Recurrent HCV after a Pre-LTx Course of SOF/DAC:
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1 Recurrent HCV after a Pre-LTx Course of SOF/DAC: Didier Samuel, Teresa Antonini Centre Hépato-Biliaire, Inserm Paris Sud Research Unit 1193 Hôpital Paul Brousse, Villejuif, France 3 rd Optimize Workshop, Using DAAs in Patients with Cirrhosis and Liver Recipients, Wien
2 Case presentation: M. D, 56 y History of HCV: Transfusional contamination Genotype 1a IL-28B polymorphism CT Peg IFN/RBV 2005 Non responder
3 Case presentation Liver function: Albumin: 37 g/l Total Bilirubin: 22 μmol/l Prothrombin: 75%, INR 1.2 Creatinine: 80 μmol/l Platelet count: 120x10 9 /L Mild ascites No hepatic encephalopathy
4 Case presentation Liver function: Albumin: 37 g/l Total Bilirubin: 22 μmol/l Prothrombin: 75%, INR 1.2 Creatinine: 80 μmol/l Platelet count: 120x10 9 /L Mild ascites No hepatic encephalopathy Child-Pugh Score A 6 MELD 9
5 Case presentation Hepatocellular carcinoma: 1 Nodule 3 cm, segm VI-VII Successfully treated by microwave ablation in 2012
6 Strategy?
7 Strategy? Anti HCV therapy?
8 Strategy? Anti HCV therapy? Liver Transplantation
9 Strategy? Anti HCV therapy? Before Liver Transplantation After Liver Transplantation
10 Impact of SVR: Risk of death HCV HCV/F4 HCV/HIV 0-10 Meta-analysis 15 studies N= patients Réduction of death % Univariate Multivariate Hill AM, AASLD 2015
11 Impact of SVR: Risk of HCC HCV n = Follow-up 6,1 y HCV/F4 n = Follow-up 6,6 y 13,9 Co-infected HCV/HIV n = Follow-up 4,7 y Meta-analysis 15 studies N= patients % pts after 5 y ,3 5, ,9 2 0,9 0 HCV HCV/F4 HCV/HIV SVR Non SVR Hill AM, AASLD 2015
12 Impact of SVR: Risk of LT HCV n = 108 Follow-up 4,2 y HCV/F4 n = Follow-up 7,7 y VIH VHC n = Follow-up 4,9 y Meta-analysis 15 studies N= patients Patients after 5 y (%) HCV 2,2 SVR 7,3 0,2 HCV/F4 Non SVR 2,7 0,6 HIV/HCV Hill AM, AASLD 2015
13 Sofosbuvir/Ledipasvir/RBV in Decompensated Cirrhotics 12 Improvement (n = 33) Stability (n = 10) Worsening (n = 4) Child- Pugh Score (n = 2) (n = 3) (n = 5) Flamm SL et al, AASLD, 2014
14 Forman, Gastroenterology 2002 High risk of recurrence HCV recurrence is universal Natural history of HCV is accelerated compared to non-transplant setting 30% of patients develop cirrhosis at 5 years post-lt
15 What Type of Treatment ( France 2012)?
16 2 nd Treatment Peg IFN/RBV/Tela Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/tid
17 2 nd Treatment Peg IFN/RBV/Tela Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/tid 8 log log W4 W8 W12
18 2 nd treatment Peg IFN/RBV/Tela Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/tid log STOP log 0 W4 W8 W12
19 2 nd Treatment Peg IFN/RBV/Tela Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/tid log STOP Mutation R155K 0 W4 W8 W12
20 2 nd Treatment Peg IFN/RBV/Tela Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/tid
21 Case presentation Deteriorating Liver function : Albumin: 24 g/l Total Bilirubin: 27 μmol/l Prothrombin: 58%, INR 1.56 Creatinine: 100 μmol/l Mild ascites No hepatic encephalopathy Child-Pugh Score B7 MELD 14 REFERRED FOR OLT
22 3rd Treatment before LT? Peg IFN/RBV Peg IFN/RBV/Tela? 2005 Non responder 2012 Non responder R155K
23 3rd Treatment before LT? SOF/RBV? SOF/SIM? SOF/DCV? SOF/LDV? Omb- ABT450/r Dasa+RBV?
24 3rd treatment before LT? SOF/ RBV? Osinusi A et al. Jama 2013
25 3rd treatment before LT? SOF/ RBV? SOF/ SIM? SOF/ DCV? SOF/ LDV? Omb- ABT450/r Dasa+ RBV?
26 SOF/ SIM? 3rd Treatment before LT?
27 3rd treatment before LT? SOF/ RBV? SOF/ SIM? SOF/ DCV? SOF/ LDV? Omb- ABT450/r Dasa+ RBV?
28 SOF/DCV SVR12% Sukowski M et al.nejm 2014
29 3rd Treatment before LT? SOF/ RBV? SOF/ SIM? SOF/ DCV? SOF/ LDV? Omb- ABT450/r Dasa+ RBV?
30 3rd treatment before LT? SOF/ RBV? SOF/ SIM? SOF/ DCV? SOF/ LDV? Omb- ABT450/r Dasa+ RBV? NOT AVAILABLE AT THAT TIME IN FRANCE
31 3rd Treatment before LT? Peg IFN/RBV 2005 Non responder Peg IFN/RBV/Tela 2012 Non responder R155K SOF/ DCV
32 3 rd Treatment Sofosbuvir Daclatasvir SOF= 400mg/d DCV= 60mg/d
33 3 rd Treatment Sofosbuvir Daclatasvir SOF= 400mg/d DCV= 60mg/d STOP
34 3 rd Treatment Sofosbuvir Daclatasvir SOF= 400mg/d DCV= 60mg/d STOP Mutation 31M,58P
35 3 rd treatment Sofosbuvir Daclatasvir Mutation 31M,58P
36 3 rd treatment Sofosbuvir Daclatasvir Mutation 31M,58P
37 SOF/ RBV? Finally.. SOF/S IM? SOF/ DCV? Omb- ABT450/r Dasa+ RBV? SOF/LD V?
38 SOF/ RBV? Finally.. SOF/S IM? SOF/ DCV? Omb- ABT450/r Dasa+ RBV? SOF/LD V?
39 SOF/ RBV? Finally.. SOF/S IM? Omb- ABT450/r Dasa+ RBV? Virological Resistance SOF/ DCV? SOF/LD V?
40 SOF/ RBV? Finally.. SOF/S IM? Omb- ABT450/r Dasa+ RBV? Virological Resistance SOF/ DCV? SOF/LD V? Virological Resistance
41 And Now?
42 Resistant variants Potent antiviral therapy eliminates sensitive variants Resistant variants can expand
43 Resistant variants Persistance of resistant virus Potent antiviral therapy eliminates sensitive variants Return to pre-treatment status
44 Finally.. - HCV population and clonal amino acid analyses in patient treated by PI, suggest that PI resistant population may return to pre-treatment levels over time For telaprevir, 60-89% of patients no longer had detectable resistant variants after a median FU of 10,6 months for G1a Sullivan et al, CID 2013
45 DISCUSSION -This patient developed NS5A resistance in addition to PI s resistance. -No clear identified Strategy - Retreat before LT? Whith what drug? - Treat after LT? - Add IFN to decrease resistance? - Add RBV? - Assess mutation before retreatment?
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