Anton Pozniak MD FRCP

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1 WHO strategic plan to end the HIV epidemic: Truth or Fiction in Developing and Middle-income Countries Anton Pozniak MD FRCP Director of HIV

2 the situation to date...

3 AIDS: A heavy toll so far 78 million people infected with HIV Crisis management 40 million AIDS-related deaths 38 million people living with HIV Strategic Response

4 Diversity of HIV epidemics

5 Still... No Cure No Vaccine We have Treatment and other Prevention tools.

6 Needle Exchange Drucker E, AIDS 1998 Male circumcision Auvert B, PloS Med 2005 Gray R, Lancet 2007 Bailey R, Lancet 2007 Treatment of STIs Grosskurth H, Lancet 2000 Microbicides for women Abdool Karim Q, Science 2010 Oral pre-exposure prophylaxis Grant R, NEJM 2010 (MSM) Baeten J, NEJM 2012 (Couples) Thigpen M, NEJM 2012 (Heterosexuals) Choopanya K, Lancet 2013 (IDU) HIV PREVENTION Female Condoms Male Condoms HIV Counselling and Testing Coates T, Lancet 2000 Sweat M, Lancet 2011 Opioid substitution therapy Mathers BM, Lancet 2010 Treatment for prevention Cohen M, NEJM, 2011 Donnell D, Lancet 2010 Tanser, Science 2013 Behavioural Intervention Note: PMTCT, Screening transfusions, Universal precautions, etc. have not been included

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8 % Treat our way out of the epidemic? HPTN 052 Immediate vs. Delayed ART in Sero-Discordant Couples HR = 96.3% reduction in transmission No difference whether index Immediate vs. Delayed ART in Sero-discordant patient was Couples Male or Female Deferred Immediate Sero-Conversions Sero-Conversions Shape: Cohen MS, et al. IAS Abst MOAX0102, Cohen MS, et al. N Engl J Med. 2011

9 HIV Transmission According to Sexual Behavior Reported by HIV-negative partner Rate of Couple Transmission (per 100 Couple-Years Follow-Up [CYFU]) Heterosexual (Male) Vaginal sex with ejaculation (192 CYFU) Heterosexual (Female) Vaginal sex (272 CYFU) MSM Receptive anal sex: With ejaculation (93 CYFU) Without ejaculation (157 CYFU) Insertive anal sex (262 CYFU) Rate (95% CI) Overall risk = Zero through condomless sex with a partner on ART (HIV RNA <200 copies/ml) 4 MSM, men who have sex with men Rodger et al. 21st CROI. Boston, Abstract 153LB

10 This led to the Test and Treat Approach Voluntary counselling and testing to the entire population and Offering immediate ART to all those testing HIV+, irrespective of clinical stage or CD4 count

11 What Is the Objective? Measuring the Effects of ART Treatment as Prevention (TasP) UNAIDS: HIV treatment targets 90% of people tested 90% of people diagnosed with HIV on treatment 90% of people on treatment with suppressed viral load 100% 80% 60% 100% 90% 81% 73% 40% 20% 0% Living with HIV Diagnosed On ART Virologically suppressed 11

12 Progress toward the first 90 by region % 47% 39% 76 % 60 % 50 % 63% 80% 58% 46% 28% 22% Asia & the Pacific Eastern & southern Africa Eastern Europe & central Asia Latin America & the Caribbean Source: UNAIDS, Global AIDS Update 2017

13 Its very different European adults, adolescents from South Africa) Cascade of care in European Union Countries (-2014) Access key population the age issue The adolescent HIV continuum of care in SA HIV Continuum of Care in the European Union CID Zanoni BC, et al. BMJ Glob Health 2016;1:e doi: /bmjgh , IAS 2017, Slogrove 13

14 Treatment as Prevention (TasP) CHILE UNAIDS: HIV treatment targets CHILE UNAIDS DATA % 80% 60% 100% 90% 81% 73% 40% 20% 69% 53% 48% 0% Living with HIV Diagnosed On ART Virologically suppressed 14

15 The First 90 90% of People Tested

16 17.1 million people living with HIV do not know their HIV status

17 Maximizing HIV Testing Yield Provider-initiated HIV testing and counseling Assisted Partner Services (partner notification) Family testing Home-based testing Community testing Self-testing

18 Stop the Waiting-Change Policy Now!! A way forward: HIV self-testing Available since 1990s UNAIDS policy since 2004 Private non-medical affair Convenience and comfort with instant robust results Circumvent barriers Preferred modality heterosexual men, young people, health workers in high prevalence settings, and key populations

19 Technology: Online platform to enhance HIV testing Online education ebooking for HIV testing and PrEP Online, supervised, HIV self-testing Integrating Community-Led Health Services with online strategies to increase access and yield of HIV testing Group A (n=194) Conventional testing at clinics Group B1 (n=117) Online counseling + offline testing Group B2 (n=145) Online counseling + online, supervised self-testing Health Professionals (n=64) Community Health Workers (n=130) Health Professionals (n=31) Community Health Workers (n=114) First-time testers (%) 35.9% 46.2% 15.4% 32.3% 48.2% HIV prevalence (%) 4.7% 17.7% 1.7% 3.2% 21.1% Community-led web recruitment high HIV-positive yield Preliminary data from TRCARC, as of 30 April 2017 Phanuphak

20 The Second 90 90% of people diagnosed with HIV on treatment

21 ART Coverage by country, million on ART, but funding cuts on the way

22 Global ART treatment demand will rise by 800,000 per year, unless HIV infection rates fall 1.8 million new HIV infections* /year Need for ART ( ): 30 million in million in million in million HIV-related deaths*/year *REF:

23 RETENTION IN CARE AND ART Starting patients on ART is just the first step...retaining people in therapy and keep the virus fully suppressed (for years) is far more complicated.

24 Interventions to improve ART initiation ART initiation increased with: Interventions with home HTC (RR=2.00) POC CD4 (RR=1.3) Improved clinic operations (RR=1.36) Package of patient services (1.54) Fox M, et. al. Interventions to improve rate or timing of ART initiation, Meta-analysis, JIAS, in press

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26 Health care worker-managed group Client-managed group Facility-based individual Out-of-facility individual

27 Results of Club model LTFU 94% retained at 12 months Viral rebound 98% suppressed at 12 months Grimsrud et al, JAIDS, 2015.

28 Technological advances Cell phones E-banking Informatics, e-health Molecular diagnostics Point of care tests Vaccines Public health approach to ART

29 Strategies to strengthen HIV continuum of care McNairy et al AIDS 2012 Linkage + ART Eligibility + Initiation Test Link Link & Retain Retain 1)Decentralize testing 2) Simplify/rapid ART initiation -Initiation algorithm -Home HTC -Package services -Improved clinic operations Peer support groups Two way SMS Outreach

30 Barriers to Testing, Treatment and Care

31 Barriers to Testing and starting Treatment Discriminatory Laws and Policies In 76 countries, same-sex sexual practices are criminalized In seven countries they are punishable by death Sex Workers MSM PWID 53% 47% 43% Percentage countries whose laws, regulations, or policies can hinder service provision for key populations MSM, men who have sex with men; PWID, people who inject drugs Source: GARPR 2013 Countries reporting existence of laws, regulations or policies that can pose obstacles to effective HIV prevention, treatment, care and support services for key populations 31

32 THE HOMOPHOBIC CLIMATE INDEX, 2016 Source: Lamontagne et al, 2016.

33 DOLUTEGRAVIR Pregnancy Interactions with rifampicin

34 Manpower-Doctor Density Map

35 Can we afford it? -Drug costs: Ending the HIV exceptionalism Setting fair prices to treat HIV, and Hepatitis < $90 per year to treat HIV with newer drugs (DTG-combination with XTC/TAF) < $90 per year to treat hepatitis B (TDF/3TC or entecavir) < $90 for 12-week course of HCV (Sofosbuvir/Daclatasvir) Percentage of projected ARV costs that are estimated to be unfunded 0 % 18 % 36 % 55 % 73 % 91 % Nearly US$ 4.2 billion of ARV requirements across 38 countries may remain unfunded from 2016 to 2020 Calmy AIDS 2017,

36 Generics can be cheap worldwide 4.0 Price per unit paracetamol simvastatin allopurinol metoclopramide warfarin UK South Africa India Estimated generic price

37 YES-The Price will be around $75/year!!!!! The TLD combination pill Dolutegravir, Lamivudine,Tenofovir DF Developed by Mylan and Aurobindo Savings over current therapies will be US$ 1.6 billion in treatment costs through 2024 Enough to provide access to medicines for an additional 3.2 million people for 5 years.

38 An essential ingredient community advocacy

39 What has been the Impact of Treatment?

40 Treatment as Prevention Test and Treat Approach Broad societal benefits of ART For every 1,000 patient-years of treatment: 226 patient deaths averted 432 children not orphaned 60 sexual transmissions of HIV averted 39 vertical (mother-to-child) infections averted 9 TB cases averted among HIV patients 2,419 life-years gained PEPFAR; President's Emergency Plan for AIDS Relief; TB, tuberculosis Source: CDC estimates from the PEPFAR ART Cost Model (PACM) for the Office of the US Global AIDS Coordinator, based on PEPFAR FY2013 APR results 40

41 Years HIV and Life Expectancy? Source: World Bank life expectancy data.

42 Can treatment alone end the AIDS epidemic? The case of Botswana Despite being very close to the UNAIDS targets of , Botswana still has unacceptably high community HIV incidence rates. at 3.1%.

43 SHIMS 2: HIV in Swaziland 44% decrease in Incidence Comparison of 2011 (SHIMS 1) and Assessments of Adults Yrs of Age Outcome, % P Value Prevalence Incidence Virologically suppressed <.0001 Nkambule R, et al. IAS Abstract MOAX0204LB.

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45 Progress in access to antiretroviral therapy: Stable 2 million new infections per year, Increasing in some regions including Chile 6

46 What about Giving ARVs to HIV negative persons? Pre-Exposure Prophylaxis

47 Is HIV epidemic control achievable? Status quo + 100% ART at CD Circumcision + Early ART + structural + PrEP + behavioral Yes, HIV epidemic control is achievable! Source: Cremin I. et al. AIDS 2013

48 HIV Incidence (per 100 person-years) Real world PrEP: PROUD Study new HIV infections with immediate versus deferred PrEP (3 versus 20 cases) 86% reduction (P=0.0002) Number needed to treat to prevent 1 HIV infection: ( ) Deferred (n=269) HIV Incidence 86% Reduction (P=0.0002) 1.3 ( ) Immediate (n=276) McCormack S, et al. Lancet. 2016;387:53-60.

49 HIV Incidence (per 100 person-years) Ipergay Trial: Event-Driven PrEP On-demand PrEP is highly effective Drug-related GI AEs (10%) HIV Incidence Sexual behavior % Reduction (P=0.002) Placebo (n=212) 0.91 On-Demand PrEP (DB) (n=219) 0.40 On-Demand PrEP (OLE) (n=248) Molina J-M, et al. 23 rd CROI. Boston, Abstract 886

50 Maximizing the Potential Effectiveness TDF/FTC (7x/week) TDF/FTC (~1x/24) 99 % 94 % Some adherence forgiveness with retained protection Anderson P et al, Sci Transl Med doses per week likely required Donnell D et al, JAIDS Cottrell ML et al, JID, 2016.

51 4 Doses/Week has Similar Efficacy to Daily TDF/FTC for MSM Anderson et al, Sci Transl Med 2012;4 (151):151ra125 # Doses/ week Estimate d efficacy 95% CI 2 76% 56-96% 4 96% 7 99% 90%- >99% 96%- >99%

52 But first there was PrEP

53 Almost there in the UK

54 New HIV diagnoses, AIDS and deaths UK Is Treatment enough? UK has almost achieved

55 Impact of generic PrEP in UK?

56 PrEP not available on the NHS too costly Generic Source of PrEP 30 month Details of source % (23/161) % % (10/161) % (52/161) Hospital 0.6 % (1/161) % (2/161) % (10/161) % (1/161) % (1/161) Not stated/unknown 37.9% (61/161)

57 But..NO PrEP on the NHS...yet.. 56 Dean st Clinic -generic PrEP 161 individuals 100% MSM 1 February 7 June /129 (90%) on daily PrEP 13/129 (10%) on event driven PrEP TDM performed in 125 individuals

58 HIV tests and diagnoses at Dean Street, London, 2015 to 2017 HIV+ diagnoses/month HIV tests/month Month

59 Number of people newly diagnosed with HIV and AIDS, and all-cause deaths among people with HIV in the ART era: United Kingdom, AIDS at HIV diagnoses is within 3 months of HIV diagnoses. 59 HIV in the United Kingdom 2017 Slide Set

60 New HIV infections (x1000) PrEP was more effective than all other individual interventions targeting the entire UK MSM population Estimated numbers of new HIV infections between 2001 and 2020 in the status quo and the maximum effect of individual intervention scenarios at 100% coverage Extension of a partnership-based model for HIV transmission in MSM aged years Status-quo scenario: total of 16,955 HIV infections in MSM in the UK, with around 2,400 new infections annually during ( 6 6 new HIV infections every day) Pre-exposure prophylaxis Test once a year Test twice a year Test and treat Reduce repeat sexual partners Reduce one-off partners Decrease condomless anal intercourse with repeat sexual partners Year MSM, men who have sex with men; PrEP, pre-exposure prophylaxis Punyacharoensin N et al Lancet 2016;3(2):e94 e104

61 Potential Effectiveness of PrEP in the USA Current PrEP use is 29% of what might be needed to cut new HIV infections by 70% With a maximum PrEP uptake of 95%, and viral suppression rate of 90% of people with HIV, the new-hiv rate would fall to about 200 per year With a PrEP uptake of 95% of those at risk, the new-hiv rate would be 70% lower than 2011 PrEP, pre-exposure prophylaxis; TasP, treatment as prevention Grant RM et al. CROI Seattle, WA. #25

62 Conclusions Still...No Cure, No Vaccine We have Treatment and other Prevention tools.but The concept of TaSP needs to be linked with prevention that is targeted and appropriate if we are to end the epidemic. Retention in care, funding, bureaucratic inefficiencies, stigma and political engagement are major obstacles. Lessons from other countries are vitally important.

63 Towards an AIDS-free Generation

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