DIFFERENTIAL BENEFITS OF DAAs IN DIFFERENT PATIENT POPULATIONS. IN PATIENTS ON A WAITING LIST FOR TRANSPLANTATION. THE CLINIC.
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1 DIFFERENTIAL BENEFITS OF DAAs IN DIFFERENT PATIENT POPULATIONS. IN PATIENTS ON A WAITING LIST FOR TRANSPLANTATION. THE CLINIC. Robert J. de Knegt, Erasmus MC, Rotterdam r.deknegt@erasmusmc.nl
2 Disclosures Honoraria for consulting or speaking (last 5 years): AbbVie, BMS, Gilead, Janssen-Cilag, Medtronic, Merck/Schering-Plough, Norgine, Roche Research grants (last 5 years): BMS, Janssen Cilag, Medtronic, Roche
3 1. Why should we treat? 2. Who should we treat? 3. How should we treat? 4. No time to waste or wait to treat, i.e. after liver transplantation?
4 1. Why should we treat?
5 HCV is a slowly progressing disease (Fast) Rate of disease progression (Slow) Persistently normal ALT, normal coffee intake Normal liver Acute infection Infection resolves spontaneously (20%) Chronic infection (80%) 30~30+ years after infection Stable hepatitis (80%) Chronic hepatitis 20 years after infection Males, alcohol use, HCV genotype 3, steatosis, obesitas, older age at infection, co-infection with HIV or HBV Cirrhosis Decompensation HCC LIVER RELATED DEATH
6 After liver transplantation HCV is a rapidly progressing disease Survival (%) Cholestatic/AIH Cryptogenic HBV Alcoholic HCV HCV Recipients with HCV have 30% higher mortality at 5 yrs Yrs ELTR- 1/ /2001 Forman LM, et al. Gastroenterology. 2002;122:
7 2. Who should we treat?
8 Characteristics of patients on the waiting-list for liver transplantation Patients with compensated cirrhosis: - Child-Pugh A, low MELD-score - Hepatocellular carcinoma Patients with decompensated cirrhosis - Child-Pugh B-C, high MELD-score - ascites, portal hypertension, low nutritional status etc.
9 3. How should we treat?
10 The goal of antiviral therapy SVR is not the goal of antiviral therapy We treat patients in order to: Increase health-related quality of life Reduce liver-related morbidity Improve life expectancy
11 Patient and compound characteristics affecting choice of therapy Severity of liver disease (Child-Pugh A, B, vs. C) Previous treatment (peg/riba failure, PI-failure) HCV genotype SVR rates vs. body of evidence
12 DAAs in HCV liver cirrhosis Current situation Compounds Genotype CP-A CP-B/C Evidence SOF/RIBA GT %/12w Moderate GT %/24w Moderate SOF/LDP/RIBA GT %/12w+RIB A %/24w+RIB A GT1 and GT4:86-90%, low High High SOF/SIM/RIBA GT1, Target 80-88% <75% High Cosmos % Low SOF/DAC/riba GT % High 3D/riba GT1 92%/12w High 97%/24w High
13 DAAs in HCV liver cirrhosis Longer duration of therapy 24 weeks and/or addition of ribavirin: Peg/riba non-responders with IL28B TT GT1a vs. GT1b Previous null-responders to peg/riba
14 Clinical cases, patient 1 48-year old man, GT3 Previous alcohol abuse HCC/RFA, recurrent HCC Relapse after peg/riba Treatment?
15 DAAs in HCV liver cirrhosis Current situation Compounds Genotype CP-A CP-B/C Evidence SOF/RIBA GT %/12w Moderate GT %/24w Moderate SOF/LDP/RIBA GT %/12w+RIBA %/24w+RIBA GT1 and GT4:86-90%, low High High SOF/SIM/RIBA GT1, Target 80-88% <75% High Cosmos % Low SOF/DAC/riba GT % High 3D/riba GT1 92%/12w High 97%/24w High
16 Clinical cases, patient 2 62-year old female, GT1b Controlled ascites/diuretics, 2x variceal bleeding Thrombocytes 70x10log9; albumin 36 g/l; bilirubin 58 mcmol/l; INR 1,2;creatin 82 mcmol/l. CPB8/MELD13. Breakthrough telaprevir/peg/riba Treatment?
17 DAAs in HCV liver cirrhosis Current situation Compounds Genotype CP-A CP-B/C Evidence SOF/RIBA GT %/12w Moderate GT %/24w Moderate SOF/LDP/RIBA GT %/12w+RIBA %/24w+RIBA GT1 and GT4:86-90%, low High High SOF/SIM/RIBA GT1, Target 80-88% <75% High Cosmos % Low SOF/DAC/riba GT % High 3D/riba GT1 92%/12w High 97%/24w High
18 Clinical cases, patient 3 62-year old female, GT1a HCC/RFA, recurrent HCC Thrombocytes 70x10log9; albumin 36 g/l; bilirubin 36 mcmol/l; INR 1,2;creatin 67 mcmol/l. CPA6/MELD11. Breakthrough telaprevir/peg/riba Treatment? Would you determine Q80K?
19 DAAs in HCV liver cirrhosis Current situation Compounds Genotype CP-A CP-B/C Evidence SOF/RIBA GT %/12w Moderate GT %/24w Moderate SOF/LDP/RIBA GT %/12w+RIBA %/24w+RIBA GT1 and GT4:86-90%, low High High SOF/SIM/RIBA GT1, Target 80-88% <75% High Cosmos % Low SOF/DAC/riba GT % High 3D/riba GT1 92%/12w High 97%/24w High
20 4. No time to waste or treat after liver transplantation?
21 DAAs in HCV liver cirrhosis Data in decompensated cirrhosis scarce Compounds Genotype CP-A CP-B/C Evidence SOF/RIBA GT %/12w Moderate GT %/24w Moderate SOF/LDP/RIBA GT %/12w+RIBA %/24w+RIBA GT1 and GT4:86-90%, low High High SOF/SIM/RIBA GT1, Target 80-88% <75% High Cosmos % Low SOF/DAC/riba GT % High 3D/riba GT1 92%/12w High 97%/24w High
22 See the forest for the trees
23 NEJM
24 NEJM
25 NEJM
26 NEJM
27 NEJM
28 NEJM
29 NEJM
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