June 11 - UPDATED training on PrEP for HIV prevention from Chicago's Project Ready, Set, PrEP! (RSP!). Visit the Project RSP!'s My PrEP Experience blog at www.myprepexperience.blogspot.com for more informational resources, including the personal stories of individuals who have chosen to use PrEP.

1. Welcome Case Managers!
Project RSP! training – June 11, 2013
Please sit by someone you don’t know.
Make a new friend!

2. Our time together
• Intros
• What is Project RSP?
• What do YOU think about PrEP?
• Overview of ARV-based prevention
• Understanding PrEP
– What is PrEP?
– What is research telling us about PrEP?
– How do you use PrEP?
– How do you get PrEP?
• Talking to clients about PrEP
2

3. • 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 – first was May 22 at Center on Halsted.
Next will be in fall and on south side. Stay tuned.
• Give voice/provide facts: Platform for PrEP users to share
experiences, interested individuals to get info –
click myprepexperience.blogspot.com.
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4. Your primer on ARV prevention
4

5. 5

6. A growing prevention toolkit
• Improved ARV therapy
• Treatment for
opportunistic infections
• Basic care/nutrition
• Prevention for positives
• Education & rights-focused
behavior change
• Therapeutic vaccines
Prior to exposure Point of transmission Treatment
•Male and female
condoms and lube
•ARV treatment to
prevent vertical
transmission (PMTCT)
•Clean injecting
equipment
•Post-exposure
prophylaxis (PEP)
•Vaginal and rectal
microbicides
•Rights-focused
behavior change
•Voluntary counseling
and testing
•STI screening and
treatment
•Male medical
circumcision
•Preventive Vaccines
•Pre-exposure
prophylaxis (PrEP)
6

7. Don’t we
have enough
to prevent
HIV already?
7

8. 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)
8

9. Testing drugs for prevention
• Phase I – small number of
ppl, short duration, safety
and acceptability
• Phase II – more
people, longer, safety and
acceptability
• Phase IIb, III – LARGE
trials, lots of people, multi-
year, does this thing work?
9

10. • Provide ARV treatment to HIV+
people who accept it voluntarily
– Improve treatment access for
HIV+ , improve health
coutcomes
– Offer treatment earlier in the
course of the disease
– Reduce individual viral
load, reduce community viral
load
– Reduction in onward HIV
transmissions
Testing, linkage to care, plus treatment – TLC+
10

11. What research says about TLC+
HPTN 052 trial
demonstrated 96%
reduction in sexual
transmission of HIV
between (mostly)
heterosexual
serodiscordant
couples.
www.ncbi.nlm.nih.gov/pmc/articles/PMC3486734/
Limitation – how applicable for
gay men or IDU?
11

12. ARV-based microbicides
• Substances in development that would
reduce sexual transmission of HIV ( they
don’t exist outside of clinical trials)
• Applied rectally or vaginally
– Gels, vaginal rings
• Future formulations could include
films, rectal enemas
• Microbicides don’t have to be ARV-
based, though most products
currently under investigation are
• Other compounds have been tested;
scientists are exploring non-ARV
formulations
12

13. Microbicides, the research says:
• CAPRISA 004 – reported 2010, first to show
efficacy
• 1% tenofovir reduced HIV in women by
39%, in South Africa
• Tested product efficacy, before and after sex
• VOICE – reported 2013, no efficacy, low
adherence
– African women in Uganda, S.
Africa, Zimbabwe
– Daily use 1% tenofovir gel, tenofovir
tablet, Truvada tablet
• FACTS – confirmatory trial
underway, CAPRISA protocol, S. Africa
13

14. Rectal microbicide trial
• MTN 017– first Phase II ever, safety and
acceptability (not efficacy)
– Modified version of tenofovir gel (booty
friendly) and Truvada tablet
– Open-label, cross-over design
• Daily gel, gel w/sex, daily Truvada (8wks ea)
– 186 gay men, transgender women
– US, Peru, South Africa, Thailand
• US = Pittsburgh, Boston, San
Francisco, Puerto Rico
– Starting later this year (US sites in
June?) 14

15. 15
YouTube
http://tinyurl.com/RectalRevEnglish
http://tinyurl.com/RectalRevSpanish

16. Post-exposure prophylaxis (PEP)
Provide 2 or 3-drug regimen of ARVs after HIV
exposure to stop infection
• Typically offered to health care
providers exposed to HIV via needle
stick
• nPEP – offered for non-occupational
exposure, sexual exposure, injection
drug use exposure
• Must be taken within 72 hours of
initial exposure, small window
• ARVs must be taken for 28 days
16

17. Accessing PEP
• Any doctor is able to prescribe
• HIV docs the best to manage PEP, most likely to
prescribe
• Available at no cost through CORE Center’s walk-in
clinic M-F 8:30am-3:30pm, 312.572.4700. Also
available at HBHC.
• Person must come in weekly for meds and monitoring
• ERs can/do start PEP, but only provide 3 days of meds
– Necessary that person is engaged with provider for
duration of regimen for monitoring and HIV testing
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18. 18

19. What is
PrEP?*
*pre-exposure prophylaxis
19

20. 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?
20

21. So, what is PreP?
• PrEP involves an HIV-negative person taking
ARVs to reduce risk of infection BEFORE HIV
exposure. It prevents HIV from reproducing in a
person’s body.
• In current approved formulation, PrEP is taken
in a single pill once a day, every day (Truvada).
.
21

22. So, what is PreP?
• Need to take 7 days of Truvada before enough
drug is “on board” for protection. Then daily.
• Truvada is currently the only drug (actually a
combination of 2 drugs) approved by the FDA
for PrEP.
• Truvada is a combination of tenofovir disoproxil
fumarate (aka tenofovir or TDF) and
emtricitabine.
22

23. 23
“Taking the Truvada does not
make me ‘reckless’ in my decision
to have unprotected sex, it makes
me feel supported by a
community of doctors and
advocates who recognize the
nuances of my situation, and are
doing all they can to
help me stay negative.”
– Woman with HIV+ partner who started
PrEP because they wanted to have a child

24. PrEP Truvada
• PrEP will not always be only Truvada
• Researchers are currently exploring
other ARV drugs that could also be used
for PrEP
• For instance, the ARV drug Maravoric
(brand name Selzentry) is currently in
clinical trials as a potential PrEP drug
• Scientists are also researching the
possibility of intermittent use of PrEP
– May not have to be taken daily
– PrEP could be delivered via injection, and
could be longterm
24

25. Dateline: July 16, 2012
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 HIV-infected partners. - FDA
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm
25

26. • 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
• Medication guide
• Community education
• Provider training
• Implementation
Dateline: July 16, 2012
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27. 27

28. How did we get here? (Research!)
• All completed trials done on tenofovir & Truvada
• 3 trials = PrEP reduced risk of HIV infection
– i-PrEX (Truvada in gay men and trans women)
44% reduction overall (reported 2010)
Efficacy at 90% + with good adherence
– Partners PrEP (Truvada and tenofovir in het couples)
75% reduction Truvada (reported 2011)
– TDF2 (Truvada heterosexual men & women)
63% reduction overall (reported 2011)
28

29. How did we get here? (Research!)
• 2 trials = PrEP did not work
– FEM-PrEP (Truvada in women – stopped 2011)
– VOICE (Truvada, tenofovir – reported 2013)
• Both had very low adherence – though
self-reports were high)
• Low/undetected drug levels
• SOON - Bangkok Tenofovir Study (BTS)
– CDC study of injection drug users (2,400 +)
• Median age 31, 80% male
– Daily tenofovir (75% chose directly-observed therapy)
– BTS results being reported in the next couple
of months
29

30. Home-grown Chicago PrEP research
• Project PrEPare
– Feasibility and acceptability trial of PrEP
– Enrolled 68 young gay/MSM
• ages 18-22
• 53% African-American, 40% Latino
– Randomized to Truvada, placebo, or
no-pill arm
– On study for 6 months
• very high retention (98.5%)
• self-reported adherence averaged 62% (range 43% - 83%);
detectable drug levels ranged from 63% - 20%
• unprotected sexual activity
decreased across all study arms
30

31. Home-grown Chicago PrEP research
• iPrEx OLE (Open Label Extension)
– First – what does “Open Label” mean?
– iPrEx randomized trial was diverse
worldwide, but not in the US
– Missing representation from
communities most affected
domestically
– Asked Chicago’s Project PrEPare
participants if they would like to join
iPrEx; 46 of 68 agreed
– Data soon!
31

32. Home-grown Chicago PrEP research
• Project PrEPare II
– Open label demonstration project AND
safety study of PrEP in young gay/MSM
ages 15-22
– Actively enrolling 300 youth in 13 US
sites, including Chicago
– Research questions:
1. How safe is PrEP use is among HIV-
uninfected young gay/MSM?
32

33. Home-grown Chicago PrEP research
• Project PrEPare II
2. What is acceptability, patterns of use, rates of
adherence and measured levels of drug exposure
when YMSM are provided PrEP and info re: safety
and efficacy of PrEP?
3. When YMSM are provided behavioral intervention
as well as PrEP and info re: the safety and efficacy of
PrEP, what are the patterns of risk?
4. Is implementing an efficacious group level or
brief individual level sexual risk reduction
intervention prior to provision of PrEP
acceptable and feasible?
33

34. Home-grown Chicago PrEP research
• Project PrEPare II
5. Is implementing a text messaging adherence
reminder intervention for youth whose adherence is
less than 80% acceptable, feasible?
6 . Are there demographic and/or behavioral
differences between youth who stay on PrEP
compared to those who discontinue?
7. Are there demographic and/or behavioral
differences between youth who interested in
participating in a PrEP study versus those who are
not?
34

35. Key research findings/Truvada
• Adherence! Adherence! Adherence!
• High adherence achieved 90%+ reduction in risk
• There appears to be a general “start-up
syndrome” w/Truvada that includes
nausea, diarrhea, abdominal pain and
headaches.
• Mild nausea most common (about 6% or less) and
resolved in 4 to 6 weeks
35

36. Key research findings/Truvada
• 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
• Very little drug resistance has been seen for
those that seroconvert, mostly among those
with unidentified HIV infection when they
started the study
36

37. 37
The research continues

38. The research continues38

39. 39

40. 40

41. 41
Relative efficacy of TLC+, PrEP, other strategies
HPTN 052 (ARV treatment as prevention)1
Medical male circumcision1
STD treatment1
Partners PrEP (FTC/TDF) in discordant couples1
Subjects with detectable drug levels3
TDF2 (FTC/TDF) in men & women1
iPrEx (FTC/TDF) in MSM1
Subjects with detectable drug levels2
CAPRISA 004 (1% TFV vaginal gel) in
women1
FEM-PrEP (FTC/TDF) in women6, VOICE (FTC/TDF, TDF, TFV vaginal gel) in women7,
HIV vaccine (RV144)1
96%
75%
90%
62%
54%
94%
42%
39%
0 10 20 30 40 50 60 70 80 90 100
Efficacy (%)
Study
Reduction in HIV
Transmission
Not Significant
Condoms in heterosexuals4
Condoms in US MSM5
80%
70%
44%
1. Adapted from Abdool Karim S and QA. Lancet 2011;S0140-6736:1136-7
2. Amico R, et al. IAC 2012. Washington DC. #TUPE310
3. Baeten J, et al. NEJM 2012;367:399-410
4. Weller S, et al. Cochrane Database Syst Rev 2002:CD003255
5. Smith DK, et al. CROI 2013; Atlanta, GA. Oral #32
6. van Damme L, et al. NEJM 2012;367:411-422
7. Marrazzo JM, et al. CROI 2013; Atlanta, GA. Oral #26LB

42. 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, herpes, or gonorrhoea
– Prevent pregnancy
– Cure HIV
– Function, on its own, as a treatment regimen for someone
already living with HIV.
– Why is Truvada, on it’s own, not considered adequate for
treatment?
42

43. Why PrEP does not work for treatment
• People with HIV require taking
at least three ARVs together
• The two drugs in Truvada are
not sufficient to control the
virus
• A HIV+ person taking Truvada
on its own runs the risk of
developing resistance to the
drug, which will limit drugs
s/he can take for treatment
43

44. CDC – Clinical Practice Guidelines
• For clinicians – not “all purpose”
• Being drafted – expect to publish second half 2013
– Now – peer review, public engagement draft guidelines
– Next step to HHS for approval – then publish
• 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
44

45. Taking PrEP – what does it take?
• Adherence! Taking the pill every
day.
• Take 7 days before enough drug
is “on board” to provide
protection
– Still must take Truvada every day
• Honest, open, and ongoing
discussions with a medical
provider about sexual activity
and HIV risk
• HIV antibody test – before first
prescription, and then every 3
months. Rx renewal tied to
renewed HIV-negative test.
45

46. Taking PrEP – what does it take?
• Hepatitis B testing
• Kidney function testing
• Bone density testing
• STI screening (and
treatment if necessary)
• Pregnancy testing
• Doctor visits approx. every
3 mos to conduct all the
above
46

47. Why would someone want to take PrEP?
47

48. 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
–Serodiscordant
48

49. 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
49

50. What about…
50

53. Is PrEP cost-effective?
• Modeling studies show the following factors to impact the cost-
effectiveness of PrEP:1-13
– Medication cost and availability of insurance coverage
– Targeted use among men and women at high risk
– Efficacy
– Changes in risk behavior
• Several analyses show PrEP to be cost-effective, particularly
when targeted to individuals at high risk of HIV acquisition2-5
1. Smith D. National Prevention Conference 2011. Atlanta. #E04
2. Juusola JL, et al. Ann Intern Med 2012;156:541-550
3. Desai K, et al. AIDS 2008;22:1829-1839
4. Walensky R, et al. CID 2012;epub April 3
5. Anderson J, et al. EACS 2009. Cologne.
6. Buchbunder S, et al. CROI 2012. Seattle. #1066
7. Grant R, et al. IAC 2006. Toronto. #THLB0102
8. Supervie V, et al. PNAS 2010;107:12381–12386
9. Paltiel DA, et al. Clin Infect Diseases 2009;48:806-15
10. Hill A, et al. CROI 2006. Denver. #Y-127
11. Hallett T, et al. CROI 2011. Boston. #99LB
12. Pretorius C, et al. PLoS ONE 2010;5:e13646
13. Abbas U, et al. PLoS ONE 2007;2:e875
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54. 54

55. Accessing PrEP
• Any doctor who can write a
prescription can write one for
Truvada as PrEP
• Most HIV docs are familiar
with PrEP
• CORE, John Stroger
Hospital, HBHC, ACCESS Grand
Blvd, TPAN (for referrals) and
more
55

56. Accessing PrEP – Howard Brown
• Howard Brown Health Center –
primary care
services, including PrEP access
• HBHC providers experienced
with PrEP, existing patient
population accessing PrEP
• Dedicated adherence
counselor, like case manager
for PrEP patients
56
www.howardbrown.org

57. Accessing PrEP – Howard Brown
• Assists w/accessing medication
assistance, copay programs
• Walgreens onsite – reduce anxiety over
filling prescription some might think
“embarrassing”
• Pediatrician on-staff for 18 to 25
• Trans Health Advocates, Adherence
Counselors support transgender
patients accessing hormones, PrEP
57
www.howardbrown.org

58. PrEP ed for your doc
• Bring along a fact
sheet if you think
your doctor may
need some PrEP ed
58
www.myprepexperience.blogspot.com

59. Accessing 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
59

60. Accessing PrEP – Gilead
1. Visit
www.truvada.com
2. Click on the link to
access information
about Truvada for a
PrEP indication
60

61. 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 (200% 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
6161*Still need to consider costs of medical care

62. Medication assistance form
62

63. www.Truvada.com – Providers
• Allows providers to:
– Access to free male and female condoms
– Obtain lab forms for free HIV-1 and HBV testing provided
that HCP has completed the online training and registered
– Gilead Medical Affairs Contact Number for subsidized
resistance testing for individuals who seroconvert
– Receive similar training on the indication to the REMS
website
– Access to Gilead’s Medication Assistance Program for
download
– Access to all REMS materials for download
63

64. www.Truvada.com – HIV neg people
• Allows HIV-1 uninfected individuals to:
– Common questions, safety information
– Access to free male and female condoms
– Opt-in for reminder service regarding regular testing for HIV-1
and other STDs (coming soon)
64

65. HIV franchise 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
• Maximum benefits: Stribild, Complera Atripla
– Monthly $400
– Annual $4,800
• Maximum benefits Truvada, Viread, Emtriva
– Monthly $200
– Annual $2,400
• Benefit automatically renews after 12 mos without need
to re-enroll
• Service Provider: McKesson
• 877.505.6986

66. Helping your clients
understand PrEP
66

67. Messages to emphasize to clients
• PrEP is an OPTION
– Not forever, but maybe for a “season”
• Person must test HIV-negative to initiate
and continue PrEP.
• Daily adherence to PrEP is essential to
reduce person’s risk of HIV – and can be
very effective.
• Taking PrEP does not guarantee 100%
protection from HIV (but does anything?)
67

68. Messages to emphasize to clients
• Daily use of Truvada as PrEP cannot and
does not function as HIV treatment. Why
is Truvada on its own not adequate for
treatment?
• PrEP user must be engaged with regular
health care for prescription, to ensure
remaining negative, staying
adherent, kidney health, etc.
• PrEP doesn’t make male or female
condoms obsolete!
68

69. 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.
69
www.myprepexperience.blogspot.com

70. Tips for talking about PrEP
• As a provider of prevention services, 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.
70

71. Adherence, Adherence, Adherence
• Strategies for adherence include:
– Take pill each day at same time
– Place pill bottle in visible place, same
place
– Set cell phone alarms
– What are some other strategies?
– What should you do if you forget a
dose?
71

72. • My PrEP Experience www.myprepexperience.blogspot.com
(training slides)
• RSP on FB https://www.facebook.com/ProjectRSP
• Project PrEPare www.projectprepare.net
• Howard Brown www.howardbrown.org
• Truvada as PrEP www.Truvada.com
• Project Inform www.projectinform.org/prep
• AVAC www.avac.org
– Thanks to AVAC for several slides.
Web resources on PrEP
72

73. Onward RSP!
• What will you do with the info you learned today?
• How will you educate your clients about PrEP?
– Your colleagues? Your friends?
• Future training?
73

74. Thank you!!
74

75. Please stay in touch
• Sybil Hosek
sybilhosek@gmail.com
• Jessica Terlikowski
jterlikowski@aidschicago.org
• Michael “Mikey” Landreth
mlandreth91@gmail.com
• Mark Bernstein
mark.bernstein@gilead.com
• Keven Cates
kevenc@howardbrown.org
• Jim Pickett
jpickett@aidschicago.org
• Project RSP!
myprepexperience@gmail.com
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