Treatment Strategies of Hepatitis B in China

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1 Treatment Strategies of Hepatitis B in China Guangbi Yao MD Shanghai Jing-An Qu Central Hospital

2 Characteristic features of CHB in China Huge amount of patients Infection during early life Maternal to infant transmission in about 30% Genotype : C, B Long immunotolerant period Insidious onset of cirrhosis and HCC Low income per capita and limited medical expenditure Awareness the importance of anti-hbv therapy Inadequate well trained medical personnels

3 Epidemiology HBsAg carrier rates in different time period Time Period 1992~ HBsAg Positive Rate 9.7% 8.2% 7.6%

4 Age Distribution of HBsAg Positive Rate of 1992 and HBsAg Positive Rate (%) ~ 2~ 3~ 4~ 5~ 6~ 10~ 15~ 20~30 Age (year)

5 HBsAg Prevalence in China Heilongjia ng Heilongjia ng Xinjiang Tibet Gansu Qinghai Shaxi Sichuan Hubei Zhejia ng HunanJiangxi Guizhou Fujian Yunnan Ningx ia Chongqing Guaangxi Liaonin Beijing g Tianjin Hebei Inner Mongolia ShanxiHenan Shandong Jiang su Anhui Guangdo ng Jilin Shangh ai Taiwan Xinjiang Tibet HBsAg Prevalence 9% Gansu Qinghai Shaxi Sichuan Hubei Zhejia ng HunanJiangxi Guizhou Fujian Yunnan Ningx ia Chongqing Guaangxi Liaonin Beijing g Tianjin Hebei Inner Mongolia ShanxiHenan Shandong Jiang su Anhui Guangdo ng Jilin Shangh ai Taiwan Hainan 7~8% 4~6% Hainan 1992~1995 epidemiologic data 2002 epidemiologic data

6 Disease Burden of CHB in China

7 Mortality of Chronic Liver Disease in China 2nd leading cause of death in infectious disease: mortality: Chronic Hepatitis and cirrhosis 24.5 / 100,000 / year Hepatocellular carcinoma 14.5 / 100,000 / year

8 Disease Burden DALY 7th Family burden 7th Society burden 2th

9 Economic Loss due to HBV Infection in China (2002) Disease Status Direct Medical Cost (RMB) Direct Nonmedical Cost (RMB) Indirect Cost (RMB) Total Cost (RMB) Chronic 12,648 1,625 6,204 20,477 Hepatitis B Compensated Cirrhosis 22,867 1,581 11,875 36,323 Decompensated Cirrhosis 21, ,458 36,753 HCC 18,497 5,591 14,179 38,267 Total 17,474 2,299 10,431 30,477 Total economic loss: 915 Billion (rate 8.05 RMB 1.0 US$)

10 Goals of Treatment Sustained suppression and elimination of viral replication Reduce and improve liver necroinflammation and fibrosis Delay or prevent the progression Improve quality of life and survival

11 Indication of Treatment HBeAg (+) CHB HBeAg (-) CHB Viral Level 10 5 copies/ml 10 4 copies/ml ALT Level 2 ULN 2 ULN

12 Available Anti-HBV Drugs in China Interferons: - Ordinary recombinant INFα1b, INFα2a, INFα2b - Pegylated Interferon α2a, Pegylated Interferon α2b Nucleoside (nudeotide) analogous: - Lamivudine, Adeforvir, Entecavir,Telbivudine Thymosin α1 (efficacy?)

13 Host: Disease status, Immuno-Response, Co-morbidity, Complication Pharmacology: Potency, Phamarcobarrier, Safety, Course Physician s awareness, knowledge and habit Choices of anti HBV Treatment Influence by pharmaceutic company lobbying Virus: Viral load, Strains: wide or mutant, Genotypes, Genetic barrier Social Economics: Price, Cost/effectiveness, Reimbursement, Acceptability

14 Anti-HBV Activity of 4 NAs in vitro Drug Lamivudine Anti HBV activity ( cell) EC 50 (μm) 0.05 Clinical Daily Dose 100mg Adefovir mg Entecavir mg Telbivudine mg

15 Genetic Barriers to Antiviral Drug Resistance LVD Wild-type virus LVD-resistant virus ADV-resistant virus ETV-resistant virus ADV 236 +/or or 202 or LVD 204 then ETV or 202 or 250 ETV* * In patients without lamivudine resistance mutations, emergent resistance with virologic rebound has been observed in one patient through 3 years of treatment (simultaneous emergence of ) US Prescribing Information for Epivir-HBV (2004), Hepsera (Aug 2006), Baraclude (July 2006) Colonno R, et al. Hepatology 2006;44(Suppl. 1):Abstract 110

16 Very Early Add-on Therapy to Keep Viral Load as Low as Possible HBV DNA Serum HBV DNA (Log10 copies/ml) Drug A Drug A + Drug B Drug A: high genetic barrier Drug B: different cross-resistance profile 2 M0 M3 M6 M9 M12 M15 M18 M21 M24 Month of therapy From Zoulim, F and Lampertico, P. et al 2007

17 Trails in China

18 Lamivudine

19 Median HBV DNA (MEq/ml) HBV DNA (MEq/ml) NUCB Time (weeks) Abbott/Chiron conversion from WK 0 to WK 52 PLA + LAM (n=107) LAM + LAM (n=322) 260

20 Median HBV DNA (MEq/mL) for Nonvatiant and YMDD Vatiant HBV DNA (MEq/mL) YMDD variant non-ymdd variant A median = 50th percentile B 25th & 75th percentile (50% of patients) C 5th & 95th percentile (90% of patients) C 2000 NUCB B A Time (Weeks)

21 HBeAg seroconversion is increased in patients with elevated baseline ALT (Total patients) Patients (%) /178 M=12 Year 1 Year 2 Year 3 Year 4 Year 5 Patients entering observation during Year 4 Patients entering observation during Year 5 M = missing data O = entered observation /143 M= /140 M=50 39 O=5 51/130 M=60 39 O=24 45/116 M= /83 M= /67 M= /65 M=25 O=5 34/63 M=27 ALT >1xULN ALT >2xULN ALT >5xULN 50 O=18 29/58 M=32 HBeAg seroconversion = HBeAg negative, HBeAb positive

22 Adeforvir

23 Adeforvir HBV DNA Negative 60% 50% 40% 30% 20% 10% 0% HBV DNA Negat i ve Rat e PAAA( N=120) AAAA( N=240) AAPA( N=120) week 52 week 104 week 156 week 208 HBV DNA negative:hbvdna<300copies/ml(roche Cobas Amplicor TM PCR)

24 Adeforvir seroconversion HBeAg Ser oconver si on Rat e 35% 30% 25% 20% 15% 10% 5% 0% PAAA( N=120) AAAA( N=240) AAPA( N=120) week 52 week 104 week 156 week 208

25 Entecavir

26 HBV DNA Level After Treatment ETV N=258 LVD N= % 4% 3% 98% 31% 45% HBV DNA (copies/ml) 10 4 < < <10 3 0% 0% 0% 5% 9% 6% 3% 13% 6% 1% 1% 0% 9% 10% 7% 7% 7% 3% <300 0% 76% 75% 0% 43% 38% BL 48 周 EOD BL 48 周 EOD AI BL: Baseline EOD:End Oral Dose

27 All Treated Patiens : Cumulative Confirmed HBV DNA < 300 Copies/mL Through 96 Weeks

28 All Treated Patiens : Cumulative Confirmed ALT 1 ULN Through 96 Weeks

29 All Treated Patiens : Cumulative Confirmed HBeAg Seroconversion and HBeAg Loss

30 Telbivudine

31 015 Efficacy at Week 104: All Patients Strong Results in Chinese Patients Telbivudine Lamivudine P value n HBV DNA from baseline (mean log 10 ) <0.001 HBV DNA non-detectable by PCR (%) <0.001 Therapeutic response * (%) <0.001 ALT normalization (%) HBeAg loss (HBeAg+ only) (%) HBeAg seroconversion (HBeAg+ only) (%) Primary treatment failure (%) 3 15 <0.001 * HBV DNA suppressed to 5 log 10, with ALT normalized OR HBeAg loss Serum HBV DNA levels never below 5 logs

32 Viral Load Achieved by Week 24: Telbivudine vs Lamivudine 20% 12% 41% > 4 log 12% 3-4 log Percent of Patients 56% 16% 13% QL-3 log < QL 30% Telbivudine, Lamivudine, n=166 n=164 HBV DNA at Week 24 P < for HBV DNA non-detectable at week 24, telbivudine vs lamivudine QL < 300 copies/ml

33 Degree of Week 24 Viral Suppression Affects Rate of HBV DNA Non-detectability at Week 104 All Telbivudine-Treated Patients 100% Percent of Patients with PCR- Nondetectable Serum HBV DNA 80% 60% 40% % 12 0% <QL QL-3 Log 3-4 Log >4 Log HBV DNA at Week 24

34 Pegylated Interferon α2a

35 Pegylated Interferon α2a Patients with HBeAg-positive CHB: HBV DNA levels at 12 months posttreatment according to type of response. HBeAg seroconversion in the long-term follow-up study was associated with HBV DNA levels; 69% of patients with sustained HBeAg seroconversion had HBV DNA levels of <10,000 copies/ml

36 Pegylated Interferon α2a Asian patients with HBeAg-negative CHB: Combined response at 24 weeks posttreatment (intention-to-treat population). A significantly higher percentage of patients administered peginterferon alfa-2a experienced a combined response of ALT normalization and HBV DNA <20,000 copies/ml than did patients given lamivudine

37 Price of Anti-HBV Drug in China Name Peg-IFNα2a Lamivudine Adefovir Entecavir Telbivudine Dosage 180µg qw 100mg qd 10mg qd 0.5mg qd 600mg qd One Year Expense (RMB) 91,000 5,475** 7,476 14,235*** 8,760 * 7.1 RMB = 1.0 US$ ** Reimbursed *** Reimbursed in several cities

38 Cost/Effective Analysis LAM vs Convention Treatment: Spend less cost, Better outcomes Long term (5years) LAM+ADV or ADV+LAM: Cost effictive, More sustained decrease progression Pegylated IFNα2a: Gain more QALYs, Spend more cost Envecavir: One year of ETV gained QALY increment cost 5,368 RMB

39 HBeAg-Positive HBV DNA <20,000 IU/mL (<10 5 copies/ml) HBV DNA 20,000 IU/mL ( 10 5 copies/ml) ALT Normal ALT Normal ALT 1-2 ULN ALT 2-5 ULN ALT >5 ULN No treatment Monitor HBV DNA, HBeAg, ALT/3-6 months No treatment Monitor HBV DNA, HBeAg, ALT/ 3 months No treatment Monitor HBV DNA, HBeAg, ALT/1 3 months Liver biopsy if patient >40 years Treat if moderate or greater inflammation or fibrosis on biopsy Treatment if persistent (3~6 months) or has concerns for hepatic decompensation Interferon- based therapy, entecavir, telbivudine lamivudine, adefovir, are all first-line options Treatment indicated May choose to observe closely for 3 months for seroconversion if no concerns for hepatic decompensation Interferon- based therapy; entecavir, telbivudine or lamivudine recommended, particularly if there is concern for hepatic decompensation Patients at risk: HCC surveillance AFP and ultrasonograph/6 months Response Non-response Monitor HBV DNA, HBeAg, ALT/1-3 months post-therapy Consider other strategies (including OLT)

40 HBeAg-Negative HBV DNA <2,000 IU/mL (<10 4 copies/ml) HBV DNA 2,000 IU/mL ( 10 4 copies/ml) ALT Normal ALT Normal ALT 1-2 ULN ALT >2 ULN No treatment Monitor HBV DNA and ALT/ 6-12 months No treatment Monitor HBV DNA and ALT/3 months No treatment Monitor HBV DNA and ALT/ 1 3 months Liver biopsy if patient >40 years Treat if moderate or greater inflammation or fibrosis on biopsy Treatment if persistent (3-6 months) or has concerns of hepatic decompensation IFN based-therapy, entecavir, adefovir, telbivudine, lamivudine, Long-term oral antiviral treatment usually required Patients at risk: HCC surveillance AFP and ultrasonograph/6 months Response Monitor HBV DNA and ALT/1-3 months post-therapy Non-response Continued monitoring to recognize delayed response or plan other strategy

41 Liver cirrhosis Compensated Decompensated Conventional supportive treatment HBV-DNA<2x10 3 IU/ml (< 10 4 cp/ml) HBV-DNA>2x10 3 IU/ml (> 10 4 cp/ml) Antiviral therapy Consider transplant ALT (HBeAg) or HBV-DNA /3months Yes Hepatitis flare No ETV Ldt LAM ADV HCC surveillance AFP and ultrasonography /3-6months ETV Ldt LAM IFN based ETV ADV Ldt LAM

42 THANK YOU!

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