Hepatitis B. What's the impact on the risk? Dr Himanshu Bhatia, Asia Chief Medical Officer ALUCA, Brisbane, Sept 2013

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1 Hepatitis B What's the impact on the risk? Dr Himanshu Bhatia, Asia Chief Medical Officer ALUCA, Brisbane, Sept 2013

2 Some quick facts about Hepatitis B Worldwide: Million are chronic infections with long term morbidity 100x as infectious as HIV,10x as infectious as HCV 75% of these individuals are in Asia and western Pacific, China alone has an estimated 90 million people chronically infected. Chief cause of cirrhosis & liver related death in world today over 600,000 deaths annually 2nd leading cause of cancer deaths after tobacco related cancers! 2

3 Hepatitis B Transmission Horizontal Transmission Sexual contact; Percutaneous Transmission IV drug use; Blood Transfusion and infection of Health Care workers Vertical Transmission : Mother to baby World wide mother to neonate (vertical) accounts for the majority of infections (90%)

4 Hepatitis B in Australia 104 Volume 32 NUM BER 4 AUGUST

5 Hepatitis B in Australia 5

6 Hepatitis B in Queensland 6

7 Blood tests for Hepatitis B infection HBsAg - surface antigen positive for > 6 months = Chronic Hepatitis B HBeAg E Antigen Indicator for viral replication and that the individual is highly infectious HbeAg is not a direct test to measure viral load, HBV DNA : a direct indicator or viral load Disease progression Suitability of treatment Risk marker for development of Cirrhosis and Hepatocellular CA 7

8 Chronic Hepatitis B Natural History Today Vassilopoulos, D. & Calabrese L. H. (2012 Nat. Rev. Rheumatol. doi: /nrrheum

9 Phase 1 Immune Tolerance Exclusively in those acquiring hepatitis B virus at birth Very common in Asian chronic hepatitis B cases Immune response to virus : nil to weak, so virus replicates fast HbeAg : Positive HBV DNA load : Very High in multiple million copies Impact on Liver : Nil to minimal Liver Biopsy : Normal ALT : Normal Treatment : Not required UW : Substandard Ratings are possible Many stay this phase for long periods and almost all move into the next phase 9

10 Phase 2 Immune Clearance (HbeAg Positive Chronic Hepatitis) This phase is seen adults and those who reach 2nd-3rd decade of neonatal infection Immune response to virus : strong: HbeAg : Positive HBV DNA load : Moderate : copies/ml Impact on liver : Significant Liver biopsy : Evidence of inflammation, fibrosis ALT : Elevated Treatment : Ideal candidates for treatment Underwriting : Varies from rateable to decline 10

11 Progression to Advanced Liver Disease 11

12 HBV DNA Levels and Risk of Cirrhosis Higher Baseline HBV DNA has increased risk of progression to cirrhosis - Relationship independent of HBeAg status HBeAg-Positive Patients P < P < BL HBV DNA, c/ml : < 104 (n = 2132) Cases of Cirrhosis: 104 Adjusted RR* Adjusted RR* HBeAg-Negative Patients P < P < P = NS to < (n = 631) (n = 451) < to < (n = 22) (n = 18) (n = 520) * With 42,115 patient-yrs of follow-up and adjusted for sex, age, anti-hcv levels, smoking, and alcohol use. 1 IU/mL equals approximately 5.6 genomes/ml. Chen CJ, et al. EASL Abstract

13 HBV DNA Levels and risk of Hepatocellular Carcinoma 10x 2-3x Chen CJ, Yang HI, Su J, et al, Jama 2006;295:

14 Chronic Hepatitis B Natural History Today Vassilopoulos, D. & Calabrese L. H. (2012 Nat. Rev. Rheumatol. doi: /nrrheum

15 Phase 3 Low or non-replicative (Inactive Carrier) Immune Response :Successful clearance of HbeAg due to spontaneous response or due to treatment HbeAg : Negative HBV DNA : Very low or undetectable Impact on liver : Lowered Liver Biopsy : Improvement ALT : Normalisation Treatment : No, but requires close surveillance UW : We love this stage! 5-10% of cases REVERT back to being HbeAg +VE. Every failed attempt to eradicate virus causes additional liver damage 15

16 Chronic Hepatitis B Natural History Today Vassilopoulos, D. & Calabrese L. H. (2012 Nat. Rev. Rheumatol. doi: /nrrheum

17 Phase 4 Reactivation HbeAg Negative Chronic Hepatitis Immune response : Pre core mutant, or due to treatment HbeAg : Negative HBV DNA : High Impact on liver : Significant Liver biopsy : Fibrosis++ ALT : Elevated E negative chronic hepatitis seen in older individuals, with more liver damage Do not revert back Require lifelong treatment Risk of Progression : High* Treatment : Requires treatment UW : Rate as chronic active hepatitis, even if HbeAg ve. Some may declined depending on overall risk factors * % have consistently elevated LFT, with % showing repeated flares 17

18 Chronic Hepatitis B Natural History Today Vassilopoulos, D. & Calabrese L. H. (2012 Nat. Rev. Rheumatol. doi: /nrrheum

19 What drugs are available today? 19

20 Treatment goals Inflammatory: to normalise serum ALT, biopsy Virologic: to decrease HBV DNA Immune: seroconversion from: HBeAg to HBeAb HBsAg to HBsAb HBV is generally not cured but controlled 20

21 Treatment response for HBeAg positive still some way to go 21

22 Treatment response for HBeAg negative still some way to go 22

23 Resistance is a big issue with hepatitis B treatment 23

24 Consider issues relating to Antiviral resistance in cases on Treatment 80 Lamivudine1 70% 65% Incidence of resistance (%) Adefovir2 60 Entecavir (LAM-resistant)3 53% Entecavir (naive)3 *** Telbivudine4 42% 40% 40 29% 25% 24% 20% 20 18% 15% 12% 11% 5% 0 0.3% 2% 0.1% 0% Year 1 Year % 0.8% Year 3 2 Year 4 Year 5 3 Lai, Clin Infect Dis 2003; Westland, Hepatology 2003; Colonno R, EASL 2007; 4 Gane, EASL Slide 25

25 Key Messages Chronic hepatitis B pattern is variable and unstable. Recognise the stage based on current evidence. Serial testing is helpful Viral load reduction and elimination is the holy grail of treatment (ie not loss of HbeAg or HbsAg). Look for evidence of viral load reductions Risk Factors for development of HCC are clearly known. Adjust decisions accordingly Treatment is likely to reduce the risk, but the risk of resistance is a concern. Know the drug outcomes 25

26 New Hepatitis Ratings in Life Guide Differentiation by endemic / non endemic regions removed Removal of age differential rating ( <20 yrs, vs > 20 yrs) in order to simplify rating structure 3 main considerations Treatment status Never treated with antiviral drugs Currently undergoing treatment Treatment completed Ratings continue to be dependent upon the HBeAg status and ALT Additional factors like HBV viral load, diabetes, AFP, GGT, alcohol abuse, family history of liver cancer Clear guidance on underwriting cases currently on treatment, allowing for more cases to be accepted. Ratings lower chronic hepatitis) in many areas, and slight increase in some (eg HbeAg negative 26

27 CI/DI Ratings- Previous LG For Critical Illness and Disability Income, ALT >1.3x = Decline 27

28 Critical Illness / Disability Income ratings For Critical Illness and Disability Income, the band up to which cases can be accepted has been increased from 1.3x to 3x, (subject to HBV DNA being available) allowing more CI/DI cases to be accepted Chronic hepatitis B : HBV DNA unknown or older than 6 months AND ALT/AST > 1.3x Moderate or severe hepatitis and/or fibrosis, cirrhosis or HCC Mild***: Never treated with anti-viral drugs: HBeAg positive HBeAg negative HBeAg status unknown D D ALT/AST 1.3x* ALT/AST 1.4x - 3x* ALT/AST 3x* **/ D +150 D +150 D 28

29 Thank you

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