Transcript No Slide Title

Topical Microbicides:
A New Hope
for Non-condom Prevention
of HIV and STIs
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www.global-campaign.org
Jo Robinson, Terrence Higgins Trust
in cooperation with the
Global Campaign for Microbicides
www.global-campaign.org
Objectives
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• What is a microbicide?
• Why is it needed?
• Basic science - how might it work?
• Clinical science - products in development
• Why this is a political issue and what you can do to
get involved
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What is a microbicide?
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• 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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Why is it needed?
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• HIV & AIDS kill 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
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90
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40
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10
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t e oo
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oz al a
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Af
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nz a
an
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To
U g go
an
Z a da
Zi mb
m
ba ia
bw
e
% used
condom with
last casual
partner
Bu
rk
in
Percentage
Women of reproductive age in
Sub-Saharan Africa who reported condom use in last sex
act
Country
% used
condom with
last main
partner
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Condom use with regular partner post
intervention
Location
Population
Condom
Use
Notes
5 US Cities
high risk ♀
17%
Consistent use
Nicaragua
general pop
7%
Consistent use
Rwanda
married women
22%
Regular use
Cameroon
youth
24%
Last any partner
Zimbabwe
sex workers
26%
Consistent use
USA
std clients
39%
Consistent use
Ukraine
IDUs
24%
High consistency
Banglades
h
Indonesia
sex workers
23%
Always use last week
sex workers
34%
Of sex acts protected
Tanzania
truck stop ♀
43%
100% use last 5 acts
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Need for rectal microbicide for anal
male-to-male sex
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• 48.8% of all men who had sex with men had had unprotected anal intercourse in
the last year (N=15,971)
• 34.5% of men with HIV said they had definitely or probably had had unprotected
anal sex a man they thought was HIV negative in the last year (N=1,070)
• 14.59% of HIV negative (at last test) or untested men said they definitely, or
probably, had had unprotected anal sex with a man they thought was HIV
positive in the last year (N=7,576)
Source:
Out and about. Findings from the United Kingdom
Gay Men’s Sex Survey 2002. Sigma Research
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Need for rectal microbicide for male-female
anal sex
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• 6 - 13% of heterosexual women in the US had anal sex in the last
year (Gross et al, 2000)
• In one US study, 32% of high-risk women participants reported
anal sex in past six months (Gross et al 2000)
• In a Chinese study of 1300 people from 41 cities, nearly 70% of
men and women reported engaging in anal intercourse (Burton
1990).
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Basic science
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How it might work
Microscopic rectal tissue
• Single layer columnar
epithelium, with crypts
• Epithelium is mobile
above a porous
basement membrane
• Rectal shedding is
common during sex
What would they be like?
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• Some will also prevent pregnancy
• Others will be microbicidal but not contraceptive
• Many candidate products are broad spectrum reducing
risk of some other STIs, in addition to HIV
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Will Women Use
Microbicides?
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• In US study, an estimates 21.3 million women interested in using a
microbicide
(Darroch & Frost, 1999)
• Even in resource-poor countries, women at risk are willing to pay twice as
much (or more) than the local price of a condom
(EU study, 1998; Hardy, et al 1998)
• Women have widely different needs and formulation preferences so
multiple products will be the key to widespread acceptability and use
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clinical trial sites in 2003
Antwerp, Belgium
London, UK
Washington, USA
Los Angeles, USA
Houston, USA
Birmingham, USA
Miami, USA
Dominican Republic
New York, USA
Cincinnati, USA
Providence, USA
Philadelphia, USA
Baltimore, USA
Norfolk, USA
Ghana
Côte d’Ivoire
Nigeria
Yaoundé, Cameroon
Brazil
Zambia
Botswana
India
Chiang Rai,
Thailand
Uganda
Tanzania
Malawi
Zimbabwe
South Africa
Alliance for Microbicide Development
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Timeline
Laboratory
Testing
2-6 Years
Phase 2
Phase 3
Phase 1
2 Years
3.5 Years
1 Year
Phase 1 and 2 penile and
rectal studies, HIV+, etc.
10 + Years
Source: Tufts Center for the
Study of Drug Development
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Where are we now?
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45
40
35
30
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25
20
15
10
5
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Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
Source: Alliance for Microbicide Development
Current microbicides in development
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• 60 product leads are under development
• 6 potential products about to enter phase
III or phase II/b trials in the next few years
• Average time for a product lead to go
through required testing and registration is
10.5 years
• 45 additional products that are still in preclinical testing
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When will microbicides be available?
1
Expect ed
launch
st
generat ion
2007
2
nd
generat ion
3
rd
generat ion
2012
2017
Formulat ion Vaginal only
Vaginal &
rect al
Vaginal &
rect al
Indicat ions
HIV, possibly ot her
STIs, cont racept ive
HIV, herpes,
gonorrhoea, HPV,
Chlamydia, choice
of cont racept ive or
non.
HIV, herpes,
gonorrhoea, HPV,
Chlamydia, choice
of cont racept ive or
non.
HIV
ef f ect iveness
50%
70%
Usages
W it h
condom/device
Used alone
Used alone
Access
Prescript ion only –
developed count ries
OTC – developing
count ries
Over t he
count er
Over t he
count er
Source: The M icrobicides Init iat ive
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85% - 95%
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What can you do now?
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• Get your organisation sign up to the Global Campaign
• Get more information and stay up to date with new developments;
sign up for email updates from Global Campaign website:
www.global-campaign.org
• Join the UK/Ireland Campaign email: [email protected]
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UK/Ireland Campaign for Microbicides
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• Objectives:
• Increasing awareness and advocacy
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• Accelerating scientific research and development
• Ensuring effective access and use
Thank you to:
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• Robin Shattock, St. George’s Hospital, London
• Charles Lacey, Imperial College, London
• Rebekah Webb, Global Campaign for Microbicides
• Kim Mulji, Naz Foundation
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