CDC Foundation & Viral Hepatitis Action Coalition: Summit for the Elimination of Hepatitis B and Hepatitis C as Public Health Threats in the United States Bruce Kreter, PharmD Senior Director, Global HCV Medical Affairs Gilead Sciences, Inc. April 28, 2017
Gilead Sciences Support of Hepatitis C Elimination Gilead supports the efforts of governments, professional organizations, patient advocacy groups, payors and healthcare professionals who have declared their intention and commitment to work toward the elimination of viral hepatitis around the world, through: Clinical research and implementation science Screening and Linkage to Care programs Partnerships with Patient Advocacy Groups Medical Education 2
TRAP HEP C Treatment as Prevention proof-of-concept study in Iceland All HCV+ patients are offered treatment with DAAs (LDV/SOF ± RBV) through NHS Baseline Demographics 100% 80% 60% 40% 20% 0% Iceland Population: 330,000 HCV seroprevalence: 0.3% (est 800-1000 patients) Treatment to all within 2 years 3rd year for search and rescue 281 298 LDV/SOF±RBV SVR12 94 96 93 281 298* 12 14 150 157 129 139 129 139 100 2 2 Overall GT1 GT3 GT4 2 2 From 12 month evaluation N = 322 Mean age, years (range) 42 (33-52) Males, n (%) 215 (67) GT1a/ GT1b/ GT3 (%) 47/ 4/ 48 Cirrhosis (Fibroscan >12,5 kpa) 20 (6) Previous treatment for HCV 46 (14) Encounter site University Hospital 208 (65) Addiction treatment center 100 (31) Penitentiary 14 (4) IV Drug Use Ever 292 (91) Within 6 months 97 (33) Within 30 days 49 (15) Current OST 44 (15) Olafsson, EASL 2017, PS-129
Australia: Building the evidence base for HCV elimination People with HIV infection HCV co-infection PWID with HCV infection Prisoners PWID on OST 4
Australia: Building the evidence base for HCV elimination (I) People with HIV infection HCV co-infection PWID with HCV infection Prisoners PWID on OST Slide: courtesy of Gregory Dore, MBBS, MPH, PhD, FRACP 5
Australia: Building the evidence base for HCV elimination (II) People with HIV infection HCV co-infection PWID with HCV infection Prisoners Prison And Transition Health (PATH) Cohort Study PWID on OST Slide: courtesy of Margaret Hellard, MBBS, FRACP, PhD, FAFPHM
HCV Continuum from Identification to Elimination (CITE): 2016 Objective: Support HCV elimination projects for high risk and high prevalence populations and geographies, including demonstration of clinical and economic value of such programs Outcome: More than 88,000 patients screened globally, 140 new screening sites added, and 43 anticipated conference presentations 7
NoCo HIV/HCV Elimination Program: 2017 Competitive grants for implementation science projects, including data collection or modeling, focused on elimination of HCV in HIV-infected populations: Can be completed within 3 years Contain a defined population (clinic, health system, geographic location or other clearly defined group that can be followed for HCV elimination outcomes) Evaluate the incidence of new HCV infection in an HIV population, including re-infection rates and change in incidence over time (e.g. molecular epidemiology of transmission)
HCV SCALE 2017: Screening, Access and Linkage to CarE High risk and high prevalence populations and geographies, including demonstration of clinical and economic value of such programs Development and performance of implementation science projects, including data collection or modeling Proposals must demonstrate the following: Clear scientific objectives based on a scientific hypothesis Potential scalability and sustainability of program to other practice settings Plan to publish and present results in scientific forums and to other organizations Studies must be completed in 3 years Gilead Confidential For Internal Discussion Only
FOCUS Q4 2016 (Gilead Government Affairs) 880K HCV Tests Since 2014 6.0% HCV Ab Seropositivity 879,413 Strategic Expansion Driven by Opioid Epidemic and Unmet Need 307,986 90,612 2014 2016 2015 52K Cumulative HCV Ab tests 26K HCV RNA+ Identified Through Testing 45K 65% HCV Median Linkage to Care 26K HCV Ab+ HCV RNA tests HCV RNA+ 2016: 74 New Partners 39 New Cities/Counties 165 Current Partnerships in 65 Cities/Counties Hospital (45%) Community /Other** (22%) Community Health Center (33%) *As of Mar. 2017 **Other includes health departments, substance use, training, and corrections. New FOCUS Cities/Counties in 2016 Existing FOCUS Cities/Counties (Dec. 2015) Planned Expansion Cities Dissemination by FOCUS Partners 354 Abstracts accepted at major conferences 41 Journal Articles published in peerreviewed journals
FOCUS: Scaled Screening and LTC for Viral Hepatitis Objective: Build capacity and support innovation to meet the challenge of 1.5-2 million undiagnosed HCV patients; requires screening at an unprecedented scale across health care systems and novel LTC networks Sample Settings Partners HCV Ab tests HCV Ab+ Emergency Departments 62 partners 165,000 8.8% Community Health Centers 63 partners 325,000 3.8% Substance Use Tx 28 partners 30,000 15.7% Corrections 10 partners 7,500 13.1% *Data through Q4 2016 FOCUS activities contributing to elimination efforts: Build screening capacity: focus on underserved populations Maximize EMRs: identify eligible patients and streamline testing processes, especially in high-volume settings Develop linkage to care networks: overcome barriers at multiple levels (patient, systems, and provider) to best align patients with treaters Disseminate findings and best practices
HepVu.org - Launched on April 26 th Partnership between Emory University s Rollins School of Public Health & Gilead Sciences Interactive website that visualizes first standardized state-level estimates of people living with past or current Hep C in U.S. Helps to address challenge of limited data to inform program planning for viral hepatitis elimination HCV Ab prevalence estimates generated by Emory University s Coalition for Applied Modeling for Prevention (CAMP), supported by CDC Website resources include: Interactive national & state maps of: Estimated state-level HCV Ab prevalence, cases & rates (2010) Reported state-level HCV mortality, cases & rates (2014) by sex, race & age State-specific profiles Blog featuring posts by viral hepatitis experts
Identification and Elimination through Independent Medical Education support Maintenance of Certification Practice-Improvement Modules in HCV for Board-Certified Addiction Medicine Specialists Measure knowledge change (before and after education) Screening improvemen ts measured by EMR Physician self-report Data gained to be used to make change in PQRS measures Patient and consumer outreach On the Road to Eradication BRIDGE HCV: Building Bridges to Reach PWIDs with the Goal to Eradicate HCV Expanding Hepatitis C Care in Critical Areas of Need Linking the 3 Cs (Care, Community, Cure) in HCV Elimination HCV Elimination at the Crossroads of Managed Care