3/9/2017

Overview

DavidAlainWohl,MD
Where are we with prevention?
NCAnnualSTDUpdate Where are we with treatment?
March8,2017
Where are we going?

Wherearewewith HIV?

Overview New HIV infections in US are down a bit

Newdiagnosesdownfrom
Where are we with prevention? ~50,000to~40,000/year
Where are we with treatment? Forwomen,40%declinesince
2005!
Where are we going? AAwomendown42%
ForMSMup11%
AAandLatinoMSMup>20%
Butslowinginrecentyears
WhiteMSMdown18%

http://www.cdc.gov/nchhstp/newsroom/docs/factsheets/hivdatatrendsfactsheet508.pdf

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http://www.cdc.gov/nchhstp/newsroom/docs/factsheets/hivdatatrendsfactsheet508.pdf

http://www.cdc.gov/nchhstp/newsroom/docs/factsheets/hivdatatrendsfactsheet508.pdf http://www.cdc.gov/nchhstp/newsroom/docs/factsheets/hivdatatrendsfactsheet508.pdf

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PrEP Tipping Point CDC:NumbersofPersonsatRiskforHIVRemainHigh,

TDF/FTCPrEP isaneffectiveinterventionforHIVpreventionbutsinceits
butPercentagesVarybyPopulation
approvaluptakehadbeenslowandselective.Thingsarestartingtochange. Estimated percentages andnumbers ofadultswithindications for PrEP,by
transmission riskgroup,UnitedStates,2015

%withPrEP
Transmission risk group Estimated number (95% Cl)
indication*
Men who have sex with men,
24.7 492,000 212,000772,000
aged 1859 yrs
Adults who inject drugs, 45,000185,000
18.5 115,000
aged >18yrs
Heterosexually active adults, 404,000846,000
0.4 624,000
aged 1859 yrs
Men** 0.2 157,000 62,000252,000
Women 0.6 468,000 274,000662,000
Total 1,232,000 661,0001 ,803,000

Mera R,etal.AIDSConference2016;Durban,SouthAfrica.AbstractTUAX0105LB
SmithD,etal.MMWRMorb MortalWkly Rep2015;64:16 Smith D, et al. MMWR Morb Mortal Wkly Rep 2015;64:1-6
BushS,etal.ASMMicrobe/ICAAC2016;Boston,MA.Abstract2651
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Gender/SexDifferencesinNewPrEPStarts
DifferencesinPrEPStartsby
intheUS(20122015) Race/EthnicityandSex/Gender*
42,545
40000
8000
4YearTotal:79,684 35,232

UniqueIndividualsInitiating
35000 7000
Men: 60,872 Male Female

FTC/TDFforPrEP(n)
30000 6000
Women: 18,812
5000
25000 21,906
4000
20000 3000
16,855
15000 2000
9,023
1000
10000 6,210
7,313
5,315 5,051 0
3,470 3,708 2012 2013 2014 2015 2012 2013 2014 2015 2012 2013 2014 2015 2012 2013 2014 2015
5000 2,740
White African-
Hispanic Asian
0 American
2012 2013 2014 2015 WhilethenumberofwomenwhoinitiateFTC/TDFforPrEPislowacross
allraces/ethnicities,therateofFTC/TDFforPrEPinitiationamongAfricanAmericanand
HispanicwomenissignificantlylessthanthatofWhitewomen

* These data represent 43.7% (n = 21,463) of unique individuals who have started
FTC/TDF for PrEP from 2012 Q3 2015.
Bush S, et al. ASM Microbe / ICAAC 2016; Boston, MA. Abstract 2651.
MeraR,etal.AIDSConference2016;Durban,SouthAfrica.AbstractTUAX0105LB.

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KHMayer,KMMaloney,KLevine,DKing, CGrasso, DKrakower,SLBoswell

IDWeek 2016Oct2630NewOrleans

KHMayer,KMMaloney,KLevine,DKing, CGrasso, DKrakower,SLBoswell

IDWeek 2016Oct2630NewOrleans

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Overview

Where are we with prevention?

Where are we with treatment?
Where are we going?

USDHHSARVGuidelinesRecommended1st Line(sortof) START:ImmediatevsDeferredTherapy

TAF/FTC/Elvitegravir/cobicistat
forAsymptomatic,ARTNaivePts
International,randomizedtrial Study closed by DSMB
following interim analysis
Abacavir/3TC/Dolutegarvir (Triumeq)
Immediate ART
ART initiated immediately
Abacavir/3TC+Dolutegarvir following randomization
HIV-positive, ART-naive (n = 2326)
adults with CD4+ cell
count > 500 cells/mm3
Deferred ART
TAF/FTC+Raltegravir (N = 4685)
Deferred until CD4+ cell count 350 cells/mm3,
AIDS, or event requiring ART
(n = 2359)

Primarycompositeendpoint(target=213)
SeriousAIDSordeathfromAIDS
TAF/FTC+Darunavir/cobicistat
SeriousnonAIDSeventsanddeathnotattributabletoAIDS
CVD,ESRD,decompensatedliverdisease,nonAIDSdefiningcancers

INSIGHT START Study Group. N Engl J Med. 2015;373:795-807.

Lundgren J, et al. IAS 2015. Abstract MOSY0302.

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START:PrimaryOutcome START:SeriousAIDSEvents
72%reducedriskofseriousAIDSeventswithimmediateART
10 Immediate ART 57%reducedriskof
Deferred ART 10
seriouseventsordeath Immediate ART

Cumulative Percent With

Cumulative Percent

8 Deferred ART
withimmediateART 8
With Event

6 5.3
68%ofprimary

an Event
6
4 endpointsoccurredinpts
2.5 4
2 withCD4+cellcounts>
500cells/mm3 2
0
0 6 12 18 24 30 36 42 48 54 60 0
Mos 0 6 12 18 24 30 36 42 48 54 60
Mos
Primary Endpoint Immediate ART Deferred ART
Serious AIDS Events Immediate ART Deferred ART
No. with event (%) 42 (1.8) 96 (4.1)
No. with event (%) 14 50
Rate/100 PY 0.60 1.38
Rate/100 PY 0.20 0.72
HR (immediate/deferred) 0.43 (95% CI: 0.30-0.62; P < .001) HR (immediate/deferred) 0.28 (95% CI: 0.15-0.50; P < .001)

INSIGHT START Group. N Engl J Med. 2015;373:795-807. INSIGHT START Study Group. N Engl J Med. 2015;373:795-807.
Lundgren J, et al. IAS 2015. Abstract MOSY0302. Lundgren J, et al. IAS 2015. Abstract MOSY0302.

START:SeriousNonAIDSEvents INCREASED PERSISTENCE OF INITIAL ART WITH INSTI-CONTAINING REGIMENS

THIBAUT DAVY, SONIA NAPRAVNIK, OKSANA ZAKHAROVA, JOSEPH J. ERON

39%reducedriskofseriousnonAIDSeventswithimmediateART

10
Immediate ART
Cumulative Percent With

Deferred ART
8
an Event

0
0 6 12 18 24 30 36 42 48 54 60 Discontinuation Virologicfailure
HR(95%CI) HR(95%CI)
Mos INSTI 0.49(0.35,0.69) 0.70(0.46,1.06)
bPI 1.24(1.05,1.47) 1.24(1.01,1.53)
Serious Non-AIDS Events Immediate ART Deferred ART Other 1.47(1.24,1.75) 1.21(0.99,1.46)
NRTI 2.98(2.38,3.74) 1.72(1.35,2.19)
No. with event 29 47
NNRTI Ref. Ref.
Rate/100 PY 0.42 0.67
HR (immediate/deferred) 0.61 (95% CI: 0.38-0.97; P = .04)

INSIGHT START Study Group. N Engl J Med. 2015;373:795-807.

Lundgren J, et al. IAS 2015. Abstract MOSY0302.

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HIVDiagnosis,LinkagetoCare,andViralSuppression

100%
PercentofpersonslivingwithHIVintheUS,

90% 86%

80%

70%
2011(source:CDC)

60%

50%
40%
40% 37%
30%
30%

20%

10%

0%
Diagnosed Engagedincare PrescribedART VirallySuppressed

BradleyH,etal.MMWR2014;63:11137.

Overview Start ART Right NOW

StandardversussamedayART
Where are we with prevention? NonpregnantARTnaveadults,WHO
stage1or2disease,CD4count<500
Where are we with treatment? cells/mm3,noTBorpneumonia
Standardgroup
Where are we going? Days7,14,21(physician/social
workervisits);day21(ARTinitiation)
SamedayARTgroup
Day1(counselingandARTinitiation);
days3,10,17(physician/social
workervisits)

StudystoppedearlybyDSMBdueto
betteroutcomesinthesamedayART
group

KoenigS,etal.JAIDS.2016;19(suppl 5):64.

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Long Acting Parenteral ART & PrEP

The AMP Studies: Defining a new

path forward
AMP = Antibody Mediated Prevention

Thesearethefirsttrialstoassessif
antibodiescanbeusedtopreventHIV
infection(similartohowantibodiesprevent
otherdiseases).

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NAACCORD:
ContributionstoMIRiskinHIV+Subjects
Populationattributablefractionsand95%confidenceintervalsfortraditionalandHIV
relatedfactors,andhepatitisCvirusinfection,NAACCORD(1Jan2000 31Dec2013)
Populationattributable

80%
70%
traction(PAF)

60%
50% 41% 43%
38%
40%
30%
20%
10% 6% 8%
10% 2% 3% 2%
0%

Population attributable fractions have been adjusted for all the risk factors in the figure, as well as age,
sex, race, HIV transmission risk, diabetes, and stage 4 chronic kidney disease.

Althoff K, et al. 24th CROI; Seattle, WA; February 13-16, 2017. Abst. 130.

NCATEC has lots of resources

http://www.med.unc.edu/ncaidstraining/prep