Rectal Microbicides: The Basics October 2008 , ESM Marc-André LeBlanc, GCM

1. Rectal Microbicides:The BasicsOctober 2008, ESMMarc-André LeBlanc, GCM

2. This presentation • Who is IRMA? • What is a rectal microbicide? • Research and advocacy • Get involved!

3. International Rectal Microbicide Advocates • Network of 650+ advocates, leading scientists, and policymakers from 6 continents • AIDS Foundation of Chicago – secretariat • Mission: support development of safe, effective, inexpensive, easy to use rectal microbicides for all that need them www.rectalmicrobicides.org

4. ¡Y en español tambien! • Released 2008 report in New Delhi • Provides rationale for rectal microbicides • Overview of current research • Outlines an advocacy agenda

5. What is a microbicide? • A product applied in the vagina or the rectum that can offer protection against HIV and other STD pathogens • Formulated as a gel, lubricant, or cream • A rectal microbicide (RM) might be delivered via suppository, douche, or an enema • Still in development – are not available yet!

6. We need a rectal microbicide that is • Safe • Effective • Easy to use • Inexpensive • Easily accessible (i.e. over the counter) • Available in various forms (lubes, suppositories, enema, condom coating...)

7. An act of unprotected anal intercourse is 5 to 80 timesmore likely to result in HIV transmission than an act of unprotected vaginal intercourse.

8. Who needs a rectal microbicide? All kinds of people are having anal intercourse (AI)…

9. AI is common globally • Prevalence & incidence not well defined • Widely practiced among MSM • Increasingly understood as relatively common between women and men • 10-40% report practicing AI • Most heterosexual AI unprotected

10. AI and Women • In absolute numbers, 7x more heterosexual women than gay men and MSM in the US practice receptive AI (conservative estimate) • Unprotected AI may be a significant source of HIV transmission in many contexts, including those labelled as “heterosexual epidemics”

11. AI – Gay men and MSM • Most HIV infections due to unprotected AI • In Western Europe, North America, Latin America : • Gay men and MSM make up most HIV infections • In many African, Asian and Latin American countries: • HIV among MSM significantly higher than general population • Globally, only 9% of MSM in 2006 received any type of prevention

12. Challenges to RM Development Compared to microbicides for vaginal use, RMs are in much earlier stages of development because of: • Scientific and biological challenges • More complex safety issues – rectum very fragile • Lack of resources • Lack of understanding of need • Political and cultural reluctance to address anal sex • Stigma • Denial • Homophobia

13. Biological challenges

14. Anatomy 101

15. Potential RMs are tested for safety Microbicides intended for vaginal use need to be tested for rectal safety Sexual lubricants should be tested for rectal safety Safety

16. Total investments = US$34M About US$7M per year U.S. public sector contributed 97.4% of overall funds Philanthropic and private sectors 2.6% RMs: Investments 2000 - 2006

17. RMs: Investments 2000 - 2006

18. Needs estimate • Conservatively, rectal field probably needs 5 candidates over 10 – 15 years • Will require minimum US$350M, or at least $35M/year for 10 years • Therefore, annual spending needs to increase 5X

19. Baseline studies What normally happens during AI? Distribution studies Where do RMs need to go? Clinical trials Are these RMs safe? Acceptability & behavioural studies What kinds of products would people use? Who is having AI? Current RM Research

20. Clinical trials • World’s first rectal microbicide safety trial: Testing UC-781 • Phase I, randomized, placebo-controlled safety and acceptability study of vaginal microbicide gel formulation applied rectally in HIV-1 seronegative adults • Part of: National Institute of Health U19 Microbicide Development Program (MDP) • $17.4 million, ends 2009 • More RM safety trials planned: tenofovir, PRO 2000, VivaGel

21. More safety trials • Rectal safety of VivaGel • Q3 2009 • polyanion dendrimer microbicide • vaginal formulation • HIV- sexually abstinent men/women w/ history anal sex • Rectal safety of PRO 2000 • polyanion microbicide • vaginal formulation, two concentrations • sequentially enroll HIV-, then HIV+ MSM • protocol in development

22. It’s all about Tenofovir • A two-site (Pittsburgh and LA), Phase 1, double-blind, placebo-controlled safety and pharmacokinetic trial of topical, vaginally-formulated 1% Tenofovir gel applied rectally • Q1 2009 • exploratory pharmacokinetics study comparing topical with oral tenofovir levels in rectal tissue, rectal fluid, and blood. • Phase 1 Randomized, Blinded, Placebo-Controlled Rectal Safety and Acceptability Study of Tenofovir 1% Gel • Q1 2009 • protocol in development

23. Lube survey IRMA’s 2007 online survey on lube use for anal sex had nearly 9,000 responses from over 100 countries, in 6 languages RESULTS • Most respondents do not always use condoms, but many use lube • RMs similar to existing lubes would probably be highly acceptable • Need to consider implications of adding saliva, vaginal fluid, water to lubes when testing them

24. Advocacy • Microbicide research is not adequately funded • Need for increased funding for both vaginal and rectal microbicides • Talk to funders, policy makers, elected officials, other government officials • Recruit researchers to the field of RM • YOU can be an advocate!

25. Advocacy from Europe Potentially critical role in propelling rectal microbicide research and advocacy • Increase and diversify funding! • Increase amount and types of research; recruit researchers • Expanding the advocacy base WE NEEDYOU!

26. If you have 5-10 minutes you can… • Read one fact sheet or news item from our website or our blog • Sign up for the IRMA listserv through the website • Pass along our web address and contact information to another advocate, researcher, policy maker or potential funder

27. If you have 30-60 minutes…. • Join one of IRMA’s regular free teleconferences featuring world leaders in RM research and advocacy- see website for what’s next: TOMORROW! • Read an excellent resource from our web site, including Less Silence, More Science • Make a presentation and host a discussion with your colleagues – like this one! • Talk to members of your community about your interest in rectal microbicides

28. To engage actively in shaping the rectal microbicide field… • Join an IRMA working groups to help us meet our objectives • Join IRMA’s Steering Committee • Become your community’s rectal microbicide spokesperson: • enlist organisational support • conduct presentations • engage the media with support from IRMA • Reach out to advocates, researchers, policy makers and funders to ask for their support

29. Resources www.rectalmicrobicides.org International Rectal Microbicide Advocates www.global-campaign.org Global Campaign for Microbicides www.microbicide.org Alliance for Microbicide Development www.amfar.org amfAR-The Foundation for AIDS Research www.mtnstopshiv.org Microbicide Trials Network www.ipm-microbicides.org International Partnership for Microbicides

30. Thank You! • Marc-André LeBlanc • Global Campaign for Microbicides • mleblanc@global-campaign.org