Eliminating Hepatitis C from New Zealand

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1 Eliminating Hepatitis C from New Zealand Catherine Stedman Associate Professor of Medicine, University of Otago, Christchurch Gastroenterology Department, Christchurch Hospital

2 Disclosures I have the following financial relationships to disclose within the past 12 months: Advisory board committees or speaking for Gilead Sciences, Abbvie 2

3 Hepatitis C in NZ Estimated in NZ with Hepatitis C Approximately 50% diagnosed The silent epidemic This virus can be cured

4 Who is at risk for Hepatitis C in New Zealand? Factor concentrates pre-1987 Jackson, 2000 Active injecting drug user Robinson Prison inmates (female) Brunton, 2000 Blood transfusion pre-1992 Brullen, 2000 Haemodialysis Marshall 1999 STD clinic McKenna,1992 6% 3% 2.5% 30% 75% 89% Caucasian blood donors Bullen, % Maori/PI blood donors Woodfield, 2000 ESR Report, % New Zealand population 1.2% 0% 25% 50% 75% 100% 4 Prevalence Rate WHAD, July 28th 2015

5 Decreasing Incidence of HCV in Australia/NZ Related to falling incidence in Injecting Drug Use 15,000 Number of new infections 10,000 5, Dore et al. HCV Projections Working Group 2007 Other IDU Migrants 5

6 Characteristics of the local HCV Population Age and Gender Christchurch Community Clinic HCV Prevalence 5.0% 4.5% 4.0% 3.5% 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% Males (2013) Females (2013) Brunton C (unpublished) 6

7 Characteristics of the local HCV Population Age and size of population 50,000 infected, median age of 47 years 8,000 Total Viremic Infected (2013) 7,000 6,000 5,000 4,000 3,000 2,000 1,000 - Most have been infected for years at time of diagnosis WHAD, 28 July, 2015 Gane E, et al. NZ Med J 2014; Dec

8 Characteristics of the local HCV Population Proportion with Cirrhosis HCV Pilots in Bay of Plenty and Wellington 788 Fibroscans performed in community Nil Moderate F0 F2 63% Unsuccessful 12% 16% have established cirrhosis 25% have at least severe fibrosis Severe Fibrosis F3 9% Cirrhosis F4 16% 8

9 The total number of HCV infections is expected to decline in New Zealand while the disease burden is expected to increase 60,000 50,000 40,000 30,000 20,000 10,000 - Total Infected Cases (Viremic) Liver related Deaths Base Base HCC 1,200 1, Decompensated Cirrhosis Base Base Gane E, Stedman C, Brunton C, Radke S, Henderson C, Estes C, et al. Impact of improved treatment on disease burden of chronic hepatitis C in New Zealand. N Z Med J 2014;127:

10 HCC deaths Incident HCC cases In fact, national estimates show an increase in HCC cases and HCC deaths Males (Ministry of Health) Females (Ministry of Health) Males (model) Females (model) Males (Ministry of Health) Females (Ministry of Health) Males (model) Females (model)

11 HCC deaths Incident HCC cases In fact, national estimates show an increase in HCC cases and HCC deaths Males (Ministry of Health) Females (Ministry of Health) Males (model) 20.0 Females (model) Current liver cancer (HCC) rates are increasing by % per year in 45.0 New Zealand Males (Ministry of Health) Females (Ministry of Health) Males (model) Females (model)

12 Number of HCCs per annum Incidence of Liver Failure from HCV is rising more rapidly than projected in 2000 ESR Report Patients with decompensated HCV cirrhosis referred for Liver Transplant HCV

13 Thousands Thousands Global: HCV is now the leading cause of liverrelated morbidity and mortality Global Burden of Disease 2013 estimated age-sex-specific all-cause mortality 450 Cirrhosis 400 Liver cancer Cirrhosis HBV Cirrhosis HCV Cirrhosis other Liver cancer HBV Liver cancer HCV Liver cancer other Deaths due to HCV more than doubled between ; Liver cancer deaths due to HCV increased 300% Cowie BC, et al. EASL 2015; Poster #P1256; Global Burden of Disease Lancet 2015;385: WHAD, 28 July,

14 Median age at death (years) HCV-infected adults are at increased risk of premature death Premature death (<65 years) and median age at death among all deaths, NYC ( ) 25% died prematurely 78 yrs 64% died prematurely 60 yrs 94% died prematurely 52 yrs 20 0 No HCV or HIV HCV mono-infected HCV/HIV co-infected Pinchoff J, et al. Clin Infect Dis 2014;58:

15 Current treatment options cannot meet the unmet medical need in New Zealand patients with HCV 1. Poor tolerability Side-effects of interferon Not suitable for elderly, or advanced disease 2. Complex dosing regimen Large number of pills Frequent monitoring Interfere with commonly prescribed drugs 3. Limited Efficacy WHAD, 28 July,

16 Numbers started on treatment Peg-IFN for GT1 Peg-IFN for GT 2/3 Boceprevir for GT 1 Treatment Rate by Year In New Zealand WHAD, 28 July, 2015 PHARMAC data on file ACS, CCST data on file 16

17 Receptor binding and endocytosis Targets in the HCV Life Cycle for Direct Acting Antiviral Agents Transport and release Fusion and uncoating Virion assembly Translation and polyprotein processing (+) RNA LD ER lumen LD NS5A inhibitors ER lumen Membranous web LD RNA replication NS3 Protease Inhibitors Non-Nuc NS5B inhibitors NUC NS5B inhibitors

18 Proof of Concept HCV Studies Inform-1 Study Dual HCV oral antivirals can suppress Hepatitis C and prevent resistance ELECTRON Study Proof of concept that HCV can be cured in interferon-free regimen of sofosbuvir + ribavirin Gane, Roberts, Stedman et al Lancet 2010 Gane E, Stedman C et al. N Engl J Med 2013

19 Fixed Dose Combination Ledipasvir Picomolar potency against HCV GT 1a and 1b 1 Effective against NS5B RAV S282T 2 Once daily, oral, 90 mg LDV NS5A inhibitor Sofosbuvir Potent antiviral activity against HCV GT 1 6 High barrier to resistance Once-daily, oral, 400-mg tablet approved for use with other agents to treat HCV infection SOF nucleotide polymerase inhibitor Ledipasvir/Sofosbuvir FDC Once-daily, oral, fixed-dose (400/90 mg) combination tablet No food effect LDV NS5A inhibitor SOF nucleotide polymerase inhibitor 1. Lawitz E, et al. EASL 2011, poster 1219; 2. Cheng G, et al. EASL 2012, poster

20 SVR12 (%) Ledipasvir/Sofosbuvir in HCV Genotype 1 Phase 3 Trials: ION-1, ION-2, ION-3 LDV/SOF LDV/SOF+RBV / / / / / / Weeks 24 Weeks 8 Weeks 12 Weeks 12 Weeks 24 Weeks ION-1 GT 1 treatment-naïve including cirrhotics ION-3 GT 1 treatment-naïve non-cirrhotic ION-2 GT 1 treatment-experienced including cirrhotics and PI failures 206/ / / / / % (1886/1952) overall SVR rate Error bars represent 95% confidence intervals. Afdhal N, et al. N Engl J Med 2014; 2014 Apr 12 [Epub ahead of print] Kowdley K, et al. N Engl J Med 2014; 2014 Apr 11 [Epub ahead of print] Afdhal N, et al. N Engl J Med 2014; 2014 Apr 12 [Epub ahead of print

21 Hepatitis C Genotype 1: Ledipasvir/Sofosbuvir Harvoni One pill Once daily 8-12 weeks 97% cure LDV SOF

22 Hepatitis C Genotype 1: Sofosbuvir/Ledipasvir Single Tablet Regimen One pill Once daily 8-12 weeks LDV SOF 97% cure >$27000 NZ per month

23 Sofosbuvir/Ribavirin in Genotypes 2 & 3 HCV: VALENCE Study Zeuzem S, et al. AASLD 2013 Poster 1085

24 Abbvie VIEKIRA PAK Combination regimen for Genotype 1 HCV HCV Receptor binding and endocytosis Transport and release 3. MID-/LATE LIFECYCLE INHIBITION - NS5A inhibitor Ombitasvir (OBV) 1. EARLY INHIBITION - NS3/4A protease inhibitor Paritaprevir (PTV) Translation and polyprotein processing Fusion and uncoating (+) RNA ER ER GOLGI RNA replication Replication, virion assembly, and egress 2. MID-LIFECYCLE INHIBITION - non-nucleoside NS5B polymerase inhibitor Dasabuvir (DSV) Lindenbach & Rice. Nature 2005:436;

25 Abbvie Viekira Pak 12 week all oral regimen Coformulated paritaprevir /ritonavir (PTV/r) 150 mg/100 mg plus Ombitasvir (OBV) 25 mg (QD) Dasabuvir (DSV) 250 mg (BID) ± Ribavirin (RBV) weight-based dose (BID) RBV RBV Ritonavir boosting Allows twice daily dosing Drug-drug interactions

26 SVR12 (%) Viekira Pak in HCV Genotype 1 non-cirrhotic patients Subtype GT1a Gt1b 0 Treatment history Treatment-naïve Treatmentexperienced Prior relapse Prior partial Prior null response response Overall results AbbVie Pty Ltd. Viekira Pak. Dossier submitted to Medsafe July 2014.

27 SVR12, % patients Abbvie Viekira Pak in HCV Genotype 1 patients with cirrhosis: Viekira Pak + RBV 88.6% 94.2% 98.5% 100% 380 patients with GT1 HCV. All patients with established cirrhosis 124 /140 GT 1a 114 / /68 GT 1b 12 weeks 24 weeks 51 /51 Poordad F et al. N Engl J Med 2014:370; Asselah T et al. J Hepatol 2014; 61:

28 New therapies open up new horizons

29 What would it take to reduce the health burden associated with chronic hepatitis C? Reduce morbidity and mortality Funding of new oral therapies for all cirrhotics Capacity to treat 2%/year Fibroscan access - to identify cirrhotics Eliminate HCV infection Funding of new oral therapies for everyone Capacity to treat 10%/year Identify the 30,000 New Zealanders who are undiagnosed Treat those who are transmitting HCV (PWID, prisoners) i.e. treatment as prevention 29

30 Impact of Different Scenarios Total Infected Cases (Viremic) Liver related Deaths 60, , , , , , Base SVR Only Elimination Base SVR Only Elimination Elimination - 1yr delay Elimination - 2 yr delay Elimination - 1yr delay Elimination - 2 yr delay HCC Decompensated Cirrhosis ,200 1, Base SVR Only Elimination Base SVR Only Elimination Elimination - 1yr delay Elimination - 2 yr delay Elimination - 1yr delay Elimination - 2 yr delay Gane E, Stedman C, Brunton C, Radke S, Henderson C, Estes C, et al. Impact of improved treatment on disease burden of chronic hepatitis C in New Zealand. N Z Med J 2014;127:

31 Viremic Prevalence (000) Healthcare Costs NZD (M) Total viremic infections peaked in 2010, but HCV related healthcare costs will continue to increase past 2035 under current Tx paradigm 70, ,000 50,000 40,000 30,000 20,000 10, In 2015, estimated annual healthcare costs of $25 million NZD By 2035, annual healthcare costs will increase 71% to $42 million NZD per year Total cumulative healthcare costs during are estimated at $700 million NZD Annual healthcare costs peak in 2038 at $43 million NZD 31

32 Increasing the number of cured HCV individuals will lead to a reduction in HCV-related healthcare costs $45 $40 $35 $30 $25 $20 $15 $10 $5 $0 Total Healthcare Costs Base Elimination - no delay Elimination - 2 yr delay SVR Only Elimination - 1 yr delay Percent Reduction in Healthcare Costs in (Million NZD) Reduction in Liver Related Deaths in Increase SVR 10% ($73) 655 Lives lost due to delay Elimination (no delay) 53% ($375) 2,980 Elimination (1 year delay) 49% ($342) 2, Elimination (2 years delay) 44% ($311) 2,

33 Hepatitis C: Conclusions HCV disease burden will increase over time even though the total number of HCV infections is expected to decline Hepatitis C is curable with short duration all-oral regimens» major shift away from interferon-based therapy» Drug costs and availability are limiting implementation of new therapy The increase in HCV related disease burden can be mitigated through higher cure rate therapies» Delaying access to treatment results in loss of lives There is potential for Hepatitis C elimination in NZ 33

34 34

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