a Jo Robinson, Terrence Higgins Trust in cooperation with the Global Campaign for Microbicides Topical Microbicides: A New Hope for Non-condom Prevention of HIV and STIs

a What is a microbicide? Why is it needed? Basic science - how might it work? Clinical science - products in development Why this is a political issue and what you can do to get involved Objectives

a What is a microbicide? Microbicides are substances that can reduce the transmission of HIV and other STD pathogens when applied vaginally and, possibly, rectally. Currently, they are topical products formulated as gels or creams applied with an applicator. Future formulations could include sponges, time-released vaginal rings or gels combined with barrier devices such as diaphragms or cervical caps.

a Why is it needed? HIV & AIDS kill more people than any other infectious disease -in Botswana, 36% of all adults are infected. -in Sub-Saharan Africa, 67% of the almost 9 million HIV  youth (15-25 years) are female HIV is rapidly becoming a “women’s epidemic” -of every 10 people newly infected with HIV, 6 are women -even in the developed world, rates of new infections among women are rising

a Women of reproductive age in Sub-Saharan Africa who reported condom use in last sex act

a 100% use last 5 acts43%truck stop ♀ Tanzania Of sex acts protected34%sex workersIndonesia Always use last week23%sex workersBanglades h High consistency24%IDUsUkraine Consistent use39%std clientsUSA Consistent use26%sex workersZimbabwe Last any partner24%youthCameroon Regular use22%married womenRwanda Consistent use7%general popNicaragua Consistent use17%high risk ♀ 5 US Cities NotesCondom Use PopulationLocation Condom use with regular partner post intervention

a Need for rectal microbicide for anal male-to-male sex 48.8% of all men who had sex with men had had unprotected anal intercourse in the last year (N=15,971) 34.5% of men with HIV said they had definitely or probably had had unprotected anal sex a man they thought was HIV negative in the last year (N=1,070) 14.59% of HIV negative (at last test) or untested men said they definitely, or probably, had had unprotected anal sex with a man they thought was HIV positive in the last year (N=7,576) Source: Out and about. Findings from the United Kingdom Gay Men’s Sex Survey Sigma Research

a Need for rectal microbicide for male-female anal sex % of heterosexual women in the US had anal sex in the last year (Gross et al, 2000) In one US study, 32% of high-risk women participants reported anal sex in past six 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).

a Basic science How it might work

Microscopic rectal tissue Single layer columnar epithelium, with crypts Epithelium is mobile above a porous basement membrane Rectal shedding is common during sex

a What would they be like? Some will also prevent pregnancy Others will be microbicidal but not contraceptive Many candidate products are broad spectrum reducing risk of some other STIs, in addition to HIV

a Will Women Use Microbicides? In US study, an estimates 21.3 million women interested in using a microbicide (Darroch & Frost, 1999) Even in resource-poor countries, women at risk are willing to pay twice as much (or more) than the local price of a condom (EU study, 1998; Hardy, et al 1998) Women have widely different needs and formulation preferences so multiple products will be the key to widespread acceptability and use

Dominican Republic Los Angeles, USA Norfolk, USA Providence, USA Philadelphia, USA Côte d’Ivoire Brazil South Africa Zimbabwe Malawi Tanzania Uganda India Chiang Rai, Thailand Nigeria New York, USA Yaoundé, Cameroon Cincinnati, USA Miami, USA Baltimore, USA London, UK Antwerp, Belgium Birmingham, USA Washington, USA Houston, USA Botswana Zambia clinical trial sites in 2003 Alliance for Microbicide Development Ghana

a Timeline Source: Tufts Center for the Study of Drug Development Laboratory Testing 2-6 Years Phase 1 1 Year Phase 2 2 Years Phase Years Phase 1 and 2 penile and rectal studies, HIV+, etc Years

a Where are we now?

a Current microbicides in development 60 product leads are under development 6 potential products about to enter phase III or phase II/b trials in the next few years Average time for a product lead to go through required testing and registration is 10.5 years 45 additional products that are still in pre- clinical testing

a When will microbicides be available?

a What can you do now? Get your organisation sign up to the Global Campaign Get more information and stay up to date with new developments; sign up for updates from Global Campaign website: Join the UK/Ireland Campaign

a UK/Ireland Campaign for Microbicides Objectives: Increasing awareness and advocacy Accelerating scientific research and development Ensuring effective access and use

a Thank you to: Robin Shattock, St. George’s Hospital, London Charles Lacey, Imperial College, London Rebekah Webb, Global Campaign for Microbicides Kim Mulji, Naz Foundation