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INTERFERON (INF)-FREE ANTIVIRAL THERAPY IN CIRRHOTIC PATIENTS INFECTED WITH HEPATITIS C ON THE WAITING LIST FOR LIVER TRANSPLANTATION. EFFICACY AND IMPACT ON DELISTING AND LIVER FUNCTION
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Reported by Jules Levin
EASL 2016 April 14-17 Barcelona
1) The combination of 2 DAAs showed high efficacy (SVR 85%) in cirrhotic patients awaiting LT. 2) The treatment with DAAs improved liver function in about 40% and led to delisting of 10% (18% of those without HCC and listed for first LT). 3) No patient with MELD >18 couldbe removed from the waiting list for clinical improvement. 4) 98% of patients treated with 2 DAAs reached LT with undetectable HCV-RNA and less than 5% had a graft reinfection. 5) These results support the use of antiviral treatment in patients awaiting LT, especially in those without HCC, listed for the first LT and MELD 
Program abstract
INTERFERON (INF)-FREE ANTIVIRAL THERAPY IN CIRRHOTIC PATIENTS INFECTED WITH HEPATITIS C ON THE WAITING LIST FOR LIVER TRANSPLANTATION. EFFICACY AND IMPACT ON DELISTING AND LIVER FUNCTION
Juan Manuel Pascasio* 1, Carmen Vinaixa2, Maria Teresa Ferrer3, Jordi Colmenero4, Angel Rubin2, Lluis Castells5, Maria Luisa Manzano6, Sara Lorente7, Milagros Testillano8, Francisco Xavier Xiol9, Esther Molina10, Luisa Gonzalez-Dieguez11, Elena Otón12, Sonia Pascual13, Begona Santos5, José Ignacio Herrero14, Magdalena Salcedo15, José Luis Montero16, Gloria Sanchez-Antolin17, Isidoro Narvaez-Rodriguez18, Flor Nogueras19, Alvaro Giraldez3, Carlos Fernandez-Carrillo20, Xavier Forns4, Martin Prieto2, Maria Carlota Londono4
1Digestive Diseases, IBIS, CIBERehd, HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, Sevilla, 2Digestive-Hepatology, CIBERehd, Hospital Universitario y Politécnico La Fe, Valencia, 3Digestive Diseases, IBIS, HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO, Sevilla, 4Hepatology, IDIBAPS, CIBERehd, Hospital Clinic, 5Internal Medicine-Hepatology, CIBERehd, Hospital Universitario Vall d´Hebron, Barcelona, 6Digestive, Hospital Universitario Virgen del Rocio, Madrid, 7Digestive Disease-Liver Transplant, Hospital Clinico Universitario Lozano Blesa, Zaragoza, 8Digestive-Hepatology, Hospital Universitario de Cruces, Vizcaya, 9Digestive, Hospital Universitario de Bellvitge, Barcelona, 10Trasplante Abdominal, Complejo Hospitalario Universitario , Santiago de Compostela, 11Hepatology, Hospital Universitario Central de Asturias, Oviedo, 12Digestive, Hospital Universitario Nuestra Senora de la Candelaria, Santa Cruz de Tenerife, 13Liver Unit, CIBERehd, Hospital General Universitario, Alicante, 14Hepatology, CIBERehd, IdiSNA, Clinica Universitaria de Navarra, Pamplona, 15Liver Transplant, CIBERehd, Hospital General Universitario Gregorio Maranón, Madrid, 16Digestive, Hospital Universitario Reina Sofia, Córdoba, 17Hepatology and Liver Transplant, Hospital Universitario Rio Ortega, Valladolid, 18Digestive, Complejo Hospitalario, Hospital Infanta Cristina, Badajoz, 19Digestive, Hospital Universitario Virgen de las Nieves, Granada, 20Digestive-Hepatology, IDIPHIM, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain
Background and Aims: There is little information on the efficacy and potential benefit of IFN-free antiviral therapy in cirrhotic patients with hepatitis C (HCV) awaiting liver transplantation (LT). The aims of the study were: 1) to analyze the efficacy of INF- free therapy with different combinations of direct-acting antivirals (DAA) in HCV-cirrhotic patients awaiting LT, and 2) to assess the impact of therapy on liver function and delisting for clinical improvement.
Methods: Multicenter retrospective study with data collected from 18 Spanish hospitals. No patients continuing antiviral therapy after LT were included.
Results: 235 patients (220 listed for the first LT and 15 for re-LT) were included. Most of the patients were infected with genotype 1 (76%, 1b 49%) and treatment-experienced [47% non-responders to Peg-IFN plus ribavirin (RBV) and 12% to combinations including one DAA]. The indication for LT was hepatocellular carcinoma (HCC) in 109 (46%) and 69% had clinical decompensations. Child-Pugh was A(35%)/B(42%)/C(15%) and the median MELD score was 13 (6-31). The DAA regimens employed were Sofosbuvir (SOF)+Daclatasvir±RBV 111(47%; 22% with RBV), SOF+RBV 45(19%), SOF+Simeprevir±RBV 44(29%; 10% with RBV), SOF/Ledipasvir±RBV 30(13%, 10% with RBV), 3D±RBV 4(2%) and 2D+RBV 1(0.4%). Median treatment duration was 23 weeks(w, 2-50). Overall virological response was 70%(157/226) at w4, 86%(173/201) at w8, 98%(218/222) at EOT. 96%(173/201) and 79%(140/177) of patients achieved SVR4 and SVR12, respectively. The use of RBV did not affect SVR12. Virological response was higher with the combination of two DAA±RBV (SVR12 83% [113/136], relapse rate 9%) as compared with the use SOF+RBV (SVR12 66% [27/41], relapse rate 32%) (p=0.022). 92(94%) out of the 98 patients who reached LT, had HCV-RNA undetectable at the time of transplant, and 93% (73/79) and 88% (54/61) of them achieved post-LT SVR4 and SVR12, respectively. Post-LT relapse rate was 23% (7/30) with SOF+RBV and 1% (2/54) with the combination of 2 DAA. 10% (21/220) of the cohort listed for first LT and 20% (21/106) of those without HCC were removed from the waiting list for clinical improvement (mean baseline MELD score improved from 13 [6-18] to 10 [6-14]).
Conclusions: The combination of 2 DAA showed high efficacy in HCV-cirrhotic patients awaiting LT. Viral eradication led to delisting of 10% (20% of those without HCC) of treated patients due to clinical and liver function improvement.
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