This document provides an overview of a presentation on pre-exposure prophylaxis (PrEP) given in Collinsville. The presentation covers what PrEP is, how it works, research on its efficacy, potential side effects, guidelines for use, barriers to access, and ways to pay for PrEP medications and services. The goal is to educate providers, advocates, and clients about PrEP as an HIV prevention strategy.

1. Welcome!
Collinsville – June 3, 2015
These slides are available at
tinyurl.com/PrEPCollinsville

2. What we will cover today
• Intros
• Overview ARV-based prevention
• Understanding PrEP
– What is PrEP?
– PrEP research
– How PrEP is taken
– Access to PrEP
– Talking to clients about PrEP
– Slides available at:
tinyurl.com/PrEPCollinsville 2

3. Ground rules
• We are all here to learn
• The only dumb questions are the
ones not asked
• Listen actively, respect others
when they are talking
• Participate to the fullest of our
abilities
3

4. 4

5. 5

6. What is the first word or
words that come to your
mind when you think
about condoms?
6

7. What is the first word or
words that come to your
mind when you think about
needle exchange?
7

8. What is the first word or
words that come to your
mind when you think about
oral contraceptives?
8

9. What is the first word or
words that come to your
mind when you think
about PrEP?
9

10. 10

11. • Sex without condoms does not automatically
= “unprotected sex.”
• Will no longer frame sex without condoms as
“unprotected.”
– Protection can mean VL suppression, it can
mean sero-adaptation, and it can mean PrEP (in
addition to male and female condoms)
11
Protection w/out condoms

12. 12

13. What is ARV-based prevention?
• Strategies that use HIV treatment
drugs (antiretrovirals or “ARVs”) to
prevent HIV infection
– TLC+ (testing, linkage to care, plus
treatment)
– ARV-based microbicides
– PEP (post-exposure prophylaxis)
– PrEP (pre-exposure prophylaxis)
13

14. 14

15. 15

16. Hold up, what is prophylaxis?
• Prophylaxis is simply the provision of
medications prior to germ or virus
exposure to prevent infection.
• This is not a new concept.
• This is not a new practice.
• Example: taking malaria drugs
before traveling to countries with
high malaria incidence
• What are examples of similar concepts?
16

17. 17

18. 18

19. • 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
Dateline: July 16, 2012
19

20. What is PrEP?
• PrEP consists of taking the ARV drug Truvada to
prevent HIV. One tablet every day.
• Truvada is a combination of tenofovir disoproxil
fumarate (aka tenofovir or TDF) and emtricitabine.
• Need to take 5 – 7 days of Truvada before enough drug
is “on board” for protection in rectum.
• Three weeks for vaginal protection.
• Truvada is currently the only drug
approved by the FDA for PrEP.
20

21. Released May 14, 2014
21
tinyurl.com/CDCprepguidelines (PDF)
tinyurl.com/CDCprepguidelineswebinar
(webinar audio/slides)

22. PrEP Clinical Practice Guideline
• For clinicians
– But incredibly useful for providers, educators, policy
folks, and advocates – YOU
• Includes info on efficacy and safety evidence,
guidelines for screening, providing PrEP to gay
men, heterosexuals, and injection drug users,
discontinuing PrEP, clinical considerations,
improving adherence, reducing risk behaviors, info
on financial case management, fact sheets, risk
index, counseling info, and quality measures
22

23. 23
Ken Like Barbie explains
PrEP

24. 24

25. Ken Like Barbie recap
• PrEP involves HIV-neg person
taking ARVs to reduce risk of
infection before HIV exposure.
• In current approved form,
PrEP is taken in a single pill –
Truvada –once a day, every
day
• Seasons of risk.
• With us, by us, for us.
25

26. www.myprepexperience.org

27. 27

28. 28
PrEP is more than a prescription
PrEP is a
program

29.  Take Truvada tablet every day.
 Provider* visits every 3 mos
 HIV testing
 Tied to Rx renewal
 Hepatitis B testing
 Kidney function testing
 STI screening
 Pregnancy testing
 Adherence counselling
 Honest, open discussions
about sex, sexual health
29
Taking PrEP…. what does it take?
*These activities don’t
all need to be done by a
doctor in their office

30.  It’s not just a pill, it’s a program
 Adherence (perfection not
required, esp for rectal)
 Take 5 – 7 days* before
enough drug is “on board” to
provide protection in the
rectum, 3 weeks for the vagina
 Then take Truvada every day
30
*This is a moving target, as we will see…..
Taking PrEP…. what does it take?

31. • iPrEX Open Label
• 1,603 participants, 1,225 on PrEP
• Most from Peru/Ecuador, 18% USA
• 100% effectiveness associated
with 4+ doses a week (rectal)
• 84% effectiveness in ppl who
took 2 -3 doses a week
• Ppl engaging in higher risk sex
self-selected for PrEP
• Adherence issues more
pronounced among young
people
31

32. 32
You can miss a dose here and there and still have excellent protection.

33. 33
Adherence is a much bigger deal for vaginal protection.

34. What PrEP does not do
• Truvada as PrEP does not
– Guarantee 100% protection from HIV (what
does?)
– Protect a person against other STIs like
chlamydia, syphilis, or gonorrhoea
– Prevent pregnancy
– Cure HIV
– Function as a treatment regimen for someone
already living with HIV.
34

35. 35
• True or False: PrEP must be started within 72 hours
of exposure to HIV.
• What is an example of “prophylaxis?”
• The FDA approved Truvada as PrEP in what year?
• True or False: It takes longer for PrEP to achieve
protection in the vagina compared to the rectum.

36. 36

37. 37

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40. 40
Science.

41. Science
• All completed trials done on tenofovir &
Truvada
• 7* studies = PrEP reduced risk of HIV infection
– i-PrEX (Truvada in gay men and trans women)
– Partners PrEP (Truvada and tenofovir in
heterosexual couples)
• TDF/FTC combination and Tenofovir alone comparably
efficacious
– TDF2 (Truvada heterosexual men & women)
– Bangkok Tenofovir Study (injection drug users)
*Will discuss the other 3 soon 41

42. 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
• Important to note – PrEP does
work for women, and the FDA
prevention indication includes
women 42

43. Key research findings
• Adherence!
• 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
43

44. Key research findings
• Some will experience 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.
44

45. Side effects
• 1 in 10 will have nausea that
subsides quickly.
• 1 in 100 will experience bone
density loss, which plateaus and
doesn’t progress. Not usually
clinically significant.
• 1 in 200 will experience kidney
problems, which resolve after
stopping. Can be safe to re-start.
45

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48. 48

49. 49
There is an urgent need to mobilize clinical
efforts, service delivery, education,
implementation research, and policy to
optimize PrEP access and use.
– Dr. Raphael Landovitz/UCLA
croiconference.org

50. PrEP’s “protease moment”
50
PROUD – 86%
IPERGAY – 86%
PARTNERS DEMO – 96%
croiconference.org

51. 51

52. 52
• True or False: PrEP does not work for women.
• True or False: About 25% of people who take
PrEP will have nausea.
• True or False: Regular STD screening is part of
the PrEP program.
• True or False: You don’t need to adhere perfectly
to PrEP to achieve high levels of protection.

53. 53

54. www.myprepexperience.org

55. 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
55

56. 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
– Injects drugs one or more times daily
– Shares injection equipment
– Injects cocaine or meth
56

57. PrEPception [PrEP C]
57

58. Truvada as PrEP
Is the first non-
barrier HIV
prevention strategy
fully controlled by
the receptive
partner.
58

60. pleasure
intimacy
connection
emotion
lust
love

61. 61
In this sample of men
who are in a
relationship with a
perceived HIV-negative
man, we found that
intimacy motivation was
the strongest predictor
of adopting PrEP.
“Intimacy Motivations and Pre-exposure Prophylaxis
(PrEP) Adoption Intentions Among HIV-Negative Men
Who Have Sex with Men (MSM) in Romantic
Relationships”
– Annals of Behavioral Medicine
August 2014

62. 62
Reclaim
pleasure

63. THOUGHTFUL
RESPONSIBLE
CAREFUL
AWARE
PRO-ACTIVE
DISCIPLINED
TAKING PREP IS

65. SAFER SEX
TAKING PREP IS

66. 66

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68. 68

69. Accessing PrEP
• Any medical provider who can
write a scrip can write one for
Truvada as PrEP
• Most HIV docs familiar with PrEP
• But….most HIV docs are not
necessarily seeing HIV-negative
patients
• Who is delivering PrEP services
in/around Collinsville?
69

70. 70

71. 71

72. Uninformed, misinformed providers

73. 73

74. Handy brochure
74
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr

75. 75
PrEPline, 855-448-7737
The CCC Pre-Exposure Prophylaxis Service
11 a.m. – 6 p.m. EST
http://nccc.ucsf.edu/2014/09/29/introducing-the-ccc-prepline/
PrEP Warm Line

76. • MyPrEPexperience.org
• Facebook group – PrEP Facts
• Facebook.com/ProjectRSP (Ready, Set, PrEP)
• PrEPWatch.org (advocacy)
• ProjectInform.org/prep
• Truvada.com (Gilead)
• WhatisPrEP.org (video)
Web resources on PrEP
76
These slides are available at
tinyurl.com/PrEPCollinsville

77. Groovy PrEP videos
77
WhatisPrEP.org
tinyurl.com/PrEPbyKLB

78. 78

79. 79

80. Drug cost

81. Service costs

82. Lab costs

83. Paying for PrEP— insurance
FDA approval of
Truvada enables
private ins to cover
Truvada
on
Medicaid
formulary
Ins companies
covering, so far
ADAP
does not
cover
PrEP
83

84. 84
the devil is in the details

85. 85
the devil is in the details

86. 86
May 1, 2015

87. 87
Our records indicate that you have received
Truvada in the past year with no other
antiretroviral agents which would suggest use for
preexposure prophylaxis. Prophylactic treatment
is not a covered benefit as listed in the Exclusion
Section of your member contract.
.
May 1, 2015

88. 88

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90. 90

91. 91

92. Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
92

93. Medication assistance
• Gilead will provide Truvada for PrEP at no cost for
individuals who qualify for the assistance program
Program
Element
Truvada PrEP Medication Assistance Program
Eligibility
Criteria
US resident, uninsured or no drug coverage, HIV-
negative, low income (500% FPL)
Drug
Fulfillment
Product dispensed by Covance Specialty
Pharmacy, labeled for individual patient use and
shipped to prescriber (30 day supply); no card or
voucher option
Recertification
Period
6 months, with 90 day status check
9393

94. Co-pay card program
Covers all Gilead HIV Products: Stribild, Complera,
Atripla, Truvada, Viread, Emtriva
• Assists patients with commercial insurance who
reside in the US, or US Territories
• Not valid for Rx that are eligible to be reimbursed
by any federal or state funded healthcare benefit
program
• Co-pay benefit provides assistance for co-pays
above $0
• Monthly benefit provided for 12 mos after
activation of card
– $400/month for all STRs (Stribild, Complera,
Atripla)
– $300/month for (Truvada, Viread, Emtriva)
• No maximum lifetime benefit but pts need to
recertify after 12 months

95. 95
• Accepting applications for new and renewal
patients. If application for assistance is
approved can begin receiving funding
immediately
• Maximum Award Level – $4,000 per year.
• Patients may apply for second grant during
eligibility period subject to funding
availability
Paying for PrEP – PAN Foundation

96. 96
USCA 2014

97. 97
• How can people pay for their PrEP
prescriptions?
• People taking PrEP need to be tested for HIV
_____ times every year.
• Why is this important?
• Name one barrier to PrEP access.

98. 98

99. 99

100. Baggage
100

101. 101

102. 102
“Party drug”
“Public health disaster”

103. 103

104. 104
Condom privilege

105. 105

106. 106
ARVs are toxic

107. “Although
pre-exposure
prophylaxis has a
great potential in reducing incidence, scale-up
might be inhibited by the same social or
structural barriers to care outcomes for black
MSM with HIV.”
107
Understanding the HIV disparities between black and white men who
have sex with men in the USA using the HIV care continuum: a modelling
study
The Lancet HIV, December 2014
doi:10.1016/S2352-3018(14)00011-3
Rosenberg, Millett, Sullivan, del Rio, Curran MD

108. 108

109. More focus, More energy and
More resources 109

110. 110

111. Messages to emphasize to clients
• PrEP is an option
– Not forever, but maybe for a “season”
– If you use condoms successfully, do you need PrEP?
• It’s not just a pill, it’s a program.
– Holistic health care
• Person must test HIV-negative to initiate
and continue PrEP.
• Adherence. Different for men and women.
• Ipergay – complexities, complications.
111

112. Tips for talking about PrEP
• Important you feel comfortable and
confident talking about PrEP.
• It’s okay to not have all of
the answers and to refer
your client to additional
resources and/or promise to
have that information next
time you see him/her.
112

113. Tips for talking about PrEP
• As a provider, you are viewed as a trusted source
of information.
• Remember any perspectives/opinions you have
about PrEP and/or people who use PrEP will
translate to your clients.
113

114. 114
• If someone doesn’t use ________
regularly, they may be a good fit for PrEP.
• PrEP is not just a pill, it’s a _________.
• Beyond a prescription, what is involved
with taking PrEP?

115. 115

116. 1000’s
NEW
HIV prevention
advocates

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125. 125

126. 126

127. Thank you!!
127

128. 128

129. CONTACT
Jim Pickett
jpickett@aidschicago.org
129
These slides are available at
tinyurl.com/PrEPCollinsville