Landmarks for Prevention and Treatment

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1 HBeAg-positive chronic hepatitis B Why do I treat my patient with a nucleos(t)ide analogue? Dr. Nancy Leung BSc(Lon) MSc(Lon) MBBS(Lon) MD(Lon), FRCP(Lon) FRCP(Edin) FHKCP FHKAM Consultant Physician, Alice Ho Miu Ling Nethersole Hospital Adjunct Associate Professor, the Chinese University of Hong Kong

2 WHY NOT!! Efficacious! Safe! Cost effective!

3 Landmarks for Prevention and Treatment HBV Vaccine Universal vaccination for newborns +/- HBIG Tenofovir Telbivudine Entecavir α-interferon Lamivudine Adefovir Pegylated Interferon α-2a

4 Milestones and Goals for Therapy Serum HBV DNA RT-PCR negative Maintained suppression on therapy Sustained suppression off therapy HBeAg loss or seroconversion HBsAg loss ALT Normal ization Improve Histology Regain Quality Of life

5 e-neg CHB Lok AS NEJM 22

6 Increasing age, persistent HBeAg positivity higher incidence of cirrhosis and HCC (3.5%/ yr), even in asymptomatic subjects Lok AS NEJM 22

7 Spectrum of HBV Disease in Clinical Practices Immune Clearance Immune tolerant Immunocompromise Transplant HCC Decompensated cirrhosis Inactive carrier state Compensated cirrhosis e-neg CHB

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9 More natural history data: Delayed HBeAg seroconversion >Age 4 Significantly Higher Risk of e-neg CHB, Cirrhosis, and HCC N= 483, no evidence of cirrhosis i or HCC at time of HBeAg seroconversion 15-year cumulative incidences HBeAg-negative hepatitis Cirrhosis HCC (A) e-sero before %, 3.7%, 2.1%, (C) e-sero after % 42.9% 7.7% (P <.1) (P <.1) (P =.29) Hazard ratio (C) vs (A) Chen YC et al Hepatology 21 51(2):

10 WHICH NA? Efficacious! Safe! Cost effective!

11 Lamivudine HBeAg seroconversion over 5 years of treatment in patients with elevated ALT Seroconversion = HBeAg-ve and HBeAb+ve Patients (%) Duration of therapy (years) 77 ALT >1 X ULN (n=41) ALT >2 X ULN (n=26)

12 Effect of Lamivudine on Disease Progression and Development of Liver Cancer in Advanced CHB: N=651 Randomized double blind placebo control trial Study terminated at second interim analysis Lamivudine Placebo 2 P< P=.47 4 Disease progression HCC Liaw YF et al N Engl J Med 23

13 Adefovir dipivoxil: Increasing HBeAg Serological Response with Prolonged Treatment* 2-5% of patients failed to achieve 2log1 reduction in serum HBV DNA 1 Year 1 (n = 296) Year 2 (n = 231) Year 3 (n = 84) 8 Patien ts (%) % 53% 33% 46% 2 23% 14% HBeAg Loss HBeAg Seroconversion *Kaplan Meier estimates Marcellin P et al EASL 25

14 Cumulative HBeAg Seroconversion over 3 Years GLOBE Telbivudine Study Among CHB Patients Achieving HBV DNA <3 cpm by Week Week 52 Week 14 Week /111 55/111 64/ patients stopped therapy 24 weeks after HBeAg seroconversion + HBV DNA <3cpm. 84% sustained response in one year. Gane E et al In Press

15 Entecavir - % of Patients Achieving HBV DNA < 3 copies/ml through h 5 Years ETV 22 HBeAg(+) ETV Long term Cohort (ETV 22 ETV 91) Proportio on of patie ents (%) HBV DNA <3 cop pies/ml Year 1 67% Year 1 Year 2 55% 83% Year 3 Year 4 89% 91% 4 Over 5 years, 4% e loss & 18 % e-seroconversion Pan et el AASLD 21 Year 5 94% n = 236/354 8/ /14 116/131 98/18 88/94 Chang TT, Lai CL et al (in preparation)

16 Entecavir -HBeAg & HBsAg Seroconversion Week 96 31% (11 / 354) HBeAg seroconversion 5% (18 / 354) HBsAg seroconversion Week 96 Year 5 23% (33 / 141) additional HBeAg seroconversion 1.4% (2 / 145) additional HBsAg seroconversion Chang TT, Lai CL et al (in preparation)

17 4 Years Tenofovir Therapy for HBeAg Positive CHB: Increasing Serological Response* *Kaplan Meier estimates % Patients s GS-US (HBeAg+) 17 HBeAg Loss % Patients HBeAg Seroconversion 1 5 S loss at year 3 was 8%, increased 5 to 15.2% at year 4 S loss 1% S seroconversion 7.5% e loss e sero Y1 Y2 Y3 Y4 Gordon SC et el AASLD Year Heathcoate J et al AASLD Year 99% and 96% maintained response at wk % HBsAg loss No resistance detected t d Stable creatinine levels Good tolerability. Gane E et al AASLD 21 Poster # 481 Heathcote J et al AASLD 21

18 Viral response usually followed by biochemical, histologic improvement, even regression of fibrosis Main Issue with NAs.. Drug Resistance

19 Drug Resistance 1 Lamivudine (Genotypic) HBeAg (+) 1 Adefovir (Genotypic) HBeAg (-) Pre evalence of res istance (% %) ive probab bility Year of treatment t t Year of treatmentt t Cumulat of res sistance (% %) Cumula ative inciden nce of re esistance (% %) Telbivudine (Viral rebound+genotypic) 5 3 HBeAg(+) HBeAg(-) Year of treatment bility %) ve Probab sistance (% Cumulati of Res Entecavir (Genotypic) HBeAg (+) and (-) <1% <1% 1% 1% Year of treatment Colonno RJ, et al. EASL, 27, Barcelona, Spain. Lok AS, et al. Gastroenterology 23;125: Borroto-Esoda K. J Hepatol 26;44(Suppl 2):S179 S18 (Poster 483). Standrigg DN, et al. J Hepatol 26;44(Suppl 2):S191(Poster 514). Lai CL, et al. Hepatology 26;44(Suppl 1):222A (Oral 91).

20 Hepatitis Flare Among Patients with Lamivudine Resistant Mutants for <1 to >4 Years vs Those Without 3-5xULN 5-1xULN >1xULN % w/any ALT Flare No YMDD <=1 >1-2 >2-3 >3-4 >4 No. at risk Duration of YMDD (Yrs) Lok et al 24

21 ADV Added to LAM in LAM-r Patients Genotypic resistance vs Virological Breakthrough log HBV-DNA at baseline genotypic resistance 3-6 monthly HBV DNA monitor during antiviral therapy to detect 1log1 cpm rise from nadir 6-8 log HBV-DNA at baseline Clinical breakthrough 4 2 >8 log HBV DNA at baseline p< Months Patients still at risk (Lampertico et al., Hepatology 25;42:

22 Early Viral Suppression Predicts Low Risk of Resistance h resistance % of patients wit 1% 1% 8% 6% 4% 2% % 8% Lamivudine in HBeAg+ CHB (FU 29 mths) 13% 32% 64% < 2 <3 log <4 log > 4 log HBV DNA at week 24 breakthrough % of patients with 8% 6% 4% 2% % 4% Adefovir in HBeAg neg CHB (FU 36 mths) 26% 67% <3 log 3-6 log > 6 log HBV DNA at week 48 Percen nt with Res sistance Telbivudine in HBeAg+ CHB (FU 14 wks) < QL QL to 4 > 4 HBV DNA at Week 24 Percen nt with Resista ance Telbivudine in HBeAg neg CHB (FU 14 wks) < QL QL to 4 > 4 HBV DNA at Week 24 Yuen M et al Hepatology 21; 34(4): Locarnini S et al J Hepat 25;42(Suppl 2):17. Di Bisceglie, et al. AASLD 26

23

24 No Resistance to Tenofovir Disoproxil Fumarate (TDF) Detected Following up to 192 Weeks of Treatment in Subjects Mono- Infected with Chronic Hepatitis B Virus A Snow-Lampart 1, K Kitrinos 1, B Chappell 1, F Myrick 1, J Schawalder 1, E J Heathcote 2, P Marcellin 3, and K Borroto-Esoda 1 1 Gilead Sciences, NC, USA; 2 Toronto General Hospital, Ontario, Canada; 3 Hospital Beaujon, Clichy, France 61 st Annual Meeting of the American Association for the Study of Liver Diseases October 29 - November 2, 21 Boston, Massachusetts, USA Poster # 1365

25 Individual courses of HBV DNA levels of 21 CHB patients with genotypic resistance to ADV during TDF monotherapy. (A) Courses of 1 patients who achieved HBV DNA levels 4 copies/ml (B) Courses of 11 patients who had detectable HBV DNA during the observation period At baseline, the mean HBV DNA level in group (A) was (4.6-9.) and group (B) 7.9 ( ) copies/ml (P.55) Month 12 mean HBV DNA level was (A) ( ) and (B) ( ) at months 12 (P.1), respectively. The pattern of the mutations associated with ADV resistance had no influence on the response to TDF treatment. Van Bommel et al Hepatology 21 51:73-81

26 WHY NOT!! Safe! SAFETY IN LONGTERM NOT PROVEN Telbivudine myopathy, neuropathy Adefovir renal tubular acidosis with hypophosphatemia; 3% of experienced increase creatinine after 4 to 5 years Tenofovir renal toxicity,? Osteoporosis Parameter Asians* (n = 163) Non-Asians* (n = 422) Grade 3/4 AEs 17 (1.4%) 5 (11.8%) AEs causing discontinuation 2 (1.2%) 5 (1.2%) Serious AEs 1 (6.1%) 61 (14%) Phosphorus < 2 mg/dl 1 (.6%) 6 (1.4%) Creatinine.5 mg/dl increase 1 (.6%) 4 (.9%) CrCl < 5 ml/min (%) 1 (.2%) Gane E et al AASLD 21 Poster # 481

27 WHY NOT!! Efficacious! Safe! Cost effective! Based on countries and regions Pricing of medication, lab tests, consultation How available is management schedule for secondary and tertiary complication e.g. transplantation

28 Hong Kong Cancer Registry for Liver Cancer: 9% related to HBV

29 My Personal Experience in Hong Kong 611 (4.3%) of 1515 CHB patients had been or are on antiviral therapy 258 (42.2%) of the treated patients were treatment naïve and and started entecavir 55 non responders to standard or pegylated interferon switched to entecavir therapy 98 participated in multicentre international clinical trials switched to entecavir after trial Ldt 1.47% TDF.33% ADV 8.84% Peg Interferon 5.73% Combo 6.87% Patient on treatment n=611 Entecavir 411 Lamivudine 58 Adefovir 54 LVD 9.49% ETV 67.27% Telbivudine 9 Tenofovir 2 Peg Interferon 35 Combo 42

30 My Personal Experience in Hong Kong E-seronconversion % for HbeAg +ve patients on Entecavir 5 e-seroconversion % 45 nversion % e-seroco < 1Yr > 1Yr > 2Yr > 3Yr > 4Yr e sero n(%) 1 (3%) 4 (26%) 26 (38%) 18 (46%) 3 (33%) On entecavir Years

31 STOP THERAPY 6-12M after HBeAg loss/serocon + serum HBV DNA neg or Maintained till HBsAg response loss /<1,IU/mL SVR relapse Serum off HBV therapy DNA neg for 1 to 2 years or till HBsAg loss/<1,iu/ml in e neg CHB When Viral to Response Stop Oral During Antiviral Anti-Viral Therapy Poor response Inadequate response early drug resistance drug resistance Anti-viral 1 7 Brunetto M AASLD 29 4 HBeAg seroconversion <2 YEARS

32 Why I treat HBeAg postive CHB with NA? Evidence based medicine Efficacy Maintained response Sustained response Safety Til Tailored dto idiid individual patient t Cost-effectiveness for patient t or healthcare system GOAL OF THERAPY

33

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