Pre-Exposure Prophylaxis Perspectives from the Southeast. Christopher Hurt, MD Assistant Professor of Medicine Division of Infectious Diseases

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1 Pre-Exposure Prophylaxis Perspectives from the Southeast Christopher Hurt, MD Assistant Professor of Medicine Division of Infectious Diseases

2 Disclosures I have no actual or potential conflicts of interest in relation to this presentation. Dr. Hurt is supported by the National Institute of Mental Health (K23MH099941). The views expressed are not necessarily those of NIMH or the NIH.

3 What is pre-exposure prophylaxis? Use of antiretroviral medications before an exposure, to reduce the risk of becoming infected Tenofovir (TDF) is the most studied agent for PrEP Once-daily dosing Few drug-drug interactions Safe and well tolerated FDA approved in 2012 USPHS guidelines in 2014 (emtricitabine / tenofovir DF = Truvada)

4 When taken consistently, oral PrEP reduces risk of HIV infection by % among cisgender MSM, heterosexual men & women, and transgender women. (84% among PWID) Grant RM, et al. NEJM. Dec 2010;363(27): Baeten JM, et al. NEJM. Aug 2012;367(5): Grant RM, et al. Lancet Inf Dis. Sep 2014;14(9):820-9 Martin M, et al. AIDS. Apr 2015;29(7):819-24

5 Individuals starting FTC/TDF for PrEP PrEP has taken off in the US USPHS / CDC guidelines issued 7x increase Mera Giler R. et al. IAS Paris 2017, abstract #WEPEC0919

6 Individuals starting FTC/TDF for PrEP PrEP has taken off in the US ,732 individuals Mera Giler R. et al. IAS Paris 2017, abstract #WEPEC0919

7 Individuals starting FTC/TDF for PrEP but its distribution is uneven Women Men Mera Giler R. et al. IAS Paris 2017, abstract #WEPEC0919

8 and it s not reaching those most at risk 22% of all new infections in 2014 among yo 83,672 men 15,060 women 24% < 25 yo 11% < 25 yo Mera Giler R. et al. IAS Paris 2017, abstract #WEPEC0919

9 and it s not reaching those most at risk US Population 2015 PrEP Utilization Sept 2016 New Infections 2015 (estimated) 13% 10% 18% 13% 26% 44% 62% 73% 24% Black Hispanic Asian Multi/Other White Mera Giler R. et al. IAS Paris 2017, abstract #WEPEC0919

10 Lifetime risk of acquiring HIV Highest Lowest Hess K et al. CROI 2016, abstract #52 Map from CDC website:

11 Lifetime risk of acquiring HIV If current rates continue, 1 out of every will be diagnosed with HIV in her/his lifetime Highest Lowest Hess K et al. CROI 2016, abstract #52 Map from CDC website:

12 Lifetime risk of acquiring HIV If current diagnosis rates persist... Hess K et al. CROI 2016, abstract #52

13 Lifetime risk of acquiring HIV If current diagnosis rates persist... 2out of 100 Black women will become HIV+ Hess K et al. CROI 2016, abstract #52

14 Lifetime risk of acquiring HIV If current diagnosis rates persist... 9out of 100 White MSM will become HIV+ Hess K et al. CROI 2016, abstract #52

15 Lifetime risk of acquiring HIV If current diagnosis rates persist out of 100 Hispanic MSM will become HIV+ Hess K et al. CROI 2016, abstract #52

16 Lifetime risk of acquiring HIV If current diagnosis rates persist out of 100 Black MSM will become HIV+ Hess K et al. CROI 2016, abstract #52

17 July 13, 2012

18 HIV prevalence in the United States, of every 100,000 Americans (1.2M HIV+ of 314.1M, in 2012)

19 HIV prevalence in the Southeast, 2012

20 Prevalence by race/ethnicity, 2012 Hispanic/Latino White

21 Prevalence by race/ethnicity, 2012 Black White

22 PrEP is now a matter of social justice

23 Potential impact of interventions, Yaylali E et al. CROI 2016, abstract #1051 Graphic from CDC

24 Potential impact of interventions, Yaylali E et al. CROI 2016, abstract #1051 Graphic from CDC

25 Potential impact of interventions, Yaylali E et al. CROI 2016, abstract #1051 Graphic from CDC

26 Potential impact of interventions, Yaylali E et al. CROI 2016, abstract #1051 Graphic from CDC

27 Proportion highly adherent Modeling the 10-year impact for MSM Percentage of Infections Averted 80% 60% 40% 20% 20% 40% 60% 80% Coverage (Percent of at-risk MSM on PrEP) If 40% are covered and 62% take PrEP consistently... 33% of expected infections in next 10 years will be averted Increasing coverage has biggest impact Maximizing adherence lowers the number needed to treat Jenness SM, et al. J Infect Dis Dec 15;214(12):

28 Access to ARVs is essential to prevention PrEP (and PEP) Treatment as prevention

29 How do we improve access and uptake? Educate providers and consumers Bring services to the people who need them Minimize losses along the cascade

30 Linking consumers to providers

31 Linking consumers to providers

32 Expanding to fill service gaps Winston-Salem Greensboro Durham Raleigh Asheville Charlotte NCATEC PrEP Provider Map 4 December 2015 Fayetteville Wilmington Greenville No PrEP provider within 1 county radius

33 Expanding to fill service gaps Winston-Salem Greensboro Durham Raleigh Asheville Charlotte NCATEC PrEP Provider Map 5 September 2017 Fayetteville Wilmington Greenville No PrEP provider within 1 county radius

34 Service gaps reflect structural barriers Data from NC-DHHS Office of Rural Health Rural counties designated Health Professional Shortage Areas (specifically in need of primary care services)

35 Foci for provider recruitment & training Data from NC-DHHS Office of Rural Health Rural counties designated Health Professional Shortage Areas (specifically in need of primary care services) State-Designated Rural Health Center

36 Foci for provider recruitment & training Winston-Salem Greensboro Durham Raleigh Asheville Charlotte Fayetteville Wilmington Greenville Historically Black college or university (HBCU)

37 Addressing barriers head-on Nat l HIV Behavioral Surveillance System (CDC) Blacks & Whites equally willing to take PrEP Educated & high income: more White users YBMSM less likely to have an indication 2 sex partners + (bacterial STI or UAI) in past 12m 1 main HIV+ partner in past 12m Behavior alone doesn t explain differential risk Fewer missteps needed for YBMSM to acquire HIV Hoots B et al. Clin Infect Dis. 2016:63(5): Hurt CB, Dennis AM. Sex Transm Dis. 2013;40(3): Hurt CB et al. JAIDS. 2012;61(4):

38 What about health departments? May 2016 survey of all 85 NC local HDs 56 directors (66%) responded 2 prescribing PrEP (now 4-5: Cabarrus, Orange, Surry, Wake ± Durham) 7 externally refer, 11 considering services Main barriers among 47 without any services: lack of local PrEP providers, lack of PrEP awareness, perceived lack of PrEP candidates Needs assessment for training/support: Help identifying clients, prescribing & mgm t, outreach and educational materials for clients Zhang, Rhea, Fleischauer, Hurt, Mobley, Seña, Swygard, McKellar. In press, JAIDS 2017.

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40 Chicago, IL

41 Structural barriers Adherence Communities of color

42 PWID could also benefit from PrEP Among 220 counties (nationally) identified by CDC as being at high risk of an IDU-associated HIV outbreak Van Handel M, et al. JAIDS (3):323-31

43 PrEP 2.0 is coming FTC / TAF dapivirine NNRTI broadly neutralizing monoclonal antibodies (bnabs) cabotegravir-la INI

44 Pregnancy Prevention HIV Prevention Education & behavior modification Education & behavior modification Condoms Condoms Rings Rings Birth control pill & injection PrEP (oral & injectable) Morning-after pill Post-exposure prophylaxis Spermicide Implantable birth control Vasectomy/Tubal Ligation Topical microbicides Broadly neutralizing Abs Implantables Vaccination Adapted from HPTN

45 Questions? Please me! Christopher Hurt, MD