Transcript Topical Microbicides: New Hope for STI/HIV Prevention

Microbicides:
New Hope for
Prevention
of HIV and
other STIs
Beatrice Nabulya
www.global-campaign.org
www.global-campaign.org
The Global Impact of HIV
People living
with HIV in
2006
New infections in
2006
39.5 million
4.3 million
Sub-Saharan Africa
24.7 million
2.8 million
Asia & Eastern Europe
10.25 million
1.23 million
North America &
Western/Central Europe
2.14 million
65,000
Other
2.49 million
242,100
Worldwide
Women are disproportionately affected by AIDS:
In Sub-Saharan Africa, young women are 4 times
more likely to be infected than young men.
www.global-campaign.org
Why We Need Female
Controlled Methods
Biology
– Women are 2-4 times more likely than men
to get HIV from unprotected sex
Economics
– Economic need or dependency
– Less able to assert their rights
Social & Cultural
– Gender norms about sexuality
– Gender based violence
Current methods (abstinence, fidelity, and condom use) often require
male consent, participation & cooperation
www.global-campaign.org
What options are available to women
Condoms
Require partners consen
Vaccine:
Unlikely to become available for a number of
years
ARVs:
Cost, distribution, storage, compliance, resistance,
increasing numbers. “Despite great gains in treatment
access, the rate of infection continues to outrun their
www.global-campaign.org
What is a Microbicide?
First Generation:
• Gels and creams
In the future:
• Sponges, vaginal rings
• Gels with barrier devices
© Salam Dahbor, Courtesy Doubleshots Studio
A substance that can reduce the transmission of HIV
and other STI pathogens when applied vaginally and,
possibly, rectally. They are not yet available.
www.global-campaign.org
We Need Microbicides That:
• Are contraceptive and non-contraceptive
• Reduce risk of other STIs
• Are safe and non-irritating
• Are inexpensive and available over the
counter
• Could be used without partner’s
cooperation or even awareness
www.global-campaign.org
How Could Microbicides Benefit
People Living with HIV/AIDS?
• Could reduce risk of co-infection with other HIV
strains
• May help protect both partners
• Could reduce risk of other STIs, yeast and
bladder infections
• May allow conception while protecting partner
www.global-campaign.org
Microbicides & Anal Sex
• Many people (women and
men) need microbicides
for anal sex
• Creating an effective
rectal microbicide is
scientifically more
complicated
• Vaginal microbicides must
be accurately labelled
Image courtesy of www.lifelube.org
www.global-campaign.org
How Effective Will
Microbicides Be?
First microbicides may be 40-60% protective
Second generation may be 60-80%
Promoted as a back-up to condoms, not as a
replacement.
“Use a microbicide with your condom for added
pleasure and protection.”
“Use a male or female condom every time you
have sex; if you absolutely can’t use a condom,
use a microbicide.”
www.global-campaign.org
Protection in Primary Partnerships:
Difficult to Achieve
• People generally are willing to to use
condoms with new partners, or during
casual or commercial sex
• But once “trust” enters the equation
the condom comes off
• Sex with a primary partner is the
biggest source of HIV infection among
women globally
www.global-campaign.org
Imagine a Full Spectrum of
Interventions
Prior to exposure
Point of
transmission
•Rights-focused
behaviour change
•Male and female
condoms and lube
•VCT
•PMTCT
•STI screening and
treatment
•Clean injecting
equipment
•Male circumcision
•Vaginal and rectal
microbicides
•Preventative
vaccines
•PREP
•Cervical barriers
•PEP
Treatment
•Anti-retroviral treatment
•Treatment for
opportunistic infections
•Basic care/nutrition
•Prevention for positives
•Education and
behaviour change
•Therapeutic vaccines
www.global-campaign.org
Comprehensive Strategies for
Protection
Social
Power
Protection
Technology
Economic
Opportunities
Source: Brady, Martha. Population Council, Conceptual Framework. 2005.
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
in 3 years including women, men and children
www.global-campaign.org
1. boosts vagina’s
natural defenses
4. anti-retrovirals
2. surfactants
3. entry inhibitors
Source: Shattock, R.; Moore, J. Inhibiting Sexual Transmission of HIV-1 Infection. Nature Reviews Microbiology. Vol 1, October 2003.
www.global-campaign.org
The Product Pipeline in 2007
3 products
3 products
30+ products
Laboratory
Testing
2-6 Years
4 products
Phase I
(safety)
Phase II
(safety)
Phase III
(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 in some cases:
HIV+, penile & rectal safety
10 or more years
Source: Alliance Pipeline Update, first week of every month - http://www.microbicide.org/publications
www.global-campaign.org
Clinical Trial Sites in 2007
EUROPE
- Belgium: Phase I/II
THE AMERICAS:
-United States: Phase I, II, IIB
-Brazil: Phase II
WEST AFRICA:
-Cameroon: Phase I, II
ASIA
-India: Phase II
-Thailand: Phase I
AUSTRALIA
- Phase 1
SUB-SAHARAN AFRICA:
-Botswana:
-Kenya: planned
-Madagascar: Phase
-Malawi: Phase II, IIB
-Rwanda: Phase I/II
-South Africa: Phase I, IIB, III
-Tanzania: Phase III
-Uganda: Phase III
-Zambia: Phase IIB, III
-Zimbabwe: Phase I, II, IIB
Source: Alliance for Microbicide
Development
www.global-campaign.org
Experience of a
Phase III Participant
Family
Planning
Informed
consent for
screening
Informed
consent
to enroll.
Condoms +
experimental
gel
Condoms
+ placebo
Recruitment:
Participant
receives
information
about the trial
in their own
language
Screening Visit 1:
Education about the
trial, HIV and
pregnancy test, STI
tests and treatment,
baseline data
collected
Screening Visit 2:
Results of tests,
counselling,
reinforce education
about trial
Randomisation:
Participant
assigned by
chance to a group.
www.global-campaign.org
3 Products Furthest Along
Preliminary
results
expected in
Product
Trial sponsor
# women to
be enrolled
Buffer Gel
HPTN035-NIH
3,100 women
South Africa, Malawi,
Tanzania, Zambia, Zimbabwe
and Philadelphia
April 2009
Carraguard
Population Council
6,299 women
South Africa – 3 locations
December 2007
PRO2000 (.5%)
HPTN035-NIH
3,100 women
South Africa, Malawi,
Zambia, Zimbabwe and
Philadelphia
April 2009
PRO2000
(.5 and 2%)
DFID, MRC
9,673 women
South Africa, Uganda,
Zambia, Tanzania
December 2009
Location
www.global-campaign.org
When can we expect a
microbicide?
• Earliest results from current Phase III trials in
2008-2009
• If shown to be effective, a microbicide may be
available in a few countries via introductory
studies in the next 5 years
• If not, we will have to
wait for results from
second generation
products
www.global-campaign.org
Public Funding is Essential
Why aren’t large
pharmaceutical
companies
investing?
– Perceived low
profitability
– Liability concerns
– Lack of in-house
expertise
– Uncertain regulatory
environment
Global Annual Microbicide
R&D Investment 2005
Philanthropic Sector, 13%
US $142.3 million
Public Sector, 87%
US $21.2 million
www.global-campaign.org
Annual Funding Needs
$3M
$3M Actual 2004 funding levels
Policy and Advocacy
need $10M
$7M
Annual funding
needs to double!
Trial sites
need $20M
$20M
Clinical testing
need $120M
$72M
$48M
Basic Scientific Research
need $130M
$65M
$65M
All combined
All combined:
$280M
Needneed
$280M
=
€220M
Additional annual funding needed
$140M
0
50
100
$140M
150
200
250
300
Millions of US Dollars (2004)
www.global-campaign.org
The Global Campaign for
Microbicides works to:
• Ensure that as science proceeds, the public
interest is protected - Accountability
• Mobilise demand and investment for research
and development of new prevention technologies
• Conduct policy advocacy for development,
introduction, access, and use
www.global-campaign.org
GCM Global Partners
Canada
Europe:
UK, Ireland, Netherlands,
Scandinavia, Spain, Germany,
France, Belgium, and Russia
Asia:
Thailand
and India
Australia
United States:
CA, CT, DC, IL, NY, MA, OH, PA, WA
Africa:
Kenya, Ghana,
Nigeria, Uganda, and
South Africa.
www.global-campaign.org
In the Global North
public
demand
public
awareness
Goal: All people
know about & have
access to
affordable
microbicides
political
support
increased
resources for
R&D ($$$)
safe and
effective
microbicides on
the market
www.global-campaign.org
In the Global South
Community involvement initiative
– Facilitating authentic public engagement
among communities hosting trials
– Providing trainings and a resource kit
Research ethics initiative
– Finding a balance between urgency and
ethical standards
– Facilitating dialogue, ethics training course
Support national advocacy efforts
www.global-campaign.org
What You Can Do
Visit www.global-campaign.org…
• Get in touch with local advocates
• Sign up for GC News
• Write to your public officials!
• Endorse the Global Campaign
• Educate others:
– Presentations – Newsletters
– Use our film
– Events
– Fact sheets
– Web-links
www.global-campaign.org
Frank Herholdt, Courtesy of Microbicide Development Project
I don’t want to die before I turn 25.
I refuse to sit down and watch my generation fall to pieces.
I am going to make a difference…Will you?
Rumbidzai Grace Mushangi, age 15, Zimbabwe
www.global-campaign.org
UK African Microbicides
Working Group
Georgina Caswell
Policy & Community Engagement Officer
+44 (0) 20 7017 8917
[email protected]
www.ahpn.org
www.global-campaign.org
www.global-campaign.org