Vaccines and Microbicides Rebekah Webb, AVAC STOPAIDS All Members Meeting: Re-prioritising Prevention London, 12 th May 2016

“It’s not just about putting pills in peoples’ mouths!” - Dr Marie Laga, Be-PrEP-ared study

% of PLHIV know their status 90% of those PLHIV on treatment 90% of those PLHIV undetectable HIV Prevention

Why do we still need research? More options = more infections averted No epidemic has ever been ended without a vaccine Need for “women-friendlier” and people-friendlier options Microbicides and vaccines are more sophisticated (PrEP = a systemic drug) Constant learning and innovation – link to a cure?

Will we ever have a vaccine? Preventive and therapeutic vaccines Proof of concept 2009: RV144 Thailand Pox-Protein Public-Private Partnership (P5) Consortium (Gates, HVTN, NIAID, SAMRI +Pharma) HVTN 702 late-2016/early results in 6 yrs Two approaches: – PLWHIV Antibodies (Bnabs): passive immunisation (AMP) – T-cell responses (Louis Picker monkey study) Moving towards a cure?

ARV-Based Prevention Includes PrEP, microbicides (gels and rings), long-acting injectables (LAIs), films, etc. These products being explored in clinical trials to date incorporate a single ARV or a combination of two ARVs Work also focused on non-ARVs and dual-purpose products (with contraception—called multipurpose prevention technologies or MPTs)

Dapivirine Ring IPM Ring Study 1950 women South Africa and Uganda 31% protection DREAM OLE (not PEPFAR) MTN ASPIRE Study 2629 women Malawi, South Africa, Uganda, Zimbabwe 27% protection HOPE OLE Flexible ring of elastic silicone Inside vagina, ring releases dapivirine slowly over time Two Phase III trials of 4-week vaginal dapivirine ring Modest HIV protection found!

PDPs Prevention research is often led by product development partnerships (PDPs) Lack of Pharma interest in prevention Non-profit mission with pharmaceutical expertise Focus on access: availability, affordability, acceptability, and adopted into the local health system; end-user experience Particularly useful in European context to pool resources

EU Prevention Research Investment Investment focused on early treatment and vaccines No investment in PrEP Limited investment in microbicides

Advocacy Agenda Deliver what we have. Provide oral PrEP to those at substantial risk (WHO) Advocate for full funding of the DREAM OLE and related studies (MDP401) Broaden and sustain the pipeline. Research into LAIs, vaccines, vaginal and rectal microbicides, MPTs & Bnabs must also continue Advocate for properly funded social science/ behavioural research components in clinical trials

Recommended Reading EATG Position Paper on Prevention (October 2015) – n_Position_Paper_now_available n_Position_Paper_now_available EATG AVAC Prevention Summit report (2016) – AVAC PxWire Vol 9. No.2: Dapivirine Ring results – files/PxWire_Vol9_No2.pdf files/PxWire_Vol9_No2.pdf

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