1. Microbicides: Who, what, where, when and how
© Salam Dahbor, Courtesy Doubleshots Studio
Rebekah Webb
Global Campaign for Microbicides

2. What is a microbicide? They do not yet exist…
A substance that can reduce the transmission of HIV and other STI pathogens when applied vaginally and, possibly, rectally.
They do not yet exist…
First generation:
Gels and creams
In the future:
Sponges, vaginal rings
Gels with barrier devices

3. Why We Need Female Controlled Methods
Biology
Women are 2-4 times more likely than men to get HIV from unprotected sex
Economics
Women are often dependent on men for income
Selling sex is a way of life
Social & cultural traditions
Male entitlement to sex, female innocence about sex
Gender based violence
Current methods (abstinence, fidelity and condom use) often require male consent, knowledge, or cooperation

4. Potential advantages Easy to use Allows intimacy and improves sex
Contraceptive and non-contraceptive versions
Reduces risk of other serious STIs
Likely to be inexpensive and available over the counter
Could be used without partner’s cooperation
(or possibly even awareness)

5. How microbicides work…
2. boost vagina’s natural defences
1. physical barriers
3. surfactants
5. anti-retrovirals
4. entry inhibitors
Source: Dr. R. Shattock

6. How would they benefit HIV+ people?
Reduce risk of re-infection with other HIV strains
Help protect both partners
Reduce risk of other STIs, yeast and bladder infections
Allow conception while protecting partner

7. How effective will they be?
First microbicides may be 40-60% protective
Second generation may be 60-80%
Should be promoted as a “back-up” to condoms, not as a replacement
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

8. 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 half of unprotected sex acts…
= 2.5 million HIV infections could be averted in
3 years including women, men and children

9. How close are we?
Ability to prevent HIV transmission from men to women is being tested
Five candidates in final stages
First results expected late 2007/early 2008
Likely to be only partially effective (if at all)
Proof of concept possible by time of next AIDS Conference
Ability to prevent HIV transmission from women to men, and during anal sex will be a next step

10. 5 Products Furthest Along

11. The Product Pipeline in 2006
As you can see, this kind of research isn’t quick to do…it can take more than a decade. Before anything can be tested in humans, the developers have to show that (a) it’s not likely to be harmful to humans and (b) it may be beneficial. The research is done in the laboratory and can take anywhere from 2 to 6 years.
Currently there are more than 30 candidates is preclinical testing.
If a product is approved for human trials, it goes first through a series of Phase I safety trials, each taking between 1-6 months. Next comes one or more Phase 2 trials to gather extended safety data and that can take up to two years. If it’s shown to be safe in these first two phases, they test to see if it is effective. The Phase 3 effectiveness trials can take up to 4 years because a large number of participants are enrolled and they get a year or two of follow up services, to see if the product has any effects after extended use. It may be necessary to do two Phase 3 trials before a product is proven effective.
While clinical trials are going on, researchers also need to undertake separate trials to look at whether the product is irritating to the penis, how the body will react if the product is inserted rectally, and whether it is as safe for HIV positive people to use as it is for HIV negative people.
If one of the products now in Phase 3 turns out to be effective, we should see proof of its effectiveness in the next 2-3 years. It will then take another year or two for the product to be considered by regulatory authorities and, if approved, go to market.
The “best case” scenario is to have a microbicide on the market in a few countries by If none of products now in Phase 3 prove to be effective, we will have to wait longer. How long it takes depends, in part, on how fast we can keep new products advancing in the pipeline11a.
* Products in phase 1-2 are counted as phase 2 and products from phase 22B are counted as phase 3 products.
Source: Alliance Pipeline Update

12. Clinical trial sites
Source: Alliance for Microbicide Development

13. Public funding is essential
Why aren’t large pharmaceutical companies investing?
Perceived low profitability
Liability concerns
Lack of in-house expertise
Uncertain regulatory environment
Philanthropic Sector, 13%
Public Sector, 87%

14. Annual funding needs to double!
$3M
Annual funding needs to double!
All combined: Need $280M

15. Imagine a full spectrum of interventions
Prior to exposure
Point of transmission
Treatment
Rights-focused behaviour change
VCT
STI screening and treatment
Preventative Vaccines
PREP
Male circumcision
Male and female condoms and lube
PMTCT
Clean injecting equipment
Vaginal and rectal microbicides
Cervical barriers
PEP
Anti-retroviral treatment
Treatment for opportunistic infections
Basic care/nutrition
Prevention for positives
Education and behavior change
Therapeutic vaccines

16. The Global Campaign for Microbicides
A broad international coalition of 250 organisations and over 50 partners
Our Goals:
Accountability - ensuring that as science proceeds, the public interest is protected
Mobilise demand and investment for research and development of new prevention technologies
Policy advocacy for development, introduction, and use

17. GCM Global Partners Europe: UK, Ireland, Netherlands,
Scandinavia, Spain, Portugal, Germany,
France, Belgium, and Russia
North America:
Canada
Asia: Thailand
and India.
United States:
CA, CT, DC, IL, NY, MA, OH, PA, WA
African:
Kenya, Ghana,
Nigeria, Uganda, and
South Africa.

18. What you can do Visit www.global-campaign.org…
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