This document provides an overview and slides from a presentation on pre-exposure prophylaxis (PrEP) given by the Chicago Department of Public Health. The presentation covers introductory topics, an overview of antiretroviral-based prevention including PrEP, details on how PrEP works and is administered, updates on clinical trials and guidelines, access and insurance coverage for PrEP, and case studies. Resources for providers and patients are also listed to provide education and support around PrEP.

1. Chicago Department of Public Health Besly Court 7.31.15
Download these slides: tinyurl.com/PrEPJuly2015

2. • Intros
• Pre and post test, evaluation
• Overview ARV-based prevention
• Understanding PrEP
– What is PrEP?
– Updates from CROI 2015 and IAS 2015
– How PrEP is taken
– Access to PrEP
– PrEP case studies
– And more…
These slides available at:
tinyurl.com/PrEPJuly2015

3. 3

4. Ground rules
• We are all somewhere on
the learning curve
• Participate to the fullest of
our abilities
• The only dumb questions
are the ones not asked
4

5. 5
Who’s
in the
room?

6. 6
Logistics

7. 7

8. 8

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

10. What is the first word or
words that come to your
mind when you think about
needle exchange?
10

11. What is the first word or
words that come to your
mind when you think about
oral contraceptives?
11

12. What is the first word or
words that come to your
mind when you think
about PrEP?
12

13. 13

14. 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)
14

15. 15

16. 16

17. 17

18. First, 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?
18

19. What is PreP?
• PrEP consists of taking the ARV drug Truvada to
prevent HIV*
• 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.
19

20. 20
#HIV2020
AIDS.gov/2020

21. 21

22. 22
#HIV2020
AIDS.gov/2020

23. 23
Approved Truvada for PrEP
July 16, 2012

24. 24
tinyurl.com/CDCprepguidelines
tinyurl.com/CDCprepguidelineswebinar
May 14, 2014

25. PrEP Clinical Practice Guidelines
• 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
25tinyurl.com/CDCprepguidelines

26. 26

27. 27
WhatIsPrEP.org

28. 28

29. 29
• True or False: PrEP must be started within 72 hours
of exposure to HIV.
• The FDA approved Truvada as PrEP in what year?
• True or False: People on PrEP should be tested for
HIV every month.
• True or False: It takes longer for PrEP to achieve
protection in the vagina compared to the rectum.

30. www.myprepexperience.org

31. 31

32. PrEP works – the science
• 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)
• TDF/FTC combination and Tenofovir alone comparably
efficacious
– TDF2 (Truvada heterosexual men & women)
– Bangkok Tenofovir Study (injection drug users)
32

33. 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 33

34. PrEP works – key 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
34

35. • 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.
35
PrEP works – key findings

36. PrEP 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.
36

37. 37

38. I don't have any regrets, but what I do
have is peace of mind. And that is exactly
what I was looking for with this
medication.
I feel great, I feel empowered, and I feel in
control of my sexual health and my health
in general.
Personal story on MyPrEPexperience.org

39. 39

40. 40

41. 41

42. PrEP’s “protease moment”
croiconference.org
PROUD – 86%
IPERGAY – 86%
www.aidsmap.com/croi2015

43. 43
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

44. 44

45. 45
PrEP is more than a prescription
PrEP is a
program

46. 46

47.  Take Truvada every day
 Provider* visits every 3 mos
 HIV testing
 Tied to Rx renewal
 Hepatitis B testing
 Kidney function testing
 STI screening
 Pregnancy testing
47
*These activities don’t
all need to be done by a
doctor in their office
Taking PrEP…
What does it take?

48.  Adherence counselling
 Perfection not required, especially for
rectal exposure
 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
 Honest, open discussions about sex,
sexual health
 PreP is “seasonal.”
 PrEP is not forever.
48
Taking PrEP…
What does it take?

49. 49

50. • 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
50

51. 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.
51

52. 52

53. 53
• 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.
• True or False: Obama says “PrEP sucks.”

54. 54

55. 55

56. www.myprepexperience.org

57. Who might be a good fit for PrEP?
•Person indicates an
interest in taking PrEP
57

58. Who might be a good fit for PrEP?
• Person is in a “magnetic” relationship
–HIV-negative and has HIV+ partner who is
not on meds, or not undetectable, or other
mitigating circumstances
58

59. Who might be a good fit for PrEP?
• Male, female, transgender person engaging in 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 59

60. PrEP-C

61. pleasure
intimacy
connection
emotion
lust
love

62. 62
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

63. 63
Reclaim
pleasure

64. 64

65. PrEP Linkage
and Retention – Year 1*
• First Visit
– HIV Ab/ag, acute infection screen, hepatitis B, Creatinine,
U/A with micro, STIs, other as clinically relevant
• Second Visit (1-2 weeks later)**
– PrEP prescription
• Third Visit (1 month later)
– Evaluate adherence, ongoing risk and side effects
• Fourth Visit (3 months later)
– HIV Ab/Ag
• Fifth Visit (3 months later)
– HIV Ab/Ag
• Sixth Visit (3 months later)
– HIV Ab/Ag, Creatinine 65
*Focused exam, clinical work-up, STIs,
adherence, partner elicitation, risk-
reduction, condom use (if appropriate),
hormone therapy, anal cancer screening
**Optional; prescription can be given
during first visit

66. Case 1
• 20 y/o YBMSM “Billy” with HIV for one year
presents with his HIV negative wife
• Can we have kids doc?
• Wife is interested, but states that they don’t
have money for sperm washing
• Billy’s viral load is undetectable
• They use condoms intermittently

67. Case 2
• 20 y/o YBMSM Maurice comes in for HIV testing, has a new partner.
• Discussed PrEP, client not interested because of concerns about side
effects and just taking a medication in general, “that we don’t know
much about”
• Had sex with a new partner and heard from a friend that the individual
was HIV positive and did not use condom. Now asking for PEP
• Follows up for HIV testing, completed 4 weeks of PEP
• PrEP shared decision making discussion ensues
• Client is now on PrEP and first in implementation project
67

68. Case 3
18 y/o young Black client KJ comes in for hormones.
Transitioning to transwoman. Has receptive sex only with
male partners - unknown HIV status
PrEP discussion ensues. Client is not interested. Discuss
getting on hormones first and re-engaging about PrEP later
Comes in 3 months later, visibly more female.
Mentions has started getting more attention
on way home from work.
PrEP discussion re-ensues,
this time “started” PrEP
Missed first PrEP follow-up appointment 68

69. Case 4
• 26 y/o BMSM, Fabrice comes in with his
partner Chris who I see for HIV
• Chris and Fabrice together for 6 years
• Monogamous relationship
• Chris has had VL <50 for 4 years
• PrEP for Fabrice?
69

70. Case 4 continued
• Start Fabrice on PrEP, doing well has been on
it a year. Creatinine just above normal limit.
• Chris still undetectable
• Continue PrEP?
70

71. Case 4 continued
• Fabrice comes in for 12 month follow-up
• I am considering stopping PrEP
• Doc, can I get viagra?
71

72. Case 4 Continued
• Threesome
• No STIs
• What now?
72

73. 73

74. 74

75. 75

76. Accessing PrEP in Chicago
• Any medical provider who can
write a scrip can write one for
Truvada as PrEP
• tinyurl.com/ChicagoPrEPproviders
76

77. 77

78. 78

79. Uninformed, misinformed providers

80. 80

81. Handy brochure
81
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to ask
Web resources
tinyurl.com/talkPrEPtoDr

82. 82
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

83. • MyPrEPexperience.org
• Chicago PrEP Line - (872) 215-1905
hivelimination.uchicago.edu/projects/programs/prep_hotline_linkage_to_care
• Chicago PrEP provider listing
tinyurl.com/ChicagoPrEPproviders
• Facebook group – PrEP Facts
• Facebook.com/ProjectRSP
• PrEPWatch.org
• ProjectInform.org/prep
• Truvada.com (Gilead)
• WhatisPrEP.org (video)
Web resources on PrEP
83

84. www.facebook.com/groups/PrEPFacts

85. 85

86. 86
PositivelyAware.com
Printed copies available
email distribution@tpan.com

87. 87

88. 88

89. FDA approval of
Truvada enables
private ins to cover
Medicaid
formulary
Ins companies
covering, so far
ADAP does
not cover
PrEP
89

90.  Drug costs
 Visit, service costs
 Lab costs

91. 91
the devil is in the details
 Premiums
 Deductibles
 Cost-sharing
 Drug formularies
 Drug tiers
 Shifting benefits
 Not easy to figure
all this out!

92. 92
http://ow.ly/PTYCK

93. Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
93

94. Medication Assistance Program
• 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
9494

95. 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

96. 96
• www.panfoundation.org/hiv-treatment-and-prevention
• 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

97. 97

98. 98
USCA 2014

99. 99
• How can people pay for their PrEP
prescriptions?
• People taking PrEP need to be tested for HIV
_____ times every year.
• Why is this important?
• Who might be a good fit for PrEP?

100. 100

101. 101

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

103. 103PrEP DENIALISM

104. 104

105. 105
Condom privilege

106. 106
Condom privilege

107. 107
“But ARVs are toxic…”

108. 108

109. 109
www.ias2015.org
www.aidsmap.com/ias2015

110. 110
www.ias2015.org
www.aidsmap.com/ias2015

111. 111
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Sybil Hosek – CORE

112. www.aidsmap.com/ias2015
• ATN 110
• 12 U.S. cities, including Chicago
• 200 gay (77.8%) and bi (13.7%) men, 18 – 22 (mean 20.18)
• 53% Black; 17% Latino; 21% White; 2% Asian/PI;
7% other/mixed
• Four HIV infections, not taking PrEP
• Adherence good overall, better among those not using condoms
• Black gay men’s adherence was not as high as others
• CALL TO ACTION – need better understanding of historical,
societal, behavioral, and attitudinal barriers to PrEP access
and adherence among those w/highest impact – young black
gay men
• Adherence among all groups decreased as
study visits moved from monthly to quarterly
Dr. Sybil Hosek – CORE

113. 113
www.ias2015.org
www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH

114. 114
• PrEP Demo Project
• SF, DC and Miami
• 557 particps; median age 35
• 48% White; 35% Latino;
7% Black; 10% other
• 98% male; 1.3% transgender
• Overall high adherence –
higher adherence among ppl not using condoms
• Two infections, not taking PrEP
• Two main findings: “1) we must do active, engaging outreach to
African American MSM and trans women about PrEP; we will
not reach sufficient numbers through passive attempts to scale-
up PrEP, and 2) adherence was lower among African Americans,
so additional programs to understand reasons for poorer
adherence and to develop support mechanisms are needed for
populations most heavily impacted by HIV. Current tools are not
enough.” www.aidsmap.com/ias2015
Dr. Al Liu – SF DPH

115. 115
www.ias2015.org
[Quote from female sex worker participating in treatment
and PrEP demo project in Johannesburg, South Africa.]

116. 116

117. 117

118. 118

119. Tips for talking about PrEP
• You need not be an expert.
• Though, it’s important you feel comfortable talking
about PrEP.
• It’s okay to not have all of the answers. Refer your
client to additional resources and/or promise to follow
up.
119

120. 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.
120

121. Messages to emphasize to clients
• PrEP is an accessible option
– Not forever, but maybe for a “season”
– If you use condoms successfully, do you need PrEP?
• It’s not just a daily pill, it’s a program.
– Holistic health care (w/regular HIV and STD
testing)
• Person must test HIV-negative to initiate
and continue PrEP.
• Adherence. Different for men and women.
121

122. THOUGHTFUL
RESPONSIBLE
CAREFUL
122
AWARE
PRO-ACTIVE
DISCIPLINED
TAKING PREP IS

123. SAFER SEX
TAKING PREP IS
123

124. PrEP elevator speech
• You get in the elevator at the 95th floor with
someone who has just asked you about PrEP.
You have until ground level to explain it to them.
»What do
you say?
• Take a few moments to think
• Volunteers to share?
124

125. 125

126. 126
"Interventions do not just work automatically,
they have to be made to work – and people have
responsibility for making them work. And herein
lies the rub – for the question we should ask is
not “what works?” but “what are we committed
to making work?”
– Dr. Flora Cornish
London School of Economics

127. 127
Open access
http://www.jiasociety.org/index.php/jias/issue/view/1474

128. 128
tinyurl.com/BlackPrEPsummit

129. 129

130. 130

131. 131

132. Thank you!!
132

133. 133

134. CONTACT
Jim Pickett
jpickett@aidschicago.org
John Schneider
jschnei1@medicine.bsd.uchicago.edu
134
#yayPrEP
Download these slides:
tinyurl.com/PrEPJuly2015