Luca Saverio Belli1, Marina Berenguer2, Paolo Angelo Cortesi3, Mario Strazzabosco4, Susanne-Rasoul Rockenschaub5, Silvia Martini6, Cristina Morelli7, Francesca Donato8, Riccardo Volpes9, Georges-Philippe Pageaux10, Audrey Coilly11, Stefano Fagiuoli12, Giuliana Amaddeo13, Giovanni Perricone14, Carmen Vinaixa2, Gabriela Berlakovich5, Rita Facchetti3, Wojciech Polak15, Paolo Muiesan16, Christophe Duvoux13. 1. Department of Gastroenterology and Hepatology, Liver Unit, Niguarda Hospital, Milan, Italy. Electronic address: luca.belli@ospedaleniguarda.it. 2. Hepatology & Liver Transplantation Unit, Hospital Universitari I Politècnic La Fe, University of Valencia & Ciberhed, Valencia, Spain. 3. Research Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy. 4. Digestive Disease Section and International Centre for Digestive Health, School of Medicine and Surgery, University of Milano Bicocca and Yale University Liver Center, Department of Medicine, New Haven, USA. 5. Division of Transplantation, Department of Surgery, University of Vienna, Vienna, Austria. 6. LiverTransplantation Center, Gastrohepatology Unit, Molinette Hospital, AOU Città della Salute e della Scienza di Torino, Turin, Italy. 7. Liver and Multi-organ Transplantation, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. 8. Division of Digestive Diseases, 'Maggiore' University Hospital, Milan, Italy. 9. Mediterranean Institute for Transplant, Palermo, Italy. 10. Department of Hepatology, Gastroenterology, and Liver Transplantation, Centre Hospitalier Universitaire (CHU) Saint Eloi, Montpellier, France. 11. Centre Hepato-Biliaire, Paul Brousse Hospital, Assistance Publique-Hôpitaux de Paris, Paris-Sud University, Villejuif, France. 12. Gastroenterology and Transplant Hepatology, Papa Giovanni XXIII Hospital, Bergamo, Italy. 13. Department of Hepatology and Liver Transplant Unit, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris, Paris-Est University, Creteil, France. 14. Department of Gastroenterology and Hepatology, Liver Unit, Niguarda Hospital, Milan, Italy. 15. Department of Surgery, Division of HPB and Transplant Surgery, Erasmus MC, University Medical Center Rotterdam, The Netherlands. 16. Department of HPB Surgery & Liver Transplantation, University of Birmingham, UK.
Abstract
BACKGROUND & AIMS: All oral direct acting antivirals (DAA) have been shown to improve the liver function of patients with decompensated cirrhosis but it is presently unknown whether this clinical improvement may lead to the delisting of some patients. The aim of this study was to assess if and which patients can be first inactivated due to clinically improvement and subsequently delisted in a real life setting. METHODS: 103 consecutive listed patients without hepatocellular carcinoma were treated with different DAA combinations in 11 European centres between February 2014 and February 2015. RESULTS: The cumulative incidence of inactivated and delisted patients by competing risk analysis was 15.5% and 0% at 24weeks, 27.6% and 10.3% at 48weeks, 33.3% and 19.2% at 60weeks. The 34 patients who were inactivated showed a median improvement of 3.4 points for MELD (delta MELD, p<0.0001) and 2 points for Child-Pugh (CP) (delta-CP, p<0.0001). Three variables emerged from the most parsimonious multivariate competing risk model as predictors of inactivation for clinical improvement, namely, baseline MELD classes (MELD 16-20: HR=0.120; p=0.0005, MELD >20:HR=0.042; p<0.0001), delta MELD (HR=1.349; p<0.0001) and delta albumin (HR=0.307; p=0.0069) both assessed after 12weeks of DAA therapy. CONCLUSIONS: This study showed that all oral DAAs were able to reverse liver dysfunction and favoured the inactivation and delisting of about one patient out-of-three and one patient out-of-five in 60weeks, respectively. Patients with lower MELD scores had higher chances to be delisted. The longer term benefits of therapy need to be ascertained. LAY SUMMARY: The excellent efficacy and safety profile of the new drugs against Hepatitis C virus, "direct acting antivirals" or DAAs, have made antiviral therapy possible also for patients with advanced liver disease and for those on the waiting list for liver transplantation (LT). This study shows for the first time that the DAAs may lead to a remarkable clinical improvement allowing the delisting of one patient out of 5.
BACKGROUND & AIMS: All oral direct acting antivirals (DAA) have been shown to improve the liver function of patients with decompensated cirrhosis but it is presently unknown whether this clinical improvement may lead to the delisting of some patients. The aim of this study was to assess if and which patients can be first inactivated due to clinically improvement and subsequently delisted in a real life setting. METHODS: 103 consecutive listed patients without hepatocellular carcinoma were treated with different DAA combinations in 11 European centres between February 2014 and February 2015. RESULTS: The cumulative incidence of inactivated and delisted patients by competing risk analysis was 15.5% and 0% at 24weeks, 27.6% and 10.3% at 48weeks, 33.3% and 19.2% at 60weeks. The 34 patients who were inactivated showed a median improvement of 3.4 points for MELD (delta MELD, p<0.0001) and 2 points for Child-Pugh (CP) (delta-CP, p<0.0001). Three variables emerged from the most parsimonious multivariate competing risk model as predictors of inactivation for clinical improvement, namely, baseline MELD classes (MELD 16-20: HR=0.120; p=0.0005, MELD >20:HR=0.042; p<0.0001), delta MELD (HR=1.349; p<0.0001) and delta albumin (HR=0.307; p=0.0069) both assessed after 12weeks of DAA therapy. CONCLUSIONS: This study showed that all oral DAAs were able to reverse liver dysfunction and favoured the inactivation and delisting of about one patient out-of-three and one patient out-of-five in 60weeks, respectively. Patients with lower MELD scores had higher chances to be delisted. The longer term benefits of therapy need to be ascertained. LAY SUMMARY: The excellent efficacy and safety profile of the new drugs against Hepatitis C virus, "direct acting antivirals" or DAAs, have made antiviral therapy possible also for patients with advanced liver disease and for those on the waiting list for liver transplantation (LT). This study shows for the first time that the DAAs may lead to a remarkable clinical improvement allowing the delisting of one patient out of 5.
Authors: Sumeyye Samur; Brian Kues; Turgay Ayer; Mark S Roberts; Fasiha Kanwal; Chin Hur; Drew Michael S Donnell; Raymond T Chung; Jagpreet Chhatwal Journal: Clin Gastroenterol Hepatol Date: 2017-06-17 Impact factor: 11.382