Transcript Topical Microbicides: New Hope for Non-Condom Prevention of HIV and other STDs

Topical Microbicides:
New Hope for
Non-Condom Prevention
of HIV and other STDs
www.global-campaign.org
Your name here
on behalf of the
Global Campaign for Microbicides
www.global-campaign.org
The Global Challenge
• AIDS kills more people than any other
infectious disease
- in Swaziland, 39% of all adults are infected.
- in Sub-Saharan Africa, 77% 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
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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.
They are not yet available.
Currently,
they are 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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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
• Likely to be inexpensive and
available over the counter
• Could be used without partner’s
cooperation or even awareness
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How would they benefit
HIV+ people?
• Reduce risk of re-infection with other
HIV strains
• Help protect both partners
• Reduce risk of other STDs, yeast and
bladder infections
• Allow conception while protecting
partner
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Microbicides & anal sex
• The biological challenge of creating
an effective rectal microbicide is
more complicated
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• Many people (women and men)
need microbicides for anal sex
• We must ensure that vaginal
microbicides are accurately labeled –
so people know the possible
consequences of using them rectally.
How effective will they be?
• First microbicides will be 40-60% protective
• Second generation will be 60-80%
• should be promoted as a“back-up”to condoms,
not as a replacement
• use with risk reduction messages, like:
– 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
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A Balancing Act to
Minimize HIV Risk
condoms
microbicides
reduces risk by 80-90%
may reduce risk by 40-60%
? consistency of use
? consistency of use
How microbicides work
1. Kill or inactivate the pathogen
(germ)
2. Create a barrier between pathogen
and vulnerable tissue
3. Interfere with entry of virus into
target cell
4. Prevent replication once virus has
entered the cell
5. Boost vagina’s natural defenses
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The Product Pipeline
5 products
3 products
10-20 products
Laboratory
Testing
2-6 Years
6 products
Phase 1
(safety)
Phase 2
(safety)
Phase 3
(efficacy)
1 to 6
Months
Up to 2
Years
2 to 4
Years
25 – 40
people
200-400
people
3,000-10,000
people
Simultaneous studies:
HIV+, penile & rectal
10 or more years
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Clinical trial sites in 2005
Quebec, Canada
New York, USA
Cincinnati, USA
Providence, USA
New Brunswick, USA
Seattle, USA
Los Angeles, USA
Chicago, USA
Houston, USA
Birmingham, USA
Vienna, Austria
Antwerp, Belgium
London, UK
Pittsburgh, USA
Baltimore, USA
Norfolk, USA
Chandigarh, India
Pune, India
Florida, USA
Santo Domingo,
Dominican Republic
Burkina Faso
Accra, Ghana
Lagos, Nigeria
Cameroon
Lusaka, Zambia
Chiang Mai, Thailand
Kenya
Kampala, Uganda
Moshi, Tanzania
Blantyre, Malawi
Harare, Zimbabwe
Johannesburg, South Africa
Durban, South Africa
Adelaide, Australia
Source: Alliance for Microbicide Development
5 Products Furthest Along
Buffer Gel
Feb 2005 - 3,220 women
South Africa, Malawi, Tanzania,
Zambia, and Philadelphia
Mar 2004 - 6,639 women
South Africa – 3 locations
Jan 2005 – 2,160 women
June 2005 - 2,574 women
Nigeria
Benin, Burkina Faso, India,
Kenya, South Africa, Uganda
.5% formulation
Feb 2005 - 3,220 women
South Africa, Malawi, Tanzania,
Zambia, and Philadelphia
.5% and 2% formulations
2005 - 11,920 women
South Africa, Uganda, Zambia,
Tanzania
Sept 2004 – 2,140 women
Nigeria
ReProtect LLC
Carraguard
Population Council
Cellulose sulfate
Global Microbicide Project
PRO 2000
Indevus Pharmaceutical, Inc.
Two trials
Savvy
Biosyn, Inc
Development will require
significant public money
Why aren’t the big pharmaceutical companies
investing?
- 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.
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What do these trials cost?
Laboratory
Testing
Phase 1
(safety)
Up to $13 Million
Phase 3
(efficacy)
$50
Up to
Million
Phase 2
(safety)
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Preliminary annual
funding needs
$3M
Actual 2004 funding levels
$3M
Policy and Advocacy
need $10M
Additional annual funding needed
$7M
Trial sites
need $20M
$20M
Clinical testing
need $120M
$72M
$48M
Basic Scientific Research
need $130M
$65M
$65M
All com bined
All combined:
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Annual funding
needs to double!
$140M
Need $280M
need $280M
0
50
100
$140M
150
200
250
Millions of US Dollars (2004)
300
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 and
- raised annually until first products available
• Without this investment, we may not see usercontrolled HIV prevention tools available within this
decade.
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public
demand
public
awareness
political
support
increased
resources for
R&D ($$$)
all people know
about & have
access to affordable
microbicides
safe and
effective
microbicides on
the market
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The Global Campaign
works through
Global North Partners in:
Canada, UK, Ireland, Netherlands,
Scandinavia, Spain and in the US in:
California
Massachusetts
Pennsylvania
Connecticut
New York
Washington
Global South Partners in:
Kenya
Uganda
South Africa
Ghana
India
Illinois
Ohio
Nigeria
Thailand
Regional networks in Africa and Southeast Asia
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U.S. Microbicide
Development Act
• Will authorize funding increases as needed
• Will require the National Institutes of Health to:
- establish a branch dedicated to microbicide research
- expand and coordinate the microbicide research
efforts of all 3 federal branches (NIH, CDC and
USAID)
• S. 550 introduced by Senators Corzine (D-NJ), Obama
(D-IL), and Snowe (R-ME)
• H.R. 3854 introduced by Reps. Shays (R-CT), Schakowsky
(D-IL), and Davis (D-IL)
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What you can do
Visit www.global-campaign.org to
• Get in touch with your local Global Campaign site
• Sign up for our bi-weekly e-newsletter, GC News
• Sign the GC petition and help collect signatures
• Host a talk on microbicides – presentations
available on our site
• Write to your legislators
• Learn more about microbicides
• Host a launch of our new video
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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 averted in
3 years including women, men and children
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