microbicides envision a product that could save lives your name here
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MicrobicidesEnvision a product that could save lives
Your name herewww.global-campaign.org
2.7 million new infections annually
33.4 million people nowlive with HIV/AIDS
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
<20% Sex workers with access to behaviour change programmes
11% HIV+ pregnant women with access to PMTCT
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
Percentage of at-risk people with access to HIV prevention
0
Rose to 45% recently
20 40 60 80 100
Global HIV Prevention Working Group 2008; WHO/UNAIDS/UNICEF 2007
The Global Campaign for Microbicides works to:
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
Protection
TechnologyEconomic
opportunities
Social power
Source: Brady, Martha. Population Council, Conceptual Framework. 2005.
What women need to protect themselves
We need microbicides that:
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?
To reduce the risk of co-infection with other HIV strains.
To reduce the risk of other sexually transmittedinfections, and yeast and bladder infections.
To allow conception whilst protecting partner.
PrEP
Clean injecting equipment
Cervical barriers: vaginal diaphragms
PMTCT
Vaccines
Voluntary counselling and
testing
HIV Prevention
Microbicides
Male and female condoms
Male circumcision
PEP
HIV preventionNot ARV-based ARV-based
Male and female condoms
Circumcision
Vaccines
Needle exchange
VCT
PEP
PrEP
Treatment for HIV+ partner
Vaginal and rectal
microbicides
Prevention of vertical
transmission(PMTCT)
With Primary Partner
With Casual or Outside Partner
Why condoms are not enough
Measure Evaluation. 1997–2002. http://www.measuredhs.com.
Source: Shattock R, Moore J. Inhibiting Sexual Transmission of HIV-1 Infection. Nature Reviews Microbiology. Vol. 1, October 2003.
2. Surfactants
3. Block binding4. Stop replication
1. Boost vagina’s natural defences
5. Future possibility
*STDs: sexually transmitted diseases
*
Early-stage concepts
Preclinical testing
More than 50 candidates
Early human safety trials
1 in large-scale
efficacy trials
The product pipeline
Source: Alliance for Microbicide Development
Outcomes of past studies
Signs of efficacy No efficacy
Safe
Carraguard®
BufferGel®
PRO 2000 0.5%
Trend toward harm
Nonoxynol-9
Savvy
Cellulose sulphate
Current and planned late-stage trials
ProductTrial 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
Source: Alliance for Microbicide Development
THE AMERICAS
United States: Phase 1, 1/ 2, 2
Puerto Rico: Phase 1
Dominican Republic: Phase 1
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
ASIA/PACIFIC
Thailand: Phase 1
Australia: Phase 1/2
Experience of a trial participant
Recruitment: Participant
receives information
about the trial in her own
language
Screening Visit 1: Education about the
trial, HIV and pregnancy test,
sexually transmitted infection tests and treatment, baseline
data collected
Screening Visit 2: Results of tests,
counselling, education about trial
reinforced
Randomisation: Participant
assigned by chance to a group
Family Planning Informed
consent for screening
Informed consent to enrol
Condoms + placebo
Condoms + experimental gel
When can we expect a microbicide?
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, CONRAD, FHI, CAPRISA
Governments (South Africa DST, US NIH, UK 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
ARV No ARV
More potent against HIV May be long lasting Not contraceptive
Could work against HIV and other sexually transmitted infections
Could be contraceptive
May cause more side effects May cause resistance Unlikely to protect against
other sexually transmitted infections
May be less potent against HIV
Must be used at time of sex
Dis
adva
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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?
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?
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
If I use a microbicide,
how will I make my man use a condom?
What will they say about me?
How much will it cost?
Where will I get it?
Questions women have about ARV-based microbicides
Will it make me
sick?
Can I use an ARV-based microbicide
when I am pregnant?
Will it hurt my baby? What about
breastfeeding?
If I think my man has HIV, but I do not know for sure, will I be able to get microbicides?
Advocates call for next steps
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.
Increase community engagement. Ensure ethical standards and dialogue.
Visit www.global-campaign.org
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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
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“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.