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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.
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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
www.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
www.global-campaign.org
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.
www.global-campaign.org
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
www.global-campaign.org
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
www.global-campaign.org
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
www.global-campaign.org
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
www.global-campaign.org
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
www.global-campaign.org
Mechanisms of Action
• Interfere with fusion of virus to target cell
www.global-campaign.org
Mechanisms of Action• Prevent replication once virus
has entered the cell– Anti-retrovirals applied topically
• Boost vagina’s natural defenses– Defensins, antibodies
• Combination approach
www.global-campaign.org
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
www.global-campaign.org
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
www.global-campaign.org
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
www.global-campaign.org
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
www.global-campaign.org
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.
www.global-campaign.org
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 !
www.global-campaign.org
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.
www.global-campaign.org
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
www.global-campaign.org
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!
www.global-campaign.org
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)
www.global-campaign.org
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.
www.global-campaign.org
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)