LookingForward…

• Howoftenwilldualtherapywithfragiledrugs(3TC,rilpivirine)leadtointegrase monotherapy?Tointegrase resistance?

• Howoftenwillresistanceemergeduringsubtherapeutic dosingwithlongactingdrugs?

NEJM 2017; 377:1605-7

NN

RTI

5.GenericART

WillTheyDecreaseCosts?

GenericTDF/3TC

GenericEFV600mg/TDF/3TC

GenericRitonavir

GenericEFV400mg/TDF/3TC

LookingForward:DOR/gTDF/g3TC

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

Lookingforward…

• Highprices=notsustainable,butwillgenericshelp?• Lackofpricetransparency

Ø “Secret”discounts&rebates,olderdrugsarecheaperØ Expensivemiddlemen(PharmacyBenefitManagers-

PBMs)Ø Copaycardstoshieldpatientsbutkeeppriceshigh

• Drugaccessisafragile“HouseofCards”• Advocacyneededhere!

And…

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.”

6.TBTreatmentforPeoplewithHIV

Gamechangerornot?

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

But…

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

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.

LookingForward:OptimalARTforTB?Newdrugs?

7.TheOpioidEpidemic

NCHS data brief, no 282. Hyattsville, MD: National Center for Health Statistics. 2017.

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.

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

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!

8.TheSTDEpidemicCulture Clashes and Funding Deficits

PrimaryandSecondarySyphilis— ReportedCasesbySexandSexualBehavior,36States*,2012–2016

*36stateswereabletoclassify≥70%ofreportedcasesofprimaryandsecondarysyphilisaseitherMSM†,MSW†,orwomenfor eachyearduring2012–2016.† MSM=Gay,bisexual,andothermenwhohavesexwithmen(collectivelyreferredtoasMSM);MSW=Menwhohavesexwithwomen only.

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

http://pittsburgh.cbslocal.com/2018/03/09/beaver-county-std-uptick/

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

GovernorScottWalkercutevidence-basedsexeducation,fundedabstinenceonlyprograms.

The2018OmnibusfederalbudgetincreasedCDC’s2019STDbudgetby$5million(replacing

fundsthatwerepreviouslycut.)

Thiswasnotanaccident– thiswasadvocacy!LookingForward:Moreadvocacyneeded!

• 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!

9.HealthPolicyThreatsACA,Medicaid,Medicare,RyanWhite,

PEPFAR,affordablemedicationsAllunderattack…

BudgetBulletDodged(Temporarily)

CongressrejectedtheWhiteHouse’sbudgetthatwouldhave

– EliminatedRyanWhiteAETCsandSPNS– CutfundingforNIAIDby$111million– CutCDCfundingby$767million– SlashedfundingforPEPFAR,theGlobalFund,globalTBprograms

Thiswasnotanaccident– thiswasadvocacy!

ThreatstothePatientProtectionandAffordableCareAct

• Marketinstability:eliminationofcostsharingreductionsresultsinhigherpremiums

• Waiversallowfinancialpenaltiesforpreexistingconditions• EliminationofEssentialHealthBenefits(prescriptiondrugs!)• Restorationoflifetimecapsonoutofpocketspending• Cheaper“junk”insurance:lowpremium,lowcoverage

Slide 33 of 79

ThreatstoContinuousAccesstoAffordableART

• Priorauthorizations• Step-therapy• 30dayquantitylimits• ARVplacedonhighesttiers,subjecttohighcoinsurance,aviolationoftheanti-discriminationclause,Section1557oftheACA

Slide 34 of 79

CopayAccumulatorProgramsIncreasing

• Manufacturerco-paycardsnolongercounttowardapatient’sdeductibleorout-of-pocketmaximum

• Insurersusemisleadingterms:“CouponAdjustment:BenefitPlanProtectionprogram”or“OutofPocketProtectionProgram.”=FAKENEWS!

• Patientgetsstuckwithentiredeductible,makingARTunaffordableformanypeople.

HOT! NewCMSBudgetGutsACA

https://www.cms.gov/About-CMS/Agency-Information/PerformanceBudget/Downloads/FY2019-CJ-Final.pdf, p10

LookingForward…MoreoftheSame!KeepYourEyeontheFinePrint!

SpeakUp!

Speakup.hiv

10.StigmaandDiscrimination

Ploumen L, Address at UN High Level Meeting on AIDS, June 9, 2016

LeadershipMatters:VastlyDifferentRealities

VS

“Quarantine”

“Whatcanwelegallydo”

“...welltheyarecarriers,withthepotentialtospreadwhereasinthepasttheydiedmorereadily…notposingarisk

“ …firststateinthenationcommittedtoendingthisepidemic.”

SlidecourtesyCarlosdelRio,JonathanColasanti

“ItwasonlywhenIlearnedaboutU=UthatIrealizedthatIhavebeenlivingforalltheseyearscarryingthisheavyweight.BecauseItookmymeds,Ikeptonliving.ButinsideIfeltlikeIwasdying.Andthatmademeafraidtogetclosetoanyoneelse.ThenightIheardaboutU=U,Icouldn’tstopcrying.ItwaslikethatburdenIdidn’tevenrealizeIwascarryingjustfellaway.”

Slide adapted from Robert Remien; CROI 2018

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

But…there’smore…Emboldenedwhitesupremacy

PoliceviolenceReligiouspersecution

Anti-immigrant&anti-LGBTQhatecrimesVotersuppression

WhyDoesThisMatter?

Wearecaughtinaninescapablenetworkofmutuality,tiedinasinglegarmentofdestiny.Whateveraffectsonedirectly,affectsallindirectly.

-MartinLutherKing,Jr

Why We Can’t Wait, 1963

CivilRights- UnderAttack- WhatDoWeDo?

ACTUP,FIGHTBACK

Slide 49 of 79

“Our lives begin to end the day

we become silent about things that

matter” #MLK50

ActivateYourInnerActivistMobilize,Organize,#Resist

Acknowledgements

AppreciationforSlides,Data,Inspiration,Support• JonathanColasanti,CarlosdelRio– GradyIDP/Emory• Demetre Daskalakis,StaceyWilkins–NYCDOH• TimHorn• MichaelMugavero• Onyema Ogbuagu• RobertRemien• DawnSmith- CDC

ACTUP,FIGHTBACK