The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes |
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| Authors: | Paola Carrai Cristina Morelli Gabriella Cordone Antonietta Romano Mariarosa Tamé Raffaella Lionetti Giada Pietrosi Ilaria Lenci Guido Piai Francesco Paolo Russo Carmine Coppola Mario Melazzini Simona Montilla Luca Pani Sandra Petraglia Pierluigi Russo Maria Paola Trotta Silvia Martini Pierluigi Toniutto the ITACOPS study group |
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| Affiliation: | 1. Liver Surgery and Liver Transplantation, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy;2. Department of Care of Organ Failures and Transplants, Internal Medicine for the Treatment of Severe Organ Failures, University Hospital – Policlinico S.Orsola‐Malpighi, Bologna, Italy;3. Hepatology Unit, Liver Transplant Department, Cardarelli Hospital, Naples, Italy;4. Unit of internal Medicine and Hepatology (UIMH), University of Padua, Rome, Italy;5. Gastroenterology Unit, University Hospital – Policlinico S.Orsola‐Malpighi, Bologna, Italy;6. Infectious Diseases‐Hepatology, National Institute for Infectious Diseases Spallanzani, Rome, Italy;7. Hepatology Unit, Department of Medicine, Mediterranean Institute for Transplantation and Advanced Specialized Therapies (IRCCS‐ISMETT), Palermo, Italy;8. Hepatology and Transplant Unit, Department of Experimental Medicine and Surgery, Tor Vergata University, Rome, Italy;9. Hepatology Unit, AORN Sant'Anna e San Sebastiano, Caserta, Italy;10. Gastroenterology/Multivisceral Transplant Unit, University Hospital Padua, Padua, Italy;11. Internal Medicine and Liver Unit, Gragnano Hospital (NA), Udine, Italy;12. Italian Drug Agency (AIFA), Roma, Italy;13. Gastrohepatology Unit, AOU Città della Salute e della Scienza di Torino, Turin, Italy;14. Department of Medical Area (DAME), Medical Liver Transplant Section, Internal Medicine, Azienda Ospedaliero‐Universitaria, Udine, Italy |
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| Abstract: | Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3–F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child–Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child–Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real‐world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function. |
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| Keywords: | cholestatic hepatitis hepatitis C liver transplantation sofosbuvir |
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