Transcript ESM presentation - Global Campaign for Microbicides

WELCOME!
European Strategy Meeting
October 27-28, 2008
www.global-campaign.org
Introductions
•
•
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Name
Organisation
Country
One thing we wouldn’t know about you, just by
looking at you…
• A few points about logistics…
www.global-campaign.org
Goals of the meeting
• Increase our knowledge of key
developments and current challenges
in the field
• Propose strategic directions for
microbicides advocacy in Europe
• Share our lessons learned, strategies,
successes and challenges with our
colleagues
www.global-campaign.org
Agenda: Day 1
• Introductions
• Review key outcomes and follow-up
since last year
• Overview of HIV prevention landscape
• Share achievements and challenges
• Hear about community experience in
trials
• Begin to look at new advocacy goals
www.global-campaign.org
Agenda: Day 2
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•
•
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Learn about resources at our disposal
Learn about rectal microbicides
Review new advocacy objectives
Discuss strategy and priorities for
Europe
• Develop concrete next steps
• Discuss outreach to key constituents
www.global-campaign.org
Outcomes from last year
&
Progress since then
www.global-campaign.org
Copenhagen 2007
• Overview of state of the field
• “Scenario planning” for future trial
results, “strawman” exercise
• Setting European advocacy goals
• Discussing the relationship between
GCM and its “partners”
• Discussing next steps
• All of this was part of and fed into
GCM’s Strategic Review Process
www.global-campaign.org
Copenhagen 2007:
Setting Goals for Europe
1. Resource mobilisation
– R&D for both VMs and RMs
– Social science research
– Advocacy and community mobilisation
2. Advocating for appropriate and
supportive policies
3. Engaging with key constituents
– African communities in Europe
– HIV+ women
– Gay men
www.global-campaign.org
Copenhagen 2007: Next Steps
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Prepare for Carraguard results
Mapping of European scientists
Consultation on FP7 and EDCTP
Funding for “missing pieces”
National level advocacy
North-South dialogue
Exhibit tour
Spreading the message
www.global-campaign.org
Since last year…
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Completed SRP (more in a moment)
Carraguard results came out
Mapping of scientists has started
New plan for funding “missing pieces”
National level advocacy continues
Exhibit still available
North-South dialogue
For more info: check out the
newsletters!
www.global-campaign.org
Partner activities 2007-8…
• Events on microbicides
– in Belgium, France, UK, Spain, the
Netherlands, Finland
• Lobbying efforts and Parliamentary
events
– in Spain, UK, Finland, France, Brussels
• Articles on microbicides published in
NGO newsletters
– in Germany, UK, Spain, France
• Presenting at conferences
www.global-campaign.org
EU policy and advocacy
• Tracking of microbicides policy (development,
research, health)
• Participation in conferences
• Policy meetings with IPM, IAVI and Stop AIDS
Alliance
• Meetings with policy staff, MEPs, Perm Reps
www.global-campaign.org
Training and capacity building
• Trainings
– UK, Belgium, France, Netherlands, Spain, EATG,
Countdown 2015, youth advocates
• Presentations and workshops at conferences
– AIDS Impact, M2008, AIDS2008
• Site visits
– Belgium, France, Spain, Netherlands, Finland
• Conference calls
• Articles, materials, resources (more
tomorrow!)
• Outreach and support in 11 countries
www.global-campaign.org
European Tour of the Exhibit
• AIDS Impact, Marseilles
• Finland: Ministry of Foreign Affairs, 3
universities and Parliament House
• Global Consultation on SRHR of PLHIV in
Amsterdam
www.global-campaign.org
For more information…
www.global-campaign.org
Key Outcomes from SRP
&
The Changing Field
European Strategy Meeting
27 October 2008
www.global-campaign.org
The Global Campaign for
Microbicides works to:
•
Ensure that as science proceeds, public and
community interests are fully protected -Accountability
•
Mobilise demand and investment for research
and development of new prevention technologies
•
Conduct policy advocacy for development,
testing, access, and use
www.global-campaign.org
Role of GCM in Microbicide
Landscape
• We build capacity for authentic civil society
engagement in the scientific process
• We advance user and community
perspectives
• We build grassroots and political support
for the long term
• We are independent and non-aligned with
any product or sponsor
www.global-campaign.org
Three-fold objectives
• Instrumental – get a product
• Strengthen Movements–
encourage cross movement linkages;
build civil society capacity
• Transform Science – forge a new
model for doing ethical research in
partnership with community
www.global-campaign.org
In their own words…
“GCM is the “go to”
organisation for
resources, turning
that language into
understandable
information…”
“GCM’s continuous
vocalising of the need
has had enormous
repercussions for
funding”
“GCM could improve in
sharing resources, especially
funding…”
“[Without GCM] we would not
have gotten this far. We would
have been slower in mobilising
political support.”
“No other organisation is so connected to the
concerns of women, communities, the whole
ethics question…”
“The way the
Campaign is
structured is one of
its strengths.”
“[GCM has contributed by]
incorporating a user
perspective throughout the
research process,
mobilising resources..,
assuring the ethical
conduct of research, and
ultimately access…”
“They could and should
stay focused on vaginal
science, women initiated
prevention options”
www.global-campaign.org
GCM’s Impact
• Generating increased public support
and funding in the Global North
• Changing the way clinical trials are
done
• Creating an enabling environment for
product development
• Fostering a bigger, louder, more
empowered grassroots constituency
• Bridging science and community
www.global-campaign.org
Scope & Mission
• Re-focus mission on women’s prevention needs
• Maintain leadership on microbicides but expand into
PrEP and other tools as they affect women
• Help co-create larger prevention research field; provide
much needed gender expertise
• Step up advocacy for access to existing prevention tools
and strategies
www.global-campaign.org
Integrated View of Prevention
Female and male condoms,
clean needles, male circumcision, VCT
Prevention
& Testing
Deliver
today
Develop
for tomorrow
Treatment Trials
Towards universal access
Vaginal and
rectal microbicides,
PrEP, vaccines…
www.global-campaign.org
STI Treatment Strategies
Microbicides
Cervical Barriers:
vaginal diaphragms
Voluntary Counseling
& Testing
Male and Female
Condoms
HIV
PREVENTION
Behavioural
Intervention (ABC)
Immunisation:
Vaccines
HSV-2 Suppressive
therapy
Male circumcision
Exposure prophylaxis
PMTCT
PEP
PrEP
24
www.global-campaign.org
www.global-campaign.org
Perceived Niche
and Reputation
• “Honest broker” between community/ civil
society and researchers
• Voice for users, trial participants, communities
and civil society
• Some criticism that GCM is too cozy with
researchers
• Evidence-based, balanced – “doesn’t sell its
soul to either side”
www.global-campaign.org
Defining CGM’s Comparative
Advantage
• Can bring SRHR and women’s groups to the
table
• Strong network in Europe
• Capacity to “hit the ground running”
• Established organisational track record
www.global-campaign.org
Strategic Review:
Take Home Messages
• GCM is taking on the right issues and pursuing broadly
supported strategies
• People can clearly articulate our objectives
• GCM fills crucial roles
– Organising (the invisible work)
– Bridging and enabling
– Timely and trusted communication (cellulose sulfate trials)
• Need to strengthen our relationships with advocates,
civil society groups and trial staff in key African
countries hosting trials
www.global-campaign.org
www.global-campaign.org
BREAK!
• Write down one achievement from
last year on a sticky note
• Add it to the Wall of Success
www.global-campaign.org
The HIV prevention landscape
&
Europe’s current engagement
www.global-campaign.org
HIV/AIDS Toolkit
Point of
transmission
After infection
• Education &
behaviour change
• Male and female
condoms
• Anti-retroviral
therapy
• Care
• Male circumcision
• Anti-retroviral
therapy (mother-tochild)
Prior to exposure
• Preventive
Vaccines
• Pre-exposure
prophylaxis (PrEP)
• HSV-2
suppression
• Post exposure
prophylaxis (PEP)
• Vaginal and rectal
Microbicides
• Education &
Behavioural
change
• Therapeutic
Vaccines
• Diaphragm,
cervical barriers &
new FCs
www.global-campaign.org
Research that Could Redefine Prevention, 9/06
Female Barrier Diaphragm
HSV-2 Treatment Infectiousness
Microbicides Carraguard
Oral PrEP - IDU
Oral PrEP West Africa
2006
Vaccines Adenovirus1
Adenovirus 2
HSV-2
Treatment –
Susceptibility
Microbicides
• BG/Pro2000
• CS – 1
• CS – 2
• Pro2000
• TDF
Vaccines Prime/Boost
Oral PrEP
• MSM
• Heterosexual
Index
Partner
Treatment
2008
2009
2010
Male
Circumcision Susceptibility
Community VCT
and HIV Support
Male Circumcision
- Infectiousness
2007
See also http://www.avac.org/timelinewebsite/index.htm
2012
www.global-campaign.org
Research That Is Redefining Prevention, 10/08
Vaccine –
Merck Adeno x2
STEP/Phambili
Female Barrier
Diaphragm
Vaccines –
Thai Prime/Boost
Microbicides –
Carraguard
Male
Circumcision –
Susceptibility
Oral PrEP –
West Africa
2006
Microbicides –
CS-1
CS-2
Oral PrEP
• Heterosexual
(FemPrEP &
Partners)
HSV-2 Treatment –
Infectiousness
Community VCT
and HIV Support
Male Circumcision
– Infectiousness
HSV-2
Treatment –
Susceptibility
2007
2008
Oral PrEP –
IDU/Thai
`
Vaginal & Oral
PrEP (VOICE)
Microbicides
• TDF/PMPA
(CAPRISA)
Vaccine –
VRC PAVE 100
Microbicides
• BG/Pro2000
•Pro2000
Oral PrEP
• MSM (iPrEx)
• Heterosexual
(Botswana)
2009
2010
Index
Partner
Treatment
2011++
See also http://www.avac.org/timeline-website/index.htm
www.global-campaign.org
QUIZ TIME!
www.global-campaign.org
QUIZ QUESTION
Which European country is the largest
donor to microbicides research?
www.global-campaign.org
EU Member States
Donors =
NORWAYS
WEDEN
DENMARK
N’LANDS
IRELAND
UK
BELGIUM
GERMANY
FRANCE
SPAIN
Targets =
FINLAND
ITALY?
www.global-campaign.org
European Funding
• Increase from 0.5m euros in 2000 to
40.3m euros in 2007
• EU member states have given IPM
71m euros
• UK has given over 75m euros
• The Netherlands and Ireland are the
largest contributors per capita
www.global-campaign.org
QUIZ QUESTION
What are the major European projects
on microbicides?
www.global-campaign.org
European Microbicide
Research
www.global-campaign.org
Mapping of scientists
• BELGIUM
Balzarini, de Haard, Jespers, Leroux-Roels, Schols,
van Roey, van der Mooter, Vanham, Voss
• DENMARK
Schooler, Pederson
• FINLAND
???
www.global-campaign.org
Mapping of scientists
• FRANCE
Le Grand, Martin, Bomsel, Belec, Vita, Rey, Tangy,
Verrier, Moog, Canard, Allaire, Storer, Delaporte,
Katlama, Paicheler? 
• GERMANY
Meurer?
• IRELAND
???
www.global-campaign.org
Mapping of scientists
• ITALY
Pozzi, Poli, Tagliabue
• THE NETHERLANDS
Van der Wijgert, Meloen, Schuitemaker?
• PORTUGAL
???
www.global-campaign.org
Mapping of scientists
• SPAIN
???
• SWEDEN
Wigzell, Wharen, Chiodl, Spetz, Biberfeld,
Thorstensson, Fenyo, Nihlmark
• SWITZERLAND
Hartley
www.global-campaign.org
Mapping of scientists
• UK
– Kelly, Shattock, McCormack, Lacey, Fletcher,
Herrera, Staphanidou
• OTHERS?
www.global-campaign.org
Mapping of Scientists
Time for homework!
www.global-campaign.org
Achievements
www.global-campaign.org
TIME FOR LUNCH!
www.global-campaign.org
The Expanding NPT Universe
and how GCM relates to it
European Strategy Meeting
27 October 2008
www.global-campaign.org
New Areas for Action:
• Female Condoms (what can we do now?)
• Circumcision (what does it mean for women?)
• ARV-Based Prevention =
 Treatment as prevention
PPTCT
PrEP
ARV-based microbicides
www.global-campaign.org
Why Female Condoms?
•
Woman-initiated and available for use now
•
Dual protection against HIV and unwanted pregnancy
•
Many potential benefits for HIV+ women
•
Increases total number of protected sex acts
•
Widespread acceptability
•
Tool for negotiation
•
Source of pleasure
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Alternative to male condom for MSM and anal sex
•
Prepares consumers, policy makers and distributors for future interventions such
as microbicides
www.global-campaign.org
FC =0.2% of the world’s condom supply
“I have never even seen
one, and I do trainings
on them!”
Winnie Muhumuza
Rwanda Women’s Community Development Network
describing the lack of access to female condoms
www.global-campaign.org
Challenges and
Opportunities
• Challenges
– Cost
– Lack of comprehensive and effective
programming
– Political will
• Opportunities
– Growing demand where accessible
– Convince local policymakers/international
donors of need!
www.global-campaign.org
UNAIDS Summary of Circumcision Data,
December 2006

Compelling observational, biological, clinical trial evidence of protective
re: STIs and HIV

Modelling indicates could avert millions of new HIV infections in East
and southern Africa, and would be highly cost-effective.

Acceptability in non-circumcising populations = high and growing.

The limited data on safety are alarming.

Safety is feasible, but will take resources.

Risk compensation must always be a concern.

Needs for training and resources are widespread outside of hospitals
www.global-campaign.org
AVAC civil soc. consultation – June
08 Women’s Caucus concerns….
Monitor & minimise potentially harmful outcomes for women –
e.g.
 decreases in condom use by men
 increases of sexual violence; GBV against women seen as “vectors”
 Blaming of HIV positive women for “bringing HIV into the
relationship”
Monitor resource allocation: balance increased spending on
circumcision with increases in prevention resources for women, e.g.




Increased access to female, as well as male, condoms
Provision of vaginal lubricants
Diagnosis and treatment of STI
Provision of safe spermicides (like BufferGel) -- used with cervical
barrier methods for contraception; may also reduce STI/HIV risk
www.global-campaign.org
ARV-based Prevention
www.global-campaign.org
Treatment as prevention
• HPTN 052 – 1750 discordant couples
– #1: ART as soon as the couple enrolls in study,
– #2: starts ART when + partner CD4 count ≤ 200250
– Result expected 2012
• BUT, effectiveness depends on knowing HIV
status promptly, as people are most
infectious during first few weeks of seroconversion
www.global-campaign.org
% of all HIV + pregnant women receiving ARV
prophylaxis
PPTCT Access Increasing but Lowest in Regions
with Greatest Need
100%
91.5%
85.6%
90%
80%
70%
60%
50%
40%
30%
21.6%23.6%
20%
10%
9.5%10.3%
13.9%
7.5%
1.6% 2.3%
0%
West and
Central Africa
C. and S
America
East and South East Asia and
Africa
Pacific
2004
C & Eastern
Europe
2005
Source: UNICEF PMTCT and Pediatric Care Report Card 2006
www.global-campaign.org
PrEP
www.global-campaign.org
What does PrEP mean for women?
• Available for high risk populations only? If so, how will high risk be
defined?
• How do we handle issues associated with accessing HIV testing
(since it will be prescribed to HIV negative people only)?
• Will women keep the pills prescribed to them? Since it is also HIV
treatment, she may give them (or they may be taken from her) for
HIV positive family members or others who «need them more» than
she does?
• What about pregnancy? Will we have data on the impact of taking
PrEP when pregnant? When breast-feeding?
• What about condom migration? If men using PrEP become less
willing to use condoms, could this have an impact on women’s risk?
www.global-campaign.org
Other PrEP Advocacy Issues
• Assure sufficient funding for trials on PrEP in
various populations, impact of intermittent use,
effects of long-term use, etc.
• Encourage testing additional, non-tenofovir-based
ARVs for use as PrEP, particular drugs that could
be “reserved” specifically for use in prevention
• In the the PrEP Committee of the CHAMP
Prevention Research Advocacy Working Group
(PRAWG), we work on these collaboratively
www.global-campaign.org
ARV-based microbicides
– all our eggs in one basket?
• What if they just don’t work? Won’t we have lost
time if no other options in the pipeline?
• HIV-positive women need options that are not
ARV-based
• Non-HIV specific microbicides are needed for
prevention of other STI, as well as HIV
• What if resistance turns out to be a problem?
www.global-campaign.org
What is Drug Resistant HIV
• To multiply, HIV must enter healthy immune cells
• Each cell can produce tens of thousands of new viruses
• Every time HIV copies itself (replicates), small errors are
introduced (like typos on a page)
• These errors are called “mutations”
• Some mutations harm the virus; occasionally they help
the virus replicate even in the presence of ARV drugs
www.global-campaign.org
Resistance (continued)
• ARV drugs do not cause resistance—resistant strains of
the virus emerge spontaneously as random mutations
occur
• Every day billions of mutated virus are produced
• “Resistant strains” can survive and multiply in the
presence of drug, whereas regular (“wild type”) virus
can’t
• Over time, resistant strains come to dominate in the body,
like weeds “crowding out” flowers in a garden
www.global-campaign.org
Mutant vs “Wild Type” Virus
• Mutant virus is often “less fit” than regular or “wild type”
virus
– In the absence of drug, mutant virus replicates more
slowly & is transmitted less often than wild type virus
– So if a person stops using PrEP or an ARV-based
microbicide, regular virus will come to dominate again
in the body
• When drug is present, the advantage shifts to resistant
virus, and it dominates
www.global-campaign.org
Possible implications of resistance
for ARV prevention
• If PrEP or ARV-based microbicides generate resistance
among users, this could limit their future HIV treatment
options
• Users could also transmit resistant virus to their
partners
• If resistant virus spreads in the wider community, it can:
– undermine the protective effect of the microbicide or PrEP
based on that drug
– Undermine treatment based on that drug
www.global-campaign.org
Resistance Mantras
Courtesy of John Mellors
• No replication = no resistance
• No infection = no resistance
www.global-campaign.org
No replication = no resistance
• Resistance only develops when the virus is replicating
• Replication only happens when viral suppression is
incomplete because:
There is not enough drug at the right place in the
body (PK issues) or
The virus is already resistant to the drug or
The person cannot or does not take their drugs as
prescribed (sub-optimum levels)
www.global-campaign.org
Limited Drug Potency or PK
Incomplete Adherence
Prior Drug Resistance
Incomplete Suppression of HIV
Evolution of Drug Resistance
Reduction of Drug Activity
Increased Viral Replication
www.global-campaign.org
So…..
The pharmacokinetics are very important
how much is absorbed & how long it stays present in vaginal tissues
By picking the right drug  chance of resistance is lowered
– Right drug = enough of it stays at the right place in the body
• good concentration in tissue but little absorption in the blood
stream
– Right drug = requires rare or multiple mutations to cause
resistance
www.global-campaign.org
No infection=no resistance
Resistance is a potential problem only for people who are or
become HIV positive
– HIV negative people cannot develop resistance
– If an ARV-based strategy completely prevents
infection, resistance won’t develop
– The more effective a microbicide or PrEP is 
the fewer the people likely to develop resistance
www.global-campaign.org
So what does this mean for ARVbased prevention?
People should be HIV negative when starting it & should stop
taking drug as soon as infection occurs
Therefore… ARV based prevention should be linked to HIV testing
Expanding HIV testing programs required for success of
ARV prevention
Ideally, we should use different ARVs for prevention than for
treatment to protect people’s future treatment options
Not possible today, but should be a goal for the future
www.global-campaign.org
But will resistance happen?
• Resistance will occur with PrEP unless people stop taking
drug as soon as they get infected
• We won’t know whether ARV-based microbicides will
select for drug-resistant virus until more research is done
• Trials are designed to limit potential for resistance (HIV
testing every month). Participants who seroconvert are
monitored closely and ensured access to drugs that work
against their virus
• Real challenge is not trials, but “real world” use
www.global-campaign.org
Why not use ARV combinations
for prevention?
• Multiple drugs may reduce resistance, but using 3 drugs
also:
– Increases costs
– Increases side effects
– Raises additional safety issues
• This may not be viable for long-term use by healthy
people
• Scientists want to begin with proof of concept and build
up from there
www.global-campaign.org
Real world questions
The working assumption is that these products will
only be used by HIV negative people, but:
Is “use by prescription” realistic?
Won’t this lead to black marketing and sale
of fake (unproven) products?
Won’t this limit access to those in more
affluent, urbanized areas?
www.global-campaign.org
More real world questions
How will you determine probability of resistance
in “real world use”?
If through a controlled introductory study, what
would that look like?
How will you handle the stigma issues that
such a study will raise?
www.global-campaign.org
Still more real world questions
-- for microbicide developers only
What if your product is ultimately associated with
the development of resistant virus?
Will you plan to market it indefinitely but only to
people who can prove they are HIV
negative?
Do you have plans to pursue non-ARV based
leads, to provide alternatives for those who
are positive or who don’t know their status?
www.global-campaign.org
We are not in this alone!
•
On Female Condoms – member of Prevention
Now! (see www: www.preventionnow.net.)
•
On circumcision, PrEP – working with AVAC,
AMAG, TAC, PRAWG and other prevention research
advocacy groups
•
On PPTCT – participating in effort lead by SANAC
(campaign starting in November)
•
On microbicides – GCM and IRMA take the
lead! collaborating with the partners above and
others
www.global-campaign.org
Questions and Discussion
www.global-campaign.org
Wrap-Up of Day 1
• Feedback: what went well? What should we
change?
• Questions or concerns we should address tomorrow
Tomorrow
• Learn about resources and rectal microbicides
• Review new advocacy objectives
• Discuss strategy and priorities for Europe
• Develop concrete next steps
• Discuss outreach to key constituents
www.global-campaign.org
Agenda: Day 2
•
•
•
•
•
•
Learn about resources at our disposal
Learn about rectal microbicides
Review new advocacy objectives
Discuss strategy and priorities for Europe
Develop concrete next steps
Discuss outreach to key constituents
www.global-campaign.org
Arwa’s Resources slides
www.global-campaign.org
MA’s RM slides
www.global-campaign.org
BREAK TIME!
www.global-campaign.org
GCM changes and
Europe’s role in new advocacy goals
European Strategy Meeting
28 October 2008
www.global-campaign.org
New GCM Structure
Capacity
Building &
Social
Mobilisation
Marc-André, Arwa, Paramita, Rebekah,
Pauline
Anna
Publications,
Tools and
E-Outreach
Planning,
Operations
and Special
Projects
Bindiya
Director &
Leadership
Team
Acting: Lori
Bindiya
Samu
Dube
Eventual home of
Community Involvement
Temporary home of
Community Involvement
Science
Policy, and
Ethics
Enabling
Trials/Africa
Program
www.global-campaign.org
Framework for Gates LoI
• Enabling trials: Create a positive enabling environment for the
timely and ethical implementation of clinical trials
• Accountability & coordination: Monitor and improve the
accountability, decision making, and resource allocation of the
microbicides field and encourage coordination
• Sustain political will: to sustain support for HIV prevention
research, especially for woman-initiated methods
• Build capacity among advocates and community members to
engage productively in decisions around research and clinical trials
жжжж
• Small grants fund: Establish an external grant making facility
that would distribute advocacy grants to NGOs and other
community groups working on HIV prevention and research
www.global-campaign.org
Percent of Costs by Activity
With Core Allocated -- in June, 2008
Communications, 6%
($215,825)
Comm. Involvement, 7%
($245,760)
Capacity Building, 12%
($424,824)
Ethics, 14% ($487,633)
NA, 6% ($218,108)
MMCI, 11% ($375,649)
India, 9% ($292,491)
Europe, 10% ($356,609)
Africa, 13% ($436,149)
Prev. Research
Advocacy, 10%
($352,331)
www.global-campaign.org
Grant-making Fund
for Prevention Advocacy
• Large unmet need for small-scale funding to
advocacy and community groups on the
ground
• Idea of grant-making fund was major
recommendation emerging from MDS civil
society working group and GCM strategic
review
“We have no choice.
• Donor funding increasingly
consolidated and difficult to access
The work has to be
done on the ground,
• Positioning groups like AVAC,GCM
and there is no way
as intermediaries complicates
that this work can
relationships with local groups
– We become a donor rather than
a partner
happen without
strengthening the
groups on the
ground.”
www.global-campaign.org
How it might work
Multiple
donors and
research groups
Seek funding
for grantmaking fund
GCM &
like-minded
organisations
Advisory
function
Funding
Established
grant-making
entity
Grant proposals
and reporting
Technical
assistance
Grassroots
advocacy
groups
Project and
core support;
Technical
assistance
www.global-campaign.org