Welcome Case Managers!

Project RSP! training – June 11, 2013

Please sit by someone you don’t know. Make a new friend!

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 PrEP2

• 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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Your primer on ARV prevention

50 Shades of ARVs

yright Project Ready Set PrEP

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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 exposurePoint of

transmissionTreatment

• 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)

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Don’t we have enough to prevent HIV already?

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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)

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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?

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• 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+

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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/

HPTN 052 trial demonstrated 96% reduction in sexual transmission of HIV between (mostly)

heterosexual serodiscordant

couples.

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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

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

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

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YouTubehttp://tinyurl.com/RectalRevEnglish http://tinyurl.com/RectalRevSpanish

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 days16

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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What is PrEP?**pre-exposure prophylaxis

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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?

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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).

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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.

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“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

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

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

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• 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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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)

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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

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

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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

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?

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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?

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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?

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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

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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

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37 The research continues

The research continues38

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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 100Efficacy (%)

StudyReduction in HIVTransmission

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. #TUPE3103. Baeten J, et al. NEJM 2012;367:399-4104. Weller S, et al. Cochrane Database Syst Rev 2002:CD003255

5. Smith DK, et al. CROI 2013; Atlanta, GA. Oral #326. van Damme L, et al. NEJM 2012;367:411-4227. Marrazzo JM, et al. CROI 2013; Atlanta, GA. Oral #26LB

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?

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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

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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

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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.

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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

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Why would someone want to take PrEP?

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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

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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

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What about…

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IntimacyConnection Emotion

Pleasure

IntimacyConnection Emotion

Pleasure

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. #E042. Juusola JL, et al. Ann Intern Med 2012;156:541-5503. Desai K, et al. AIDS 2008;22:1829-18394. Walensky R, et al. CID 2012;epub April 35. Anderson J, et al. EACS 2009. Cologne.6. Buchbunder S, et al. CROI 2012. Seattle. #10667. Grant R, et al. IAC 2006. Toronto. #THLB0102

8. Supervie V, et al. PNAS 2010;107:12381–123869. Paltiel DA, et al. Clin Infect Diseases 2009;48:806-1510. Hill A, et al. CROI 2006. Denver. #Y-12711. Hallett T, et al. CROI 2011. Boston. #99LB12. Pretorius C, et al. PLoS ONE 2010;5:e1364613. Abbas U, et al. PLoS ONE 2007;2:e875

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Access to PrEP – How do you get it?

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

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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

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www.howardbrown.org

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

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www.howardbrown.org

PrEP ed for your doc

• Bring along a fact sheet if you think your doctor may need some PrEP ed

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PS – They probably will!

www.myprepexperience.blogspot.com

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

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Accessing PrEP – Gilead

1. Visit www.truvada.com

2. Click on the link to access information about Truvada for a PrEP indication

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Medication assistance• Gilead will provide Truvada for PrEP at no cost* for

individuals who qualify for the assistance programProgram 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

Medication assistance form

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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

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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)

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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

Helping your clients understand PrEP

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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?)

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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!

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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.

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www.myprepexperience.blogspot.com

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.

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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?

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• 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

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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

Thank you!!

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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 75