The Big Picture: The current and evolving HIV prevention landscape Patrick Ndase, MBChB, M.P.H University of Washington Beyond Phase III: Seeking stakeholder perspectives on next steps with the for HIV prevention in women 6 August 2014, Lilongwe
Overview 2010-2014 Rapid Recap Lessons learned 2014-2018 Fast Forecast Opportunities in the offing
The HIV Prevention Timeline 2010-2014 HPTN 052 results TasP in serodiscordant couples (May 2011) iprex results Truvada in MSM (Nov 2010) Partners PrEP Truvada and tenofovir in serodiscordant couples (July 2011) CDC TDF2 Truvada in men and women (July 2011) FDA approval of Truvada for prevention (July 2012) The Ring Study starts April 2012 ASPIRE starts August 2012 Pop-ART (HPTN 071) starts Test and Treat/TasP (Nov 2013) Bangkok tenofovir study (in IDUs) results (June 2013) CAPRISA 004 results tenofovir gel (July 2010) FACTS 001 starts tenofovir gel (Oct 2011) CAPRISA 008 starts Tenofovir gel Nov 2012 HVTN 097 starts vaccine (June 2013) 2010 2011 2012 2013 2014 FEM-PrEP stops Truvada in women (April 2011) VOICE stops tenofovir arm (in women) (Sept 2011) VOICE stops tenofovir gel (in women) (Nov 2011) VOICE results tenofovir gel, Truvada, tenofovir (in women) (March 2013) HVTN 505 stops vaccine (May 2013)
2010-2014: Rapid Recap A time to celebrate: The first proof of concept for a vaginal microbicide (CAPRISA 004) The first proof of concept for oral PrEP (iprex), i.e., a daily pill FDA approval of Truvada based on iprex and Partners PrEP HPTN 052 and TasP Breakthrough of the Year A time to reflect: Two studies (FEM-PrEP and VOICE) no product was effective for HIV prevention women didn t use them A vaccine didn t work to prevent HIV (HVTN 505) A time to look ahead: Start of FACTS 001 trial of tenofovir gel aiming to replicate CAPRISA 004 results A new product (dapivirine vaginal ring) enters Phase III trials
The HIV Prevention Landscape 2014 2018? Ongoing PrEP demonstration projects Pop-ART (HPTN 071) Test and Treat/TasP (continues) MCC approval of Truvada for PrEP?? FACTS 001 results tenofovir gel (early 2015) CAPRISA 008 results Tenofovir gel (2015) Series of HVTN vaccine trials begins?? The Ring Study results (2016) ASPIRE results (early 2016) Tenofovir gel approval?? Ring Study openlabel trial? (2016?) MTN-025 ASPIRE open-label trial?? (mid 2016?) Rectal microbicide Phase III trial? (reduced glycerin tenofovir gel) (2016)?? Dapivirine ring approval?? Vaccine efficacy trials?? 2014 2015 2016 2017 2018
2014-2018: Fast Forecast???? Tenofovir gel Results of FACTS-001 Possible regulatory approval? Dapivirine ring Results of ASPIRE Results of The Ring Study Possible regulatory approval? PrEP and TasP Approval of Truvada for prevention? Introduction? Increased emphasis on earlier treatment for prevention New approaches, new trials The start of large trials of new vaccines? Rectal microbicide in Phase III trial? Long-acting injectables in Phase II trials? Combined ARV/contraceptive ring?
Developing a range of options for women Pill Ultimate goals: Gel Vaginal ring Vaginal film Products that are long-acting, safe, effective, low-cost and user-friendly Multiple options - maximize choice & optimize effectiveness Finding products that work is not enough - need to develop HIV prevention approaches that also are: Less stigmatizing Can be incorporated into daily life Are desirable to the people who need them Injectable
Thank you