Pre-Exposure Prophylaxis PrEP where are we now? Marie Laga Institute of Tropical Medicine

Transcription

1 Pre-Exposure Prophylaxis PrEP where are we now? Marie Laga Institute of Tropical Medicine

2 New HIV diagnoses Belgium 2014

3 Treatment of STIs Treatment as prevention Condoms Oral preexposure prophylaxis PrEP HIV PREVENTION TOOLS HIV Counselling and Testing Behavioural Interventions Post Exposure prophylaxis (PEP) focused on reducing sexual transmission

4 What is PrEP? New prevention method for HIV(-) people to reduce risk of acquiring HIV Involves (oral )use of ARV One pill a day every day or event driven (=around sex) blocks HIV replication preventing HIV infection from establishing

5 Why PrEP for MSM? MSM main driver of the HIV epidemic An additional HIV barrier method for episodes in life with higher risk behavior, not life long Allows vulnerable MSM to take control, in context of high drug and alcohol use

6 Clinical Trials: Protective effect varies

7 High concentration of TDF in rectal tissue

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9 PrEP Science summary from trials Variable protective effect in different populations Analysis of subgroups of high adherers showed level of protection > 90%, especially among MSM No serious toxicity observed so far, some evidence of reduction of bone density effects No evidence of increasing drug-resistant virus possibly linked to the strong prevention effect if used biggest risk is acute phase infection at initiation on PrEP Prove of concept PrEP works if used correctly!

10 The Food and Drug Administration (FDA) has approved the new use of Truvada to be taken once daily and used in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected 16 July, 2012

11 Reflection paper 2012 The EMA/CHMP is following the scientific developments in this area. the agency is prepared to evaluate future marketing authorisation applications for PrEP. In 2015?..

12 HIV Trends in Europe

13 No PrEP strategy across the EU PrEP only avalailable in the context of research ( UK, Fr, NL, B) ECDC will continue to follow closely the ongoing research studies, and looks forward to the full results of the PROUD and IPERGAY clinical studies..will assess how to best integrate the new evidence in the current European prevention framework.. Carefully understand the impact of any PREP strategy on condom use and risky sexual behavior.., as well as cost implication From ECDC document November 2014

14 Design: 545 MSM enrolled 276 assigned to IMMEDIATE daily use of PrEP 269 assigned to DEFERRED (12 months) Reach group with substantial risk? HIV Incidence deferred arm: 9/100 py Confirm efficacy in real life? Protective effect 86% Risk Compensation? STI high but similar in both groups; low condom use but no decline among PrEP users Ref: McCormack et al, The Lancet 2015

15 PrEP around sex event-driven does it work? 2-24 H Protection 86% day day day day day day 24 H Ref Molina et al, in press NEJM

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17 Addressing outstanding questions by context

18 PrEP in Belgium Interest Research groups since 2012 : ITM, CHU Saint Pierre, U Liege HIV plan Belgium : PrEP demonstration projects priority action point Funding : 2014 successful application (ITM) to IWT TBM for demonstration project among MSM 2015 Gilead accepts to donate the medication

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20 Study Be-PrEP-ared Design: open-label cohort study Outcomes: uptake, acceptability and feasibility of PrEP Study drug: Truvada Study population: 200 HIV (-) MSM at risk Study site: Institute of Tropical Medicine (ITM), Antwerp Follow-up: 18 months (starting Sept 2015) Study regimen: participants self-select in 2 groups (*): 1) Daily PrEP 2) Event-driven PrEP * Switch-over between groups is possible

21 Mixed Methods approach Topics to explore Current preventive needs Uptake, acceptability and feasibility of PrEP Adherence Risk compensation and condom use STI trends Safety Viral Resistance Real life effectiveness Study team Working together across disciplines, teams and departments

22 Sub Study on Improving Adherence and Sexual Well- being Partners : ITM, VUB and University Hospital Antwerp with KBS funding 1. Participatory development of two interventions 2. Intervention evaluation: adherence, sexual well-being n=100 n=100 Mixed method evaluation: qualitative indicators to assess acceptability; quantitative to assess outcome using Be-PrEP-ared indicators (RCT: max. 9 months follow-up)

23 Community involvement Community Advisory Board Cavaria European AIDS Treatment Group Boysproject Het Roze Huis A Sensoa Toys 4 Boys Wel Jong Niet Hetero and independent experts

24 The website

25 Study Perspectives of Health Care providers Partners ITM, UA Based on Dutch AmPrEP survey(ggd Amsterdam); adapted to Belgian context Knowledge of PrEP Experience with (the demand of) PrEP, sexual counseling and STI testing Attitudes towards PrEP Self-perceived role in the provision of PrEP

26 Perspectives of Health Care providers Methods Internet-based survey Anonymous, self-administered online questionnaire All healthcare providers with HIV experience (HIV clinicians, family physicians, gynaecologists, internists, nurses, psychosocial health care providers, ); distribution BREACH, Domus Medica, ARC min. time to fill in the form Using google forms [Nl, Fr, E] Launching January months online access to the survey Focus group discussions

27 The Future RESEARCH WORLDWIDE

28 ARRV-Based Prevention Pipeline RESEARCH on DRUGS and DELIVERY systems for PREP R November 2015 From avac.org/infographic PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV IPM Pop Council IPM IPM TaiMed CONRAD HPTN/ACTG CONRAD IPM Gilead CHAARM IPCP NIAID IPM IPM IPM CONRAD GSK/ViiV Janssen R ACTIVE DRUG IPM Pop Council CONRAD Albert Einstein IPM CONRAD TFV Tenofovir DAR Darunavir ImQuest CHAARM ImQuest Pop Council R DELIVERY SYSTEM TFV TDF Tenofovir prodrug Tenofovir disoproxil fumarate DAP GRF Dapivirine Griffithsin CDC IPM RTI IPM Oral pills Vaginal tablet TFV/ FTC Tenofovir/ emtricitabine DS003 DS003 (BMS793) PBS Vaginal gel R Rectal gel TDF/ FTC Tenofovir disoproxil fumarate/emtricitabine IQP IQP-0528 Pop Council Pop Council Mintaka PBS Vaginal ring Vaginal film Phosphate buffered saline Long acting injectable Thin film polymer Nano-fiber MIV 150 TMC 278 MVA RAL MIV 150 Ripilvirine Maraviroc Raltegravir 5P12 5P12-RANTES 744 MAb GSK 744 Monoclonal antibody No drug tested currently

29 The Future IMPLEMENTATION

30 > 3 per 100 years

31 Experience with Real life implementation

32 Population Impact of TasP and PrEP 30-63% of high risk MSM report PrEP use STI rates +++ From Grant, IAPAC conference Paris, 2015

33 PrEP and cost-effectiveness? Cost of the drug ( + medical FU) Targeting high incidence populations Adherence levels (affecting effectiveness) From Cambiano V, EATG webinar Update on PrEP 2015

34 PrEP Access and Implementation steps EUROPE Open letter to Gilead to ask for price reduction of Truvada for European market Accelerate process for European Medicine Agency license BELGIUM Continue to support and expand Implementation research Creation Belgian PrEP task force from BREACH Public Health + other relevant stake holders Dialogue with authorities on realistic steps for roll out and access Involvement and voice of Communities Consider other Key Populations (female sex workers, SAM)? Learn from neighboring countries

35 Just a few days ago in France

36 It s not just about putting pills in peoples mouth! An important new tool to be integrated in combination prevention for HIV Maximizing the opportunities for Prevention and improving Sexual well being If done right, may be a game changer in addressing the HIV epidemic