy Day; Graham S Cooke Journal: Open Forum Infect Dis Date: 2021-06-09 Impact factor: 3.835