clinical impact of new data from croi 2016

8/19/2019 Clinical Impact of New Data From CROI 2016

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CCO Independent Conference Coverage*of the 2016 Conference on Retroviruses and Opportunistic InfectionsFebruary 22-25, 2016Boston, assachusetts

Clinical Impact of New Data FromCROI 2016

!CCO is an independent "edica# education co"pany that provides state-of-the-art "edica#infor"ation to hea#thcare professiona#s throu$h conference covera$e and other educationa# pro$ra"s%

&his pro$ra" is supported by independent educationa# $rants fro"'ii' (ea#thcare )a*or +upporter and erc%


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Faclt%

&oel '( )allant +D +,-Medical Director of Specialty Services+outhest C3R4 Center +anta Fe, e eico Adjunct Professor of Medicine7ivision of Infectious 7iseases8ohns (opins 9niversity +choo# of edicineBa#ti"ore, ary#and

C"arle# .( -ic/# +DProfessor of Clinical MedicineDirector , Oen C#inic9niversity of Ca#ifornia, +an 7ie$o+an 7ie$o, Ca#ifornia


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Di#clo#re#

&oel '( )allant +D +,- has disc#osed that he hasreceived consu#tin$ fees fro" Bristo#-yers +:uibb,;i#ead +ciences, 8anssen, erc, and 'ii' and fundsfor research support fro" 3bb'ie, Bristo#-yers +:uibb,

;i#ead +ciences, 8anssen, erc, +an$a"o, and 'ii'%C"arle# .( -ic/# +D has disc#osed that he hasreceived consu#tin$ fees fro" Bristo#-yers +:uibb,;i#ead +ciences, 8anssen, erc, and 'ii'%


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,revention


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.+D $b#td% of i,r' !DFF!C ,r', v#,lacebo in -I34Neg -ig"4Ri#/ +$+!)5

i/r4. doub#e-b#ind, rando"i??. >>@ re#ativereduction in cu"u#ative (I' ris ith &7FAF&C vs /BO)P = %005B1C

i/r4 7D3 B7 substudy ) = >?EB2C.

+"a## net decrease in spine )-0%?1@ and tota# hip )-0%61@ B7ith &7FAF&C vs /BO at 2> )P = %001 for bothG no differencein fracture rate beteen $roups )P = %62

Current ana#ysis eva#uated B7 chan$es after /r4/ stop visitBHC

+#ide credit. c#inica#options%co"

1% ;rant R, et a#% 4n$# 8 ed% 2010GH6H.25E-25??%2% u##i$an J, et a#% C#in Infect 7is% 2015G61.52-5E0%H% ;rant R, et a#% CROI 2016% 3bstract >EKB%

DXA:

i,r' RC!edian. 1%2 yrs

,r', )apedian. 1%5 yrs

i,r' O'1%> yrs

. 'ver% 27 5/# ,r',dc

6 +o# ,o#tdc

O''nroll

8

http://www.clinicaloptions.com/oncologyhttp://www.clinicaloptions.com/oncology


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7ata co"pared for &F'-7/ L or M 16 f"o#A viab#e /BC, concentrationassociated ith ?0@ reduction in (I' infection ris in +A&;

+#ide credit. c#inica#options%co";rant R, et a#% CROI 2016% 3bstract >EKB%!P L %001G NP L %05

C " a n g e i n . + D F r o m

i ,

r ' ' n r o l l m e n t 9 : ;

$pine-ip

. 5/ 27 Dc 64+o# ,o#tdc

O''nroll

. 5/ 27 Dc 64+o# ,o#tdc

O''nroll

2%0

1%5

1%00%50

-0%5-1%0

-1%5

2%01%51%00%5

0-0%5-1%0-1%5

H%0

2%0

1%0

0-1%0

-2%0

-H%0

H%0

2%0

1%00

-1%0

-2%0

-H%0

Age < 2= >r#/#acebo 2> &F'-7/ L 16 2> &F'-7/ M 16

Age ? 2= >r#

Age < 2= >r#

Age ? 2= >r#

!

!! N

!!

.+D $b#td% of i,r' .+D Recover%After Di#contination of !DFF!C ,r',



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Ca#e Report +lticla## Re#i#tant -I3Infection De#pite -ig" Ad"erence to ,r',

>H-yr-o#d + ac:uired "u#tic#ass resistant (I'-1 infection fo##oin$2> "os of ora# once-dai#y &7FAF&C /r4/

/har"acy records, b#ood concentration ana#yses, and c#inica# historysupport recent and #on$-ter" adherence to /r4/

/r4/ fai#ure #ie#y resu#t of eposure to /r4/-resistant, "u#tic#assresistant (I'-1 strain

Jno 7C, et a#% CROI 2016% 3bstract 16?aKB%

Drg Cla##+tation# Detected on Da% @Following p274,o#itive !e#t

'#timated Fold4C"ange in IC=0 orC"ange in Re#pon#e 9Drg;

R&I >1K, 6;, 6?7, 0R, 1E>', 21541%? )3BC, 61 )H&C, HE )F&C, 1%H

)&7FR&I 1E1C >H )'/

/I 10I o re#evant chan$e

I+&I 51, ?2PReduced )R3K, resistant )4';,

reduced )7&;




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+!N4020A$,IR' I,+402@ Dapivirine3aginal Ring for -I3 ,revention in 5omen

+i#icone e#asto"er va$ina# "atri rin$ containin$ R&I dapivirine25 "$G rin$ rep#aced every > s

Rando"i


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+!N4020A$,IR' I,+402@ 'fficac% and$afet% of Dapivirine 3aginal Ring 4fficacy for (I' prevention si"i#ar in both studies

o c#inica##y re#evant safety differences beteen ar"s

!4c#udes 2 sites ith #o adherence%

1% Baeten 8, et a#% CROI 2016% 3bstract 10?KB%2% Baeten 8, et a#% 4n$# 8 ed% 2016G4pub ahead of print%H% e# 3, et a#% CROI 2016% 3bstract 110KB%

Otcome

A$,IR'1,2 1= $ite# A$,IR'1,2 1E $ite#* !"e Ring $td%H

Dapivirine9n B 1E0;

,lacebo9n B 1E06;

Dapivirine9n B 11;

,lacebo9n B 11@;

Dapivirine9n B 1E00;

,lacebo9n B 6=0;

(I' infections, n 1 ? 5> E5 56

(I' incidence )per100 /s

H%H >%5 2%E >%> >%1 6%1

-I3 protectionefficac% :

2@ 9P B (076; E@ 9P B (00@; E1 9P B (070;

Among womenolder t"an 21%r#

4 =6 9P < (001; E@ 9P B (10;




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GCAIR Cabotegravir A in -I34Negative+en at ow Ri#/ for -I3 Infection

Cabote$ravir. potent I+&I for"u#ated as ora# tab#et and for K3I in*ection

Rando"i


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/ea C3B K3 eposure hi$her and trou$h eposure #oer thanpredicted because of "ore rapid absorption and re#ease after in*ection

S 0@ of pts had Ctrou$h L > protein-bindin$ ad*usted IC?0G every-E-dosin$ no under investi$ation

+ e a n 9 $ D

; , l a # m a C A .

C o n c e n t r a t i o n 9 g 2 m 6 ;

!ime From Fir#t I+ Do#e 95/#;aroit< , et a#% CROI 2016% 3bstract 106% Reproduced ith per"ission%

;eo"etric "ean Ctrou$h

ith 10 "$ /O P7.1%H5 T$A"K )K3&&4

> /rotein-bindin$ad*usted IC?0.0%66> T$A"K

/rotein-bindin$ad*usted IC?0.0%166 T$A"K

10

1

0%1

0%010 1 > E 121H 1E 2>25 H0 H6

Observed C3B E00 "$ I every 12 s )UCK3IRG n = ?>+i"u#ated C3B E00 "$ I every 12 s )"a#es


GCAIR ,redicted v# Ob#ervedCabotegravir A ,"armaco/inetic#



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GCAIR InJection $afet% and ,ainOtcome#

I+R events occurred in ?H@ ofpts ith I C3B vs 5@ ithp#acebo

o discontinuations for 34sdurin$ in*% phaseG hoever, >

pts ho ithdre consent notedin*% to#erabi#ity as reason

On 0 )none of ti"e to 6 )a## ofti"e painAdisco"fort sca#eassessed at H0, 6@ of pts

in C3B ar" reported painAdisco"fort a## of the ti"e

21@ of pts in C3B ar" reportedbein$ dissatisfied ith study"edication 34s

aroit< , et a#% CROI 2016% 3bstract 106%urray , et a#% CROI 2016% 3bstract >1% Reproduced ith per"ission%

I$R'vent

CA. 9n B 7; ,lacebo 9n B 21;

'vent#:

+eanDration

Da%#

'vent#:

+eanDration

Da%#

/ain ?2 5%> 2 2%0

;r 1 >5 26

;r 2 H 2

;r H 10 0

/ruritus 10 2%5 6 1%E

+e##in$ E H%E 0

odu#eAbu"p E ?% 0

ar"th H%2 0

Bruisin$ 6 H%H 2 2%0

Induration 6 >%H 0




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/t satisfaction assessed by :uestionnaire at 1E of I treat"entG ased pts toco"pare satisfaction of current I vs past ora# therapy1

In separate "aca:ue study, C3B K3 conferred EE@ protection )21A2> ani"a#sa$ainst I' eposure to +I'"ac251G resu#ts "ay be re#evant to hu"ans ho in*ectdru$s2

GCAIR ,atient $ati#faction 5it" I+!"erap% v# Oral ,"a#e

+#ide credit. c#inica#options%co"1% aroit< , et a#% CROI 2016% 3bstract 106% 2% 3ndres C7, et a#%CROI 2016% 3bstract 105% Reproduced ith per"ission%

, t # 9 : ;

-ow #ati#fied are %o wit" %orcrrent treatmentK

100

E0

60

>0

20

0,lacebo 9n B 21;CA. 9n B 1;

ore eutra# Kess100

E0

60

>0

20

0

-ow #ati#fied wold %o be to continewit" %or pre#ent form of treatmentK

62

2E

@1 2 @71

1=27

=,lacebo 9n B 21;CA. 9n B 1;

1= 111

0



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-,!N406A=E0= +araviroc4.a#ed ,r',for +$+

Rando"i


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-,!N406A=E0= $afet% !olerabilit% and'fficac%

6 $rade HA> 34sG rates si"i#ar across ar"s ?@ discontinued study dru$ ear#y

Rates of study dru$ discontinuation )P = %6 and ti"e to per"anentdiscontinuation )P = %6 si"i#ar across ar"s

5 ne (I' infections occurred durin$ study for annua# incidence rateof 1%>@ )?5@ CI. 0%E-2%HG a## R5 tropicG no trans"itted dru$ resistance

Age 9>r#; Race ofNewl% Infected ,t

$td% ArmFir#t -I3L!e#t 5/

-I341 RNAcm

,la#ma Drg Conc( at$eroconv( 3i#it 9ngm;*

20, b#ac 'C &7F > 122,150 'C. 0N &F'. 0

61, 3sian 'C a#one 16 ?E1 'C. 1>521, "ied race 'C a#one 2> 106,2>0 'C. 0N

H5, hite 'C a#one H2 1H,626 'C. 6%

H6, b#ac 'C a#one >E 52,1?1 'C. 0%

;u#ic R, et a#% CROI 2016% 3bstract 10H% Reproduced ith per"ission%

!3nticipated predose steady-state 'C concentration. H2 n$A"K% N9ndetectab#e p#as"a dru$concentrations at every study visit%




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Initial Antiretroviral !"erap%


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+M417E400@ Doravirine L !DFF!C v#'F3 L !DFF!C In !reatment4Naive ,t# 7oravirine. investi$ationa# R&I ith potent activity a$ainst co""on R&I resistance "utations, P7 dosin$, no

//I dru$dru$ interactions, i"proved C+ safety vs 4F' in ear#y studies

/art 2 of 2-part rando"iE

3R&-naive (I'-infectedpts ith (I'-1 R3M 1000 copiesA"K,

C7> ce## countM 100 ce##sA""H

) = 1H2!

Wk $

Doravirine 100 mg HD L !DFF!C)n = 66

'faviren 600 mg HD L !DFF!C)n = 66

Wk %&

!>2 pts receivin$ doravirine 100 "$ P7 &7FAF&C and >H pts receivin$ efaviren< 600 "$ P7 &7FAF&Cin part 1 of this study ere inc#uded in this ana#ysis%

;ate## 8, et a#% CROI 2016% 3bstract >0% +#ide credit. c#inica#options%co"



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+M417E400@ ,rimar% 'ndpoint

;ate## 8, et a#% CROI 2016% 3bstract >0% Reproduced ith per"ission%

@(@

@@(@@(

1(=@E(1

@2(

=@(=

6E(0

72(1

26(

7@(2

2@(

12(01=(@

6(=E(@

0 > E 12 16 20 2> 2E H2 H6 >0 >> >E

100

E0

60

>0

20

0

7oravirine 100 "$4faviren< 600 "$

5/ 7 -I341 RNA < 70 cm nN 9:;

7oravirine E>A10E )%E

4faviren< E5A10E )E%

7ifference )?5@ CI. -1%1 )-12%2 to 10%0

!reatment 5/

- I 3 4 1 R N A


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+M417E400@ Clinical Adver#e 'vent#

;ate## 8, et a#% CROI 2016% 3bstract >0% Reproduced ith per"ission%

Clinical A'# : DOR L !DFF!C9n B 10;

'F3 L !DFF!C9n B 10;

DifferenceDOR'F3 9=: CI;

M 1 34 E%0 EE%? -1%? )-10%? to %1

+erious 34s 6%5 E%H -1%? )-?%5 to 5%6

7eath 0 0

7Ac for 34s 2%E 5%6 -2%E )-?%2 to H%07ru$-re#ated 34s! H1%5 56%5 -25%0 )-H%H to 11%E

7iarrhea 0%? 6%5

ausea %> 5%6

7i%6 6%5

!+pecific 34s occurrin$ in M 5@ of pts inc#uded%



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$witc" and +aintenance

$trategie# for 3irologicall%$ppre##ed ,atient#


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)$410 $witc" From $ppre##ive !DF4to !AF4Containing AR! 5/ 7 'fficac%

Rando"iE by I&& F73 snapshotGnoninferiority "ar$in 10@

!F&CA&3F dosin$. 200A10 "$ ith boosted /IsG200A25 "$ ith unboosted third dru$%

-I341 RNA < =0 cm

at 5/ 7 :

;a##ant 84, et a#% CROI 2016% 3bstract 2?%

!reatment difference1(E: 9=: CI42(=: to =(1:;


$witc" F!C!DF to F!C!AF*Continue third 3R'

)n = HHH

Contine F!C!DFContinue third 3R'

)n = HH0

(I'-infected pts ith(I'-1 R3 L 50 cA"K,e;FR M 50 "KA"in

hi#e receivin$

F&CA&7F third 3R') = 66H

Wk $ Wk %&

7(E

E(0


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)$410 Renal Otcome# 5it" $witc"From !DF4 to !AF4Containing AR!

o proi"a# rena# tubu#opathy or Fanconi syndro"e in eitherar"


+ e d i

a n e ) F R C " a n g e

9 m 6 2 m i n ;

5/

E%>

2%E

P L %001

&3F

&3F

>0

20

0

-20

->0 + e d i a n

: C " a n g e a t 5 / 7

,rotein Albmin R., P24+

Qrine ,rotein4to4CreatinineRatio

@(@

417(6

4@(@

416(E

4E(6

12(E1(2 22(0

&7F

&7F

P L %001

P L %001

P L %001

P L %001

;a##ant 84, et a#% CROI 2016% 3bstract 2?% Reproduced ith per"ission%

20

10

0

-100 12 2> H6 >E


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)$410 .+D C"ange# 5it" $witc" From!DF4 to !AF4Containing AR!

+#ide credit. c#inica#options%co";a##ant 84, et a#% CROI 2016% 3bstract 2?% Reproduced ith per"ission%

$pine>

2

0 + e a

n : c " a n g e

i n . + D 9 = : C I ;

1(=

40(2

P L %001

BK 2> >E

5/#F!C!AF nF!C!DF n

H21H20

H10H10

H00H06

-ip>

2

0

1(1

40(2

BK 2> >E

5/#

H21H1

H0?H05

H00H0H

P L %001

? E: .+D Increa#e at 5/ 7 : F!C!AF F!C!DF P 3ale

+pine H0 1> L %001

(ip 1 ? %00H


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A!!'42 Cabotegravir I+ L Rilpivirine I+for ong4Acting +aintenance AR! u#ticenter, open-#abe# phase IIb study

/ri"ary endpoints. (I'-1 R3 L 50 cA"K by F73 snapshot, /7'F, and safety at "aintenance H2

+#ide credit. c#inica#options%co"ar$o#is 73, et a#% CROI 2016% 3bstract H1KB%

CA. 700 mg I+ R,3 600 mg I+ H75)n = 115

CA. 600 mg I+ R,3 00 mg I+ H5)n = 115

!/ts ith (I'-1 R3 L 50 cA"K fro" 16 to 20 continued to "aintenance phase% 6 ptsdiscontinued for 34s or death in induction ana#ysis%

3R&-naive (I'-infected pts ith

C7> ce## countV 200 ce##sA""H

) = H0? CA. E0 mg ,O A.CE!C ,O HD)n = 56

CA. E0 mg ,O HD A.CE!C

Wk '( pri)ary analysis;

dose selection

Wk (!

Induction Phase* +aintenance Phase

Wk 1 Wk %&Wk 1&: ,P

PO added


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A!!'42 +aintenance 5/ E2 3irologic'fficac% 9I!!4+aintenance 'po#ed;

'iro#o$ic efficacy of P> and PE I re$i"ens si"i#ar to ora# re$i"en

o I+&I, R&I, or R&I resistance "utations detected


ar$o#is 73, et a#% CROI 2016% 3bstract H1KB%

Reproduced ith per"ission%

=7 1

7< 1 7 < 1= =

3irologic$cce##

3irologicNon4

re#pon#e

No3irologic

Data

- I 3

4 1 R N A < = 0 c 2 m 6

9 : ;100

E0

60

>0

20

0

I C3B R/' P> )n = 115I C3B R/' PE )n = 115Ora# C3B 3BCAH&C )n = 56

!reatment Difference# 9=: CI;

H5

47(

E(@

12(2

I+Oral

-12-10 -E -6 -> -2 0 2 > 6 E 10 12

H75

4=(

2(

11(=

-12-10 -E -6 -> -2 0 2 > 6 E 10 12


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A!!'42 $afet% !"rog" +aintenance5/ E2

ost fre:uent I+Rs ere pain )6@, se##in$ )@, andnodu#es )6@

I+R eventsAin*ection. 0%5H

??@ of I+Rs $rade 1A2G none $rade >

/roportion of pts reportin$ I+Rs decreased ith ti"e fro" E6@ on7ay 1 to HH@ at H2G 1@ of pts ithdre for I+Rs

+#ide credit. c#inica#options%co"ar$o#is 73, et a#% CROI 2016% 3bstract H1KB%

A'# : ,ooled CA. L R,3 I+ Arm#9n B 2E0;

Oral CA. L A.CE!C9n B =6;

7ru$-re#ated $rade HA> 34s)ec#udin$ I+Rs H 0

+erious 34s 6 5

34s #eadin$ to ithdraa# H 2


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A!!'42 5/ E2 ,t $ati#faction 5it"+aintenance !"erap% v# Oral Indction


ar$o#is 73, et a#% CROI 2016% 3bstract H1KB%

Reproduced ith per"ission%

, t # 9 : ;

-ow #ati#fied are %o wit" %orcrrent treatmentK

100

E0

60

>0

20

0H5

9n B 106;H759n B 100;

Oral CA.9n B 7;

ore eutra# Kess

100

E0

60

>0

20

0H59n B 106;

H759n B 100;

Oral CA.9n B 7;

ore eutra# Kess

-ow #ati#fied wold %o be to continewit" %or pre#ent form of treatmentK

@ 6 @1

2

E 1

E

@1

2

2 1

1


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$econd4line

Antiretroviral !"erap%


30/47

AC!) =2@E $econd4line ,3R!3 L NR!I#v# ,3R!3 L RA in African $etting#

(I'-infected ptsith (I'-1 R3

V 1000 copiesA"Kafter initia# 3R& ith

R&I R&Is) = 512

Wk $:

pri)ary endpoint

opinavirRitonavir L Raltegravir )n = 25E

opinavirRitonavir L .e#t Available NR!I#*)n = 25>

Wk %&

.

!R&Is se#ected accordin$ to a#$orith", inc#udin$ substitution of


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AC!) =2@E 3irologic Failre and !oicit%

o differences in nu"ber of 3I7+ events, serious non-3I7+events, or deaths beteen ar"s

7ifference in 'F throu$h >E.

R3K R&Is. -H%>@ )?5@ CI. -E%>@ to 2%5@

9pper bound of CI L 10@. R3K noninferior

9pper bound of CI V 0. R3K not superior

Cu"u#ative probabi#ity of $rade M H toicity event hi$her ithK/'AR&' R&Is vs K/'AR&' R3K

+tratified #o$-ran P = %0>0

;reater increases in tota#, K7K-, and non-(7K cho#estero# andtri$#ycerides ith R3K vs R&Is

Ka Rosa 3, et a#% CROI 2016% 3bstract H0% +#ide credit. c#inica#options%co"


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AC!) =2@E Impact of .a#elineRe#i#tance on Ri#/ of 3irologic Failre

o differences beteen ar"s, or after ad*ust"ent for base#ine (I'-1 R3, > adherence, previous &7F use, country1

3C&; 52H overa## resu#ts consistent ith 43R4+&, +4CO7-KI4 tria#s 2,H

1% Ka Rosa 3, et a#% CROI 2016% 3bstract H0%2% /aton I, et a#% 4n$# 8 ed% 201>GH1.2H>-2>%

H% 3"in 8, et a#% /Ko+ One% 2015G10.e011E22E%

.a#eline NR!I Re#i#tance -R for 3F in .ot" Arm#9=: CI; P 3ale

J65R, M H &3s, P151 or 6? insAde#

es vs no )ref0%>? )0%H1-0%6 %001

I3+ R&I "utations

M H vs L H )ref0%>5 )0%H0-0%0 L %001

J65R andAor 1E>'AI

o J65R but 1E>'AI vs no 1E>'A1 )ref

J65R and 1E>'AI vs no 1E>'A1 )ref0%>1 )0%25-0%60%1? )0%0E-0%>>

L %001



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Antiretroviral !"erap%

Dring ,regnanc%


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I+,AAC! ,1026# D!) in ,regnanc%

On$oin$, nonrando"i


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,107# 'ffect of !DF Dring ,regnanc%on Newborn .one +ineral Content

eborn BC co"pared beteen"others rando"i


36/47


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'ro$IDA Impact of !DF 'po#re onRi#/ of /ractures in -I34Infected ,t#

/rospective ana#ysis of 11,E20 (I'-infected pts

Fo##oed fro" base#ine )8an 200> to #ast visit or death toassess for fractures, fe"ora# osteonecrosis

Bor$es 3(, et a#% CROI 2016% 3bstract >6% Reproduced ith per"ission%

!DF 'po#re

An% Fractre

IRR 9=: CI;

O#teoporotic Fractre*

IRR 9=: CI;

Qnivariate +ltivariateS +ltivariateS

4ver used vs neverused

1%1Y )1%>2-2%06 1(70T 91(1=41(@0; 1%10 )0%6-1%5E

On &7F vs not on

&7F 1%HEY

)1%16-1%6> 1(2=T

91(1=41(@0; 1%12 )0%?-1%60

Cu"u#ative &7FeposureA5 yrs

1%2EY )1%1H-1%50 1%0E )0%?>-1%25 0%?? )0%6?-1%>H

!Fracture of the spine, ar", rist, or hip% N 3d*usted for de"o$raphics, (I'-specific variab#es, andco"orbidities% YP L %05



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'ro$IDA A##ociation .etween Q#e of$pecific AR3# and Ri#/ of Osteonecrosis

Bor$es 3(, et a#% CROI 2016% 3bstract >6% Reproduced ith per"ission%

!Race, previouis fe"ora# necrosis at base#ine, fracture, nadir C7> ce## count, a$e, 3I7+ and non-3I7+-definin$ "a#i$nancy, non"a#i$nant 3I7+ event%

&7FK/'AR&'

+P'I7'ddI&7FK/'AR&'

+P'I7'ddI

'ver Q#ed AR3

0%5

5%0

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O # t e o n e c r o #

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'ac" AR3 inclded in#eparate model and adJ#tedfor all ot"er variable#*

'ac" AR3 mtall% adJ#ted for#e of t"e ot"er AR3# andadJ#ted for all ot"er variable#*



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)$ 107111 Renal $afet% of !AF v# !DF in,atient# at -ig" Ri#/ of Midne% Di#ea#e

;+ 10> and 111. rando"i>- studies of 4ACAFA&3Fvs 4ACAFA&7F in 1>> 3R&-naive pts ith e;FR M 50 "KA"in 1

/ost hoc ana#ysis of rena# outco"es by base#ine CJ7 ris cate$ory andby 7.3.7 ris score2

(i$h CJ7 ris. M 2 rena# ris factors )fe"a#e se, a$e M 50 yrs, b#ac race,+3I7 use, C7> L 200 ce##sA""H, history of dys#ipide"ia, hypertension,diabetes, and c#inica# or subc#inica# rena# events

Ko CJ7 ris. W 1 rena# ris factor

I"proved rena# outco"es ith &3F vs &7F ith hi$h or #o CJ7 ris

Incident CJ7 throu$h 2 yrs. &3F 0%1@ vs &7F 1%6@

Feer discontinuations for rena# 34s, chan$es in e;FRC;, :uantitativeproteinuria ith &3F in a## CJ7 ris $roups

1% +a /4, et a#% Kancet% 2015GHE5.2606-2615%

2% oh# 7, et a#% CROI 2016% 3bstract 6E1% +#ide credit. c#inica#options%co"


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Compari#on of C3D Ri#/ $core# in -I34Infected ,t# Co"pared epected and observed I event rates usin$ > ris scores in 10,EH2 (I'-infected pts ith 22? incident I events in CIC+

H $enera# popu#ation C'7 ris scores )Fra"in$ha", 3&/H, 201H 3CCA3(3 3+C'7 p#us (I'-specific 7.3.7 score in CIC+ pts

'ariations across "ode#s anticipated $iven di fferences in outco"e

3R& use )ie, 7.3.7 score did not i"prove discri"ination vs 3+C'7

7iscri"ination $reater ith 3+C'7 vs other "ode#s for a## outco"es

(arre##Zs C for I ith 3+C'7

&ype 1 I. 0% )CI. 0%H-0%E1

&ype 2 I. 0%2 )CI. 0%6-0%E

3## I. 0%> )CI. 0%1-0%

Crane (, et a#% CROI 2016% 3bstract >2% +#ide credit. c#inica#options%co"


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(I' positive

Dot#'pected%r# of liferemainingat age 20

Mai#er ,ermanente ife 'pectanc% in-I34Infected v# Qninfected ,er#on#

3na#ysis of #ife epectancy in 2>,6E (I'-infected and 25,600 (I'-uninfectedadu#t pts in Jaiser /er"anente Ca#ifornia 1??6-2011G 2 $roups "atched fora$e, se, "edica# center, yr

arcus 8K, et a#% CROI 2016% 3bstract 5>% Reproduced ith per"ission%

(I' ne$ative

ine#Deat"#

per100000

,>#

E000

6000

>000

2000

0

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60

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0

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HE1

P L %001

P = %062

1E4>r )ap

1??6-1??

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2000-2001

2002-200H

200>-2005

2006 200 200E 200? 2010 2011



43/47


44/47

Brad#ey (, et a#% CROI 2016% 3bstract 5H% Reproduced ith per"ission%

!(I'-1 R3 L 200 cA"K at #ast test% N(I'-1 R3 L 200 cA"K at a## tests fro" previous 12 "os%

100

E0

60

>0

200

, t # 9 : ;

200? 2010 2011 2012 201H >r

[trend = %01

[trend = %02

[trend = %0H

= 60 6266 6

@2 @7 @6 @@ 0

0 2 E 7

3R& prescription 'ira# suppression! +ustained vira# suppressionN


Increa#ing Rate# of 3iral $ppre##ion inQnited $tate# From 2004201E

edica# onitorin$ /ro*ect 200?-201H. survei##ance dataon 3R& prescription and vira# suppression in adu#ts


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Ribaudo (8, et a#% CROI 2016% 3bstract >6% Reproduced ith

per"ission%

0%5

0%>

0%H

0%2

0%1

0 C m

l a t i v e 3 F , r o b a b

i l i t %

5/# $ince $td% 'ntr%

0 1?22> >E 6> E0 12E 160?6

o"enen

5/ 6 QnadJ#ted -R 5omen v# +en1%> )?5@ CI. 1%1-1%?G P = %026


0%5

0%>

0%H

0%2

0%1

0

5/# $ince $td% 'ntr%0 1?22> >E 6> E0 112 12E 1>> 160 16?6

B#ac(ispanichite

5/ 6 QnadJ#ted -R .lac/ v# 5"ite2%E )?5@ CI. 2%0-H%EG P L %001

5/ 6 QnadJ#ted -R -i#panic v# 5"ite2%0 )?5@ CI. 1%>-2%EG P = %001

112 1>> 16

AC!) A=2=@ $e and Racial Di#paritie# in3irologic Otcome# 5it" AR!

Rando"i


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AC!) A=2=@ +ltivariable Anal%#i# ofRi#/ Factor# A##ociated 5it" 3F

RaceAethnicity ad*ust"ent e#i"inated ecess 'F ris for o"en )P = %20

+ociode"o$raphic factor ad*ust"ent e#i"inated ecess 'F ris forKatinos )a(R. 1%16G ?5@ CI. 0%>-1%E>, but not for b#ac pts )a(R. 1%6EG?5@ CI. 1%1>-2%>6

3dditiona# factors associated ith increased 'F ris. youn$er a$e,recent nonadherence, underei$ht, hi$h base#ine (I'-1 R3, #oinco"e, #ess education, and history of I' dru$ use

Ribaudo (8, et a#% CROI 2016% 3bstract >6% +#ide credit. c#inica#options%co"


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)o Online for +ore CCOCoverage of CROI 2016U

Cap#le $mmarie# of the "ost c#inica##y re#evant ne data

On4demand adio of po#t4CROI 5ebinar ith epert facu#tyco""entary on the c#inica# i"pact of ey studies

clinicaloption#(com-I3Retrovir#e# 2016

clinical impact of new data from croi 2016

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