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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
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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
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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
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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$%
-I341 RNA < =0 cm
at 5/ 7 :
;a##ant 84, et a#% CROI 2016% 3bstract 2?%
!reatment difference1(E: 9=: CI42(=: to =(1:;
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$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"
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+ 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$i"en
o I+&I, R&I, or R&I resistance "utations detected
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ar$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 $ati#faction 5it"+aintenance !"erap% v# Oral Indction
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ar$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%
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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$, nonrando"i
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,107# 'ffect of !DF Dring ,regnanc%on Newborn .one +ineral Content
eborn BC co"pared beteen"others rando"i
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'ro$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
1(1(@=
1(@1(@@ 1(@0
1(72 1(E1(==
1(E 1(7E
%25%25%1%20%2%051%0H1%015%02%01HP V a#ue.
A d J # t e d *
I R R f o r
O # t e o n e c r o #
i # 9 = : C I ;
'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
E0
60
>0
20
0
>H?
1?
6H
0
65
5H
105>
HE1
P L %001
P = %062
1E4>r )ap
1??6-1??
1??E-1???
2000-2001
2002-200H
200>-2005
2006 200 200E 200? 2010 2011
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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
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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
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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