Therapy of decompensated cirrhosis Pre-transplant for HBV and HCV

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1 Therapy of decompensated cirrhosis Pre-transplant for HBV and HCV Universitätsklinikum Leipzig Thomas Berg Sektion Hepatologie Klinik und Poliklinik für Gastroenterologie und Rheumatologie Leber- und Studienzentrum am Checkpoint, Berlin

2 Therapy of decompensated cirrhosis Pre-transplant for HBV and HCV Topics 1. Who should be treated? 2. How treatment regimen? 3. Efficacy effect on long-term prognosis - Prevention of liver transplantation? 4. Predictors of response? 5. Safety

3 Actuarial Survival in HBV End Stage Liver Disease 100 Historical Comparisons 80 Patients surviving (%) 60 Cirrhosis 2 55% Decompensated cirrhosis 3 14% Years Perrillo et al., , Weissberg et al., , and De Jongh et al.,

4 Patients With End Stage Chronic Hepatitis B Treated with Lamivudine Median 4 2 Median Albumin (g/dl) 3.5 Bilirubin (mg/dl) Baseline n= 27 n=22 n=17 Weeks of Therapy Perrillo et al. Hepatology 2001

5 Actuarial Survival in HBV End Stage Liver Disease Historical Comparisons 100 Lamivudine in decompensated CHB % Patients surviving (%) 60 Cirrhosis 2 55% Decompensated cirrhosis 3 14% Years Perrillo et al., , Weissberg et al., , and De Jongh et al.,

6 Treatment of acute on chronic liver failure due to HBV reactivation: A placebo controlled trial Gark H et al. Hepatology 2011; 53:

7 NUCs - Lamivudine (LMV) and Entecavir (ETV) in decompensated HBV cirrhosis: predictors of survival 51 Hyun JJ et al. Liver Int 2012; 32: 656

8 Decline in the number of patients placed on the liver transplantation waiting list for hepatitis B-related indications in the US Kim WR. Hepatology 2009;49:S28-S Patients on Waitlist, n Patients on the liver transplantation list due to: End-stage Cirrhosis HCC Acute Liver Failure HBV end-stage cirrhosis HCC Year

9 HCC risk during long-term NUC treatment? Papatheodoridis G et al. Gut 2011; 60: 1109 % Patients with HCC ,2 0,6 5,9 Greece HEPNET Greece cohort study; N=818 Chronic Hepatitis B, no cirrhosis compensated Cirrhose (n=160) Decompensated Cirrhose (n=56) 1 2,7 10,6 (n=517) Years on treatment (HBeAg negativ > 12 months on treatment starting with lamivudine) 1,7 6,8 13,9 3,2 9,2 19,3

10 Charakteristics of different HBV nucleos(t)id analogues Nucleosid analogue Nucleotid analogue Antiviral potency LdT (Sebivo ) Lam (Zeffix ) ADV TDF ETV (Viread *) (Baraclude ) (Hepsera ) Genetic barrier

11 Charakteristics of different HBV nucleos(t)id analogues Nucleosid analogue Nucleotid analogue Antiviral potency The optimal oral antiviral agent to use TDF ETV in patients LdT with decompensated HBV (Sebivo ) Lam (Zeffix ) ADV (Viread *) (Baraclude ) cirrhosis remains unclear (Hepsera ) Genetic barrier

12 Current HCV treatment in decompensated disease Pitfalls 1. Very low response in HCV genotype 1 2. PEG-IFN and RBV poorly tolerated 3. Risk for serious complications (infections) 4. Prolonged duration of treatment 5. Use pre-transplantation is off-label

13 Lamivudine (LMV) vs. Entecavir (ETV) in decompensated HBV cirrhosis Undetectable HBV DNA Viral breakthrough 51 Hyun JJ et al. Liver Int 2012; 32: 656

14 Lamivudine (LMV) vs. Entecavir (ETV) in decompensated HBV cirrhosis: Survival 51 Hyun JJ et al. Liver Int 2012; 32: 656

15 Efficacy of different nucleos(t)ide analogs in patients with decompensated HBV liver cirrhosis HBV DNA < 400 cop/ml 51 Liaw Y-F et al. Hepatology 2011; 53:62

16 Renal safety of different nucleos(t)die analog regimens in patients with decompensated liver cirrhosis 51 Liaw Y-F et al. Hepatology 2011; 53:62

17 Lactic acidosis during entecavir treatment in patients with decompensated cirrhosis Lange C et al. Hepatology 2009; 50: 2001 Lactate (mg/dl) / Creatinine-Clearance ETV TDF ph L C p Lactate Creatinine-Clearance ph Day of ETV treatment Patient D ETV, entecavir TDF, tenofovir disoproxil fumarate

18 Lactic acidosis during entecavir treatment in patients with decompensated cirrhosis Lange C et al. Hepatology 2009; 50: 2001 MELD score 22 (22, 25, 28, 29, 38) No lactic acidosis n=11 lactic acidosis n=5 Lactic acidosis reversible after entecavir discontinuation: n=4 Lethal outcome: n=1 (fulminant liver failure is a differential diagnosis) MELD score < 22 (6-17) Development of lactic acidosis correlated with the MELD score and its single parameters INR, bilirubin, creatinine (p<0.005 each)

19 Summary 5. The preventive effect of NUC therapy in HCC development has yet to be convincingly demonstrated Peng C-Y et al. J Hepatol 2012; 57: Oral antiviral agents are safe and effective in restoring liver function and improving patient survival, especially if therapy is initiated early enough 2. The clinical improvement can result in withdrawal from transplant list 3. Entecavir and tenofovir are first line drugs considering efficacy and resistance profile 4. In the era of NUCs, interferon is contraindicated in this patient population

20 Current antiviral treatment modalities in patients with (de)compensated HCV cirrhosis before transplantation 51 Roche B and Samuel D. Liver Int 2012; 32 (Suppl 1):120

21 Goals of treatment 1. SVR: Halt disease progression (avoid LTx?) 2. Prevent HCV recurrence (protect graft) pre-transplant virologic response = posttransplant virologic response

22 Experience of dual combination therapy in patients with decompensated HCV cirrhosis berfore transplantation Outcome Percentage of patients SVR 20% SVR in MELD > 18 0% Dose reductions 49% Discontinuation 43% Bacterial infections 25% in MELD > 18/ Child C 46-50% Septic schock 10% 51 Iacobellis A et al. J Hepatol 2007; 46:206; Carrion JA et al. J Hepatol 2009; 50:719

23 Clinical decompensation on Peg-IFNa/RBV according to the stage of the HCV disease Clinical decompensation on-treatment Range 0-3% Range 9-60% Vezali et al. Clin Therap 2010; 32:2117

24 Long-term survival in patients with decompensated HCV cirrhosis after antiviral therapy: SVR makes the difference 51 Iacobellis A et al. Clin Gastroenterol Hepatol 2011; 9:6249

25 Decompensated HCV cirrhosis after antiviral therapy: Incidence of decompensation events and death during follow-up according to SVR status 51 Iacobellis A et al. Clin Gastroenterol Hepatol 2011; 9:6249

26 Potential treatment candidates: listed with HCV Very sick, high MELD Multiple clinical complications MELD > 25 Hospital-bound Sick, low MELD Ascites, encephalopathy, MELD < 25 (typically < 15) Wounded, not working Not sick, HCC upgrade No or few clinical complications Disease MELD typically < 15 At home, working

27 Can succesful treatment avoid transplant? Very sick, high MELD Multiple clinical complications MELD > 25 Hospital-bound Sick, low MELD Ascites, encephalopathy, MELD < 25 (typically < 15) Wounded, not working Not sick, HCC upgrade No or few clinical complications Disease MELD typically < 15 At home, working Antiviral treatment eradicates HCV NO Maybe NO

28 Who can we treat with PEG-IFNa/RBV? Very sick, high MELD Multiple clinical complications MELD > 25 Hospital-bound Sick, low MELD Ascites, encephalopathy, MELD < 25 (typically < 15) Wounded, not working Not sick, HCC upgrade No or few clinical complications Disease MELD typically < 15 At home, working The Achille s heel tolerability and safety NO Maybe, LDLT, Favorable predictors YES

29 Treatment of cirrhosis with Boceprevir and Telaprevir Triple regimens 100 Boceprevir Telaprevir On-treatment response rates HCV RNA negative (%) Week 4 of TT Week 12 of TT Herode C, et al. 2012

30 Treatment of cirrhosis with Boceprevir and Telaprevir Triple regimens 100 Boceprevir Telaprevir On-treatment response rates HCV RNA negative (%) Treatment-associated mortality ~ 2% Week 4 of TT Week 12 of TT Herode C, et al. 2012

31 Who can we treat IFN-free regimens Very sick, high MELD Multiple clinical complications MELD > 25 Hospital-bound Sick, low MELD Ascites, encephalopathy, MELD < 25 (typically < 15) Wounded, not working Not sick, HCC upgrade No or few clinical complications Disease MELD typically < 15 At home, working The Achille s heel bioavailability YES YES YES

32 Antiviral treatment modalities in patients with (de)compensated HCV cirrhosis before transplantation achieving SVR avoid transplantation transplantation No post-transplant mortality risk Mortality risk! achieving response - avoid reinfection transplantation + post-transplant mortality risk! transplantation Treat reinfection

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