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[Quote from female sex worker participating in treatment
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Uploaded byJim Pickett
Project RSP! Training on PrEP - Peoria, IL - August 18, 2015
The document discusses Pre-Exposure Prophylaxis (PrEP), specifically the use of Truvada as an HIV prevention method, and covers its clinical guidelines, efficacy, and the critical importance of adherence. It highlights that while PrEP is effective, it requires regular medical oversight and does not offer complete protection against STIs or pregnancy. The presentation also addresses financial assistance options for those needing access to PrEP medication.
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Project RSP! Training on PrEP - Peoria, IL - August 18, 2015
- 1. UnityPoint Methodist MedicalCenter – Peoria, IL – 8.18.15 Download these slides: tinyurl.com/PeoriaPrEP_Aug18_2015
- 2. In the next40 minutes • Intros • Pre/Post tests, evaluations • Understanding PrEP –What is PrEP, how it’s taken, access –Updates from CROI 2015 and IAS 2015 • PrEP case studies, elevator speech, and more • SO MUCH FUN These slides available at: tinyurl.com/PeoriaPrEP_Aug18_2015
- 3. Ground rules • Weare all somewhere on the learning curve • Participate to the fullest of our abilities • The only dumb questions are the ones not asked 3
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- 8. What is thefirst word or words that come to your mind when you think about condoms? 8
- 9. What is thefirst word or words that come to your mind when you think about needle exchange? 9
- 10. What is thefirst word or words that come to your mind when you think about oral contraceptives? 10
- 11. What is thefirst word or words that come to your mind when you think about PrEP? 11
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- 13. What is ARV-basedprevention? • 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) 13
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- 17. First, what isprophylaxis? • 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? 17
- 18. What is PreP? •PrEP consists of taking the ARV drug Truvada to prevent HIV* • Truvada is a combination of tenofovir disoproxil fumarate (aka tenofovir or TDF) and emtricitabine. • Need to take 5 – 7 days* of Truvada before enough drug is “on board” for protection in rectum. • Three weeks for vaginal protection. • Truvada is currently the only drug approved by the FDA for PrEP. 18
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- 22. 22 Approved Truvada forPrEP July 16, 2012
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- 24. PrEP Clinical PracticeGuidelines • 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 24tinyurl.com/CDCprepguidelines
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- 28. 28 • True orFalse: PrEP must be started within 72 hours of exposure to HIV. • The FDA approved Truvada as PrEP in what year? • True or False: People on PrEP should be tested for HIV every month. • True or False: It takes longer for PrEP to achieve protection in the vagina compared to the rectum.
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- 31. PrEP works –the science • 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) 31
- 32. Bumps in theroad 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 32
- 33. PrEP works –key findings • Adherence! • 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 33
- 34. • Some willexperience 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. 34 PrEP works – key findings
- 35. PrEP 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. 35
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- 37. I don't haveany regrets, but what I do have is peace of mind. And that is exactly what I was looking for with this medication. I feel great, I feel empowered, and I feel in control of my sexual health and my health in general. Personal story on MyPrEPexperience.org
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- 41. PrEP’s “protease moment” croiconference.org PROUD– 86% IPERGAY – 86% www.aidsmap.com/croi2015
- 42. 42 There is anurgent need to mobilize clinical efforts, service delivery, education, implementation research, and policy to optimize PrEP access and use. – Dr. Raphael Landovitz/UCLA croiconference.org
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- 44. 44 PrEP is morethan a prescription PrEP is a program
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- 46. Take Truvadaevery day Provider* visits every 3 mos HIV testing Tied to Rx renewal Hepatitis B testing Kidney function testing STI screening Pregnancy testing 46 *These activities don’t all need to be done by a doctor in their office Taking PrEP… What does it take?
- 47. Adherence counselling Perfection not required, especially for rectal exposure Take 5 – 7 days before enough drug is “on board” to provide protection in the rectum, 3 weeks for the vagina Then take Truvada every day Honest, open discussions about sex, sexual health PreP is “seasonal.” PrEP is not forever. 47 Taking PrEP… What does it take?
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- 49. • iPrEX OpenLabel • 1,603 participants, 1,225 on PrEP • Most from Peru/Ecuador, 18% USA • 100% effectiveness associated with 4+ doses a week (rectal) • 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 49
- 50. What PrEP doesnot 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. 50
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- 53. 53 • True orFalse: PrEP does not work for women. • True or False: About 25% of people who take PrEP will have nausea. • True or False: Regular STD screening is part of the PrEP program. • True or False: You don’t need to adhere perfectly to PrEP to achieve high levels of protection. • True or False: Obama says “PrEP sucks.”
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- 56. Who might bea good fit for PrEP? •Person indicates an interest in taking PrEP 56
- 57. Who might bea good fit for PrEP? • Person is in a “magnetic” relationship –HIV-negative and has HIV+ partner who is not on meds, or not undetectable, or other mitigating circumstances 57
- 58. Who might bea good fit for PrEP? • Male, female, transgender person engaging in 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 58
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- 61. 61 In this sampleof men who are in a relationship with a perceived HIV-negative man, we found that intimacy motivation was the strongest predictor of adopting PrEP. “Intimacy Motivations and Pre-exposure Prophylaxis (PrEP) Adoption Intentions Among HIV-Negative Men Who Have Sex with Men (MSM) in Romantic Relationships” – Annals of Behavioral Medicine August 2014
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- 65. Accessing PrEP inIllinois • Any medical provider who can write a scrip can write one for Truvada as PrEP • aidschicago.org/i-need/prep/prep-clinics-and- providers – Most listings are in Chicago – ONE in Champaign-Urbana 65
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- 70. Handy brochure 70 Designed tohelp individuals talk to their doctors about PrEP Before, during, after visit Questions to ask Web resources tinyurl.com/talkPrEPtoDr
- 71. 71 PrEPline, 855-448-7737 The CCCPre-Exposure Prophylaxis Service 11 a.m. – 6 p.m. EST http://nccc.ucsf.edu/2014/09/29/introducing-the-ccc-prepline/ PrEP Warm Line
- 72. • MyPrEPexperience.org • ChicagoPrEP Line - (872) 215-1905 hivelimination.uchicago.edu/projects/programs/prep_hotline_linkage_to_care • Chicago PrEP provider listing tinyurl.com/ChicagoPrEPproviders • Facebook group – PrEP Facts • Facebook.com/ProjectRSP • PrEPWatch.org • ProjectInform.org/prep • Truvada.com (Gilead) • WhatisPrEP.org (video) Web resources on PrEP 72
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- 75. 75 PositivelyAware.com Printed copies available emaildistribution@tpan.com
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- 78. FDA approval of Truvadaenables private ins to cover Medicaid formulary Ins companies covering, so far ADAP does not cover PrEP 78
- 79. Drug costs Visit, service costs Lab costs
- 80. 80 the devil isin the details Premiums Deductibles Cost-sharing Drug formularies Drug tiers Shifting benefits Not easy to figure all this out!
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- 82. Paying for PrEP– Gilead 1. Visit www.truvada.com 2. Click on the link to access information about Truvada for a PrEP indication 82
- 83. Medication Assistance Program •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 8383
- 84. Co-pay card program Coversall 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
- 85. 85 • www.panfoundation.org/hiv-treatment-and-prevention • Acceptingapplications for new and renewal patients. If application for assistance is approved can begin receiving funding immediately • Maximum Award Level – $4,000 per year. • Patients may apply for second grant during eligibility period subject to funding availability Paying for PrEP – PAN Foundation
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- 88. 88 • How canpeople pay for their PrEP prescriptions? • People taking PrEP need to be tested for HIV _____ times every year. • Why is this important? • Who might be a good fit for PrEP?
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- 91. 91 “Party drug” “Public healthdisaster”
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- 95. 95 “But ARVs aretoxic…”
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- 97. Tips for talkingabout PrEP • You need not be an expert. • Though, it’s important you feel comfortable talking about PrEP. • It’s okay to not have all of the answers. Refer your client to additional resources and/or promise to follow up. 97
- 98. Tips for talkingabout 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. 98
- 99. Messages to emphasizeto clients • PrEP is an accessible option – Not forever, but maybe for a “season” – If you use condoms successfully, do you need PrEP? • It’s not just a daily pill, it’s a program. – Holistic health care (w/regular HIV and STD testing) • Person must test HIV-negative to initiate and continue PrEP. • Adherence. Different for men and women. 99
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- 101. SAFER SEX TAKING PREPIS 101
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- 103. 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? 103
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- 108. www.aidsmap.com/ias2015 • ATN 110 •12 U.S. cities, including Chicago • 200 gay (77.8%) and bi (13.7%) men, 18 – 22 (mean 20.18) • 53% Black; 17% Latino; 21% White; 2% Asian/PI; 7% other/mixed • Four HIV infections, not taking PrEP • Adherence good overall, better among those not using condoms • Black gay men’s adherence was not as high as others • CALL TO ACTION – need better understanding of historical, societal, behavioral, and attitudinal barriers to PrEP access and adherence among those w/highest impact – young black gay men • Adherence among all groups decreased as study visits moved from monthly to quarterly Dr. Sybil Hosek – CORE
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- 110. 110 • PrEP DemoProject • SF, DC and Miami • 557 particps; median age 35 • 48% White; 35% Latino; 7% Black; 10% other • 98% male; 1.3% transgender • Overall high adherence – higher adherence among ppl not using condoms • Two infections, not taking PrEP • Two main findings: “1) we must do active, engaging outreach to African American MSM and trans women about PrEP; we will not reach sufficient numbers through passive attempts to scale- up PrEP, and 2) adherence was lower among African Americans, so additional programs to understand reasons for poorer adherence and to develop support mechanisms are needed for populations most heavily impacted by HIV. Current tools are not enough.” www.aidsmap.com/ias2015 Dr. Al Liu – SF DPH
- 111. 111 www.ias2015.org [Quote from femalesex worker participating in treatment and PrEP demo project in Johannesburg, South Africa.]
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- 115. 115 “Interventions do notjust work automatically, they have to be made to work – and people have responsibility for making them work. And herein lies the rub – for the question we should ask is not “what works?” but “what are we committed to making work?” – Dr. Flora Cornish London School of Economics
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- 122. CONTACT Jim Pickett jpickett@aidschicago.org Sara Semelka ssemelka@aidschicago.org 122 #yayPrEP Downloadthese slides: tinyurl.com/PeoriaPrEP_Aug18_2015