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

www.global-campaign.org

Topical Microbicides:

New Hope for Non-Condom Prevention

of HIV and other STDs

Your name hereon behalf of the

Global Campaign for Microbicideswww.global-campaign.org


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, USANorfolk, USA

Providence, USAPhiladelphia, USA

Côte d’Ivoire

BrazilSouth Africa

ZimbabweMalawiTanzaniaUganda

India Chiang Rai, ThailandNigeria

New York, USA

Yaoundé, Cameroon

Cincinnati, USA

Miami, USA

Baltimore, USA

London, UKAntwerp, Belgium

Birmingham, USA

Washington, USA

Houston, USA

BotswanaZambia

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 22 Years

Phase 33.5 Years

Phase 1 and 2 penile and rectal studies, HIV+, etc.

10 + 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-clinical 50• Total clinical 17

• 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 relativelylittle 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:Kenya GhanaUganda IndiaSouth 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 onwww.global-campaign.org, or e-mailing us at [email protected]

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.... 20% 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)

Documents

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