PrEP 'n Lunch 'n Learn

PrEP ‘n Lunch ‘n Learn 1.22.14

Jessica Terlikowski and Jim Pickett Your PrEP Squad

Meme by Pedro Alonso Serrano

Today

• Project RSP!• What is PrEP?

• What does/doesn’t it do?

• How do you get it?• Why is it important?

• PrEP’n AFC2

What is the first word or words that come to your mind when you think about condoms?

But first, honesty please

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What is the first word or words that come to your mind when you think about PrEP?

Honesty please

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• 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

• Give voice/provide facts: Platform for PrEP users to share experiences, interested individuals to get info – click myprepexperience.blogspot.com.

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Unrestricted

educational grant from

Gilead for 2013

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• We are NOT “pushing” PrEP• We are NOT telling anyone to stop using

condoms or other forms of protection• We are pushing education• Knowledge is power• Ignorance is not strength

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DISCLAIMER

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Meme by Pedro Alonso Serrano

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Project RSP! in 2014

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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.

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• www.truvadapreprems.com • Medication guide• Community education• Provider training• Implementation

Dateline: July 16, 2012

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How did we get here?

• 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)

– TDF2 (Truvada heterosexual men & women)

– Bangkok Tenofovir Study (injection drug users)

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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

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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

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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

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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

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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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SEX

pleasureintimacy

connectionemotion

lust

love

What is the first word or words that come to your mind when you think about PrEP?

Honesty please

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DANGERRISKSHAME

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Meme by Pedro Alonso Serrano

PrEP takes work

• Truvada as PrEP means…– A daily pill

– On-going engagement with healthcare

• Quarterly HIV testing

• Adherence support/counseling

• Regular STD screening and treatment

• Tests for toxicities, bone density

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PrEP Truvada

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PrEP aint magic

• 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 as a treatment regimen for someone already living with HIV.

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Seat belts aint perfect

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How do you get PrEP?

Accessing PrEP

• Any doctor who can write a prescription can write one for Truvada as PrEP

• Most HIV docs are familiar with PrEP

• Research (Project PrEPare)• Demo, implementation

(UC and ACCESS Grand Blvd)

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Accessing PrEP – Howard Brown

• 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— 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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Clinical Practice Guidelines

• Interim guidelines for different pops already available• Final guidelines being drafted – expect to publish soon• For clinicians – not “all purpose”• 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• Remember the REMS

www.truvadapreprems.com 45

New, handy brochure!

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Designed to help individuals talk to their doctors about PrEP

Before, during, after visitQuestions to askWeb resources

http://www.cdc.gov/hiv/pdf/risk_PrEP_TalkingtoDr_FINALcleared.pdf

Groovy PrEP videos

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WhatisPrEP.org

tinyurl.com/PrEPbyKLB

• MyPrEPexperience.blogspot.com • Truvada.com • ProjectInform.org/prep• PrEPWatch.org• PrEPfacts.org• WhatisPrEP.org

Web resources on PrEP

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Be PrEPared for the unPrEPared

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Meme by Pedro Alonso Serrano

Snapshot of PrEP prescriptions

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PrEP prescriptions – how many, who?

• “Status of Truvada (TVD) for HIV Pre-Exposure Prophylaxis (PrEP) in the United States: An Early Drug Utilization Analysis” – presented at Interscience Conference on Antimicrobial Agents and Chemotherapy, Sept ’13

• http://www.natap.org/2013/ICAAC/ICAAC_18.htm • Drug info from 55% of all US pharmacies,

“nationally representative”• 49 states, 700 cities,• Algorithm to exclude treatment, PEP, off-

label Hep-B treatment

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PrEP prescriptions

• 1,774 unique PrEP users between January 2011 and March 2013 (starting before FDA approval)

• 1,674 prescribers (620 also prescribed Truvada as Tx)

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PrEP prescriptions

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PrEP prescriptions

• Approx. half of all Rx were started before FDA approval in summer 2012

• Approx. half of all Rx written for female PrEP users

• Largest percentage Rx written in the Southeast

• Average age of PrEP users + 35 yrs• Approx. 13% of users since

FDA approval are under the age of 25

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Meme by Pedro Alonso Serrano

The only important thing to know and do is always wear acondom. - Larry Kramer

The guys these sensible health care folks are trying to reach are not sensible. They are self-identified idiots who can only be saved by a vaccine. - Dan Savage

What can AFC do to support

knowledge of, and access to,

PrEP?59

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Thank you