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PrEP 'n Lunch 'n Learn
1. PrEP ‘n Lunch ‘n Learn 1.22.14
Meme by Pedro Alonso Serrano
Jessica Terlikowski and Jim Pickett
Your PrEP Squad
2. Today
• Project RSP!
• What is PrEP?
• What does/doesn’t
it do?
• How do you get it?
• Why is it important?
• PrEP’n AFC
2
3. But first, honesty please
What is the first word or
words that come to your
mind when you think
about condoms?
3
4. Honesty please
What is the first word or
words that come to your
mind when you think
about PrEP?
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5. Unrestricted
educational
grant from
Gilead for
2013
• Trainings: Help Chicago providers, educators, and others
working directly with our community to understand PrEP
and what it means for us and HIV prevention.
• Community forums: Interactive and fun discussions done
“talk show” style
• Give voice/provide facts: Platform for PrEP users to share
experiences, interested individuals to get info –
click myprepexperience.blogspot.com.
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8. • We are NOT “pushing” PrEP
• We are NOT telling anyone to stop using
condoms or other forms of protection
• We are pushing education
• Knowledge is power
• Ignorance is not strength
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13. Dateline: July 16, 2012
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm
Today, the US Food and Drug
Administration approved Truvada
(emtricitabine/tenofovir disoproxil
fumarate), the first drug approved to
reduce the risk of HIV infection in
uninfected individuals who are at high
risk of HIV infection and who may
engage in sexual activity with HIVinfected partners.
13
14. Dateline: July 16, 2012
• Truvada is approved for use as part of a comprehensive HIV
prevention strategy that includes other prevention methods, such
as safe sex practices, risk reduction counseling, and regular HIV
testing. - FDA
– Must be confirmed HIV-negative before prescription
– FDA required development of Risk Evaluation and Mitigation
Strategy (REMS) for use of Truvada as PreP to ensure safe use
• www.truvadapreprems.com
• Medication guide
• Community education
• Provider training
• Implementation
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15. How did we get here?
• All completed trials done on tenofovir &
Truvada
• 4 trials = PrEP reduced risk of HIV infection
– i-PrEX (Truvada in gay men and trans women)
– Partners PrEP (Truvada and tenofovir in
heterosexual couples)
– TDF2 (Truvada heterosexual men & women)
– Bangkok Tenofovir Study (injection drug users)
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16. Bumps in the road for women
• 2 trials = PrEP did not work
– FEM-PrEP (Truvada in women – stopped
2011)
– VOICE (Truvada, tenofovir – reported
2013)
• Both trials had very low adherence –
(though self-reports were high)
• Both trials found low/undetected
drug levels
16
17. Key research findings
• Adherence! Adherence! Adherence! (take
the pill every day… every day means every
day…)
• High adherence achieved 90%+ reduction
in risk
• Truvada PrEP trials to date have not shown
increases in sexual risk behavior among
participants
• Across all PrEP studies of Truvada, there
have been no serious safety problems
17
18. Key research findings
• For some, there appears to be a general
“start-up syndrome” w/Truvada that
includes nausea, diarrhea, abdominal pain
and headaches.
• Nausea most common (under 10%) and
resolved in 4 to 6 weeks
• Very little drug resistance has been seen, only
among those with unidentified HIV infection
when they started the study
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20. Who might be a good fit for PrEP?
• Person indicates an interest in taking PrEP
• Person is in a “magnetic” relationship
–HIV-negative and has HIV+ partner
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21. Who might be a good fit for PrEP?
• Sexual activity within high prevalence area or
social network, and/or:
– Doesn’t use male or female condoms consistently
– Diagnosed with STI(s)
– Exchanges sex for money, food, shelter, drugs, etc.
– Uses illicit drugs or depends on alcohol
– Is or has been incarcerated
– Does not know partner’s HIV status and one of the
above factors is true for partner
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36. PrEP takes work
• Truvada as PrEP means…
– A daily pill
– On-going engagement with
healthcare
• Quarterly HIV testing
• Adherence support/counseling
• Regular STD screening and treatment
• Tests for toxicities, bone density
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38. PrEP aint magic
• Truvada as PrEP does not
– Guarantee 100% protection from HIV (what does?)
– Protect a person against other STIs like chlamydia, syphilis,
herpes, or gonorrhoea
– Prevent pregnancy
– Cure HIV
– Function as a treatment regimen for someone already living
with HIV.
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41. Accessing PrEP
• Any doctor who can write a
prescription can write one
for Truvada as PrEP
• Most HIV docs are familiar
with PrEP
• Research (Project PrEPare)
• Demo, implementation
(UC and ACCESS Grand Blvd)
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42. Accessing PrEP – Howard Brown
• HBHC providers
experienced with PrEP,
existing patient
population accessing
PrEP
• Dedicated adherence
counselor, like case
manager, for PrEP
patients
www.howardbrown.org
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43. Accessing PrEP— insurance
FDA approval of
Truvada enables
private ins to cover
Truvada
on
Medicaid
formulary
ADAP
does not
cover PrEP
Ins companies
covering, so far
43
44. Accessing PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
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45. Clinical Practice Guidelines
•
•
•
•
Interim guidelines for different pops already available
Final guidelines being drafted – expect to publish soon
For clinicians – not “all purpose”
Includes info on evidence, guidelines for screening,
providing PrEP to gay men and heterosexuals,
discontinuing PrEP, clinical considerations, improving
adherence, reducing risk behaviors, info on financial case
management, fact sheets, risk index, counseling info, and
quality measures
• Remember the REMS
www.truvadapreprems.com
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46. New, handy brochure!
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
http://www.cdc.gov/hiv/pdf/risk_PrEP_TalkingtoDr_FINALcleared.pdf
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52. PrEP prescriptions – how many, who?
• “Status of Truvada (TVD) for HIV Pre-Exposure
Prophylaxis (PrEP) in the United States: An Early
Drug Utilization Analysis” – presented at
Interscience Conference on Antimicrobial Agents
and Chemotherapy, Sept ’13
• http://www.natap.org/2013/ICAAC/ICAAC_18.htm
• Drug info from 55% of all US pharmacies,
“nationally representative”
• 49 states, 700 cities,
• Algorithm to exclude treatment, PEP,
offlabel Hep-B treatment
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53. PrEP prescriptions
• 1,774 unique PrEP users between
January 2011 and March 2013 (starting
before FDA approval)
• 1,674 prescribers (620 also prescribed
Truvada as Tx)
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55. PrEP prescriptions
• Approx. half of all Rx were started before
FDA approval in summer 2012
• Approx. half of all Rx written for female
PrEP users
• Largest percentage Rx written in the
Southeast
• Average age of PrEP users + 35 yrs
• Approx. 13% of users since
FDA approval are under the age of 25
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58. The guys these sensible
health care folks are trying to
reach are not sensible. They
are self-identified idiots who
can only be saved by a
vaccine.
- Dan Savage
59. What can AFC do
to support
knowledge of,
and access to,
PrEP?
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Jim and/or JessicaWe will write these down on flipcharts. The goal from this exercise is to name some of the opinions, attitudes, and feelings re: PrEP. We are starting with condoms because they are much less charged a subject.