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Welcome!
Springfield – May 14, 2015
These slides are available
at tinyurl.com/PrEPSpfld
What we will cover today
• Intros
• Overview ARV-based prevention
• Understanding PrEP
– What is PrEP?
– PrEP research
– H...
Ground rules
• We are all here to learn
• The only dumb questions are the
ones not asked
• Listen actively, respect others...
4
5
What is the first word or
words that come to your
mind when you think
about condoms?
6
What is the first word or
words that come to your
mind when you think about
needle exchange?
7
What is the first word or
words that come to your
mind when you think about
oral contraceptives?
8
What is the first word or
words that come to your
mind when you think
about PrEP?
9
10
• Sex without condoms does not automatically
= “unprotected sex.”
• Will no longer frame sex without condoms as
“unprotect...
12
What is ARV-based prevention?
• Strategies that use HIV treatment
drugs (antiretrovirals or “ARVs”) to
prevent HIV infecti...
14
15
Hold up, what is prophylaxis?
• Prophylaxis is simply the provision of
medications prior to germ or virus
exposure to prev...
17
18
• Truvada is approved for use as part of a comprehensive HIV
prevention strategy that includes other prevention methods,
s...
What is PreP?
• PrEP consists of taking the ARV drug Truvada to
prevent HIV. One tablet every day.
• Truvada is a combinat...
Released May 14, 2014
21
tinyurl.com/CDCprepguidelines (PDF)
tinyurl.com/CDCprepguidelineswebinar
(webinar audio/slides)
Released May 14, 2014
22
tinyurl.com/CDCprepguidelines (PDF)
tinyurl.com/CDCprepguidelineswebinar
(webinar audio/slides)
PrEP Clinical Practice Guideline
• For clinicians
– But incredibly useful for providers, educators, policy
folks, and advo...
24
Ken Like Barbie explains
PrEP
25
Ken Like Barbie recap
• PrEP involves HIV-neg person
taking ARVs to reduce risk of
infection before HIV exposure.
• PrEP p...
www.myprepexperience.org
28
29
PrEP is more than a prescription
PrEP is a
program
 Take Truvada tablet every day.
 Provider* visits every 3 mos
 HIV testing
 Tied to Rx renewal
 Hepatitis B testing
...
 It’s not just a pill, it’s a program
 Adherence (perfection not
required, esp for rectal)
 Take 5 – 7 days* before
eno...
• iPrEX Open Label
• 1,603 participants, 1,225 on PrEP
• Most from Peru/Ecuador, 18% USA
• 100% effectiveness associated
w...
33
You can miss a dose here and there and still have excellent protection.
34
Adherence is a much bigger deal for vaginal protection.
What PrEP does not do
• Truvada as PrEP does not
– Guarantee 100% protection from HIV (what
does?)
– Protect a person agai...
36
• True or False: PrEP must be started within 72 hours
of exposure to HIV.
• What is an example of “prophylaxis?”
• The ...
37
38
39
40
41
Science.
Science
• All completed trials done on tenofovir &
Truvada
• 7* studies = PrEP reduced risk of HIV infection
– i-PrEX (Tru...
Bumps in the road for women
• 2 trials = PrEP did not work
– FEM-PrEP (Truvada in women –
stopped 2011)
– VOICE (Truvada, ...
Key research findings
• Adherence!
• High adherence achieved 90%+
reduction in risk
• Truvada PrEP trials to date have
not...
Key research findings
• Some will experience a general “start-up
syndrome” w/Truvada that includes nausea,
diarrhea, abdom...
Side effects
• 1 in 10 will have nausea that
subsides quickly.
• 1 in 100 will experience bone
density loss, which plateau...
47
48
49
PrEP’s “protease moment”
50
PROUD – 86%
IPERGAY – 86%
PARTNERS DEMO – 96%
croiconference.org
51
There is an urgent need to mobilize clinical
efforts, service delivery, education,
implementation research, and policy ...
PROUD – London
52
Daily PrEP works in the real world.
Quite well! It was easily incorporated
into sexual health clinics. R...
53
Ipergay – France, Canada
Challenges our daily adherence
messaging. Only applicable to
gay men and rectums. And what
do ...
54
Partners Demo – Kenya, Uganda
PrEP and TasP are synergistic and can be
combined programmatically. Shared
responsibility...
55
56
• True or False: PrEP does not work for women.
• True or False: About 25% of people who take
PrEP will have nausea.
• T...
57
www.myprepexperience.org
Who might be a good fit for PrEP?
• Person indicates an interest in taking PrEP
• Person is in a “magnetic” relationship
–...
Who might be a good fit for PrEP?
• Sexual activity within high prevalence area or social
network, and/or:
– Doesn’t use m...
PrEPception [PrEP C]
61
Truvada as PrEP
Is the first non-
barrier HIV
prevention strategy
fully controlled by
the receptive
partner.
62
pleasure
intimacy
connection
emotion
lust
love
65
In this sample of men
who are in a
relationship with a
perceived HIV-negative
man, we found that
intimacy motivation wa...
66
Reclaim
pleasure
THOUGHTFUL
RESPONSIBLE
CAREFUL
AWARE
PRO-ACTIVE
DISCIPLINED
TAKING PREP IS
SAFER SEX
TAKING PREP IS
69
70
Accessing PrEP
• Any medical provider who can
write a scrip can write one for
Truvada as PrEP
• Most HIV docs familiar wit...
72
73
Uninformed, misinformed providers
75
Handy brochure
76
Designed to help individuals talk to
their doctors about PrEP
Before, during, after visit
Questions to...
77
PrEPline, 855-448-7737
The CCC Pre-Exposure Prophylaxis Service
11 a.m. – 6 p.m. EST
http://nccc.ucsf.edu/2014/09/29/in...
• MyPrEPexperience.org
• Facebook group – PrEP Facts
• Facebook.com/ProjectRSP (Ready, Set, PrEP)
• PrEPWatch.org (advocac...
Groovy PrEP videos
79
WhatisPrEP.org
tinyurl.com/PrEPbyKLB
80
81
Drug cost
Service costs
Lab costs
Paying for PrEP— insurance
FDA approval of
Truvada enables
private ins to cover
Truvada
on
Medicaid
formulary
Ins companie...
86
the devil is in the details
87
the devil is in the details
Paying for PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indi...
Medication assistance
• Gilead will provide Truvada for PrEP at no cost for
individuals who qualify for the assistance pro...
Co-pay card program
Covers all Gilead HIV Products: Stribild, Complera,
Atripla, Truvada, Viread, Emtriva
• Assists patien...
91
• Accepting applications for new and renewal
patients. If application for assistance is
approved can begin receiving fu...
92
USCA 2014
93
• How can people pay for their PrEP
prescriptions?
• People taking PrEP need to be tested for HIV
_____ times every yea...
94
95
Baggage
96
97
98
“Party drug”
“Public health disaster”
99
100
Condom privilege
101
102
ARVs are toxic
103
“Although
pre-exposure
prophylaxis has a
great potential in reducing incidence, scale-up
might be inhibited by the same so...
105
More focus, More energy and
More resources 106
107
Messages to emphasize to clients
• PrEP is an option
– Not forever, but maybe for a “season”
– If you use condoms successf...
Tips for talking about PrEP
• Important you feel comfortable and
confident talking about PrEP.
• It’s okay to not have all...
Tips for talking about PrEP
• As a provider, you are viewed as a trusted source
of information.
• Remember any perspective...
111
• If someone doesn’t use ________
regularly, they may be a good fit for PrEP.
• PrEP is not just a pill, it’s a ______...
112
1000’s
NEW
HIV prevention
advocates
118
119
120
121
122
123
124
Thank you!!
125
126
CONTACT
Jim Pickett
jpickett@aidschicago.org
127
These slides are available
at tinyurl.com/PrEPSpfld
PrEP Training - Springfield, IL - May 14, 2015
PrEP Training - Springfield, IL - May 14, 2015
PrEP Training - Springfield, IL - May 14, 2015
PrEP Training - Springfield, IL - May 14, 2015
PrEP Training - Springfield, IL - May 14, 2015
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PrEP Training - Springfield, IL - May 14, 2015

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This PrEP training was delivered by Jim Pickett to people working in HIV in Springfield, IL on May 14, 2015. This training was conducted in collaboration with AIDS Foundation of Chicago, Illinois Department of Public Health, and the Midwest AIDS Training and Education Center.

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PrEP Training - Springfield, IL - May 14, 2015

  1. 1. Welcome! Springfield – May 14, 2015 These slides are available at tinyurl.com/PrEPSpfld
  2. 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/PrEPSpfld 2
  3. 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. 4
  5. 5. 5
  6. 6. What is the first word or words that come to your mind when you think about condoms? 6
  7. 7. What is the first word or words that come to your mind when you think about needle exchange? 7
  8. 8. What is the first word or words that come to your mind when you think about oral contraceptives? 8
  9. 9. What is the first word or words that come to your mind when you think about PrEP? 9
  10. 10. 10
  11. 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. 12
  13. 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. 14
  15. 15. 15
  16. 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. 17
  18. 18. 18
  19. 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. 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. 21. Released May 14, 2014 21 tinyurl.com/CDCprepguidelines (PDF) tinyurl.com/CDCprepguidelineswebinar (webinar audio/slides)
  22. 22. Released May 14, 2014 22 tinyurl.com/CDCprepguidelines (PDF) tinyurl.com/CDCprepguidelineswebinar (webinar audio/slides)
  23. 23. 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 23
  24. 24. 24 Ken Like Barbie explains PrEP
  25. 25. 25
  26. 26. Ken Like Barbie recap • PrEP involves HIV-neg person taking ARVs to reduce risk of infection before HIV exposure. • PrEP prevents HIV from reproducing in a person’s body. • In current approved form, PrEP is taken in a single pill – Truvada –once a day, every day 26
  27. 27. www.myprepexperience.org
  28. 28. 28
  29. 29. 29 PrEP is more than a prescription PrEP is a program
  30. 30.  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 30 Taking PrEP…. what does it take? *These activities don’t all need to be done by a doctor in their office
  31. 31.  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 31 *This is a moving target, as we will see….. Taking PrEP…. what does it take?
  32. 32. • 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 32
  33. 33. 33 You can miss a dose here and there and still have excellent protection.
  34. 34. 34 Adherence is a much bigger deal for vaginal protection.
  35. 35. 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. 35
  36. 36. 36 • 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.
  37. 37. 37
  38. 38. 38
  39. 39. 39
  40. 40. 40
  41. 41. 41 Science.
  42. 42. 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 42
  43. 43. 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 43
  44. 44. 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 44
  45. 45. 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. 45
  46. 46. 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. 46
  47. 47. 47
  48. 48. 48
  49. 49. 49
  50. 50. PrEP’s “protease moment” 50 PROUD – 86% IPERGAY – 86% PARTNERS DEMO – 96% croiconference.org
  51. 51. 51 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
  52. 52. PROUD – London 52 Daily PrEP works in the real world. Quite well! It was easily incorporated into sexual health clinics. Results only applicable to gay men.
  53. 53. 53 Ipergay – France, Canada Challenges our daily adherence messaging. Only applicable to gay men and rectums. And what do we really know about men having infrequent sex?
  54. 54. 54 Partners Demo – Kenya, Uganda PrEP and TasP are synergistic and can be combined programmatically. Shared responsibility is important aspect. Works in resource challenged settings. Applicable to hetero women and men.
  55. 55. 55
  56. 56. 56 • 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.
  57. 57. 57
  58. 58. www.myprepexperience.org
  59. 59. 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 59
  60. 60. 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 60
  61. 61. PrEPception [PrEP C] 61
  62. 62. Truvada as PrEP Is the first non- barrier HIV prevention strategy fully controlled by the receptive partner. 62
  63. 63. pleasure intimacy connection emotion lust love
  64. 64. 65 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
  65. 65. 66 Reclaim pleasure
  66. 66. THOUGHTFUL RESPONSIBLE CAREFUL AWARE PRO-ACTIVE DISCIPLINED TAKING PREP IS
  67. 67. SAFER SEX TAKING PREP IS
  68. 68. 69
  69. 69. 70
  70. 70. 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 Lisle? 71
  71. 71. 72
  72. 72. 73
  73. 73. Uninformed, misinformed providers
  74. 74. 75
  75. 75. Handy brochure 76 Designed to help individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
  76. 76. 77 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
  77. 77. • 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 78 These slides are available at tinyurl.com/PrEPSpfld
  78. 78. Groovy PrEP videos 79 WhatisPrEP.org tinyurl.com/PrEPbyKLB
  79. 79. 80
  80. 80. 81
  81. 81. Drug cost
  82. 82. Service costs
  83. 83. Lab costs
  84. 84. 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 85
  85. 85. 86 the devil is in the details
  86. 86. 87 the devil is in the details
  87. 87. Paying for PrEP – Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 88
  88. 88. 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 8989
  89. 89. 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
  90. 90. 91 • 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
  91. 91. 92 USCA 2014
  92. 92. 93 • 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.
  93. 93. 94
  94. 94. 95
  95. 95. Baggage 96
  96. 96. 97
  97. 97. 98 “Party drug” “Public health disaster”
  98. 98. 99
  99. 99. 100 Condom privilege
  100. 100. 101
  101. 101. 102 ARVs are toxic
  102. 102. 103
  103. 103. “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.” 104 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
  104. 104. 105
  105. 105. More focus, More energy and More resources 106
  106. 106. 107
  107. 107. 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. 108
  108. 108. 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. 109
  109. 109. 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. 110
  110. 110. 111 • 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?
  111. 111. 112
  112. 112. 1000’s NEW HIV prevention advocates
  113. 113. 118
  114. 114. 119
  115. 115. 120
  116. 116. 121
  117. 117. 122
  118. 118. 123
  119. 119. 124
  120. 120. Thank you!! 125
  121. 121. 126
  122. 122. CONTACT Jim Pickett jpickett@aidschicago.org 127 These slides are available at tinyurl.com/PrEPSpfld

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