I Campos-Varela1,2,3, A Moreno4, A Morbey5, G Guaraldi6, H Hasson7, K R Bhamidimarri8, L Castells9,10, P Grewal11, I Baños12, P Bellot13,14, D M Brainard15, J G McHutchison15, N A Terrault3. 1. Universidade de Santiago de Compostela (CLINURSID), Santiago de Compostela, Spain. 2. Hospital of Santiago de Compostela, Santiago de Compostela, Spain. 3. University of California-San Francisco, San Francisco, CA, USA. 4. Hospital Ramón y Cajal, Madrid, Spain. 5. Hospital Curry Cabral, Lisbon, Portugal. 6. Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Modena, Italy. 7. Scientific Institute Ospedale San Raffaele, Milan, Italy. 8. Division of Hepatology, University of Miami-Miller School of Medicine, Miami, FL, USA. 9. CIBERehd, Instituto de Salud Carlos III, Barcelona, Spain. 10. Hospital Universitario Vall d'Hebron, Barcelona, Spain. 11. Mount Sinai School of Medicine, New York, NY, USA. 12. Hospital Universitario Puerta de Hierro, Madrid, Spain. 13. CIBERehd, Instituto de Salud Carlos III, Madrid, Spain. 14. Hospital General Universitario, Alicante, Spain. 15. Gilead Sciences, Foster City, CA, USA.
Abstract
BACKGROUND: For liver transplant recipients with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infection, recurrence after LT is associated with a higher risk of graft loss than for HCV mono-infected patients. Prior HCV treatment options were limited by side effects and drug-drug interactions. AIM: To evaluate treatment outcomes with sofosbuvir (SOF)-based therapy among HIV/HCV coinfected liver transplant recipients. METHODS: Access to SOF and ribavirin (RBV) prior to regulatory approval was attained via an international compassionate access program for transplant recipients with a life expectancy of 1 year or less in the absence of HCV treatment. This report focuses on the short and longer term outcomes in HCV-HIV co-infected liver transplant recipients. RESULTS: Twenty patients were treated, nine with early severe recurrence and 11 with cirrhosis. Eleven patients received SOF and RBV, one SOF, RBV and Peg-interferon, three SOF, RBV and simeprevir and five SOF, RBV and daclatasvir. Of the 18 patients who completed treatment, 16 (89%) achieved sustained virological response 12 weeks after the end of treatment (SVR12). Liver function tests (including bilirubin and albumin) improved significantly over time. Nineteen serious adverse events occurred in eight (40%) patients, none of them related to SOF. Two patients died during treatment and another, 1 year after the end of therapy, due to progressive end-stage liver disease. Importantly, HIV suppression was not compromised. No significant drug-drug interactions were reported. CONCLUSIONS: Sofosbuvir-based regimens are safe, well-tolerated and provide high rates of SVR in HCV-HIV co-infected patients with severe recurrence after-liver transplant.
BACKGROUND: For liver transplant recipients with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) co-infection, recurrence after LT is associated with a higher risk of graft loss than for HCV mono-infected patients. Prior HCV treatment options were limited by side effects and drug-drug interactions. AIM: To evaluate treatment outcomes with sofosbuvir (SOF)-based therapy among HIV/HCV coinfected liver transplant recipients. METHODS: Access to SOF and ribavirin (RBV) prior to regulatory approval was attained via an international compassionate access program for transplant recipients with a life expectancy of 1 year or less in the absence of HCV treatment. This report focuses on the short and longer term outcomes in HCV-HIV co-infected liver transplant recipients. RESULTS: Twenty patients were treated, nine with early severe recurrence and 11 with cirrhosis. Eleven patients received SOF and RBV, one SOF, RBV and Peg-interferon, three SOF, RBV and simeprevir and five SOF, RBV and daclatasvir. Of the 18 patients who completed treatment, 16 (89%) achieved sustained virological response 12 weeks after the end of treatment (SVR12). Liver function tests (including bilirubin and albumin) improved significantly over time. Nineteen serious adverse events occurred in eight (40%) patients, none of them related to SOF. Two patients died during treatment and another, 1 year after the end of therapy, due to progressive end-stage liver disease. Importantly, HIV suppression was not compromised. No significant drug-drug interactions were reported. CONCLUSIONS:Sofosbuvir-based regimens are safe, well-tolerated and provide high rates of SVR in HCV-HIV co-infectedpatients with severe recurrence after-liver transplant.
Authors: Isabel Campos-Varela; Jennifer L Dodge; Norah A Terrault; Danielle Brandman; Jennifer C Price Journal: Am J Transplant Date: 2021-07-08 Impact factor: 9.369
Authors: Giovanni Guaraldi; Roberto Rossotti; Gabriella Verucchi; Marcello Tavio; Luisa Pasulo; Barbara Beghetto; Giovanni Dolci; Giulia Nardini; Lorenzo Badia; Anna Magliano; Maria Cristina Moioli; Massimo Puoti Journal: Open Forum Infect Dis Date: 2017-05-29 Impact factor: 3.835
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: Isabel Campos-Varela; Jennifer L Dodge; Marina Berenguer; René Adam; Didier Samuel; Fabrizio Di Benedetto; Vincent Karam; Luca S Belli; Christophe Duvoux; Norah A Terrault Journal: Transplantation Date: 2020-10 Impact factor: 5.385