PrEP: Roadblocks to implementation
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1 1 Què és el VIH i què és la sida? PrEP: Roadblocks to implementation Pep Coll pcoll@irsicaixa.es 14th European Meeting on HIV & Hepatitis 2016 AIDS Research Institute
2 Disclosures és el VIH i què és la sida? Research grant: Gilead Advisory Boards : Gilead, ViiV
3 Agenda és el VIH i què és la sida? Background Roadblocks Challenges
4 What és el VIH about i què és la sida? Europe?
5 Background és el VIH i què és la sida? PrEP works!!!
6 Background és el VIH i què és la sida?
7 PrEP és el VIH works i què és la sida? if it s taken Adherence is crucial But high protection even with adherence not 100% in MSM and transgender women iprex OLE study Grant R et al. CROI 2014
8 What és el VIH about i què és la sida? Europe? PROUD study in UK Ipergay study in France and Canada
9 What és el VIH about i què és la sida? Europe?
10 What és el VIH about i què és la sida? Europe?
11 What és el VIH about i què és la sida? Europe?
12 What és el VIH about i què és la sida? Europe?
13 What és el VIH about i què és la sida? in real world? Kaiser Permanente study 657 MSM San Francisco 32 months follow-up NO NEW HIV INFECTIONS Volk JE et al. No New HIV Infections With Increasing Use of HIV Preexposure Prophylaxis in a Clinical Practice Setting. Clin Infect Dis Nov 15;61(10): doi: /cid/civ778.
14 What és el VIH about i què és la sida? in real life? Ongoing demonstration projects: Amsterdam Antwerp Bologna Spain?
15 Where és el VIH i què is és PrEP la sida? available in Europe? France 60 PrEP clinics Fully covered by the national health insurance Available since January 2016 Provided through a Recommendation of Temporary Use (RTU)
16 Where és el VIH i què is és PrEP la sida? available in Europe? Jean-Michel Molina
17 Where és el VIH i què is és PrEP la sida? available in Europe? UK PROUD study finished by April 2016 NHS: prevention is remit of local health authorities
18 1 Què és el VIH i què és la sida?
19 Where és el VIH i què is és PrEP la sida? available in Europe? PROUD designed to mimic real-world Until April 2016 NHS not responsible for prevention but local authorities
20 Where és el VIH i què is és PrEP la sida? available in Europe?
21 Where és el VIH i què is és PrEP la sida? available in Europe? Demonstration projects Amsterdam Antwerp Spain?
22 14 Què és el VIH i què és la sida? What are we waiting for?
23 Roadblocks és el VIH i què és la sida? Indication of Truvada for PrEP not yet approved by the European Medicines Agency Submitted in January 2016 Approved by FDA in July 2012
24 Roadblocks és el VIH i què és la sida? Knowledge and beliefs about PrEP among health professionals
25 New England prescribers perceived numerous barriers to prescribing PrEP Clinician perceived barriers to prescribing PrEP (N = 155) Time constraints (eg, to discuss PrEP, counselling/monitoring) Concerns about whether insurers will cover the cost of PrEP Lack of pt request for PrEP Limited number of high-risk, HIV-uninfected pts Clinicians not aware of guidance from normative bodies (eg, CDC) Clinicians not trained to prescribe PrEP Not a barrier Minor barrier Moderate barrier Major barrier Clinicians not aware of PrEP % 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Krakower DS, et al. PLoS One. 2015;10:e
26 Roadblocks és el VIH i què és la sida? 43 % who had not prescribed PrEP did not envision doing so in the future 26 % were unfamiliar with CDC guidance on PrEP (more than 2 years after publication) Most concerned about side effects, drug resistances or increased risk behaviour Krakover et al. Knowledge, Beliefs and Practices Regarding Antiretroviral Medications for HIV Prevention: Results from a Survey of Healthcare Providers in New England PLoS One. 2015;10(7):e
27 Roadblocks és el VIH i què és la sida? Community Lack of information Survey among MSM in Rhode Island (N = 178) 71 % had little or no information about PrEP Merchant et al. Preferences for HIV pre-exposure prophylaxis (PrEP) information among menwho-have-sex-with-men (MSM) at community outreach settings. J Gay Lesbian Ment Health ; 20(1): doi: /
28 Roadblocks és el VIH i què és la sida? Stigma and lack of community acceptance of PrEP Adherence may be compromised in situations where there is a need to conceal PrEP use Haire BG. Preexposure prophylaxis-related stigma: strategies to improve uptake and adherence a narrative review. HIV/AIDS - Research and Palliative Care.2015;7: Participants reported that they were unlikely to disclose PrEP use to family due to fear of rejection or being seen as promiscuous Galea et al. Acceptability of pre-exposure prophylaxis as an HIV prevention strategy: barriers and facilitators to pre-exposure prophylaxis uptake among at-risk Peruvian populations. Int J STD AIDS. 2011;22(5):
29 Roadblocks és el VIH i què és la sida? Concerns, fears & misconceptions Toxicity % Adverse Events similar in PrEP and placebo groups Small decrease in renal function and bone mineral density (often not progressing or reversible)
30 Roadblocks és el VIH i què és la sida? Concerns, fears & misconceptions Drug resistances Low risk of resistance to tenofovir or FTC during use of PrEP Higher risk among those acutely HIV-infected when starting PrEP How implementing PrEP on large scale affects resistance overall is unknown
31 Roadblocks és el VIH i què és la sida? Concerns, fears & misconceptions Risk compensation No differences in condom use, number of sexual partners and STI incidence Increased in IAVI Kenia study San Francisco study: high STI incidence and a 41 % decrease in reported condom use among a sub-set of PrEP users Regular STI screening
32 Roadblocks és el VIH i què és la sida? Concerns, fears & misconceptions Cost Cost-effectivity analysis Offering PrEP is expected to be cost-effective where the incidence of HIV is greater than 3 per 100 person-years and perhaps also at lower incidence
33 Challenges és el VIH i què és la sida? Address skepticism from clinicians, gay community, payers and general population Increase PrEP awareness among health professionals and people at risk Adapt prevention messages to include PrEP
34 Challenges és el VIH i què és la sida? Define appropriate models of care and access points (hospitals, sexual health clinics, primary care, community-based organizations) Monitor and evaluate PrEP implementation New formulas (vg long acting drugs) Reduce cost of drugs for PrEP
35 Challenges és el VIH i què és la sida? Address remaining skepticism from physicians, the Gay community, the payers and the general population Increase PrEP awareness among clinicians and people at risk SAN FRANCISCO AIDS FOUNDATION Provide information about how well PrEP works Build community support for PrEP
36 14 Què és el VIH i què és la sida? What are we waiting for?
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