Transcript The State of NPT Research

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New Prevention
Technologies
Workshop
Module 5:
State of NPT
Research
STATUS OF RESEARCH
What happened with these trials?
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Nonoxynol 9
Savvy
Circumcision
Cellulose Sulphate
Merck vaccine
CAPRISA 004
(tenofovir gel)
iPrEx
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AIDSVAX
AIDSVAX/ALVAC
MIRA (Diaphragm)
PRO 2000
BufferGel
Carraguard
FEM-PrEP
Treatment as
prevention
Outcomes of past studies
Safe
Tend towards
harm
Signs of efficacy
Circumcision
AIDSVAX/ALVAC
CAPRISA 004
(tenofovir gel)
iPrEx
Treatment as
prevention
No efficacy
Carraguard
BufferGel
PRO 2000
AIDSVAX
MIRA (diaphragm)
FEM-PrEP
Nonoxynol-9
Savvy
Cellulose sulphate
Merck vaccine
NPT late-stage trials:
When will we know?
2012+
PrEP
Injection drug users
PrEP
Serodiscordant couples
PrEP/Microbicides
Women
Vaccine*
Men who have sex with men
PrEP: When will we know?
Where
Who
What
When
Thailand (CDC)
Injection drug users
tenofovir
2012
Uganda, Kenya
(Partners PrEP)
Serodiscordant couples
(men and women)
tenofovir, Truvada
2012
South Africa, Uganda,
Zambia, Zimbabwe
(VOICE)
Women
tenofovir (pill &
gel), Truvada
2013
Microbicides: When will we know?
Product
Trial sponsor
Tenofovir gel
MTN
(VOICE)
Phase
2b
Location(s)
South Africa,
Uganda,
Zambia,
Zimbabwe
Results
expected
2013
Vaccines: When will we know?
Phase 2
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Where
Who
What
When
US (HVTN/NIH)
Men who have sex with
men
Prime/boost
(DNA/Ad5)
2012
2009-10 discovery of new “broadly neutralizing
antibodies” – possibly good target for further research
SOCIAL AND
BEHAVIOURAL
ISSUES
Social and Behavioural Issues
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Perceptions of “risk”
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Risk compensation (e.g., condom substitution?)
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Gender implications
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Stigma
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Community preparedness
Social and Behavioural Questions
o
How would the introduction of NPTs impact the risk,
negotiation, and autonomy of receptive sexual partners
who generally have low control over condom use by
their insertive partners?
o
How best can CBOs be supported for NPT preparedness
and communications at the community level?
o
What are the social mechanisms by which NPTs could
serve as a catalyst for broader structural changes in
gender norms?
ACCESS TO NPTs
Who will have access? Who
decides?
The general public?
How will decisions be
made?
Most « at-risk » groups?
Who is that in the
national context?
What factors will
influence this?
How will it be available?
Will it require a
prescription?
Is it available now?
Will testing be a
condition?
Who will pay?
What practical questions are raised?
Will receptive partners
(male or female) who use
a partially effective NPT
find it harder to get their
partner to use a condom?
What if I use this
differently than how it
was tested in trials?
How will our healthcare
system deal with the
increase in testing?
What ethical questions are raised?
What are the implications
of limiting access to
prevention options only to
certain groups?
How do we deal with
access inequality within
our country? Between
countries?
How do we deal with the
stigma of associating
some prevention tools
with high-risk
populations?
The elephant in the room….
Is it ethical to supply ARVs to HIV-negative
people for prevention even though most HIVpositive people who need ARVs to prolong
their lives do not get them?
What research questions are raised?
What if someone
uses this when
they are HIV+?
Do trial results in one
population translate
to other populations?
Can I take this when I’m
pregnant?
Will it hurt my baby?
What about
breastfeeding?
Exercise
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What are some of the key considerations to keep in
mind when thinking about access to NPTs for:
 Women in African countries
 Women in Canada
 Gay men in developing countries
 Gay men in Canada
 Canadians of African or Caribbean descent
 Persons who inject drugs
 Aboriginal people
Public Funding is Essential
Why aren’t large
pharmaceutical
companies
investing?
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Perceived low
profitability
Liability concerns
Lack of in-house
expertise
Uncertain regulatory
environment
Global Annual Microbicides R&D
Investment 2009 in USD$ millions
Source: HIV Vaccines and Microbicides
Resource Tracking Working Group
“Sure, you know about [all types of existing and new
prevention options]...
We need you to unravel the secrets of the science, to
make all of that elusive and mysterious information accessible
to the untutored rest of us…
Somehow, along with the science, we need the activism. They
are inseparable.”
Stephen Lewis
Co-Director, AIDS-Free World, and
Former United Nations Secretary-General’s
Special Envoy for HIV/AIDS in Africa (2001–2006)
July 19, 2009
International AIDS Society Conference
Cape Town, South Africa
© Nick Wiebe 2006