Embed Size (px)
Citation preview
Welcome!
CDPH – November 17, 2014
Our time together
• Intros
• What is Project RSP?
• Overview ARV-based prevention
• Understanding PrEP
– What is PrEP?
– PrEP research
– How PrEP is taken
– Access to PrEP
– Talking to clients about PrEP
2
Ground rules
• We are all here to learn, and to gain a deeper understanding.
• We know that the only dumb questions are the ones not asked.
• We will listen actively, and respect others when they are talking.
• We will participate to the fullest of our abilities.
3
4
5
• Trainings: Help Chicago providers, educators, and others working directly with our community to understand PrEP and what it means for us and HIV prevention.
• Give voice/provide facts: Platform for PrEP users to share experiences, interested individuals to get info – click myprepexperience.org
6
Unrestricted educational grants from Gilead in 2013, 2014
And look for us on FB too
7
Unrestricted educational grant from
Janssen Therapeutics
2014
Exploring the PipelineLubes, Rings, Films, Fibers, and Shots 4 HIV Prevention• Webinar• Thursday, December 11, 2014• 2:00-3:30pm
• We are NOT “pushing” PrEP
• We are NOT telling anyone to stop using condoms or other forms of protection
• We are not pitting one intervention over another
• We are pushing education
• Knowledge is power
• Ignorance is not strength8
9
11
Quick survey, pre-test
• Help assess what you think and know now, pre-training
• Post-test after training
• Note changes in knowledge, perceptions
When can I stop making wild guesses and start making educated guesses?
12
13
What is the first word or words that come to your mind when you think about condoms?
14
What is the first word or words that come to your mind when you think about
needle exchange?
15
What is the first word or words that come to your mind when you think about
oral contraceptives?
16
What is the first word or words that come to your mind when you think about PrEP?
17
Prevention Paradigm 2013 and beyondDifferent Strokes for Different Folks
Method Contraception HIV Prevention
Behavior ✓ ✓
Barrier Methods ✓ ✓
Gels ✓
Rings ✓
Oral pill ✓ ✓
Injectables ✓
Implants ✓
Surgical procedures ✓ ✓
Treatment ✓
A growing prevention toolkit
• Treating POZ individuals has prevention benefits
• 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& testing•STI screening & treatment•Male medical circumcision•Pre-exposure prophylaxis (PrEP)•Preventive Vaccines*
19
20
We interrupt
this broadcast
21
• 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)
• Institutional implementation has started, but will require some time to fully take effect– However, we can implement/re-frame NOW in our
prevention education efforts
22
Protection w/out condoms
23
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)
24
25
Post-exposure prophylaxis (PEP)
Provide 2 or 3 ARV drug regimen after HIV exposure to stop infection
• Occupational – offered to health care providers exposed to HIV, e.g. via needle stick
• nPEP – offered for non-occupational exposure, meaning sexual exposure, injection drug use exposure
• Must be taken within 72 hours of initial exposure
• NY State guidelines – 36 hours
• ARVs must be taken for 28 days 26
Accessing PEP
• Baseline HIV testing
• Any doctor is able to prescribe
– 2 drug regimen – Truvada (tenofovir + emtricitabine)
– 3 drug regimen – Truvada and Isentress(raltegravir)
– In most cases with non-occupational exposure, likely to prescribe 3 drugs
• ERs can/do start PEP, but typically only provide 3 days of meds, a “starter pack”
• HIV docs the best to manage PEP, most likely to prescribe
27
Accessing PEP
• Person must be engaged with provider for duration of 28-day regimen for monitoring and HIV testing
• HIV test at 4-6 wks, 3 mos, 6 mos
• Can cost $1,000 + for the 28-day regimen
– Insurance can cover
– Medicaid coverage inconsistent
– Pharma access programs can help
• NASTAD fact sheet
28
29
“Meta-analysis: only half the people who start PEP complete the course.”
PEP challenges
30
“Of those who completed the course, 31.1% failed to attend a follow-up visit that would include HIV testing.”
PEP challenges
31
32
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?
33
34
We interrupt
this broadcast
- One more time
Released May 14, 2014
35
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 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
36
What is PreP?
• Truvada is a combination of tenofovir disoproxilfumarate (aka tenofovir or TDF) and
emtricitabine.
• Need to take 7 days of Truvada before enough drug is “on board” for protection in the rectum.
Three weeks for vaginal protection.
• Truvada is currently the only drug approved by the FDA for PrEP.
37
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 once a day, every day (Truvada).
39
www.myprepexperience.org
41
• True or False: PEP must be started within 72 hours of exposure to HIV.
• Where can you get started on PEP if your doctor’s office is closed?
• What is an example of “prophylaxis?”
• True or False: PrEP is a pill you take three days before you want to have sex in order to be
protected from HIV.
42
• 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
43
44
46
A: Research
• 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)
47
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
48
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
49
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.
50
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.
51
52
53
54
We interrupt
this broadcast
- One last time
NEW research
• iPrEX Open Label
• 1,603 participants, 1,225 on PrEP
• Most from Peru/Ecuador, 18% USA
• 100% effectiveness associated with 4+ doses a week
• 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 55
56
57
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, Chicago
– Evaluating:
• Safety of PrEP use among young HIV-neg gay/MSM
• Acceptability, patterns of use, and adherence
• Risk patterns
• Texting to encourage adherence
• Demographic and/or behavioral differences among youth
– Interested in a PrEP study
– Who stays on PrEP
58
Chicago Research
• SHIPP (Sustainable Health Center Implementation PrEP Pilot) – June 1
– Implementation project examining PrEP use in primary care settings in Chicago, Newark, Houston, and Philadelphia• Serves women and men
• Access Grand Boulevard Specialty Clinic
• 5401 South Wentworth Avenue, 773-288-6900
• PS-PrEP – Jan 1– Randomized clinical trial of PrEP linkage
program by DIS staff, UC and CDPH
59
Chicago Research
• Facebook PrEP - Sept 1
– PrEP bridgers educate community about PrEP and disseminate information
• Contact John Schneider at [email protected]
to learn more!
60
Chicago Research
• Howard Brown Health Center
• Evaluating PrEP in community health center setting
• Collects info on why patient AND provider are considering PrEP
• Data quality can be monitored by visit types, provider, and testing location
• Process enabling improved communication and tracking of those interested in PrEP, on PrEP, discontinuing PrEP
61
62
• True or False: PrEP does not work for women.
• True or False: Most people who take PrEP will have nausea.
• True or False: The FDA approved the HIV drug Truvada for use as prevention in July 2012.
63
ARV-Based Prevention Pipeline (March 2014)
IPCP NIAID
Pop Council
Pop Council
CONRAD
Albert Einstein
CONRADGSK
IPM
CONRAD
Janssen
TaiMed
Pop Council
HPTN/ACTGIPM CONRAD IPM Gilead
IPM
IPM
IPM
IPM
IPM
IPM
Pop Council
RTI
Pop Council
Mintaka
PBS
ImQuest
ImQuest
Vaginal gel
Oral pills
Vaginal film
Vaginal tablet
Vaginal ringLong acting
injectable
DELIVERY SYSTEM
Thin film
polymer
Nano-fiberPhosphate
buffered saline
PB
S
RRectal gel
IPM
IPM
IPM
IPM
R
IPM
R
MVA
TDF/
FTC
TFV/
FTC
TMC
278
MIV
150
GRF
TFV
TDF
DAP
744
MAbMaraviroc
Tenofovir
GSK 744
Tenofovir disoproxil
fumarate/emtricitabine
Dapivirine
Ripilvirine
MIV 150
Tenofovir disoproxil
fumarate
Monoclonal antibody
Tenofovir/
emtricitabine
Griffithsin
DS003 DS003 (BMS793)
DAR Darunavir
No drug tested
currently
5P12 5P12-RANTES
IQP IQP-0528
TFV Tenofovir
prodrug
ACTIVE DRUG
RAL Raltegravir
CDC
CONRAD
R
PRE-CLINICAL PHASE I PHASE II PHASE III PHASE IV
Adapted from AVAC Report 2013: Research & Reality. www.avac.org/report2013
66
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
67
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
68
69
70
Truvada as PrEP
Is the first non-barrier HIV
prevention strategy
fully controlled by the receptive
partner.
71
72
www.myprepexperience.org
74
Taking PrEP – what does it take?
• It’s not just a pill, it’s a program
• Adherence
• Take 7 days before enough drug is “on board” to provide protection in the rectum, 3 weeks for the vagina
– Then take Truvada every day
75
Taking PrEP – what does it take?
• HIV testing
• Hepatitis B testing
• Kidney function testing
• STI screening
• Pregnancy testing
• Provider visits every 3 mosto conduct all the above
– Honest, open discussions about sex, sexual health
76
77
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.
78
79
80
www.myprepexperience. org
Accessing PrEP in Chicago
• Any medical provider who can write a scrip can write one for Truvada as PrEP
• Most HIV docs familiar with PrEP
• Research (Project PrEPare)
• UC and ACCESS Grand Blvd
• Howard Brown Health Center
• CORE Center – clinic coming soon
• Chicago PrEP Working Group
82
Accessing PrEP in Chicago
• Howard Brown Health Center
• PEP and PrEP offered on sliding scale
• Host a PrEP/PEP line
• Dedicated PrEP Advocate to assist clients
• Contact Bryan Bautista-Gutierrez
– 773.388.1600
83
Accessing PrEP in Chicago
• U of C Infectious Disease Clinic
• 1-888-824-0200
• PrEP docs:
– Jean-Luc Benoit
– Shirley Stephenson
– David Pitrak
– Renslow Sherer
84
Accessing PrEP in Chicago
• Access Grand Blvd Specialty Clinic.
• Call 773-288-6900
• PrEP docs:– Jean-Luc Benoit
– John Schneider (takes clients 16-18)
– David Pitrak
– Teresa Kodiak (takes under 16-18)
– Nancy Glick
• Any problems scheduling please contact John Schneider at [email protected]
85
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
86
InsuranceMedicaid
Devil in the details
• Prior auth
• Deductibles
• Co-pays
• Tiers
• Confusion
87
Accessing PrEP— insurance
Accessing PrEP – Gilead
1. Visit www.truvada.com
2. Click on the link to access information about Truvada for a PrEP indication
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
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
Gilead support
programs
Medication Assistance Program
500% FPL
Co-pay program
$300/mo.
91
Newly improved – october 15, 2014
92
93
94
• True or False: Only HIV specialists are able to prescribe Truvada as PrEP
• People taking PrEP need to be tested for HIV _____ times every year.
• How are people getting their PrEP prescriptions paid for?
• True or False: Only people with HIV-positive partners are eligible for PrEP.
95
Handy brochure
97
Designed to help individuals talk to their doctors about PrEP
Before, during, after visitQuestions to askWeb resources
tinyurl.com/talkPrEPtoDr
98
PrEPline, 855-448-7737The 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
• MyPrEPexperience.org
• Truvada.com (Gilead)
• ProjectInform.org/prep
• PrEPWatch.org (advocacy focused)
• PrEPfacts.org
• WhatisPrEP.org (video)
Web resources on PrEP
99
101
102
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.
103
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.
104
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.
105
106
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?107
108
• If someone doesn’t use ________ regularly, they may be a good fit for PrEP.
• True or False: You can take Truvada on its own for treatment.
• Name one organization in Chicago that is prescribing PrEP for people who need it.
109
110
Client scenario activities
• Break off into small groups
• We will provide sample client scenarios
• Read assigned scenarios over with your group, consider potential responses, take notes, assign person to report
• Re-convene and report back
• 10 hot minutes from now
111
Post-test
Let’s see where
you are at!
112
113
Thank you!!
114
115
• John [email protected]
• Sara [email protected] • Jim Pickett
• Project RSP! [email protected]
116
Connect
