Topical Microbicides: New Hope for Non-Condom Prevention of HIV and other STDs Your name here on behalf of the Global Campaign for Microbicides

The Global Challenge AIDS kills 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

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.

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 STDs, in addition to HIV

How would they benefit HIV+ women? Reduce risk of re-infection with other HIV strains Help protect their partners -- that is, bi-directional effect Reduce risk of other STDs, yeast and bladder infections Increase chances of getting pregnant safely and having HIV negative babies

Microbicides & anal sex The biological challenge of creating an effective rectal microbicide is more complicated Many people (women and men) need microbicides for anal sex We must ensure that vaginal microbicides are accurately labeled – because some people will think of trying to use them that way

How effective will they be? First microbicides will be 40-60% protective Second generation products will be 60-80% should be promoted as an adjunct or “back- up” to condoms, not as a replacement use with harm reduction messages, such as: –Use a male or female condom every time you have sex; if you absolutely can’t use a condom, use a microbicide –Use a microbicide with your condom for added pleasure and protection

How microbicides are developed Kill or inactivate the pathogen –disrupt the surface membrane –create an inhospitable environment for the pathogen Create a barrier between pathogen and vulnerable tissue –Coat mucous membranes with gel

Mechanisms of Action Interfere with fusion of virus to target cell

Mechanisms of Action Prevent replication once virus has entered the cell –Anti-retrovirals applied topically Boost vagina’s natural defenses –Defensins, antibodies Combination approach

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

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

Are they only tested on women? Men are enrolled in some trials: - Baseline studies on the impact of anal intercourse on body -“Male tolerance” studies (impact of candidate microbicides on penis & urethra) -Rectal safety studies being designed

Current Product Status Total pre-clinical50 Total clinical17 Phase I 10 Phase I/II 1 Phase II 4 Phase I/III 1 Phase III 1 Source: Alliance for Microbicide Development

Development will require significant government investment Large pharmaceutical companies have relatively little interest in pursuing microbicides -perceived low profitability -liability concerns -lack of in-house expertise -uncertain regulatory environment For the last 20 years, almost all funding for contraceptive development and related research has come from governments and foundations.

Funding realities and needs Pharmaco-Economic Analysis showed: Discovery through Phase II costs about $10 mil Phase III trials can cost an additional $46-50 mil If existing portfolio were owned by a single Pharmco, it would need to invest roughly $775 million over the next five years to ensure success BUT, at 2002 levels, only $230 million available from governmental and philanthropic grants Therefore, $500 million shortfall at least !

The Advocates’ Message There is a broad-based, demonstrable demand for user-controlled prevention methods North American and European Union investment in microbicide research and development should be -substantially increased in the coming year, and -raised annually until first products reach the market. Without this investment, we may not see user- controlled HIV prevention tools available within this decade.

Global Campaign for Microbicides Unifying umbrella for NGO activism and interaction with scientific community 25 active partner organizations; 200 endorsing groups worldwide Served by two secretariats with small core staffs – one in Washington and one in London Centralized fundraising and financial support to partner groups International steering committee

Currently organizing with... Global North Partners in: Canada UK Ireland US Global South Partners in: KenyaGhana Uganda India South Africa Thailand Evolving partnerships & endorsers in many other countries!

Microbicide Development Act of 2003 (S. 859) Will authorize funding increases as needed Will require the NIH to: - establish a branch dedicated to microbicide research -- thus creating a single line of administrative accountability for progress - expand and coordinate the research efforts of all the federal branches working on microbicides (NIH, CDC and USAID)

What you can do as an individual... 1) Find out where the Global Campaign is active in your area by looking on or ing us at 2) Sign up to get our bi-weekly e-newsletter, GC News 3) Get any organizations, community groups, or networks you are involved with to host a program on microbicides. 4) Sign the Global Campaign petition and help collect signatures.

Potential public health impact If a ……….….60% effective product Offered to.…..73 lower income countries Is used by % people reached by health care during…… …50% of unprotected sex acts = 2.5 million HIV infections averted over 3 years (including women, men and children)