1. Page 1 HIV Treatment-as-Prevention (TasP) for people who use illicit drugs and implications for HCV TasP: The North American experience M-J MILLOY Research scientist, British Columbia Centre for Excellence in HIV/AIDS; Assistant professor, Division of AIDS, Department of Medicine, University of BC 8th International AIDS Society Conference on HIV pathogenesis, Treatment & Prevention Vancouver, 22 July 2015

2. Page 2 I have no conflicts of interest to declare.

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5. Page 5 Figure 1: Gains in life expectancy among ART-treated HIV+ in North America

6. Page 6 HIV+ people who use drugs have not benefitted equally from HAART –Lower rates of access to HAART –Lower levels of adherence to HAART –Higher rates of discontinuation –Elevated rates of suboptimal HIV/AIDS treatment outcomes

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8. Page 8 After IAS 2015: Will people who use drugs in North America reap the full benefit from TasP/90-90-90?

9. Page 9 Figure 1: New HIV diagnoses in Vancouver among PWID, 1985 to 1996

10. Page 10 HIV outbreak among PWID in Vancouver’s Downtown Eastside (DTES) Proximate: Shift to cocaine injection “Deadly public policy” –Housing policies –Needle exchange restrictions –Police enforcement and incarceration –Changes in resource economy

11. Page 11 Scale-up of HIV/AIDS treatment for people who use drugs –2005: Immediate initiation of PWID in HIV/AIDS clinical guidelines –2010: STOP HIV/AIDS pilot project in DTES Seek, Test, Treat and Retain (STTR) –Ongoing: province-wide TasP-based effort

12. Page 12 AIDS Care Cohort to evaluate Exposure to Survival Services (ACCESS) –Open longitudinal prospective cohort –HIV+ people who use illicit drugs –Recruited from community settings in Vancouver’s Downtown Eastside (DTES) –Complementary cohort to VIDUS –Ongoing since 2005

13. Page 13 ACCESS study: Baseline –817 participants; mean age = 43 (IQR: 37-48) –535 (66%) male; 466 (57%) Caucasian –Homeless/marginally housed: 586 (73%) –Live in the DTES: 528 (65%) –Recently incarcerated: 188 (15%) –Illicit drug use patterns: 136 (17%) ≥ daily heroin injectors 292 (36%) ≥ daily crack cocaine smokers

14. Page 14 Engagement in HIV care, ACCESS study, 2006 – 2012 (n = 805)

15. Page 15 Incidence of resistance, ACCESS study, 2006 - 2012

16. Page 16 Plasma HIV non-detectability, ACCESS, 2006 to 2013, (n = 805 participants)

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19. Page 19 CD4 cell count at treatment initiation, ACCESS, 2005 to 2013 (n = 357)

20. Page 20 Maximally-assisted therapy (MAT) –“To improve access and adherence to ART by minimizing barriers through a multidisciplinary care approach” –Directly-observed therapy; on-site MMT –15% ACCESS participants in MAT –Among people with ≥ 1 day ART in last 180: 90% MAT participants achieved optimal adherence 63% non-MAT achieved optimal adherence

21. Page 21 HIV Cascade of Care among ACCESS –Improvements in ART engagement, ART adherence and viral suppression –Relevant patient-level factors: Initiation of ART at higher CD4 cell counts; Adherence supports, including methadone co- dispensation; Decrease in pill burden –Other factors?

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24. Page 24 Factors associated with plasma HIV RNA rebound (n = 277)

25. Page 25 HIV treatment initiation among PWID: –Illicit drug use patterns not associated with treatment initiation –Barriers to treatment initiation: Illicit income generation (drug dealing, sex work, binning, etc.) Incarceration

26. Page 26 HIV Cascade of Care among ACCESS –Improvements in ART engagement, ART adherence and viral suppression –Possible effect on HIV transmission patterns?

27. Page 27 Figure 2: HIV seroconversion rate, 1996 to 2012, VIDUS

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29. Page 29 New HIV diagnoses in BC among injection drug users, 1985 – 2012 (BC Centre for Disease Control)

30. Page 30 >96% decrease in rate of new HIV infections in DTES associated with: –Scale-up of HAART –Scale-up of low-barrier methadone –Needle exchange to needle distribution –Opening supervised injection facility –Heroin prescription trial

31. Page 31 TasP initiatives in North America: –Province of British Columbia –San Francisco, California –New York State

32. Page 32 TasP initiatives in North America: –Province of British Columbia –San Francisco, California –New York State Limited commitments to scale up TasP Limited data on HIV care cascade

33. Page 33 Figure 3: HIV care cascade, ALIVE study, Baltimore MD, 1998 - 2011

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37. Page 37 “If you would have asked me last year if I was for a needle exchange program, I would have said you’re nuts… I thought, just like a lot of people do, that it’s enabling — that you’re just giving needles out and assisting them in their drug habit.”

38. Page 38 “If you would have asked me last year if I was for a needle exchange program, I would have said you’re nuts… I thought, just like a lot of people do, that it’s enabling — that you’re just giving needles out and assisting them in their drug habit.” — Public health nurse, Indiana

39. Page 39 “If you would have asked me last year if I was for a needle exchange program, I would have said you’re nuts… I thought, just like a lot of people do, that it’s enabling — that you’re just giving needles out and assisting them in their drug habit.” — Public health nurse, Indiana. “But then I did the research on it, and there’s 28 years of research to prove that it actually works.”

40. Page 40 Despite decades of evidence… –HIV outbreak driven by poor distribution to sterile syringes ongoing in Indiana, Saskatchewan –Methadone remains sub-optimally delivered in many settings –Correctional settings remain key drivers of poor access to HIV prevention and treatment –1 public Supervised Injection Facility

41. Page 41 TREATMENT-AS-PREVENTION –Vancouver: TasP treatment scale-up associated with improvements in HIV care cascade and declines in new HIV infections –Limited commitment to TasP scale-up in North American settings; limited data on HIV care cascade –Repeating failures of HAART, PEP, PrEP, etc.?

42. Page 42 HIV PREVENTION IN NORTH AMERICA –Ongoing preventable HIV outbreaks –Criminalization limits optimal HIV/AIDS treatment and prevention –Further research not needed on effectiveness of TasP, HAART, MMT, SIF, etc. –Need to identify barriers to optimal delivery of all HIV prevention tools for people who use drugs in all settings

43. Page 43 “Reinstating the [US federal government] ban [on needle exchange funding] is murderous. It's saying that people who use drugs should contract fatal and expensive diseases and die....this is a truly shameful moment, when we go backward instead of forward, and let a politics of ignorance, of stigma, of hate, win out over compassion, science and a desire for a healthy community.” Laura Thomas, Drug Policy Alliance

44. Page 44 Acknowledgements ACCESS study participants for contributions to the research Current and past researchers and staff ACCESS supported by United States National Institutes of Health (R01-DA021525) M-JSM supported in part by US NIH (R01-DA021525)