Thompson Part 2 · TST: tuberculin skin test; IGRA: interferon gamma release assay. Non-inferiority...
Transcript of Thompson Part 2 · TST: tuberculin skin test; IGRA: interferon gamma release assay. Non-inferiority...
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LookingForward…
• Howoftenwilldualtherapywithfragiledrugs(3TC,rilpivirine)leadtointegrase monotherapy?Tointegrase resistance?
• Howoftenwillresistanceemergeduringsubtherapeutic dosingwithlongactingdrugs?
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NEJM 2017; 377:1605-7
NN
RTI
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5.GenericART
WillTheyDecreaseCosts?
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GenericTDF/3TC
GenericEFV600mg/TDF/3TC
GenericRitonavir
GenericEFV400mg/TDF/3TC
LookingForward:DOR/gTDF/g3TC
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Generics
Average Wholesale Price (AWP)
Wholesale Acquisition Cost (WAC)
Average Manufacturer Price (AMP) Nonfederal Average Manufacturer Price (Non-FAMP)
Federal Supply Schedule (FSS) Price
Federal Ceiling Price
Federal Ceiling; “Big 4” Price
Best Price
Medicaid Price340B Price
Private sector prices
Rebates to PBMsCopay assistance
Other price concessions
Unit rebate: 23.1% / 13% of AMP orAMP – Best Price plus
CPI penalties
76% of non-FAMP minus additional discounts
Supplemental rebates and discounts negotiated (including ADAPs)
Supplemental discounts negotiated (VA and DoD)
Negotiation on most-favored commercial customer price
DrugPricing:TheSimpleVersion
Federal Upper Limit
State Maximum Allowable Cost
Slide courtesy Tim Horn, ACTHIV 2018
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Lookingforward…
• Highprices=notsustainable,butwillgenericshelp?• Lackofpricetransparency
Ø “Secret”discounts&rebates,olderdrugsarecheaperØ Expensivemiddlemen(PharmacyBenefitManagers-
PBMs)Ø Copaycardstoshieldpatientsbutkeeppriceshigh
• Drugaccessisafragile“HouseofCards”• Advocacyneededhere!
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And…
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UnintendedConsequences
• Decoupling of single tablet regimens can lead to desynchronization of med refills• “I couldn’t afford both copays, so I only got one of them this
time.”• Generic costs are not necessarily cheap
• Some insurers place all generics on the highest tier• Generics may not be covered by “copay cards” may cost
the patient more than the more “expensive” drug• “They told me that they wouldn’t cover my TruvadaTM since
there is now a generic. But the generic cost $300. I couldn’t afford it.”
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6.TBTreatmentforPeoplewithHIV
Gamechangerornot?
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BRIEF-TB/A5279 Study:1MonthofRifapentine/IsoniazidtoPreventTBinPeopleWithHIV
Swindells S, et al. 25th CROI. Boston, 2018. Abstract 37LB.
Phase 3 (n=2996)
Open-label• HIV infected (≥13 years of age)• No evidence of active TB with
either:• TST reactivity ≥5 mm
and/or + IGRA, OR• Live in high TB burden
area• Permitted ART while on
rifapentine• Efavirenz- or nevirapine-
based regimens
Week 0 4 36 156
*Rifapentine 450 mg/day (<45 kg) or 600 mg/day (≥45 kg). All patients received vitamin B6 (25 mg) with INH.TST: tuberculin skin test; IGRA: interferon gamma release assay.Non-inferiority design: 1.25/100 person-years (ie, upper 95% CI of rate up to 3.25/100 person-years, 62.5% of control event rate).
Rifapentine +Isoniazid 300
mg/day
Isoniazid 300 mg/day
No Treatment
No Treatment
1monthRifa/INHnon-inferiorto9monthsINHalone
Endpoints:TB,TBdeath,ordeathfromunknowncauses
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But…
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Rifapentine (RPT)PK• InducesCYP3A4,thereforeinteractswithmostPIs,someINIs• DTGPKstudywithINH/RPTterminatedearlyduetotoxicity(2of3pts)
– Nausea,vomiting,fever,hypotensionrequiringhospitalization,grade2-4transaminaseelevation
• DTGexposuredecreased46%,Day14;Cmin decreased74%,Day15– OnesubjecthadmultipleCmin values<0.3μg/mL
Brooks K, et al. CROI 2017. Abstract 409a
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PKwithRifampinTAF/Rifampin:ProbablyOK• ImpactofrifampinonTVF-DP
plasmaconcentrations– TDF:decreased55%– TAF:decreased36%
• ImpactofrifampinonTVF-DPintracellularconcentrations– TDF:decreasedby40%– TAF:increasedby76%relative
toTDFwithoutrifampin• Nodatawithrifapentine
BIC/Rifampin: JustSayNo!• PlasmaBICconcentrations:
~60%lower• TroughBICconcentrations:
~80%lower• Twicedailydosingdoesnot
mitigatetheeffect• Nodatawithrifapentine but
wouldavoid
Cerrone M, et al. 25th CROI. Boston, 2018. Abstract 28LB. Custodio JM, et al. 25th CROI. Boston, 2018. Abstract 34.
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LookingForward:OptimalARTforTB?Newdrugs?
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7.TheOpioidEpidemic
NCHS data brief, no 282. Hyattsville, MD: National Center for Health Statistics. 2017.
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OpioidDeathsRise,EspeciallyinYouth15-19
Curtin SC, Tejada-Vera B, Warner M. Drug overdose deaths among adolescents aged 15–19 in the United States: 1999–2015. NCHS data brief, no 282. Hyattsville, MD: National Center for Health Statistics. 2017.
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NewClustersofHIVInfectionAssociatedwithIDU
https://www.cincinnati.com/story/news/2018/01/09/nky-cincinnati-see-sharp-rise-hiv-cases-linked-injected-drug-use-cdc-assist-nky/1012532001/
https://www.bostonglobe.com/metro/2017/12/16/uptick-hiv-among-injecting-drug-users-raises-fears-resurgent-epidemic/Mrzu1glhYosSGR3mVEEiLP/story.html
• NorthernKentucky:18cases(upfrom0to5/yr)• Cincinnati:126cases(upfrom91)• Massachusetts:78casesamongPWID,100%increase
http://www.bostonglobe.com/metro/2018/04/05/cdc-investigate-puzzling-surge-hiv-lawrence-lowell-among-injecting-drug-users/XHgt4NKAgdxVKgdzH8TZbI/story.html
April 5, 2018
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LookingForward…
• Remind lawmakers about ID complications of the opioid epidemicØ HIV, hepatitis B and CØ Infective endocarditisØ Skin and soft tissue infections
• Ryan White clinics need expansion funding to offer Medication Assisted Treatment
• Bills are pending on “The Hill.” Advocacy is urgently needed right now!
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8.TheSTDEpidemicCulture Clashes and Funding Deficits
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PrimaryandSecondarySyphilis— ReportedCasesbySexandSexualBehavior,36States*,2012–2016
*36stateswereabletoclassify≥70%ofreportedcasesofprimaryandsecondarysyphilisaseitherMSM†,MSW†,orwomenfor eachyearduring2012–2016.† MSM=Gay,bisexual,andothermenwhohavesexwithmen(collectivelyreferredtoasMSM);MSW=Menwhohavesexwithwomen only.
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PrimaryandSecondarySyphilis— ReportedCasesbySexandSexualBehavior,36States*,2012–2016
*36stateswereabletoclassify≥70%ofreportedcasesofprimaryandsecondarysyphilisaseitherMSM†,MSW†,orwomenfor eachyearduring2012–2016.† MSM=Gay,bisexual,andothermenwhohavesexwithmen(collectivelyreferredtoasMSM);MSW=Menwhohavesexwithwomenonly.
Bi
Benzathine Penicillin G Crisis
• Unavailable – sole source manufacturing chain = stock-outs
• Unaffordable – prices as high as $350 per dose, far exceeding reimbursement
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http://pittsburgh.cbslocal.com/2018/03/09/beaver-county-std-uptick/
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http://www.foxnews.com/health/2018/03/08/shock-in-milwaukee-over-new-outbreak-hiv-and-syphilis-including-babies-and-teens.html
• 125personswithHIV,syphilisorboth– 13%increaseinHIV;29%syphilis;12%gonorrhea
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GovernorScottWalkercutevidence-basedsexeducation,fundedabstinenceonlyprograms.
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The2018OmnibusfederalbudgetincreasedCDC’s2019STDbudgetby$5million(replacing
fundsthatwerepreviouslycut.)
Thiswasnotanaccident– thiswasadvocacy!LookingForward:Moreadvocacyneeded!
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• Ceftriaxone MIC of 0.5 mg/L • Azithromycin MIC of >256 mg/L (high-level azithromycin resistant, HLAziR)• Susceptible only to spectinomycin. • “This is the first global report of HLAziR N. gonorrhoeae which is also resistant to ceftriaxone.”
Public Health England, Health Protection Report Volume 12 Number 11
Looking Forward: With an accelerating STD epidemic, Bad Bugs are just a flight away from your clinic!
• Advocacy for state/federal STD clinic funding• Antimicrobial stewardship• New drugs needed!
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9.HealthPolicyThreatsACA,Medicaid,Medicare,RyanWhite,
PEPFAR,affordablemedicationsAllunderattack…
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BudgetBulletDodged(Temporarily)
CongressrejectedtheWhiteHouse’sbudgetthatwouldhave
– EliminatedRyanWhiteAETCsandSPNS– CutfundingforNIAIDby$111million– CutCDCfundingby$767million– SlashedfundingforPEPFAR,theGlobalFund,globalTBprograms
Thiswasnotanaccident– thiswasadvocacy!
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ThreatstothePatientProtectionandAffordableCareAct
• Marketinstability:eliminationofcostsharingreductionsresultsinhigherpremiums
• Waiversallowfinancialpenaltiesforpreexistingconditions• EliminationofEssentialHealthBenefits(prescriptiondrugs!)• Restorationoflifetimecapsonoutofpocketspending• Cheaper“junk”insurance:lowpremium,lowcoverage
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Slide 33 of 79
ThreatstoContinuousAccesstoAffordableART
• Priorauthorizations• Step-therapy• 30dayquantitylimits• ARVplacedonhighesttiers,subjecttohighcoinsurance,aviolationoftheanti-discriminationclause,Section1557oftheACA
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Slide 34 of 79
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CopayAccumulatorProgramsIncreasing
• Manufacturerco-paycardsnolongercounttowardapatient’sdeductibleorout-of-pocketmaximum
• Insurersusemisleadingterms:“CouponAdjustment:BenefitPlanProtectionprogram”or“OutofPocketProtectionProgram.”=FAKENEWS!
• Patientgetsstuckwithentiredeductible,makingARTunaffordableformanypeople.
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HOT! NewCMSBudgetGutsACA
https://www.cms.gov/About-CMS/Agency-Information/PerformanceBudget/Downloads/FY2019-CJ-Final.pdf, p10
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LookingForward…MoreoftheSame!KeepYourEyeontheFinePrint!
SpeakUp!
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Speakup.hiv
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10.StigmaandDiscrimination
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Ploumen L, Address at UN High Level Meeting on AIDS, June 9, 2016
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LeadershipMatters:VastlyDifferentRealities
VS
“Quarantine”
“Whatcanwelegallydo”
“...welltheyarecarriers,withthepotentialtospreadwhereasinthepasttheydiedmorereadily…notposingarisk
“ …firststateinthenationcommittedtoendingthisepidemic.”
SlidecourtesyCarlosdelRio,JonathanColasanti
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“ItwasonlywhenIlearnedaboutU=UthatIrealizedthatIhavebeenlivingforalltheseyearscarryingthisheavyweight.BecauseItookmymeds,Ikeptonliving.ButinsideIfeltlikeIwasdying.Andthatmademeafraidtogetclosetoanyoneelse.ThenightIheardaboutU=U,Icouldn’tstopcrying.ItwaslikethatburdenIdidn’tevenrealizeIwascarryingjustfellaway.”
Slide adapted from Robert Remien; CROI 2018
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AND…
• No White House Office of National AIDS Policy• Presidential Advisory Council on HIV/AIDS disbanded• National HIV/AIDS Strategy removed from White
House website
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But…there’smore…Emboldenedwhitesupremacy
PoliceviolenceReligiouspersecution
Anti-immigrant&anti-LGBTQhatecrimesVotersuppression
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WhyDoesThisMatter?
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Wearecaughtinaninescapablenetworkofmutuality,tiedinasinglegarmentofdestiny.Whateveraffectsonedirectly,affectsallindirectly.
-MartinLutherKing,Jr
Why We Can’t Wait, 1963
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CivilRights- UnderAttack- WhatDoWeDo?
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ACTUP,FIGHTBACK
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Slide 49 of 79
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“Our lives begin to end the day
we become silent about things that
matter” #MLK50
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ActivateYourInnerActivistMobilize,Organize,#Resist
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Acknowledgements
AppreciationforSlides,Data,Inspiration,Support• JonathanColasanti,CarlosdelRio– GradyIDP/Emory• Demetre Daskalakis,StaceyWilkins–NYCDOH• TimHorn• MichaelMugavero• Onyema Ogbuagu• RobertRemien• DawnSmith- CDC
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ACTUP,FIGHTBACK