Management of hepatitis C: pre- and post-liver transplantation. Piyawat Komolmit Bangkok

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1 Management of hepatitis C: pre- and post-liver transplantation Piyawat Komolmit Bangkok

2 Liver transplantation and CHC Cirrhosis secondary to HCV is the leading cause of liver transplantation in the US and other regions Infection of the allograft by HCV is inevitable after transplantation into an HCV-infected recipient 10 21% of recipients have fibrosis/cirrhosis at 5 years after transplant Fibrosing cholestatic hepatitis occurs in up to 10% of patients post-transplant, and leads to accelerated allograft failure and death ESLD = end-stage liver disease Forman LM, et al. Gastroenterology 2002; 122: 889

3 HCV infection is a major cause of liver transplantation in the Asia-Pacific area China Japan HBV 79% Other 14% Thailand: Chula HCV 7% Other 62% Australia HBV 17% HCV 21% Other 21% HBV 39% HCV 40% Other 72% HCV 19% HBV 9% Chinese registry (CLRT) 2006 Australian National Liver Transplantation Unit 2006 Morioka, et al., Ann Surg, 2007

4 Frequency of liver transplant (LT) due to HCV in Chulalongkorn University Hospital (Jan 2003 May 2011) n=79 n=29 HBV (31) 39% Others (19) 24% HCV (29) 37% HCC 66% Decompensatio n 34% Indications for LT in HCV cirrhosis Komolmit P, et al. Data on file

5 Controlling HCV in patients undergoing liver transplantation Listed Transplant Chronic hepatitis Graft loss Biggins SW, Terrault NA. Infect Dis Clin N Am 2006; 20: 155

6 Controlling HCV in patients undergoing liver transplantation Listed Transplant Chronic hepatitis Graft loss Prevent graft infection Pre-transplant anti-viral therapy Biggins SW, Terrault NA. Infect Dis Clin N Am 2006; 20: 155

7 Controlling HCV in patients undergoing liver transplantation Listed Transplant Chronic hepatitis Graft loss Prevent graft infection Prevent infection or risk of disease progression Pre-transplant anti-viral therapy Prophylactic or pre-emptive therapies Biggins SW, Terrault NA. Infect Dis Clin N Am 2006; 20: 155

8 Controlling HCV in patients undergoing liver transplantation Listed Transplant Chronic hepatitis Graft loss Prevent graft infection Prevent infection or risk of disease progression Prevent cirrhosis and graft failure Pre-transplant anti-viral therapy Prophylactic or pre-emptive therapies Antiviral therapy for recurrent disease Biggins SW, Terrault NA. Infect Dis Clin N Am 2006; 20: 155

9 Controlling HCV in patients undergoing liver transplantation Listed Transplant Chronic hepatitis Graft loss Prevent graft infection Prevent infection or risk of disease progression Prevent cirrhosis and graft failure Pre-transplant anti-viral therapy Prophylactic or pre-emptive therapies Antiviral therapy for recurrent disease Re-transplant Biggins SW, Terrault NA. Infect Dis Clin N Am 2006; 20: 155

10 Case study

11 Case history 51-year-old Thai male Weight: 65 kg (BMI: 23.1) Presented with fatigue and leg edema Moderate ascites, prescribed diuretics Diagnosed with HCV HCV genotype: 3a HCV viral load: > IU/mL Platelets: /µL; bilirubin: 3 mg/dl ALT: 145 IU/L; Alb: 2.8 g/dl INR: 1.4 Creatinine: 1.2 mg/dl CTP score: C; MELD score: 16 CTP = Child-Turcotte-Pugh; INR = International Normalized Ratio MELD = model for end-stage liver disease

12 QUESTION

13 What treatment would you prescribe for this patient? 1 Supportive care and prevention of complications 2 Immediate treatment 3 Immediate treatment and place patient on transplant list 4 Place patient on transplant list, but do not treat

14 If you selected to treat this patient for HCV now, what could you expect?

15 HCV treatment before liver transplant Goals Achieve an SVR Stop disease progression Prevent post-transplantation recurrence of HCV Everson GT. Hepatology 2005; 42: 456

16 Patients (%) SVR in pre-lt patients receiving LADR IFN -2b or Peg-IFN -2b plus RBV (treatment-naive patients)* Peg-IFN -2a or Peg-IFN -2b plus RBV (relapsers) n= G1 Non-G1 * IFN -2b (1.5 MU three times a week) or Peg-IFN -2b (0.5 µg/kg/wk) plus RBV (600 mg/day) Peg-IFN -2a (90 µg/wk initially, every 2 wks) or Peg-IFN -2b (0.5 µg/kg/wk) plus RBV (600 mg/day) LADR = low accelerating dosage regimen Everson GT. Hepatology 2005; 42: 456

17 The majority of patients clearing HCV RNA pre-lt remain HCV RNA clear post-lt Event Post-transplantation (n=47) Pre-transplantation RNA-positive RNA-negative RNA-positive (32) 32 0 RNA-negative (15) 3 12 (80%) 100% of patients RNA-positive pre-transplant recurred post-transplant 80% of patients RNA-negative pre-transplant remained negative post-transplant None of the patients who had LDLT experienced recurrence LDLT = living donor liver transplantation Everson GT. Hepatology 2005; 42: 456

18 The majority of patients clearing HCV RNA pre-lt remain HCV RNA clear post-lt Event Post-transplantation (n=47) Pre-transplantation RNA-positive RNA-negative RNA-positive (32) 32 0 RNA-negative (15) 3 12 (80%) 100% of patients RNA-positive pre-transplant recurred post-transplant 80% of patients RNA-negative pre-transplant remained negative post-transplant None of the patients who had LDLT experienced recurrence LDLT = living donor liver transplantation Everson GT. Hepatology 2005; 42: 456

19 The majority of patients clearing HCV RNA pre-lt remain HCV RNA clear post-lt Event Post-transplantation (n=47) Pre-transplantation RNA-positive RNA-negative RNA-positive (32) 32 0 RNA-negative (15) 3 12 (80%) 100% of patients RNA-positive pre-transplant recurred post-transplant 80% of patients RNA-negative pre-transplant remained negative post-transplant None of the patients who had LDLT experienced recurrence LDLT = living donor liver transplantation Everson GT. Hepatology 2005; 42: 456

20 Clinically significant adverse events in patients receiving LADR Adverse events occurred in only 6% of patients (15/124) Encephalopathy Sepsis Worsening ascites GI bleeding Pulmonary embolism Pneumonia Venous thrombosis Death (4) Everson GT. Hepatology 2005; 42: 456

21 Treatment decision Patient was placed on a transplant list, but it was decided not to treat HCV at this point

22 Follow-up: patient had DDLT 6 months later Liver transplantation was successful without any complications Immunosuppressive drugs: Cyclosporine, mycophenolate, short course of prednisolone HCV RNA at week 3 post-lt was > IU/mL LFT at week 3 was normal DDLT = deceased donor liver transplantation; LFT = liver function test

23 HCV post-liver transplant Universally recurrent Acute hepatitis within 1 4 months of liver transplant Chronic hepatitis within 2 3 months of liver transplant 60 80% chronic hepatitis Fibrosing cholestatic hepatitis: 2 8% Accelerated course of disease Shorter time to cirrhosis 5-year rate of cirrhosis 10 25% Increased risk of decompensation (42% in 1 year) 1. Gane E, et al. N Engl J Med 1996; 334: Sanchez-Fueyo A, et al. Transplantation 2002; 73: Samuel D, et al. Gastroenterology 2003; 124: Dumortier J, et al. J Hepatol 2004; 40: 669

24 QUESTION

25 What would you do next for this post-transplant recurrent HCV? 1 Pre-emptive or prophylactic treatment Protocol treatment in every case of post-lt recurrent HCV Treatment when patient develops significant clinical or pathologic evidence of CHC No treatment and wait for re-transplantation if indicated

26 If you selected prophylactic (pre-emptive) treatment, what could you expect?

27 Patients with undetectable HCV RNA (%) Prophylactic treatment after liver transplant for HCV: Peg-IFN -2a plus ribavirin Prophylaxis arm (n=54)* Observation arm switched to treatment (n=14) * Peg-IFN -2a 135 µg/week for 4 wks, then 180 µg/week for 44 weeks plus RBV mg/day; Same regimen as for prophylaxis arm, but only upon significant HCV recurrence RVR cevr 24 weeks undetectable 48 weeks undetectable SVR Bzowej N. Liver Transpl 2011; 17: 528

28 Patients with undetectable HCV RNA (%) Prophylactic treatment after liver transplant for HCV: Peg-IFN -2a plus ribavirin Prophylaxis arm (n=54)* Observation arm switched to treatment (n=14) * Peg-IFN -2a 135 µg/week for 4 wks, then 180 µg/week for 44 weeks plus RBV mg/day; Same regimen as for prophylaxis arm, but only upon significant HCV recurrence RVR cevr 24 weeks undetectable 48 weeks undetectable SVR Bzowej N. Liver Transpl 2011; 17: 528

29 Treatment decision It was decided to treat for HCV when the patient developed significant clinical or pathologic evidence of chronic hepatitis C

30 18 months post-lt: Liver biopsy result: Lobular inflammation Portal inflammation Moderate fatty liver Focal bridging fibrosis HAI score: (Near cirrhosis) Patient was prescribed Peg-IFN -2a 180 µg/wk plus ribavirin 800 mg/day for 48 weeks HAI = histologic activity index

31 Patient s treatment outcome HCV RNA undetectable (<50 IU/mL) at 3 and 6 months Patient achieved SVR Nearly 8 years post-lt, the patient is healthy without recurrence of HCV

32 SVR rates in treatment of post-liver transplant recurrent hepatitis Regimen SVR (%) Discontinuations (%) IFN IFN + RBV Peg-IFN Peg-IFN + RBV Arjal RR, et al. Aliment Pharmacol Ther 2007; 26: 140

33

34 Q&A

35 Conclusions (i) Peg-IFN-based treatment in combination with ribavirin can minimize recurrence after liver transplantation LADR of Peg-IFN/IFN plus RBV may render blood free of HCV RNA, stabilize clinical course, and prevent post-transplantation recurrence Prophylactic treatment after liver transplant could potentially reduce the risk of HCV recurrence

36 Conclusions (ii) Treatment of post-lt CHC with Peg-IFN/RBV is effective Selection of patients who require treatment is mandatory Requires experience in management of complications Inform and gain consent before drug therapy as serious or fatal complications may happen

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