Rectal microbicides advocacy Issues, work and collaboration Kim Mulji UK rectal microbicides working group

Why we need rectal microbicides What some of the development challenges are, and where we are at Rectal microbicides advocacy work Objectives

Male to male sex High rates of condom use are difficult to maintain, as the rate of new HIV infections shows New data reveals reasons for concern: –UK: 48.8% UAI in the past year –San Francisco: 32-37% UAI in past month STI rates confirm UAI prevalence

Women at risk In US, an estimated 23% of women have had anal sex at some point in their lives (Laumann, 1994) 32% of high-risk women reported anal sex in past 6 months (Gross et al, 2000) In a Chinese study of 1300 people from 41 cities, nearly 70% of men and women reported engaging in anal intercourse (Burton 1990)

We need a product that is… Inexpensive Easily accessible (over the counter) Easy to use Safe, non-irritating Available in various forms (in lubes, suppositories, on condoms) Effective -- how effective? Long lasting - but how long?

Laboratory Testing 2-6 Years Phase 3 (efficacy) 2 to 4 Years Simultaneous studies: HIV+, penile & rectal 10 or more years 5 products 3 products 6 products products Phase 1 (safety) 1 to 6 Months Phase 2 (safety) Up to 2 Years 25 – 40 people people 3,000-10,000 people Vaginal microbicide research in 2005

Physiological differences VaginaAnus-colon-rectum Most of the epithelium is 40 cell layers thick Very fragile epithelium, 1 cell layer thick. Other and fewer CD4 cells than rectum More inflammatory cells under surface (CD4 receptors) Acidic pHAlkaline, rather than acidic pH Enclosed pouchOpen-ended tube - how much coverage needed?

The rectum and colon

Research questions Dosing – how much, what is acceptable? Application Methods? Dilution – how would it spread? What assays (tests) to measure impact? How does rectal shedding of HIV impacts risk? Using baseline research, clinical studies and behavioral research to investigate.

Baseline research To learn more about: The impact of intercourse on rectal tissue (trauma, inflammation, speed of healing) How HIV infection occurs in the rectum – what cells are most vulnerable What markers can we look at to determine impact of a product on the rectum?

Behavioral research To learn more about… Prevalence of unprotected anal intercourse – both men and women Preferences re: formulation and delivery systems Sexual practices that affect microbicide feasibility How much product is acceptable

More vital steps 1.Safety trials on what happens if rectal application of first vaginal microbicides 2.Testing over the counter lubes to see how safe they are 3.Advocacy for increased research

Microbicide research is drastically under-funded Pressure not to address anal sex Need policies that would increase research support for both vaginal and rectal microbicides –e.g., Microbicide Development Act in U.S. Advocacy for rectal microbicides

Rectal microbicides working groups Organising internationally in the UK, US and Canada Presence at: –Microbicides 2004 and 2006 conferences –UK CHAPS conference –Gay men’s health related conferences in the USA Web resource:

Joint activities Joint research to identify trends in spending and research on rectal microbicides, identify areas where more research and effort are needed, and assessing what, if any, public policies are aimed at increasing investment in rectal microbicides Joint abstract for Microbicides 2006 conference, to disseminate above research and garner advocacy efforts Discussion on collaborative work on lubricant safety Joining each other’s conference calls Joint work at other international meetings Ongoing collaboration

What you can do Learn more about rectal microbicides –Check out –Check Global Campaign website for their fact-sheet Discuss rectal microbicides within your organisation/group Join an existing working group or form a new one