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Project RSP! Training on PrEP for HIV Prevention

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This is a training on PrEP (pre-exposure prohylaxis) for HIV prevention, designed for people who work in the HIV prevention field. The training is designed by AIDS Foundation of Chicago's Project …

This is a training on PrEP (pre-exposure prohylaxis) for HIV prevention, designed for people who work in the HIV prevention field. The training is designed by AIDS Foundation of Chicago's Project Ready, Set, PrEP! (RSP!). For more information on PrEP, visit the project's blog at www.myprepexperience.blogspot.com.

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  • Sybil
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    • 1. Welcome!Project RSP! training
    • 2. Our time together• 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
    • 4. • 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 is May 22, 2013 at Center onHalsted, 6p – 9p, please join us.• Give voice/provide facts: Platform for PrEP users to shareexperiences, interested individuals to get info –click myprepexperience.blogspot.com.4
    • 5. 5
    • 6. Your primer on ARV prevention6
    • 7. 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)7
    • 8. 8
    • 9. Prevention Paradigm 2013 andbeyondDifferent Strokes for Different FolksMethod Contraception HIV PreventionBehavior ✓ ✓Barrier Methods ✓ ✓Gels ✓Rings ✓Oral pill ✓ ✓Injectables ✓Implants ✓Surgical procedures ✓ ✓Treatment ✓
    • 10. 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)10
    • 11. Other terms in useTLC+• Treatment asPrevention(TasP)• Test and Treat(TnT)• Treatment forPrevention(T4P)PrEP• OralPrevention• Oral PrEPMicrobicides• Topical PrEP• TopicalPrevention11
    • 12. Pills, lubes, and more pillsPrEPMicrobicides –rectal, vaginalTLC+12
    • 13. 13
    • 14. • Provide ARV treatment to HIV+ peoplewho accept it voluntarily– Improve treatment access for HIV+– Offer treatment earlier in the courseof the disease– Reduce community viral load– Reduction in onward HIVtransmissionsTesting, linkage to care, plus treatment – TLC+14
    • 15. 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?15
    • 16. ARV-based microbicides• Substances in development that wouldreduce sexual transmission of HIV• 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-ARVformulations16
    • 17. 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, tenofovir tablet,Truvada tablet• FACTS – confirmatory trial underway,CAPRISA protocol, S. Africa17
    • 18. 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?) 18
    • 19. 19YouTubehttp://tinyurl.com/RectalRevEnglishhttp://tinyurl.com/RectalRevSpanish
    • 20. Post-exposure prophylaxis (PEP)Provide 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• Must be taken within 72 hours ofinitial exposure, small window• ARVs must be taken for 28 days20
    • 21. 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• 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 testing21
    • 22. What isPrEP?**pre-exposure prophylaxis22
    • 23. 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?23
    • 24. So, what is PreP?• PrEP involves an HIV-negative person taking ARVs to reducerisk of infection BEFORE HIV exposure. It prevents HIV fromreproducing in a person’s body.• In current approved formulation, PrEP is taken in a single pillonce a day, every day (Truvada).• Truvada is currently the only combination of drugs approvedby the FDA for PrEP.• Truvada is a combination of tenofovir disoproxil fumarate(aka tenofovir or TDF) and emtricitabine.24
    • 25. 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 longterm25
    • 26. 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.htm26
    • 27. • 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, 201227
    • 28. • Dear Healthcare Provider Letter• Training Guide for Healthcare Providers• Important Safety Information for Healthcare Providers• Safety Information Fact Sheet• Agreement Form• Checklist for Prescribers• Medication Guide• Important Safety Information for Uninfected Individuals• Full Prescribing Information• www.truvadapreprems.com28What’s in the REMS?*28*Risk Evaluation and Mitigation Strategy
    • 29. CDC Interim Guidance on PrEP - 2011Before Starting PrEP• Conduct HIV antibodytest• Test for acute HIVinfection• Determine if women arepregnant, planningpregnancy, orbreastfeeding• Confirm person is atongoing high risk• If partner is poz,determine if ontreatment• Screen/vaccinate for hepB• Screen/treat STIs• Don’t prescribe PrEP tobreastfeeding women• Tell women that safetyof PrEP while pregnantnot fully assessed, butno harm reportedStarting PrEP Regimen• Prescribe one Truvadatablet daily• Prescribe no more that90-day supply,renewable only afterconfirmed HIV-. Ensurenegative pregnancy test.If pregnant, confirmwoman understandsabout PrEP use duringpregnancy• If hep B+, considerTruvada for treatmentand HIV PrEP• Provide risk reduction,PrEP adherencecounseling, andcondomsFollow-Up While on PrEP• Test for HIV antibodyevery 2-3 months• Conduct pregnancy testfor women at eachfollow-up visit; ifpregnant, discusscontinued PrEP use withpatient and prenatalcare provider• Evaluate and supportPrEP adherence at eachvisit, or more often ifneeded• Assess risk behaviorsand provide condomsand counseling every 2-3 months. Test for STIsand treat, if presentStopping PrEP• Test for HIV to confirmstatus• If poz, test for resistanceand link to care• If neg, link to riskreduction services• If hep B active whenPrEP started, considerongoing treatment• If pregnant, tell prenatalcare provider of PrEPuse in early pregnancyand coordinate care toprevention MTCtransmission29
    • 30. 30
    • 31. 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)31
    • 32. 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 +)– Daily Tenofovir (75% chose directly-observed therapy)– BTS results being reported in thenext couple of months32
    • 33. 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-pillarm– 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 decreasedacross all study arms33
    • 34. Home-grown Chicago PrEP research• iPrEx OLE (open label extension)– 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 coming!34
    • 35. 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?35
    • 36. 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?36
    • 37. 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?37
    • 38. 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.• Nausea most common (under 10%) andresolved in 4 to 6 weeks38
    • 39. Key research findings/Truvada• None of the Truvada PrEP trials to date haveshown increases in sexual risk behavior amongparticipants• Across all PrEP studies of Truvada, there havebeen no serious safety problems• Very little drug resistance has been seen, onlyamong those with unidentified HIV infectionwhen they started the study39
    • 40. 40The research continues
    • 41. 41
    • 42. 42
    • 43. The research continues43
    • 44. 44Relative 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
    • 45. 45Condom Efficacy By Consistency of Use AmongMen Who Have Sex with Men (MSM) in the USCondoms offer substantial but partial protection against HIV infection1Reported sexual behavior and condom usein 6-month intervalReceptive or Insertive Anal IntercourseEfficacyAlways use vs. Never use 69.7 %Sometime vs. Never use 4.4 %1. Smith DK, et al. CROI 2013; Atlanta, GA. Oral #322. Weller S, et al. Cochrane Database Syst Rev 2002:CD003255Analyzed efficacy of condoms in reducing HIV transmission inHIV-uninfected MSM who had anal sex with at least 1 HIV-infected partner from 2 USstudies (N=3490): VaxGen 004 and Project Explore1
    • 46. What PrEP does not do• PrEP does not– Guarantee a 100% protection from HIV (nothing does)– Protect a person against other STIs like chlamydia,syphilis, herpes, or gonorrhoea– Prevent pregnancy• Male and female condoms are still necessary to protectagainst STIs and unplanned pregnancy– Cure HIV– Function as a treatment regimen for someone alreadyliving with HIV46
    • 47. 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 treatment47
    • 48. 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, improvingadherence, reducing risk behaviors, info on financial casemanagement, fact sheets, risk index, counseling info, andquality measures48
    • 49. Taking PrEP – what does it take?• Adherence! Taking the pill every day.• Honest, open, and on-going discussions with amedical provider about sexual activity, HIV risk• HIV antibody test – before first prescription, beforeeach prescription renewal• Hepatitis B testing• Kidney function• STI screening• Pregnancy testing• Doctor visits approx. every 3 mosto conduct all the above49
    • 50. Who should take PrEP?• Person indicates interest in taking PrEP• Why would someone want to take PrEP?• Person is HIV-negative and has HIV+ partner50
    • 51. Who might be a good fit for PrEP?• Sexual activity within high prevalence area or socialnetwork, 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 abovefactors is true for partner51
    • 52. What about…52
    • 53. And about condoms…54
    • 54. And about condoms…• Male and female (insertive) condoms are two of the mosteffective ways to reduce sexual transmission of HIV, STIs,and unintended pregnancy• FDA’s indication advises use of condoms while on PrEP– Results from PrEP clinical trials reflect condom promotion,and increased use based on self-report– PrEP doesn’t protect against STIs or pregnancy• However, PrEP on its own is an option for individualswho are not always able to use condoms55
    • 55. 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:e87556
    • 56. Advantages• Minimal side effects• Convenience• EffectivenessDisadvantages• Resistance• BehavioralCost• PrEP estimated $14,400/yr (varies by source andattendant services)• Annual cost of ARV for POZ = $24,000 +/-• Intervention not foreverCDPH2011PolicyAnalysis57
    • 57. 58
    • 58. Accessing PrEP— from your doctor• Any doctor who can write aprescription can write one forTruvada as PrEP• Most HIV docs are familiarwith PrEP• CORE, John StrogerHospital, TPAN doesreferrals, etc.• Bring along a fact sheet if youthink your doctor may needsome PrEP ed!59
    • 59. Accessing PrEP—insuranceFDA approval ofTruvada enablesprivate ins to coverTruvadaonMedicaidformularySome inscompanies, stateshave not yet decidedto coverADAPdoes notcover PrEP60
    • 60. Accessing PrEP – Gilead1. Visitwww.truvada.com2. Click on the link toaccess informationabout Truvada for aPrEP indication61
    • 61. Alternatively, you can visitwww.start.truvada.comAccessing PrEP62
    • 62. • Free male and female condoms are availablethrough www.Truvada.comMale and female condoms63
    • 63. 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 check6464
    • 64. Medication assistance form65
    • 65. • Uninsured, financial need• Available through www.Truvada.com• Prescribers must first complete an onlineassessment of the REMS materials, and thenmay register to offer free testingFree HIV/HBV testing66
    • 66. Hepatitis B and PrEP• The drugs in Truvada treat Hep B• A person considering PrEP must be tested for Hep Bbefore starting PrEP• If person is negative, he/she should get the Hep Bvaccine• People with Hep B may still be able to take Truvada forPrEP– This decision must be made with the advice of clinician– Any decision to stop should be done in conjunction with amedical provider67
    • 67. www.Truvada.com – Providers• Allows providers to:– Access to free 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 subsidized testingfor 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 download68
    • 68. www.Truvada.com – HIV neg people• Allows HIV-1 uninfected individuals to:– Common questions, safety information– Access to free condoms– Opt-in for reminder service regarding regular testing for HIV-1and other STDs (coming soon)69
    • 69. Helping your clientsunderstand PrEP70
    • 70. 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?)71
    • 71. Messages to emphasize to clients• Daily use of Truvada prescription of PrEPcannot and does not function as HIVtreatment.• PrEP user must be engaged with regularhealth care for prescription, to ensureremaining negative, staying adherent,kidney health, etc.• PrEP doesn’t make male or femalecondoms obsolete!72
    • 72. Tips for talking about PrEP• Important you feelcomfortable and confidenttalking about PrEP.• It’s okay to not have all ofthe answers and to referyour client to additionalresources and/or promiseto have that informationnext time you see him/her.73
    • 73. 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.74
    • 74. 75“It is frustrating to hear experts say thatprescribing Truvada to someone couldgive them an unrealistic sense of safetyfrom becoming HIV+. Im sure thatstrue for some...but judging from myown REAL (not hypothetical)experience, it makes me more aware ofthe risks Im taking. I am reminded ofthose risks on a daily basis, every time Iopen that bottle and swallow that bluepill. I dont take them lightly. If I did, Iwouldnt go through the trouble of usingTruvada.”– Woman with HIV+ partner who started PrEPbecause they wanted to have a child
    • 75. Adherence, Adherence, Adherence• Adherence to PrEP regimen is critical• PrEP works if you take it.It doesn’t work if you don’t take it.• Clients may need additional adherence support• Strategies for adherence include:– Take pill each day at same time– What might other strategies be?– Place pill bottle in visible place, same place– Set cell phone alarms76
    • 76. • My PrEP Experiencewww.myprepexperience.blogspot.com (training slides)• RSP on FB https://www.facebook.com/ProjectRSP• Project PrEPare www.projectprepare.net• Truvada as PrEP www.Truvada.com• Project Inform www.projectinform.org/prep• AVAC www.avac.org– Thanks to AVAC for several slidesWeb resources on PrEP77
    • 77. 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?78
    • 78. Please stay in touch• Sybil Hoseksybilhosek@gmail.com• Staci BushStaci.Bush@gilead.com• Jessica Terlikowskijterlikowski@aidschicago.org• Jim Pickettjpickett@aidschicago.org• Project RSP!myprepexperience@gmail.com79
    • 79. Thank you!!80