Transcript Slide 1

Pre-Exposure Prophylaxis:
PrEP for Prevention
Roy Berkowitz MA, NCC
Inova Juniper Program
703-321-2622
[email protected]
PrEP Overview
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What is it?
Who is it for?
What’s the controversy?
Who’s prescribing it?
What’s happening now?
Handouts and Websites
PrEP- What is it?
PrEP is an FDA approved HIV prevention strategy
where HIV negative people who are at risk of
getting HIV take one pill of Truvada daily
to reduce their chance of getting HIV.
•Truvada is given to people already infected with HIV :
Truvada combines two anti-HIV drugs (tenofovir and emtricitabine
[emtriva])
•The drugs in the pill help prevent HIV from multiplying, so if you
are exposed to HIV it is less likely to multiply in your cells and
therefore, it can help to keep the virus from causing a lasting
infection.
PrEP vs. PEP/nPEP
PrEP (Pre-Exposure Prophylaxis) =
taking the drugs before person is exposed
PEP (Post-Exposure Prophylaxis)=
taking meds after person is exposed
Pre Exposure Prophylaxis (PrEP)
indicated for HIV negative people at on-going high risk of HIV infection
• January 2011 -MMWR Interim Guidance for MSM: “Truvada, taken
orally 1x day as PrEP, is safe and partially effective in reducing HIV
acquisition among MSM when provided with regular monitoring of
HIV status and ongoing risk-reduction and PrEP medication
adherence counseling”
• August 2012 -Interim Guidance for heterosexually active adults
• June 2013- Interim Guidance for injecting drug users
Findings: PrEP is effective and safe and offers
a high level of protection against HIV
when adherent to daily medication dose.
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July 2012
• FDA* announced it has approved the drug
combination of 300 mg tenofovir and 200 mg
emtricitabine (TDF/FTC; brand name Truvada)
for daily use by uninfected adults to help
prevent the sexual acquisition of HIV.
* As of Feb 2014, USA is only country to license drug for this indication
PrEP is
not meant as
a replacement
for condom use!
“PrEP can tip the balance: when you do all
these things together. It needs to be an addon with all these other [prevention] methods.”
ID Doc
Counseling Individuals on Comprehensive HIV Prevention
TRUVADA for a PrEP indication should only be used as part of a
comprehensive HIV prevention strategy. TRUVADA for PrEP does not
replace existing HIV prevention strategies..
New Clinical Guidelines were released May 14, 2014
These Clinical Practice Guidelines replace the
previous interim guidance documents
Who is PrEP for?
CDC, May 2014
PrEP is for adults* at substantial risk of acquiring HIV
and who are HIV-negative** and:
•In an on-going sexual relationship with a positive partner
•Gay or bisexual man who has had anal sex w/o a condom or dx with
STD in past 6 months
• Heterosexual man or woman who does not regularly use condoms
with partners of unknown HIV status and at substantial risk of HIV
infection (IDUs, bisexual male partners)
•Have injected drugs in past 6 months and who have shared injection
equipment or been in drug tx for injection use in past 6 months
•Serodiscordant couples who are trying to get pregnant
*Data on efficacy and safety for adolescents not sufficient
**HIV-Negative status must be documented
Who is PrEP not for?
PrEP is not meant to be used by:
• People with HIV
•People not willing to adhere to treatment protocol
• People not available or willing to participate in
regular diagnostic monitoring
•People with signs/symptoms of acute infection
• People who successfully and consistently use other
prevention methods
•Women who are breastfeeding
CDC Clinical Guidelines, May 2014
It is recommended as
“one prevention option”
in preventing HIV transmission...
“…patients should be
encouraged and enabled
to use PrEP in combination with other effective
prevention methods.” p.10
“The more prevention options patients choose,
the greater their protection.”
May 2014, CDC Fast Fact Sheet
CDC Clinical Guidelines, May 2014
• “A physician can support consistent condom
use by providing brief clinical counseling… or by
referring patient to…[or] community-based or
local health department …services.”p. 27
• “Clinicians should provide access, directly or by
facilitated referral, to proven effective riskreduction services.” p. 10
How Should People using PrEP be Monitored?
• CDC guidelines recommend that people taking PrEP
be seen at least every 3 months for provider to:
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Test for HIV to ensure HIV negative status
Check side effects of truvada
Evaluate and support adherence
Assess risk behaviors, reinforce condom use and other
prevention messages
– Conduct pregnancy test *
– Assess STI symptoms and test and treat as needed
- Assess Renal function (baseline and then at least every
6 months)
*Not full info on how Truvada affects fetus
if you take it for PrEP but appears safe for
HIV + women who are already pregnant
and take it during pregnancy
CDC also suggests that prescription
not be more than 90 day supply,
renewable only
after HIV testing confirms an HIV negative result.
REMEMBER…
Ideally, PrEP will be time limited:
perhaps person has changed sexual activity,
or client and his/her partner are both negative
and have decided not to have sex outside relationship.
Although CDC has developed clinical
guidelines for PrEP,
And it is FDA approved…
Public and
Health Care Provider reactions
to PrEP
have been mixed.
Concerns: The Controversy
• It is a commitment and responsibility (though hopefully not forever)
– It is not to be taken intermittently or as needed (e.g. before having sex): it
takes one week for enough Truvada to protect you
• If person becomes infected with HIV while taking PrEP,
person could develop resistance to Truvada (so other meds
will need to be used)
• It will not protect person from other STIs
• Truvada can cause stomach upset in the first weeks of taking it.
The drug, though low on side effects as HIV meds go, has
been linked to kidney and bone problems in a small percentage
of HIV-positive users.
A concern of many people:
Will taking PrEP
increase Sexual Risk-Taking?
Will it contribute to a
“shift to condomless sex”?
Michael Weinstein, pres of AIDS Healthcare Foundation
“…MSM
who were previously low risk
drifting into a higher risk category.”
Uptake on PrEP for HIV Slow Among MSM, Lancet , February 1, 2014
• “We don’t know the side effects of this drug. It
hasn’t been studied enough. It will encourage
slutty behavior. And why the hell don’t people
use condoms?”
-Objections raised to “the pill”
approved by FDA 54 years ago
Benefits
• From a public health perspective… PREP may be [significant] in the
context of a robust, and multi-faceted combination prevention
program [which includes condoms]…
• Being on PrEP may actually make people safer because it raises their
consciousness about their health: being on PrEP requires seeing a
doctor four times a year for an HIV test and kidney and bone tests. It
may actually bolster safer choices.
• PrEP advocates say it’s safer and cost effective to be on Truvada
during periods of high risk than to live with/treat HIV for a lifetime.
(Most cost effective when targeted to populations with high HIV incidence)
• Puts prevention in the hands of the person most at risk
It is another tool in the Tool Kit…
Along with condoms, which people
have not used consistently or correctly
A Low/Undetectable Viral Load
is the most important thing...
PrEP offers added protection
Cost and Coverage
Cost- About $13,600 annually
(about $1,130 monthly)
• Most health insurances cover it
(patient just pays co-pay for doctor’s visit, and lab
tests and drug co-pay*)
At Johns Hopkins clinic: $30.00 co-pay/month
Remember, there are
varying degrees of benefit
for all prescription drugs
• Insurance may require prior authorization
1-855-330-5479
Access to meds and co-pays for medical care visits
for those Uninsured
Stigma around PrEP:
‘Barebacking Sluts’ ‘Truvada Whore’
• “Recent cases we are aware of make this plain, where doctors
…refuse to give PrEP to those who need it… Also, comments on
blogs reacting to people describing their PrEP use have been
accusatory and absolutely reprehensible, essentially a new
version of slut shaming. David Evans, Project Inform
In some literature, people are advised to be
cautious about telling others they are on PrEP.
Who prescribes PrEP in VA?
Prescriber Barriers
• Not having information about PrEP
• Discomfort with asking patients about sexual
activity
• Being unwilling to write a prescription
(e.g. for ethical reasons)
• Increased paperwork
• Increased visits required
• Not having skills required or available to address
all related issues (e.g. benefits and risks, risk
reduction strategies, side effects, etc.)
Updates on PrEP:
What’s Happening Now?
Uptake of pre-exposure prophylaxis, sexual practices, and
HIV incidence in men and transgender women who have sex
with men: a cohort study Lancet Infect Dis 2014 Published Online July 22, 2014
•Data from iPrEx Open-Label Extension (OLE) Demonstrate High
Interest in PrEP, Longer-term Evidence of Safety and Efficacy,
and No Sign of Increased Risk Behavior Among PrEP Users
•iPrEx OLE is the first PrEP demonstration project to report on its experience
All 1603 gay men and tg women who have sex with men were participants in past double blind studies (of 72 weeks) so trial might
be biased towards a highly motivated population. (waiting to hear results from other studies where people had not previously
participated in a study)
http://dx.doi.org/10.1016/
S1473-3099(14)70847-3
•No participant who took PrEP four or more times a
week became HIV positive.
•For those who took the pills two or three times a week, the
HIV risk reduction was 84%, showing that adherence doesn't
necessarily need to be perfect in order for PrEP to be
effective.
•Despite speculation that being on PrEP would lead to "risk
compensation," or an increase in riskier sexual behavior, the
opposite was observed.
•Sexual practices among both groups in the study became
safer, based on self-report. Syphilis incidence, a marker of
sexual risk behavior, was similar between both groups.
INJECTABLE PrEP: Longer Acting
March 4, 2014
Injections Providing Protection Against AIDS in Monkeys, Studies Find
• Two studies by different laboratory groups each found 100%
protection in monkeys that got monthly injections of
antiretroviral drugs, and there was evidence that a single shot
every three months might work just as well… If the findings
can be replicated in humans, they have the potential to
overcome a major problem in AIDS prevention: that many
people fail to take their antiretroviral pills regularly… adherence
has been the ‘Achilles’ Heel’ of PreP.
• Dr. Ho’s team tested 16 monkeys with rectal washes of HIV. All
the injected monkeys were protected…All six who got the
placebo were infected quickly.
http://www.nextprepstudy.org/
NEXT-PrEP, [Novel Exploration of Therapeutics (NEXT) for PreExposure Prophylaxis (PrEP)], also known as the HPTN 069/ACTG
5305 study, is an HIV prevention study that is being done to learn
more about the safety and acceptability of four different drug
combinations when used as PrEP by men who have sex
with men and by women who have sex with men.
• The drugs in this study are called maraviroc (also called
Selzentry or MVC), emtricitabine (also called Emtriva or FTC), and
tenofovir (also called Viread or TDF).
Project PrEPare
Project PrEPare is for 15 to 17 year old guys & trans girls who
are exploring their sexuality and are interested in learning
positive approaches to their sexual health.
• When will Project PrEPare begin, and how long will it last?
Project PrEPare began in fall of 2012, and is still open to
participation by 15, 16 & 17 year olds. Participants attend 9
visits in 12 months time.
• Children’s Hospital in DC is a site
http://www.projectprepare.net/
September 17, 2014
Washington State: PrEP-DAP
• In April 2014, the Washington state’s health department started the
PrEP Drug Assistance Program, which pays the entire cost of PrEP
for uninsured people, and covers co-payments and deductibles for
those who do have coverage. On average, PrEP-DAP is covering
$400 a month in out-of-pocket costs for its insured participants,
according to David Kern, who oversees the program.
• Mr. Campos has cited PrEP-DAP as one possible model for San
Francisco, though the exact approach will be determined based on
the December report…he noted that every prevented H.I.V.
infection saves $355,000 in treatment costs, a significant offset to
the cost of subsidizing PrEP.
PrEP
Handouts and Websites
for the Client
and the Clinician
to assist in learning about and
prescribing PrEP
2014
Resources and Information
*http://www.cdc.gov/hiv/basics/prep.html
PrEP 101: Basic Facts Sheet for the public
*http://www.cdc.gov/hiv/pdf/risk_PrEP_TalkingtoDr_FINALcleared.pdf
Brochure on talking with your doctor about PrEP
Resources and Information
*www.projectinform.org/prep- booklets, info and 4 videos
Is Taking PrEP
The Right Choice for You?
PrEP: A New Option for Women
For Safer Loving
How to Get PrEP?
Free copies available in English & Spanish
(and PDF version)
www.projectinform.org/prep
Check out our videos and our online
resource page here!
http://nmac.org/prepareforlife/
Resources and Information
*www.aids.gov
*www.prepfacts.org
*www.aidsinfonet.org- Fact Sheet #160
*www.prep4tomorrow.org -Johns Hopkins Clinic
(currently looking for participants for trial).
For More Information Contact: 443-310-6738
*www.myprepexperience.blogspot.com- features real
stories from people who have chosen to use PrEP as one way to
protect themselves from HIV
Introducing the CCC PrEPline!
September 29, 2014
PrEPline, 855-448-7737
The CCC Pre-Exposure Prophylaxis Service
11 a.m. – 6 p.m. EST
We’re excited to announce our brand new service,
the CCC Pre-Exposure Prophylaxis consultation telephone service, or PrEPline.
This service will provide free, expert advice to clinicians across the country on
PrEP, an important new HIV prevention tool. PrEP involves providing
antiretroviral drug treatment to HIV uninfected persons to prevent HIV infection
“Many of the clinicians prescribing PrEP will have had limited experience prescribing
antiretroviral drugs,” said Dr. Goldschmidt (UCSF Professor of Family and Community Medicine
and Director of the CCC) . “We will guide these clinicians as they work through decisions
about who might benefit from PrEP and for whom it’s not advisable to prescribe PrEP, how
to provide follow-up to ensure safe medication use, and protocols for averting
and identifying new transmissions. Key to PrEP will be continually evaluating patients’ ability
to adhere to a daily PrEP regimen, as missed doses can negate the benefits of PrEP.”
Resources and Information
For Providers
Welcome to PrEP Watch, a clearinghouse for
information on pre-exposure prophylaxis (PrEP) for
HIV prevention. PrEP Watch includes information on
data, additional research, cost, access and advocacy
efforts in the United States and across the globe.
http://www.prepwatch.org/
Resources and Information
For Providers
www.cdc.gov/hiv/pdf/PrEPguidelines2014.pdf
The first comprehensive Clinical Practice Guidelines were posted
by CDC on May 14, 2014, replacing the interim guidelines.
http://www.cdc.gov/hiv/pdf/PrEP_fact_sheet_final.pdf
1 Page CDC Fact Sheet, May 2014
www.hivguidelines.org/clinical-guidelines/and CLICK
Pre-Exposure Prophylaxis -New York State, January 2014
http://www.cdc.gov/hiv/prevention/research/prep/
Information on Clinical Trials
Clinical Providers’ Supplement
www.cdc.gov/hiv/pdf/guidelines/PrEPProviderSupplement2014.pdf
•Patient/Provider Checklist
•HIV Incidence Risk Index for Men Who Have Sex With Men
•PrEP-related ICD, CPT and LOINC Codes
•Potential PrEP Practice Quality Measures
•Methods for Developing the PrEP Clinical Practice Guideline
•Supplemental Counseling Information (for the Provider)
-Medication Adherence Counseling
-Sexual Risk Reduction Counseling
•Patient Information Sheets
-PrEP, Truvada
-Acute HIV Infection and PrEP
-PrEP During Conception, Pregnancy, and Breastfeeding
http://aidsetc.org/resources
Click RESOURCE LIBRARY
and then click GUIDELINES
For access to all Updated Guidelines
Virginia’s Prep Workgroup
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Information
Training
Provider Information
Pilot Study