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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
3rd Optimize Workshop, Using DAAs in Patients with Cirrhosis and Liver Recipients, Wien
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Case presentation: M. D, 56 y
History of HCV: Transfusional contamination
Genotype 1a
IL-28B polymorphism CT
Peg IFN/RBV 2005
Non responder
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Case presentation
Liver function: Albumin: 37 g/L
Total Bilirubin: 22 μmol/L
Prothrombin: 75%, INR 1.2
Creatinine: 80 μmol/L
Platelet count: 120x109/L
Mild ascites
No hepatic encephalopathy
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Case presentation
Liver function: Albumin: 37 g/L
Total Bilirubin: 22 μmol/L
Prothrombin: 75%, INR 1.2
Creatinine: 80 μmol/L
Platelet count: 120x109/L
Mild ascites
No hepatic encephalopathy
Child-Pugh Score A 6
MELD 9
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Case presentation
Hepatocellular carcinoma: 1 Nodule
3 cm, segm VI-VII
Successfully treated by microwave ablation in 2012
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Strategy?
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Strategy?
Anti HCV therapy?
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Strategy?
Anti HCV therapy?
Liver Transplantation
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Strategy?
Anti HCV therapy?
After Liver Transplantation
Before Liver Transplantation
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Hill AM, AASLD 2015
Impact of SVR: Risk of death
HCV
-90
-80
-30
-20
-10
Réd
uctio
n of
dea
th %
-70
-60
-50
-40
-71 -62
HCV/F4
-73
-84
HCV/HIV
-75 -73
Univariate Multivariate
0 Meta-analysis 15 studies N= 34 563 patients
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Hill AM, AASLD 2015
Impact of SVR: Risk of HCC
HCV 0
2
4
14
16
18
20
% p
ts a
fter
5 y
6
8
10
12
HCV/F4 HCV/HIV
2,9
9,3
5,3
13,9
0,9
10
HCV n = 12 496 Follow-up
6,1 y
HCV/F4 n = 4 987 Follow-up
6,6 y
Co-infected HCV/HIV n = 2 085 Follow-up
4,7 y
SVR Non SVR
Meta-analysis 15 studies N= 34 563 patients
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Hill AM, AASLD 2015
Impact of SVR: Risk of LT
Meta-analysis 15 studies N= 34 563 patients
HCV 0
2
4
14
16
18
20
Patie
nts
afte
r 5
y (%
)
6
8
10
12
HCV/F4 HIV/HCV
0
2,2 0,2
7,3
0,6 2,7
HCV n = 108
Follow-up 4,2 y
HCV/F4 n = 1 046
Follow-up 7,7 y
VIH VHC n = 2 039
Follow-up 4,9 y
SVR Non SVR
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Sofosbuvir/Ledipasvir/RBV in Decompensated Cirrhotics
Flamm SL et al, AASLD, 2014
12
11
10
9
8
7
6
5
Improvement (n = 33) Worsening
(n = 4)
(n = 2)
(n = 3)
(n = 5)
Stability (n = 10)
Chi
ld- P
ugh
Scor
e
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•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
Forman, Gastroenterology 2002
High risk of recurrence
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What Type of Treatment ( France 2012)?
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Peg IFN/RBV/Tela
Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/Tid
2nd Treatment
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2nd Treatment
Peg IFN/RBV/Tela
Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/Tid
0
1
2
3
4
5
6
7
8
W4 W8 W12
log
log
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2nd treatment
Peg IFN/RBV/Tela
Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/Tid
0
1
2
3
4
5
6
7
8
W4 W8 W12
log
log
STOP
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2nd Treatment
Peg IFN/RBV/Tela
0
1
2
3
4
5
6
7
8
W4 W8 W12
log STOP
Mutation R155K
Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/Tid
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2nd Treatment
Peg IFN/RBV/Tela
Peg α2a: 180 μg/w RBV: 1000 mg/d (15mg/Kg) Telaprevir: 750 mg/Tid
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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
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3rd Treatment before LT?
2005 Non responder
Peg IFN/RBV Peg IFN/RBV/Tela
2012 Non responder
R155K
?
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3rd Treatment before LT?
SOF/RBV?
SOF/SIM? SOF/DCV?
SOF/LDV? Omb-ABT450/r Dasa+RBV?
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3rd treatment before LT?
SOF/RBV?
Osinusi A et al. Jama 2013
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3rd treatment before LT?
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
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3rd Treatment before LT?
SOF/SIM?
www.hcvforum.org
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3rd treatment before LT?
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
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SOF/DCV SVR12%
Sukowski M et al.NEJM 2014
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3rd Treatment before LT?
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
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3rd treatment before LT?
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
NOT AVAILABLE AT THAT
TIME IN FRANCE
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3rd Treatment before LT?
2005 Non responder
Peg IFN/RBV Peg IFN/RBV/Tela
2012 Non responder
R155K
SOF/ DCV
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3rd Treatment
Sofosbuvir Daclatasvir
SOF= 400mg/d DCV= 60mg/d
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3rd Treatment
Sofosbuvir Daclatasvir
SOF= 400mg/d DCV= 60mg/d
STOP
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3rd Treatment
Sofosbuvir Daclatasvir
SOF= 400mg/d DCV= 60mg/d
STOP
Mutation 31M,58P
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3rd treatment
Sofosbuvir Daclatasvir
Mutation 31M,58P
http://www.genafor.org
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3rd treatment
Sofosbuvir Daclatasvir Mutation
31M,58P
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Finally..
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
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Finally..
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
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Finally..
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
Virological Resistance
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Finally..
SOF/RBV?
SOF/SIM?
SOF/DCV?
SOF/LDV?
Omb-ABT450/r Dasa+ RBV?
Virological Resistance
Virological Resistance
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And Now?
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Resistant variants
Potent antiviral therapy eliminates sensitive variants
Resistant variants can expand
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Resistant variants
Potent antiviral therapy eliminates sensitive variants
Persistance of resistant virus
Return to pre-treatment status
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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
Sullivan et al, CID 2013
For telaprevir, 60-89% of patients no longer had detectable resistant variants after a median FU of 10,6 months for G1a
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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?