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Rectal Microbicides: The Basics Date, Location Your Name. This presentation. Overview of epidemic and prevention Who is IRMA? What is a microbicide? What is a rectal microbicide? Research and advocacy Get involved!. Global HIV/AIDS Picture. 33.2 million people living with HIV/AIDS
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This presentation • Overview of epidemic and prevention • Who is IRMA? • What is a microbicide? • What is a rectal microbicide? • Research and advocacy • Get involved!
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
Prior to exposure Point of transmission Treatment What if we had a complete HIV toolkit? • Rights-focused behaviourchange • 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
International Rectal Microbicide Advocates • Network of 600+ advocates, leading scientists, and policymakers from 6 continents • 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
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!
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...)
An act of unprotected anal intercourse is 5 to 80 timesmore likely to result in HIV transmission than an act of unprotected vaginal intercourse.
Who needs a rectal microbicide? All kinds of people are having anal intercourse (AI)…
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
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”
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
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
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
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
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
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? RM Research
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 trials planned: tenofovir, PRO 2000…
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
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!
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
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
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
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.
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
Thank You • Your name • Your organization • Your email address