1. Rectal Microbicides: The Basics Date, Location Your Name, Organization

2. This presentation Overview of epidemic and prevention Who is IRMA? What is a microbicide? What is a rectal microbicide? Research and advocacy Get involved!

3. Global HIV/AIDS Picture 33.2 million people living with HIV/AIDS 2.5 million new infections each year Women account for about half of all new infections Over 25 million people have died About 95% live in developing countries About 90% do not know their status

4. Increased to 34% in 2007

5. What if we had a complete HIV toolkit? Prior to exposure Point of transmission Treatment Rights-focused behaviour change Voluntary counselling and testing STI screening and treatment Preventive Vaccines Pre-exposure prophylaxis (PREP) Male circumcision Male and female condoms and lube ART to prevent perinatal transmission Clean injecting equipment Post-exposure prophylaxis (PEP) Vaginal and rectal microbicides Cervical barriers Improved antiretroviral therapy Treatment for opportunistic infections Basic care/nutrition Prevention for positives Education and behavior change Therapeutic vaccines

6. International Rectal Microbicide Advocates Network of 600+ 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 Released 2008 report in New Delhi: Less Silence, More Science: Advocacy to Make Rectal Microbicides a Reality www.rectalmicrobicides.org

7. 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!

8. 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...)

9. An act of unprotected anal intercourse is 5 to 80 times more likely to result in HIV transmission than an act of unprotected vaginal intercourse.

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

11. 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

12. 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”

13. AI – Gay men and MSM Most HIV infections due to unprotected AI In North America, Western Europe, 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

14. 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

15. VaginaRectum Most of the epithelium is 40 cell layers thick Very fragile epithelium, 1 cell layer thick. Fewer CD4 cells than rectum More inflammatory cells under surface (CD4 receptors) Acidic pHAlkaline, rather than acidic pH Enclosed pouchOpen-ended tube Biological challenges

16. Anatomy 101

17. Safety 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

18. RMs: Investments 2000 - 2006 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%

19. RMs: Investments 2000 - 2006

20. 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

21. Current RM Research 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?

22. 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…

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. 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

26. 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 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

27. 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

28. Global Campaign for Microbicides A worldwide effort co-sponsored by groups working on HIV/AIDS Reproductive health Women’s empowerment Gay health Working to educate, raise awareness and generate collective advocacy for increased political and public investment in microbicide development. Partners with IRMA.

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 Your name Your organization Your email address