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PrEP
What is it?
How may it help women?
Today’s agenda

What is PrEP?

How would it work?

What do we know about it?
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When will we know more?
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What could it mean for women?
33 million people now
live with HIV/AIDS
2.7 million new infections annually
Among 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
Unmet needs for HIV prevention
<20% Sex workers with access to behaviour change programmes
11% Births getting drugs as needed to stop vertical transmission
10-12% Adults in Africa accessing HIV testing
9% MSM 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
Up to 45%
recently
What is PrEP?
Taking medicine to prevent rather than to treat a
disease or condition
For example:

Taking pills to prevent malaria when you travel.
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Using hormonal contraceptives (injections or
pills) to prevent pregnancy

Taking pills to avoid pneumonia, if you are
at risk.
Imagine a full tool box
Before exposure
Point of
transmission
• Counselling
& testing
• Male medical
circumcision
• Pre-exposure
Prophylaxis
(PrEP)
• Preventive
vaccines
• Treating a
positive partner
• Male & female
condoms with
lubricant
• Preventing
vertical
transmission
• Clean injecting
equipment
• Vaginal & rectal
microbicides
• Cervical barriers
After exposure

Post-exposure
prophylaxis
(PEP)
Why test ARVs
to prevent HIV?
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

ARVs already are used to prevent
vertical transmission (or PMTCT).
PEP already is used to prevent infection
after medical accidents or rape.
Monkeys that get ARVs prior to exposure
are less likely to be infected with “monkey
forms” of HIV.
Current late-stage PrEP trials
Where
Who
What
When
US (CDC)*
MSM
tenofovir
2010
Thailand (CDC)
IDUs
tenofovir
2010
Brazil, Ecuador,
Peru, US, Thailand,
South Africa (iPrEX)
MSM
Truvada
2010
Botswana (CDC)
Heterosexual men
and women
Truvada
2011
Uganda, Kenya
(Partners PrEP)
Serodiscordant
couples (men and
women)
tenofovir,
Truvada
2012
Kenya, Tanzania, South
Africa (FEMPrEP)
Women
Truvada
2012
South Africa, Uganda,
Zambia, Zimbabwe**
(VOICE)
Women
tenofovir (pill
& gel); Truvada
2012
*CDC: US Centers for Disease Control and Prevention
**TBD: Malawi may be added
What makes a drug a good
candidate for PrEP?
Now being tested: Truvada (tenofovir+emtricitabine combined)
tenofovir (Viread)
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Easy to use: Only one pill required per day (maybe less).
Safe: Few side effects in HIV-positive people.
Powerful: Stays in the bloodstream a long time.
Unique resistance profiles: If resistance develops, other
treatment options still exist.
Safety concerns?
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Safety is a critical issue for PrEP use
Look carefully at people with pre-existing conditions:
hepatitis B and C, kidney problems, bone density
Pregnancy, post-menopause (osteoporosis),
adolescents (bone formation)
Look carefully at drug clearance in people with low body
weight, including women and Asians
Why so many different studies?
Why is PrEP being tested in drug users, men who have sex
with men, discordant couples, & high-risk women?
Drug resistance:
a concern with PrEP
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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.
If a mutation makes HIV able to resist an ARV
drug, it is called drug-resistant HIV.
Think of weeds in a garden
If you use weed killer:

Some weeds die.

Others thrive,
grow bigger, and
take over.
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The weed killer
accidentally helps
resistant weeds –
it takes away all
their competition.
To stop the big weeds:
• Take away the first
weed killer.
• Introduce other weed
killers that stop all
weeds – big and small.
Slide concept by Jeanne
Marrazzo, MD and John
Mellors, MD, MTN
PrEP & the risk of resistance
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Be sure person is HIV negative when starting PrEP.
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User must get tested for HIV regularly.
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If user tests positive, PrEP use must stop right away.
– OTHERWISE –
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Drug-resistant virus can emerge.
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Tenofovir and Truvada may no longer work for the person.
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The person must use other ARVs that may be less effective.
Preventing resistance
in clinical trials
PrEP trials test participants every month.
Those who sero-convert:
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Stop using PrEP right away.
Are checked over time for drug
resistant virus.
Are assured they will get ARVs that
will work against their virus.
Preventing resistance in
the real world
1.
2.
3.
Make sure no one gets PrEP without an
HIV test.
Make HIV testing much more common.
Recognise that spread of drug-resistant HIV
is a risk to:
– The people who become HIV-positive.
– Those they transmit it to.
– The effectiveness of national HIV programs.
In an ideal world
ARVs for
treatment
ARVs for
prevention
Is it possible? Is it ethical?
Research & Readiness Map
Large scale
implementation
Introductory studies and
post-marketing surveillance
Bridging studies
Large-scale
effectiveness studies

Safety studies
in humans
Animal trials
Women’s questions about PrEP
If I think my
husband has HIV,
will I be able to get
PrEP?
Even if the doctor
gives me pills,
will I be able to
keep them for
myself?
If I take PrEP,
how will I make
a man use a
condom?
More questions
People will notice if
I have to go in for
testing and to get
my pills. What will
they say about me?
Will my husband
let me go to the
clinic?
How much
will it cost?
Where will I get it?
Will it
make me
sick?
Can I take PrEP
when I’m pregnant?
Will it hurt my baby?
What about
breastfeeding?
Next steps for science
• Gather more data on how PrEP works across
populations.
• Address safety concerns through current trials
and further research
• Learn how to monitor widespread resistance.
• Study intermittent use: for example, taking it
only when you expect to have sex.
• Find out about impact on pregnancy and breast
feeding.
• Test other ARVs to see if they might also work
as PrEP.
Next steps for
community readiness
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Figure out how to make HIV testing much
more widespread and acceptable.
Discover how to provide regular access to HIV
testing and resistance monitoring.
Develop strategies to minimise black
marketing and sharing of PrEP drugs.
Conduct large-scale community education
about PrEP benefits and risks.
Addressing women’s concerns
Women in every country using PrEP must be involved in
designing and implementing:
•
Appropriate programs for men and women on HIV
testing, PrEP, stigma, and prevention challenges.
•
HIV testing and PrEP access plans that guard
privacy and help women keep pills for their own use.
•
Support systems to help women develop and share
strategies for managing their HIV risk.
•
Local and global leaders who demand resources to
support these efforts.
What YOU can do
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Join an advocacy group that is asking
questions about new HIV prevention tools,
including PrEP.
Invite women’s groups to take on HIV
prevention, and HIV/AIDS advocates to
address women’s needs.
Imagine equal access to HIV prevention
for women and ask “Why not?”
Where to go for information
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Global Campaign for Microbicides
www.global-campaign.org
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PrEP Watch
www.prepwatch.org
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CHAMP’s Prevention Research
Advocacy Working Group
www.champnetwork.org
What does PrEP mean for women?
The answer depends on us!
“Science teaches us
everything except
what to think and what to do.”
– Søren Kierkegaard
Questions you may get from the audience
This section is for speaker’s reference only. It does not need to be
displayed as part of the presentation.
The next two slides are for the speaker’s use. They will help you answer
questions you may get from the audience.
The most frequently asked question is “how do you know that?” The next
slide has a list of sources for the facts in this presentation. You can cite
these as the sources for your information.
In the notes section are some other questions, and ideas on how to
answer them.
These are the questions we have heard so far. If you get questions
that you think should be included to help future speakers, please
send them to Anna Forbes at [email protected]. Thanks!
“How do you know that?”
The notes here indicate the sources of
facts in this presentation. Commonly
known numbers are not cited here, only
the less common statistics and facts.
You can cite these as the sources for
your information.