Future Challenges for Research

Future Challenges for Research HIV Epidemic in Southeastern U.S. Role of the NIH Office of AIDS Research 2nd Annual TN-CFAR Workshop Nashville, TN March 24, 2017 Maureen M. Goodenow, Ph.D. Associate Director for AIDS Research Director, Office of AIDS Research Towards an AIDS Free Generation 1

Overview HIV infection in the U.S. South East and District of Columbia NIH and OAR HIV Research Epidemic Control Research Data Policy 2

Rates of Diagnoses of HIV Infection: 2015 N = 39,920 Total Rate = 14.7 3

HIV Diagnoses by Sex & Transmission Category United States: 2015 4

HIV Diagnoses by Sex & Racial/Ethnicity Category United States: 2015 5

HIV Across the Life Span Neonates Infants Children Preteens Adolescents Youth Adults Seniors 2 9 13 18 24 65 Age [yrs]

Adolescents and Youth 7

United States Epidemic: 2014 People living with HIV across age groups 1.2 million infected individuals Youth 13-24 years: 5.8% of cases Over 55 years: > 25% of cases Source: CDC Surveillance Report #26-2014 8

Geographic Distribution of HIV Infection: 2015 N = 970,319 Total Rate = 360.0 Aged 20 24 Years Aged 13 19 Years N = 32,195 Total Rate = 138.7 N = 6,161 Total Rate = 20.6 9

United States Epidemic: 2015 New HIV diagnosis across age groups AGES NOS RATE/100K 15-19 1698 8.0 20-24 7084 33.4 25-29 7510 31.2 30-39 9631 22.0 40-54 9730 15.0 >55 3715 5.0 >40% TOTAL 39,513 12.3 Source: CDC Surveillance Report #27-2015 10

Rates of Diagnoses of HIV Infection: 2015 N = 39,920 Total Rate = 14.7 37% of population/ >50% of new diagnoses 11

HIV in the Southeast CDC 2014 State Diagnosis Prevalence U.S. 15.0 357.8 Florida 43.3 609.0 Georgia 27.1 564.0 Maryland 26.7 638.9 Mississippi 19.4 363.8 South Carolina 18.7 393.5 Alabama 16.6 306.2 North Carolina 15.9 348.0 Tennessee 13.6 295.0 Virginia 13.2 298.5 Kentucky 9.3 176.7 West Virginia 5.5 120.2 * Per 100,000 12

HIV Prevalence in Tennessee 2013 Haywood County/ Brownsville 630/100K Shelby County/ Memphis 838/100K Davidson County/ Nashville 713/100K 297/100K

Memphis: HIV and Poverty 2013 HIV Prevalence 838/100K Poverty

Nashville: HIV and Poverty 2013 HIV Prevalence: 713/100K

HIV in the Southeast * Per 100,000 State Diagnosis Prevalence U.S. 15.0 357.8 DISTRICT OF COLUMBIA 66.1 2665.0 Florida 43.3 609.0 Georgia 27.1 564.0 Maryland 26.7 638.9 Mississippi 19.4 363.8 South Carolina 18.7 393.5 Alabama 16.6 306.2 North Carolina 15.9 348.0 Tennessee 13.6 295.0 Virginia 13.2 298.5 Kentucky 9.3 176.7 West Virginia 5.5 120.2 16

HIV Prevalence International Country Prevalence Ethiopia 1.00% Haiti 2.00% * Rwanda 3.00% Cote d Ivoire 4.00% * Kenya 5.00% * Uganda 7.00% Malawi 10.00% Mozambique 11.00% Zambia 12.00% Namibia 16.00% Zimbabwe 16.70% South Africa 19.00% Lesotho 23.00% Swaziland 28.00% District of Columbia By age By Race/Gender CDC 2015

2007 DC population: 580,000 >1300 new HIV diagnoses Prevalence rate of 3%

DC PFAP

DC PFAP: A Unique Intramural/Extramural Partnership Intramural Department of Health Extramural

District of Columbia 2015 HIV Cases Newly Diagnosed HIV per 100,000 persons by census tract and ward

District of Columbia 2011-2015 Number of Newly Reported Chronic Hepatitis C Cases N=9,232

NIH HIV/AIDS Research Portfolio Washington, DC 24

HIV/AIDS in 2017 In just 30 years, A previously fatal and much-feared disease has been converted to a treatable disorder with nearly normal life expectancy. Almost half of the world s infected individuals are receiving ART. 25

HIV/AIDS in 2017 But, annually new cases exceed 2 million worldwide AND ~40,000 new cases in the U.S. Flat/declining resources persist Long term co-morbidities are poorly understood No vaccine, no cure 26

NIH 27 Institutes and Centers [ICs], each with a specific research agenda, often focusing on particular diseases or body systems. Annual public research investment ~$32 billion Investment in HIV/AIDS research ~$3 billion NIH Office of AIDS Research [OAR] 27

Executive Branch Secretary Health and Human Services NIH Office of the Director Office of AIDS Research National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute of Biomedical Imaging and Bioengineering National Center for Complementary and Integrative Health John E. Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine National Center on Minority Health and Health Disparities Warren G. Magnuson Clinical Research Center Center for Information Technology Center for Scientific Review 28

Overview: NIH HIV/AIDS Research Portfolio Comprehensive program of research and training focused on HIV infection, associated co-infections, comorbidities, and complications Transcends every area of clinical medicine and basic scientific investigation Multi-IC, multidisciplinary, global Largest public investment in HIV/AIDS research in the world ($3.0 Billion in FY 2016) 29

3,500 HIV/AIDS Funding History, 1982 - Present 3,000 Dollars in Millions 2,500 2,000 1,500 1,000 500 0 1982 1987 1992 1997 2002 Fiscal Year 2007 2012 30 2017

3,200 32,000 3,000 31,000 Dollars in millions 2,800 2,600 2,400 2,200 HIV/AIDS current dollars HIV/AIDS constant dollars Dollars in millions 29,000 27,000 25,000 23,000 21,000 NIH current labor/hhs NIH constant labor/hhs 2,000 19,000 1,800 2000 2002 2004 2006 2008 2010 2012 2014 17,000 2000 2002 2004 2006 2008 2010 2012 2014 31

OAR V1.0 V2.0 V3.0 1985-2000 2001-2016 2016 2030 32

OAR Leadership V1.0 V2.0 V3.0 1985-2000 2001-2016 2016-2030 1988-1994 1994-1997 1998-2000 2000-2015 2015-2016 2016- Anthony Fauci William Paul Neal Nathanson Jack Whitescarver Robert Eisinger Maureen Goodenow 33

NIH Office for AIDS Research [OAR] Roles Coordinate Convene Catalyze 34

OAR Coordinates Scientific, budgetary, legislative, and policy elements of NIH HIV/AIDS research. Strategic plan as a roadmap for allocation of funds Budget, receive, and disperse across NIH all funds for HIV/AIDS research Ensure that research dollars are invested in the highest priority areas of scientific opportunity in the global fight against HIV/AIDS 35

THE NIH DIRECTOR Statement on NIH Efforts to Focus Research to End the AIDS Pandemic August 12, 2015 Extraordinary progress has been made in HIV/AIDS research over the last 34 years, transforming what was once a terrifying and almost inevitably fatal disease into a treatable disorder. People with HIV/AIDS can now experience an almost normal life expectancy if antiretrovirals are started promptly and continued for life. But the disease remains a significant public health concern, with approximately 50,000 new infections per year in the United States and two million new infections worldwide. The global human and economic costs continue to be staggering. 36

Overarching High Priority Areas Reduce Incidence of HIV/AIDS Next Generation HIV Therapies Research Toward a Cure HIV- Associated Comorbidities & Coinfections Basic Research, Health Disparities, Training, Behavioral & Social Sciences 37

Overview: NIH HIV/AIDS Research Portfolio Comprehensive program of research and training focused on HIV infection, associated co-infections, comorbidities, and complications Transcends every area of clinical medicine and basic scientific investigation Multi-IC, multidisciplinary, global Largest public investment in HIV/AIDS research in the world ($3.0 Billion in FY 2016) 38

NIH HIV Research Agenda Prevention Vaccine[s] Monoclonal antibodies Long-acting antiretrovirals Research toward Cure Safe Simple Scalable Sustainable Therapeutics Long-acting treatments Sustained viral remission 3Cs Comorbidities Co-infections Complications 39

Funding by the Overarching Priorities Crosscutting Reducing Incidence Comorbidities & Coinfections Develop a Cure Next Generation Therapies

Funding by Areas of Emphasis Information Dissemination Develop a Cure Training, Infrastructure, Capacity Building Etiology & Pathogenesis Therapeutics Microbicides Behavior & Social Science

HIV/AIDS Discovery Milestones 1985-2000 2000-2015 2015 2030 HIV identified CD4 receptor NHP model Diagnostic test AZT approved HAART PMTCT bnabs PrEP TaSP VMMC Efficacy signals for products Combination prevention Immune therapies Signal for rings 90/90/90 Long acting ARV Controlled viral remission/ functional cure Vaccine[s] New discoveries 42

HOW HAS FEDERAL RESEARCH ON AIDS/HIV DISEASE CONTRIBUTED TO OTHER FIELDS? 1990 Office of Technology Assessment U.S. Congress Requested by: House Committee on Government Operations Subcommittee on Human Resources and Intergovernmental Relations survey of leading multidisciplinary scientists documented contribution of AIDS/HIV research to other research fields 43

Cross Cutting Outcomes from Federal Research for HIV/AIDS significant benefits from AIDS/HIV research have flowed to a wide variety of fields ranging from the basic sciences to clinical applications and public health 44

Newly Emergent Research Opportunities for HIV/AIDS Compelling new ideas about treatment that translate to prevention New optimism about research towards a cure and sustained viral remission Trans-disciplinary discoveries in human immunology, genomics, virology, & structural biology raise expectations for a successful vaccine strategy 45

OAR version 3.0 Translate the urgency to reach 90/90/90 goals Coordinate an NIH-wide acceleration from basic science discovery to translation and implementation Where are the roadblocks? Change the trajectory of the epidemic by discovering approaches to simple, safe and sustainable strategies for prevention, treatment, and cure. 46

OAR version 3.0 Provide incentives for transdisciplinary collaborations & partnerships Meet the challenges of HIV/AIDS combined with comorbidities, coinfections, & complications Align investments with the demographics of the epidemic Focus, prioritize, and follow the science Be prepared for unexpected discovery 47

Preparing OAR for the Future Expanded role to prevent new infections, develop strategies for sustained viral suppression, and achieve an AIDS-free generation Continue to conduct portfolio reviews and funding plans Resources will be reallocated to high priority projects Coordinate and leverage interdepartment, interagency, and non-government players to expand HIV research and avoid redundancy 48

Action Items Coordinate an NIH-Wide acceleration from discovery to translation and implementation Where are the roadblocks? Change the trajectory of the epidemic by discovering approaches to simple, safe and sustainable strategies for prevention, treatment, and cure Can we apply lessons from international to domestic scenarios? 49 49

Action Items Think Globally! Break down barriers within and across agencies. Translate the urgency to reach 90/90/90 UNAIDS goals by challenging the research community to accelerate research & development Support incentives for developing partnerships through novel mechanisms to meet the challenges of HIV/AIDS across the life span combined with comorbidities, coinfections, & complications research 50

Defining A Sustainable HIV Response Sustainability is not only about funding A sustainable response can only be achieved when the epidemic is under control and no longer expanding How can we achieve epidemic control? Right things Right places Right now Right way 51

Research Data Policy What we decide over the next 3 to 5 years sets the path to 2030 52

NIH Turning Discovery Into Health 53