Will HCV therapies deliver global impact? Professor Greg Dore
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1 Will HCV therapies deliver global impact? Professor Greg Dore
2 Disclosures Gregory Dore has received research grants awarded to his institution from Gilead, Bristol Myers Squibb, Abbvie, Merck, and Janssen; Gregory Dore has served on advisory boards for Gilead, Bristol Myers Squibb, Abbvie, Merck, and Janssen; Gregory Dore has received honoraria from Gilead, Bristol Myers Squibb, Abbvie, Merck, and Janssen; Gregory Dore has received travel support from Gilead, Bristol Myers Squibb, Abbvie, and Merck. 2
3 The global burden of chronic HCV infection is enormous and escalating, with limited impact of HCV treatment
4 Global chronic HCV prevalence Prevalence (Viremic) 0.0%-0.6% 0.6%-0.8% 0.8%-1.3% 1.3%-2.9% 2.9%-7.8% Total Infected (Viremic) 0-200K 200K-650K 650K-1.9M 1.9M-3.5M 3.5M-9.2M 4 Gower E et al. J Hepatol 2014
5 Global chronic HCV prevalence 5 Gower E et al. J Hepatol 2014
6 Global HCV treatment uptake: pre-ifn free DAA * * 6 Razavi H et al. J Viral Hep 2014
7 Thousands Thousands Global deaths from end-stage liver disease Cirrhosis HCC Cirrhosis alcohol Cirrhosis HBV Cirrhosis HCV Cirrhosis other HCC alcohol HCC HBV HCC HCV HCC other Deaths due to HCV more than doubled between ; HCC deaths due to HCV increased 300% 7 Cowie B, et al. ILC 2015; Global Burden of Disease Lancet 2015;385: ;
8 Viremic Infections (by Stage) Chronic HCV liver disease burden Estimates and projections of Decomp Cirrhosis and HCC in Australia Australia 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 - Decomp Cirrhosis HCC 8 Sievert W et al. JGH 2014
9 The development of interferon-free HCV therapy provides one of the major advances in clinical medicine in recent decades
10 IFN-free DAA therapy: OST vs non-ost GT1, treatment naïve, F0-4; 12 weeks duration Non-OST OST 70 SVR12 % /70 54/56 SOF/LDV PTV/OBV/DSV/RBV GZR/EBR 10 Afdhal N, NEJM 2014; Feld J, NEJM 2014; Lalezari J, IAC 2015; Zeuzem S, ILC2015; Jacobson I, AASLD 2014
11 IFN-free DAA therapy: HCV vs HIV/HCV GT1, treatment naïve, F0-4; 12 weeks duration HCV HIV/HCV SVR12 % /70 54/56 SOF/LED PTV/OBV/DSV/RBV SOF/DCV GZR/EBR 11 Afdhal, NEJM2014; Naggie, CROI2015; Feld, NEJM2014; Rockstroh, WAC2014; Wyles, CROI2015; Zeuzem, ILC2015; Rockstroh, ILC2015; Poordad, ILC2015
12 Normalized FACIT-F Normalized FACIT-F Normalized FACIT-F IFN-free DAA therapy Patient reported outcomes during and following treatment SOF+PEG-IFN/RBV SOF+RBV SOF/LDV EoT F/U F/U Week w4 w EoT F/U w4 Week F/U w EoT F/U F/U w4 w12 Week PRO Measurement Scale 66/70 100/101 NORMALIZED TOTAL FACIT-F NORMALIZED FACIT-FS 12 Younossi ZM, AASLD 2014, #77 (Courtesy Ed Gane)
13 Global HCV genotype distribution 13 Gower E et al. J Hepatol 2014
14 Sofosbuvir/Velpatasvir GT1-6, treatment naïve and exp. (28%), F0-4 (21% F4), 12 wks SVR12 % /41 11/11 18/30 24/30 5/11 323/ /215 66/70 201/ / / /216 54/56 116/ /214 34/35 211/217 41/41 100/101 31/47 GT1 GT2 GT3 GT4 GT5 GT6 14 Gilead press release, 21 Sep 2015
15 Interferon-free HCV therapy drug pricing is a major impediment to global impact
16 HCV treatment pricing: 12 week regimens (US) $US 1, Listed Discounted ? SOF/SIM SOF/LED PTV/OBV/DSV GZV/ELB 16
17 Sofosbuvir Medicaid restrictions in US Liver disease stage 17 Barua S, et al. Ann Intern Med 2015
18 HCV treatment: minimum costs $US Monitoring Genotype Treatment SOF/RBV (24 wk) SOF/LED (12 wk) SOF/DCV (12 wk) GZV/ELB (12 wk) 18 van de Ven et al. Hepatology 2015;61:
19 HCV treatment: drug price reform Strategies Pharmaceutical industry competition Discounting, risk-sharing arrangements, volume taxation Voluntary licenses (Gilead + Generic companies in 101 LMICs) Compulsory licenses Advocacy/Activism 19
20 Australian PBAC approach Independent body that advises Australian Government Recommended that all people with chronic HCV be eligible Probable price per course (8, 12, or 24 weeks) Required cost-effectiveness $15,000/ICER Probable treatment cap: 60,000 over 5 years Treatment provided above cap at reduced or no profit Ongoing price negotiations and Federal Cabinet approval required 20
21 There are multiple barriers to HCV treatment among PWID
22 Global harm reduction strategies Only 41% (n=82) of countries had implemented NSPs 22 Mathers B, et al. Lancet 2010
23 Global harm reduction strategies Only 35% (n=70) of countries had implemented OST 23 Mathers B, et al. Lancet 2010
24 Sofosbuvir Medicaid restrictions in US Illicit drug use 24 Barua S, et al. Ann Intern Med 2015
25 Sofosbuvir Medicaid restrictions in US AASLD/IDSA HCV treatment guidelines Recent and active IDU should not be seen as an absolute contraindication to HCV therapy. Scale up of HCV treatment in persons who inject drugs is necessary to positively impact the HCV epidemic in the United States and globally. 25
26 The broad implementation of interferon-free HCV therapy has the potential to markedly reduce disease burden Australia should be in an unique position to address the burden of HCV disease, if PBAC recommendations are approved
27 HCV treatment and care cascade in Australia 27 Kirby Institute 2015
28 PBAC recommendations: March, July 2015 Sofosbuvir + Ledipasvir for GT1 Sofosbuvir + Daclatasvir for GT1 and 3 Sofosbuvir + Ribavirin for GT2 Sofosbuvir + PEG-IFN/RBV for GT1 Paritaprevir/r + Ombitasvir + Dasabavir (+/- RBV) for GT1 No liver disease stage or drug use restrictions General practitioner prescribing and community pharmacy dispensing 28
29 Impact of HCV treatment on disease burden Base case Increase SVR with no increase in annual treated population and no fibrosis-restricted eligibility Increase SVR and annual treated population Increase SVR and annual treated population restricted to F3 ( ) then unrestricted (all F0) from Sievert W, et al. J Gastroenterol Hepatol;29 (Suppl 1):1 9
30 HCV treatment uptake in United States Chronic HCV = 3,400, * Extrapolated * % CDA 2015: Polaris Observatory (
31 HCV treatment uptake in Spain Chronic HCV = 473, * Extrapolated * % CDA 2015: Polaris Observatory (
32 The way forward Global leadership (UN, WHO, partner orgs, Country champions) Massive increase in HCV screening Linkage to treatment and care Utilisation of HIV and harm reduction frameworks Simplified HCV treatment monitoring Enhanced epidemiological and evaluation capacity Civil society involvement 32
33 Positive international HCV developments WHA resolution 63.18: Viral Hepatitis Global Public Health Priority (2010) WHA resolution 67.6: Enhanced call for Member State action (May 2014) WHO release 1 st International HCV Treatment Guidelines (April 2014) Global Fund for AIDS, TB and Malaria include HCV treatment (March 2015) WHO add new DAAS including sofosbuvir to Essential Medicines List (2015) WHO 2030 HCV targets: 90% incidence and 65% mortality decline; 80% treat World Hepatitis Summit (September 2015) 33
34 HCV diagnosis and treatment uptake 6% Bubble Area: Viremic HCV Prevalence France 5% Austria Germany Treatment Rate (%) 4% 3% 2% Egypt Czech Republic Turkey England Spain Switzerland Belgium Sweden Canada Australia Brazil Portugal Denmark 1% 0% 20% 40% 60% 80% 100% Diagnosis Rate (%) 34 Dore GJ, et al. J Viral Hep 2014
35 Simplified HCV treatment monitoring Drug and alcohol clinics Primary health care / GPs HIV & Sexual health Community health centres Prisons NSP services Diagnosis/monitoring Point of care (PoC) HCV diagnosis HCV core antigen (whole blood) HCV RNA (dried blood spot) Simplified disease staging Limited treatment monitoring (SVR12 only?) No post-treatment HCC surveillance Decentralised 35
36 Advocacy and Activism 36
37 Acknowledgements Kirby Institute, UNSW Australia - A/Prof Jason Grebely - A/Prof Gail Matthews - Dr Tanya Applegate - Dr Maryam Alavi - Dr Behzad Hajarizadeh - Ms Pip Marks - Dr Michelle Micallef Australian Collaborators - Prof Andrew Lloyd - Prof Margaret Hellard - Prof Jacob George - Dr Alex Thompson - Hepatitis Australia, Hepatitis NSW - AIVL, NUAA International Collaborators - INHSU - A/Prof Natasha Martin, A/Prof Peter Vickerman - Prof Jordan Feld - Prof Ed Gane - Prof Sharon Hutchison, Prof David Goldberg - ACTIVATE network Civil Society - Tracy Swan (TAG) - Karyn Kaplan (TAG/HepCoalition) - Ludmila Maistat (Alliance Ukraine) - Jude Byrne (INPUD) Funding - NHMRC - NIH - CIHR - NSW Health Department - Gilead Sciences - Merck - Abbvie - BMS 37
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