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Project RSP! Training on PrEP for HIV Prevention

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June 11 - UPDATED training on PrEP for HIV prevention from Chicago's Project Ready, Set, PrEP! (RSP!). Visit the Project RSP!'s My PrEP Experience blog at www.myprepexperience.blogspot.com for more informational resources, including the personal stories of individuals who have chosen to use PrEP.

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Project RSP! Training on PrEP for HIV Prevention

  1. 1. Welcome Case Managers!Project RSP! training – June 11, 2013Please sit by someone you don’t know.Make a new friend!
  2. 2. 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
  3. 3. • Trainings: Help Chicago providers, educators, and othersworking directly with our community to understand PrEPand 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 shareexperiences, interested individuals to get info –click myprepexperience.blogspot.com.3
  4. 4. Your primer on ARV prevention4
  5. 5. 5
  6. 6. A growing prevention toolkit• Improved ARV therapy• Treatment foropportunistic infections• Basic care/nutrition• Prevention for positives• Education & rights-focusedbehavior change• Therapeutic vaccinesPrior to exposure Point of transmission Treatment•Male and femalecondoms and lube•ARV treatment toprevent verticaltransmission (PMTCT)•Clean injectingequipment•Post-exposureprophylaxis (PEP)•Vaginal and rectalmicrobicides•Rights-focusedbehavior change•Voluntary counselingand testing•STI screening andtreatment•Male medicalcircumcision•Preventive Vaccines•Pre-exposureprophylaxis (PrEP)6
  7. 7. Don’t wehave enoughto preventHIV already?7
  8. 8. What is ARV-based prevention?• Strategies that use HIV treatmentdrugs (antiretrovirals or “ARVs”) toprevent HIV infection– TLC+ (testing, linkage to care, plustreatment)– ARV-based microbicides– PEP (post-exposure prophylaxis)– PrEP (pre-exposure prophylaxis)8
  9. 9. Testing drugs for prevention• Phase I – small number ofppl, short duration, safetyand acceptability• Phase II – morepeople, longer, safety andacceptability• Phase IIb, III – LARGEtrials, lots of people, multi-year, does this thing work?9
  10. 10. • Provide ARV treatment to HIV+people who accept it voluntarily– Improve treatment access forHIV+ , improve healthcoutcomes– Offer treatment earlier in thecourse of the disease– Reduce individual viralload, reduce community viralload– Reduction in onward HIVtransmissionsTesting, linkage to care, plus treatment – TLC+10
  11. 11. What research says about TLC+HPTN 052 trialdemonstrated 96%reduction in sexualtransmission of HIVbetween (mostly)heterosexualserodiscordantcouples.www.ncbi.nlm.nih.gov/pmc/articles/PMC3486734/Limitation – how applicable forgay men or IDU?11
  12. 12. ARV-based microbicides• Substances in development that wouldreduce sexual transmission of HIV ( theydon’t exist outside of clinical trials)• Applied rectally or vaginally– Gels, vaginal rings• Future formulations could includefilms, rectal enemas• Microbicides don’t have to be ARV-based, though most productscurrently under investigation are• Other compounds have been tested;scientists are exploring non-ARVformulations12
  13. 13. Microbicides, the research says:• CAPRISA 004 – reported 2010, first to showefficacy• 1% tenofovir reduced HIV in women by39%, in South Africa• Tested product efficacy, before and after sex• VOICE – reported 2013, no efficacy, lowadherence– African women in Uganda, S.Africa, Zimbabwe– Daily use 1% tenofovir gel, tenofovirtablet, Truvada tablet• FACTS – confirmatory trialunderway, CAPRISA protocol, S. Africa13
  14. 14. Rectal microbicide trial• MTN 017– first Phase II ever, safety andacceptability (not efficacy)– Modified version of tenofovir gel (bootyfriendly) 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, SanFrancisco, Puerto Rico– Starting later this year (US sites inJune?) 14
  15. 15. 15YouTubehttp://tinyurl.com/RectalRevEnglishhttp://tinyurl.com/RectalRevSpanish
  16. 16. Post-exposure prophylaxis (PEP)Provide 2 or 3-drug regimen of ARVs after HIVexposure to stop infection• Typically offered to health careproviders exposed to HIV via needlestick• nPEP – offered for non-occupationalexposure, sexual exposure, injectiondrug use exposure• Must be taken within 72 hours ofinitial exposure, small window• ARVs must be taken for 28 days16
  17. 17. Accessing PEP• Any doctor is able to prescribe• HIV docs the best to manage PEP, most likely toprescribe• Available at no cost through CORE Center’s walk-inclinic M-F 8:30am-3:30pm, 312.572.4700. Alsoavailable 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 forduration of regimen for monitoring and HIV testing17
  18. 18. 18
  19. 19. What isPrEP?**pre-exposure prophylaxis19
  20. 20. Hold up, what is prophylaxis?• Prophylaxis is simply the provision ofmedications prior to germ or virusexposure to prevent infection.• This is not a new concept.• This is not a new practice.• Example: taking malaria drugsbefore traveling to countries withhigh malaria incidence• What are examples of similar concepts?20
  21. 21. So, what is PreP?• PrEP involves an HIV-negative person takingARVs to reduce risk of infection BEFORE HIVexposure. It prevents HIV from reproducing in aperson’s body.• In current approved formulation, PrEP is takenin a single pill once a day, every day (Truvada)..21
  22. 22. So, what is PreP?• Need to take 7 days of Truvada before enoughdrug is “on board” for protection. Then daily.• Truvada is currently the only drug (actually acombination of 2 drugs) approved by the FDAfor PrEP.• Truvada is a combination of tenofovir disoproxilfumarate (aka tenofovir or TDF) andemtricitabine.22
  23. 23. 23“Taking the Truvada does notmake me ‘reckless’ in my decisionto have unprotected sex, it makesme feel supported by acommunity of doctors andadvocates who recognize thenuances of my situation, and aredoing all they can tohelp me stay negative.”– Woman with HIV+ partner who startedPrEP because they wanted to have a child
  24. 24. PrEP Truvada• PrEP will not always be only Truvada• Researchers are currently exploringother ARV drugs that could also be usedfor PrEP• For instance, the ARV drug Maravoric(brand name Selzentry) is currently inclinical trials as a potential PrEP drug• Scientists are also researching thepossibility of intermittent use of PrEP– May not have to be taken daily– PrEP could be delivered via injection, andcould be longterm24
  25. 25. Dateline: July 16, 2012Today, the US Food and Drug Administrationapproved Truvada (emtricitabine/tenofovirdisoproxil fumarate), the first drug approvedto reduce the risk of HIV infection inuninfected individuals who are at high risk ofHIV infection and who may engage in sexualactivity with HIV-infected partners. - FDAhttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312210.htm25
  26. 26. • Truvada is approved for use as part of a comprehensive HIVprevention strategy that includes other prevention methods, suchas safe sex practices, risk reduction counseling, and regular HIVtesting. - FDA– Must be confirmed HIV-negative before prescription– FDA required development of Risk Evaluation and MitigationStrategy (REMS) for use of Truvada as PreP to ensure safe use• Medication guide• Community education• Provider training• ImplementationDateline: July 16, 201226
  27. 27. 27
  28. 28. 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)28
  29. 29. 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 – thoughself-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 coupleof months29
  30. 30. 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, orno-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 activitydecreased across all study arms30
  31. 31. Home-grown Chicago PrEP research• iPrEx OLE (Open Label Extension)– First – what does “Open Label” mean?– iPrEx randomized trial was diverseworldwide, but not in the US– Missing representation fromcommunities most affecteddomestically– Asked Chicago’s Project PrEPareparticipants if they would like to joiniPrEx; 46 of 68 agreed– Data soon!31
  32. 32. Home-grown Chicago PrEP research• Project PrEPare II– Open label demonstration project ANDsafety study of PrEP in young gay/MSMages 15-22– Actively enrolling 300 youth in 13 USsites, including Chicago– Research questions:1. How safe is PrEP use is among HIV-uninfected young gay/MSM?32
  33. 33. Home-grown Chicago PrEP research• Project PrEPare II2. What is acceptability, patterns of use, rates ofadherence and measured levels of drug exposurewhen YMSM are provided PrEP and info re: safetyand efficacy of PrEP?3. When YMSM are provided behavioral interventionas well as PrEP and info re: the safety and efficacy ofPrEP, what are the patterns of risk?4. Is implementing an efficacious group level orbrief individual level sexual risk reductionintervention prior to provision of PrEPacceptable and feasible?33
  34. 34. Home-grown Chicago PrEP research• Project PrEPare II5. Is implementing a text messaging adherencereminder intervention for youth whose adherence isless than 80% acceptable, feasible?6 . Are there demographic and/or behavioraldifferences between youth who stay on PrEPcompared to those who discontinue?7. Are there demographic and/or behavioraldifferences between youth who interested inparticipating in a PrEP study versus those who arenot?34
  35. 35. Key research findings/Truvada• Adherence! Adherence! Adherence!• High adherence achieved 90%+ reduction in risk• There appears to be a general “start-upsyndrome” w/Truvada that includesnausea, diarrhea, abdominal pain andheadaches.• Mild nausea most common (about 6% or less) andresolved in 4 to 6 weeks35
  36. 36. Key research findings/Truvada• Truvada PrEP trials to date have not shownincreases in sexual risk behavior amongparticipants• Across all PrEP studies of Truvada, there havebeen no serious safety problems• Very little drug resistance has been seen forthose that seroconvert, mostly among thosewith unidentified HIV infection when theystarted the study36
  37. 37. 37The research continues
  38. 38. The research continues38
  39. 39. 39
  40. 40. 40
  41. 41. 41Relative efficacy of TLC+, PrEP, other strategiesHPTN 052 (ARV treatment as prevention)1Medical male circumcision1STD treatment1Partners PrEP (FTC/TDF) in discordant couples1Subjects with detectable drug levels3TDF2 (FTC/TDF) in men & women1iPrEx (FTC/TDF) in MSM1Subjects with detectable drug levels2CAPRISA 004 (1% TFV vaginal gel) inwomen1FEM-PrEP (FTC/TDF) in women6, VOICE (FTC/TDF, TDF, TFV vaginal gel) in women7,HIV vaccine (RV144)196%75%90%62%54%94%42%39%0 10 20 30 40 50 60 70 80 90 100Efficacy (%)StudyReduction in HIVTransmissionNot SignificantCondoms in heterosexuals4Condoms in US MSM580%70%44%1. Adapted from Abdool Karim S and QA. Lancet 2011;S0140-6736:1136-72. 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:CD0032555. 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
  42. 42. What PrEP does not do• Truvada as PrEP does not– Guarantee 100% protection from HIV (what does?)– Protect a person against other STIs likechlamydia, syphilis, herpes, or gonorrhoea– Prevent pregnancy– Cure HIV– Function, on its own, as a treatment regimen for someonealready living with HIV.– Why is Truvada, on it’s own, not considered adequate fortreatment?42
  43. 43. Why PrEP does not work for treatment• People with HIV require takingat least three ARVs together• The two drugs in Truvada arenot sufficient to control thevirus• A HIV+ person taking Truvadaon its own runs the risk ofdeveloping resistance to thedrug, which will limit drugss/he can take for treatment43
  44. 44. 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 forscreening, providing PrEP to gay men andheterosexuals, discontinuing PrEP, clinicalconsiderations, improving adherence, reducing riskbehaviors, info on financial case management, factsheets, risk index, counseling info, and quality measures44
  45. 45. Taking PrEP – what does it take?• Adherence! Taking the pill everyday.• Take 7 days before enough drugis “on board” to provideprotection– Still must take Truvada every day• Honest, open, and ongoingdiscussions with a medicalprovider about sexual activityand HIV risk• HIV antibody test – before firstprescription, and then every 3months. Rx renewal tied torenewed HIV-negative test.45
  46. 46. Taking PrEP – what does it take?• Hepatitis B testing• Kidney function testing• Bone density testing• STI screening (andtreatment if necessary)• Pregnancy testing• Doctor visits approx. every3 mos to conduct all theabove46
  47. 47. Why would someone want to take PrEP?47
  48. 48. 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–Serodiscordant48
  49. 49. Who might be a good fit for PrEP?• Sexual activity within high prevalence area orsocial 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 theabove factors is true for partner49
  50. 50. What about…50
  51. 51. 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, particularlywhen targeted to individuals at high risk of HIV acquisition2-51. 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. #THLB01028. 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:e87553
  52. 52. 54
  53. 53. Accessing PrEP• Any doctor who can write aprescription can write one forTruvada as PrEP• Most HIV docs are familiarwith PrEP• CORE, John StrogerHospital, HBHC, ACCESS GrandBlvd, TPAN (for referrals) andmore55
  54. 54. Accessing PrEP – Howard Brown• Howard Brown Health Center –primary careservices, including PrEP access• HBHC providers experiencedwith PrEP, existing patientpopulation accessing PrEP• Dedicated adherencecounselor, like case managerfor PrEP patients56www.howardbrown.org
  55. 55. Accessing PrEP – Howard Brown• Assists w/accessing medicationassistance, copay programs• Walgreens onsite – reduce anxiety overfilling prescription some might think“embarrassing”• Pediatrician on-staff for 18 to 25• Trans Health Advocates, AdherenceCounselors support transgenderpatients accessing hormones, PrEP57www.howardbrown.org
  56. 56. PrEP ed for your doc• Bring along a factsheet if you thinkyour doctor mayneed some PrEP ed58www.myprepexperience.blogspot.com
  57. 57. Accessing PrEP— insuranceFDA approval ofTruvada enablesprivate ins to coverTruvadaonMedicaidformularyIns companiescovering, so farADAPdoes notcover PrEP59
  58. 58. Accessing PrEP – Gilead1. Visitwww.truvada.com2. Click on the link toaccess informationabout Truvada for aPrEP indication60
  59. 59. Medication assistance• Gilead will provide Truvada for PrEP at no cost* forindividuals who qualify for the assistance programProgramElementTruvada PrEP Medication Assistance ProgramEligibilityCriteriaUS resident, uninsured or no drug coverage, HIV-negative, low income (200% FPL)DrugFulfillmentProduct dispensed by Covance SpecialtyPharmacy, labeled for individual patient use andshipped to prescriber (30 day supply); no card orvoucher optionRecertificationPeriod6 months, with 90 day status check6161*Still need to consider costs of medical care
  60. 60. Medication assistance form62
  61. 61. www.Truvada.com – Providers• Allows providers to:– Access to free male and female condoms– Obtain lab forms for free HIV-1 and HBV testing providedthat HCP has completed the online training and registered– Gilead Medical Affairs Contact Number for subsidizedresistance testing for individuals who seroconvert– Receive similar training on the indication to the REMSwebsite– Access to Gilead’s Medication Assistance Program fordownload– Access to all REMS materials for download63
  62. 62. 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-1and other STDs (coming soon)64
  63. 63. HIV franchise co-pay card program• Covers all Gilead HIV Products: Stribild, Complera, Atripla,Truvada, Viread, Emtriva• Assists patients with commercial insurance who reside inthe US, or US Territories• Not valid for Rx that are eligible to be reimbursed by anyfederal or state funded healthcare benefit program• Co-pay benefit provides assistance for co-pays above $0• Monthly benefit provided for 12 mos after activation ofcard• 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 needto re-enroll• Service Provider: McKesson• 877.505.6986
  64. 64. Helping your clientsunderstand PrEP66
  65. 65. Messages to emphasize to clients• PrEP is an OPTION– Not forever, but maybe for a “season”• Person must test HIV-negative to initiateand continue PrEP.• Daily adherence to PrEP is essential toreduce person’s risk of HIV – and can bevery effective.• Taking PrEP does not guarantee 100%protection from HIV (but does anything?)67
  66. 66. Messages to emphasize to clients• Daily use of Truvada as PrEP cannot anddoes not function as HIV treatment. Whyis Truvada on its own not adequate fortreatment?• PrEP user must be engaged with regularhealth care for prescription, to ensureremaining negative, stayingadherent, kidney health, etc.• PrEP doesn’t make male or femalecondoms obsolete!68
  67. 67. Tips for talking about PrEP• Important you feel comfortable andconfident talking about PrEP.• It’s okay to not have all ofthe answers and to referyour client to additionalresources and/or promise tohave that information nexttime you see him/her.69www.myprepexperience.blogspot.com
  68. 68. Tips for talking about PrEP• As a provider of prevention services, you areviewed as a trusted source of information.• Remember any perspectives/opinions you haveabout PrEP and/or people who use PrEP willtranslate to your clients.70
  69. 69. Adherence, Adherence, Adherence• Strategies for adherence include:– Take pill each day at same time– Place pill bottle in visible place, sameplace– Set cell phone alarms– What are some other strategies?– What should you do if you forget adose?71
  70. 70. • 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 PrEP72
  71. 71. 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
  72. 72. Thank you!!74
  73. 73. Please stay in touch• Sybil Hoseksybilhosek@gmail.com• Jessica Terlikowskijterlikowski@aidschicago.org• Michael “Mikey” Landrethmlandreth91@gmail.com• Mark Bernsteinmark.bernstein@gilead.com• Keven Cateskevenc@howardbrown.org• Jim Pickettjpickett@aidschicago.org• Project RSP!myprepexperience@gmail.com75

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