Microbicides
Envision a product that could save lives
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33.4 million people now
live with HIV/AIDS
2.7 million new infections annually
Amongst newly infected people:
50% are women (higher in some areas)
95% live in developing countries
80–90% of HIV+ people in southern
Africa do not know they have HIV
Percentage of at-risk people with
access to HIV prevention
<20% Sex workers with access to behaviour change programmes
11% HIV+ pregnant women with access to PMTCT
Rose to 45%
recently
10–12% Adults in Africa accessing HIV testing
9% Men who have sex with men with access to appropriate
behaviour change programmes
9% Sexually active people with access to male condoms
8% Injection drug users with access to harm reduction programmes
0
20
40
60
80
100
Global HIV Prevention Working Group 2008; WHO/UNAIDS/UNICEF 2007
The Global Campaign for
Microbicides works to:
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Ensure accountability; as science
proceeds, protect the public interest.
Mobilise demand and investment for
research and development of new
prevention technologies.
Conduct advocacy for development,
introduction, access, and use of new
prevention products.
What is a microbicide?
A new type of product being
developed that people could use
vaginally or rectally to protect
themselves from HIV and possibly
other sexually transmitted
infections.
How might a microbicide be delivered?
A suppository or a
gel applied with
an applicator
before sex
Contents of a
vaginal ring that
stays in place for
up to a month
Developing a
film, vaginal
tablet, soft-gel
capsule
What women need to protect
themselves
Social
power
Protection
Technology
Economic
opportunities
Source: Brady, Martha. Population Council, Conceptual Framework. 2005.
We need microbicides that:
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Are both contraceptive and not contraceptive.
Help reduce the risk of getting other sexually
transmitted infections.
Are inexpensive and easily available.
Can be used without a partner’s active cooperation.
Can be used vaginally or rectally.
Can be used by HIV+ people (products not based
on ARVs).
Why would HIV+ people want
microbicides?
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To reduce the risk of co-infection with other
HIV strains.
To reduce the risk of other sexually transmitted
infections, and yeast and bladder infections.
To allow conception whilst protecting partner.
Vaccines
Male and female condoms
PrEP
PEP
Microbicides
PMTCT
HIV
Prevention
Cervical barriers:
vaginal diaphragms
Male
circumcision
Clean injecting
equipment
Voluntary
counselling and
testing
HIV prevention
ARV-based
Not ARV-based
Male and female
condoms
Circumcision
Vaccines
Needle exchange
VCT
Vaginal
and rectal
microbicides
Prevention
of vertical
transmission
(PMTCT)
PEP
PrEP
Treatment for
HIV+ partner
Why condoms are not enough
With Primary Partner
With Casual or Outside Partner
Measure Evaluation. 1997–2002. http://www.measuredhs.com.
1. Boost vagina’s
natural defences
2. Surfactants
*
5. Future possibility
4. Stop replication
3. Block binding
*STDs: sexually transmitted diseases
Source: Shattock R, Moore J. Inhibiting Sexual Transmission of HIV-1
Infection. Nature Reviews Microbiology. Vol. 1, October 2003.
The product pipeline
1 in
large-scale
efficacy
trials
Early human
safety trials
Preclinical
testing
More than 50
candidates
Early-stage
concepts
Source: Alliance for
Microbicide Development
Outcomes of past studies
Signs of efficacy
Safe
Trend
toward harm
No efficacy
Carraguard®
BufferGel®
PRO 2000 0.5%
Nonoxynol-9
Savvy
Cellulose sulphate
Current and planned late-stage
trials
Product
Trial sponsor
# women to
be enrolled
Location(s)
First results
expected
Tenofovir gel
CAPRISA, CONRAD,
USAID, FHI
980 women
South Africa
Early 2010
Tenofovir gel
MTN
1,680 (in gel
arms of trial)
South Africa,
Uganda, Zambia,
Zimbabwe
2012
Dapivirine (TMC 120)
IPM
TBD
Various
TBD
Tenofovir gel
MRC/UVRI
TBD
Mozambique, South
Africa, Tanzania,
Uganda, Zambia
TBD
Source: Alliance for Microbicide Development
Clinical trial sites in 2010
THE AMERICAS
United States:
Phase 1, 1/ 2, 2
Puerto Rico:
Phase 1
Dominican Republic:
Phase 1
ASIA/PACIFIC
Thailand: Phase 1
Australia: Phase 1/2
SUB-SAHARAN AFRICA
Kenya: Phase 1
South Africa: Phase 1, 2B, 3
Tanzania: Phase 3
Uganda: Phase 2, 3
Zambia: Phase 3
Zimbabwe: Phase 3
Source: Alliance for Microbicide Development
Experience of a trial participant
Family
Planning
Informed
consent for
screening
Informed
consent
to enrol
Condoms +
experimental gel
Condoms
+ placebo
Recruitment:
Screening Visit 1:
Screening Visit 2:
Randomisation:
Participant
receives
information
about the trial in
her own
language
Education about the
trial, HIV and
pregnancy test,
sexually transmitted
infection tests and
treatment, baseline
data collected
Results of tests,
counselling,
education about trial
reinforced
Participant
assigned by
chance to a group
When can we expect a
microbicide?
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Results of CAPRISA 004 study of tenofovir gel
announced in July 2010.
Found safe and effective: 39% reduction in
infections
A larger trial now needed to confirm the results
–
then one to two years for product review and
licensing in each country
Who is doing the research?
Research entity
Examples
Funding sources
Not-for-profit health
groups and academic
institutions
MTN,
Governments (South
CONRAD,
Africa DST, US NIH, UK
FHI, CAPRISA DFID), philanthropic
foundations
Public-private
partnerships
IPM
European/US/Canadian
governments,
philanthropic
foundations, UNFPA,
World Bank
Smaller
pharmaceutical
companies
Endo
StarPharma
Venture capital, some
government grants
Comparing microbicides: ARV vs.
no ARV
Disadvantages
Advantages
ARV
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More potent against HIV
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May be long lasting
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Not contraceptive
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May cause more side effects
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May cause resistance
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Unlikely to protect against
other sexually transmitted
infections
No ARV
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Could work against HIV
and other sexually
transmitted infections
Could be contraceptive
May be less potent against
HIV
Must be used at time of
sex
If ARV-based microbicides work…
1. Only taken if you KNOW you are HIV negative.
– So regular HIV testing is necessary.
2. May be available by prescription only.
– So access to a qualified health care provider is
necessary.
3. Only the dosing used in trials is known to work.
– For now, must be applied daily or before sex.
What is drug resistance?
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HIV makes thousands of copies of
itself daily.
Every time HIV copies itself, errors can
occur, like typing errors on a page.
These are mutations—changes that
can make the virus weaker or stronger.
A mutation that makes HIV able to
resist an ARV drug = drug-resistant
HIV.
Drug resistance from
microbicides?
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Most likely when using only one drug or one
type of ARV.
Can become HIV+ whilst using ARV-based
microbicide.
Continued use if you do not know you are
HIV+ may lead to resistance.
Options for treatment may be more limited—
you might pass on resistant virus.
There are unanswered questions at this point.
Questions women have about
microbicides in general
What will they
say about me?
How much
will it cost?
Where will I get it?
If I use a
microbicide,
how will I make my
man use a
condom?
Questions women have about
ARV-based microbicides
If I think my man has
HIV, but I do not know
for sure, will I be able
to get microbicides?
Will it
make me
sick?
Can I use an ARVbased microbicide
when I am pregnant?
Will it hurt my baby?
What about
breastfeeding?
Advocates call for next steps
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Research and develop microbicides that are:
–
ARV based and not ARV based.
–
Contraceptive, non-contraceptive, and broad
spectrum.
–
Designed specifically for vaginal use and rectal
use.
Conduct more research into resistance, alternate
dosing, and impact on pregnancy and breastfeeding.
Call for action on access issues: cost, testing, and
prescription only.
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Increase community engagement.
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Ensure ethical standards and dialogue.
Visit www.global-campaign.org
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Sign up for GC News
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Endorse the Global Campaign
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Take the e-course
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Download FREE materials to educate others:
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Presentations
–
Fact sheets
Order materials:
–
Short film and discussion guide
–
Exhibit
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
“How do you know that?”
The notes for this slide list the sources for
facts in this presentation. You can cite
these as the sources for your information.
This list includes sources for facts and
statistics that are not well known. We do
not list sources here for commonly known
statistics.
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Topical Microbicides: New Hope for STI/HIV Prevention