In this downloadable slideset, expert faculty members Andrew Carr, MBBS, MD, FRACP, FRCPA; Daniel R. Kuritzkes, MD; and Ian M. Sanne, MBBCH, FCP(SA), review key studies presented at the 2016 International AIDS Conference. Format: Microsoft PowerPoint (.ppt) File size: 1.28 MB Date posted: 8/5/2016

1. This activity is supported by an independent educational grant from
ViiV Healthcare
July 18-22, 2016
Durban, South Africa
Highlights of AIDS 2016
CCO Official Conference Coverage
of the 21st International AIDS Conference
In partnership with

2. Slide credit: clinicaloptions.com
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3. Faculty
Andrew Carr, MBBS, MD,
FRACP, FRCPA
Professor of Medicine
University of New South Wales
Director
HIV, Immunology, and Infectious
Disease Unit
St Vincent’s Hospital
Sydney, Australia
Daniel R. Kuritzkes, MD
Chief, Division of Infectious Diseases
Brigham and Women’s Hospital
Professor of Medicine
Harvard Medical School
Boston, Massachusetts
Ian M. Sanne, MBBCH, FCP(SA)
Associate Professor, Internal Medicine
and Infectious Diseases
Clinical HIV Research Unit
Department of Medicine
Faculty of Health Sciences
University of Witwatersrand
Johannesburg, South Africa

4. Disclosures
Andrew Carr, MBBS, MD, FRACP, FRCPA, has disclosed that he has
received consulting fees from Gilead Sciences, Mayne Pharma, MSD,
and ViiV Healthcare, funds for research support from Bristol-Myers
Squibb, Gilead Sciences, MSD, and ViiV Healthcare, and has served on
advisory boards for Gilead Sciences, MSD, and ViiV Healthcare.
Daniel R. Kuritzkes, MD, has disclosed that he has received consulting
fees from Bionor, CytoDyn, Gilead Sciences, GlaxoSmithKline,
InnaVirVax, Janssen, Merck, Teva, United Biopharma, and ViiV
Healthcare.
Ian M. Sanne, MBBCH, FCP(SA), has disclosed that he has received
consulting fees from Merck and funds for research support from Pfizer.

5. HIV Treatment Studies

6. ARIA: DTG/ABC/3TC vs ATV + RTV +
TDF/FTC in Treatment-Naive Women
 Multinational, randomized, open-label phase IIIb trial
– Primary endpoint: Wk 48 HIV-1 RNA < 50 copies/mL
Orrell C, et al. AIDS 2016. Abstract THAB0205LB. Slide credit: clinicaloptions.com
DTG/ABC/3TC QD
(n = 248)
ATV + RTV + TDF/FTC QD
(n = 247)
ART-naive women*
with HIV-1 RNA
≥ 500 copies/mL,
HLA-B*5701 negative,
and CrCl ≥ 50 mL/min
(N = 495)
Wk 48
*Women enrolled in North America, European Union, Argentina, Puerto Rico, Russian Federation,
South Africa, and Thailand.
Dosing: ATV 300 mg, RTV 100 mg, TDF/FTC 300/200 mg, DTG/ABC/3TC 50/600/300 mg.
After 48 wks, pts in the DTG/ABC/3TC arm could enter the continuation phase.
Women
who became
pregnant offered
option to enter
DTG/ABC/3TC
pregnancy study
NCT02075593
Stratified by
HIV-1 RNA ≤ or > 100,000 copies/mL,
CD4+ cell count ≤ or > 350 cells/mm3

7.  Primary virologic outcomes (ITT-E analysis)
ARIA: DTG/ABC/3TC Superior to ATV +
RTV + TDF/FTC at Wk 48
Slide credit: clinicaloptions.comOrrell C, et al. AIDS 2016. Abstract THAB0205LB.
HIV-1 RNA < 50 copies/mL, % DTG/ABC/3TC ATV + RTV + TDF/FTC
Baseline HIV-1 RNA, copies/mL
 ≤ 100,000 83 74
 > 100,000 80 64
Baseline CD4+ cell count, cells/mm³
 ≤ 350 85 72
 > 350 78 71
Outcome, % (n)
DTG/ABC/3TC
(n = 248)
ATV + RTV
+ TDF/FTC
(n = 247)
Treatment
Difference
(95% CI)
P Value
Virologic success (HIV-1 RNA
< 50 copies/mL)
82 (203) 71 (176) 10.5
(3.1-17.8)
.005
Virologic nonresponse 6 (16) 14 (35) -- --
No virologic data 12 (29) 15 (36) -- --
 Virologic outcomes by baseline randomization strata (ITT-E analysis)

8. ARIA: Safety Outcomes
Slide credit: clinicaloptions.comOrrell C, et al. AIDS 2016. Abstract THAB0205LB.
AE, %
DTG/ABC/3TC
(n = 248)
ATV + RTV + TDF/FTC
(n = 247)
Discontinuations due to AE 4 7
Serious AE 5 8
Fatal AE < 1* 0
Drug-related serious AE 0 1
Any AE 79 80
Grade 2-4 AE 46 55
Drug-related AE occurring
in ≥ 5% of pts in either arm
33 49
 Nausea 13 14
 Diarrhea 5 7
 Dyspepsia 2 6
 Ocular icterus 0 7
 Headache 2 6
 Jaundice 0 5
*1 death deemed unrelated to study drugs.

9.  Randomized trial in women receiving ART or stopping ART following
pregnancy
Slide credit: clinicaloptions.com
PROMISE: Continuing vs Stopping ART in
Postpartum, Non–Breast-feeding Women
Currier J, et al. AIDS 2016. Abstract THAB0103LB.
Continue ART
(n = 827)
Stop ART*
(n = 825)
HIV-infected, ART-naive (except PMTCT)
postpartum women without guideline-
specified indication for ART, CD4+ cell
count ≥ 400 cells/mm3
, not breastfeeding
(N = 1652)
Randomized within
42 days of delivery
*Restarted ART if CD4+ cell count fell below 350 cells/mm3
or was clinically indicated.
Pts seen 4 wks post enrollment,
then every 12 wks through 84 wks
after last enrollment
 Study sites: Argentina, Botswana, Brazil, China, Haiti, Peru, Thailand, and United States
 Median follow-up: Continue ART arm, 2.31 yrs; Stop arm, 2.35 yrs
 ART during study (Continue ART arm): 74% LPV/RTV based, 19% ATV/RTV based

10. Slide credit: clinicaloptions.com
PROMISE: Efficacy and Safety
 Between treatment arms, no significant difference in primary safety or efficacy
endpoints; continuing ART associated with lower HIV event rate
Currier J, et al. AIDS 2016. Abstract THAB0103LB.
Outcome, n (Rate/100 PY) Continue ART (n = 827) Stop ART (n = 825) HR (95% CI)
Primary efficacy composite
endpoint events
4 (0.21) 6 (0.31) 0.68 (0.19-2.40)*
 AIDS-defining events 2 (0.10) 3 (0.15) 0.67 (0.11-4.02)
 Serious non-AIDS event 0 0 --
 Death 2 (0.10) 4 (0.20) 0.52 (0.09-2.81)
Primary safety composite
endpoint events† 260 (18.4) 232 (15.4)‡
--
Composite of HIV/AIDS-related
or WHO stage 2/3 events
57 (3.09) 99 (5.49) 0.56 (0.41-0.78)
WHO stage 2/3 events 39 (2.02) 80 (4.36) 0.47 (0.32-0.68)§
 189 (23%) pts in Continue ART arm experienced virologic failure; in pts with virologic
failure who had resistance testing, 52/155 (34%) had evidence of resistance
*P = .54. †
Time to first grade 3/4 sign or symptom or grade 2-4 chemistry or hematology result. ‡
P = .08.
§
P < .001.

11.  Multinational, randomized, double-blind phase III trial
– Primary endpoint: Wk 48 HIV-1 RNA < 40 copies/mL
– Reformulated RAL 600 mg tablets allow 1200 mg QD dosing
Slide credit: clinicaloptions.com
ONCEMRK: RAL 1200 mg QD vs
400 mg BID + TDF/FTC in ART-Naive Pts
Cahn P, et al. AIDS 2016. Abstract FRAB0103LB.
RAL 1200 mg* QD +
TDF/FTC
(n = 533)
RAL 400 mg BID +
TDF/FTC
(n = 269)
ART-naive adults
with HIV-1 RNA
≥ 1000 copies/mL
(N = 802)
Pts
followed
for 14 days
96 wksRandomized 2:1 48 wks
 Baseline HIV-1 RNA > 100,000 copies/mL: 28.1% to 28.6%
*Two 600-mg tablets.

12. Slide credit: clinicaloptions.com
ONCEMRK: RAL 1200 mg QD Noninferior
to RAL 400 mg BID at Wk 48
Cahn P, et al. AIDS 2016. Abstract FRAB0103LB.
Reproduced with permission.
 Wk 48 HIV-1 RNA < 40 copies/mL in pts with BL HIV-1 RNA > 100,000 copies/mL:
RAL QD, 86.7%; RAL BID, 83.8% (∆ 2.9; 95% CI: -6.5-14.1)
 RAL QD associated with overall safety profile similar to RAL BID
100
80
60
40
20
0
PtsWithHIV-1RNA
<40copies/mL(%)
0 4 8 12 16 20 24 28 32 36 40 44 48
Treatment Wk
RAL 1200 mg QD + TDF/FTC
RAL 400 mg BID + TDF/FTC
88.388.786.583.5
78.2
51.9
53.5
76.3
82.1 87.4 87.2 88.9

13. STRIIVING: Switch From Suppressive ART
to Fixed-Dose DTG/ABC/3TC
 Multicenter, randomized, open-label phase IIIb study
– Conducted in US, Canada, and Puerto Rico
– Primary endpoint: HIV-1 RNA < 50 copies/mL at Wk 24
Pts with HIV-1 RNA
< 50 copies/mL
on stable ART ≥ 6 mos,
no previous virologic failure, HLA-
B*5701 negative
(N = 553)
DTG/ABC/3TC
(n = 275)
Wk 48Wk 24
*Containing 2 NRTIs plus NNRTI, PI, or INSTI.
Baseline ART*
(n = 278)
DTG/ABC/3TC
(n = 244)
Slide credit: clinicaloptions.comLake J, et al. AIDS 2016. Abstract THAB0203.

14. STRIIVING: Virologic Outcomes at Wk 48
 High Wk 48 rates of virologic response for early (83%) and late (92%)
switch to DTG/ABC/3TC
 No cases of protocol-defined virologic failure
– 1 pt in early switch arm (< 1%) and 3 pts in post-switch BL ART arm (1%)
had HIV-1 RNA ≥ 50 c/mL at Wk 48 but all resuppressed to < 50 c/mL
Slide credit: clinicaloptions.comLake J, et al. AIDS 2016. Abstract THAB0203.
Outcome, % DTG/ABC/3TC,
Wk 24
(n = 275)
Baseline ART,
Wk 24
(n = 278)
DTG/ABC/3TC,
Wk 48
(n = 275)
Wk 24 Switch to
DTG/ABC/3TC,
Wk 24-48
(n = 244)
Virologic success (HIV-1
RNA < 50 copies/mL)
85 88 83 92
Virologic nonresponse 1 1 < 1 < 1
No virologic data 14 10 17 7

15. LATTE-2: Cabotegravir IM + Rilpivirine IM
for Long-Acting Maintenance ART
 Multicenter, open-label, randomized phase IIb study
– Primary endpoints: HIV-1 RNA < 50 copies/mL at maintenance
Wk 32, PDVF, and safety
Slide credit: clinicaloptions.comMargolis DA, et al. AIDS 2016. Abstract THAB0206LB.
CAB 400 mg + RPV 600 mg IM Q4W
(n = 115)
CAB 600 mg + RPV 900 mg IM Q8W
(n = 115)
*Pts with HIV-1 RNA < 50 copies/mL from Wk 16-20 continued to maintenance phase.
†
Pts eligible for Q4W or Q8W LA extension past Wk 96.
ART-naive HIV-
infected pts younger
than
18 yrs of age with
CD4+ cell count
> 200 cells/mm3
(N = 309)
CAB 30 mg + ABC/3TC 600/300 mg PO QD
(n = 56)
CAB 30 mg +
ABC/3TC 600/
300 mg PO QD
Wk 32
Wk 20
Induction Phase* Maintenance Phase
Day 1 Wk 96†Wk 16: RPV 25 mg
PO QD added
Wk 48

16. LATTE-2: Efficacy and Safety Through
Maintenance Wk 48
 Virologic efficacy of Q4W/Q8W IM
therapy similar to oral therapy
 99% of ISRs for pts receiving
injectable therapy grade 1 (82%)
or 2 (17%); none grade 4
– Most frequent ISRs:
pain (67%), nodules (7%), swelling
(6%)
– Reported ISRs decreased over time
(86% Day 1, 29% Wk 48)
– 2/230 pts (< 1%) withdrew for ISRs
(both in Q8W arm)
 AEs leading to withdrawal
– Pooled Q4W/Q8W IM arms, 4%
– Oral arm, 2%
Slide credit: clinicaloptions.comMargolis DA, et al. AIDS 2016. Abstract THAB0206LB
Outcome, % (n)
IM CAB +
RPV Q4W
(n = 115)
IM CAB
+ RPV
Q8W
(n = 115)
Oral CAB
+ ABC/3TC
(n = 56)
Virologic success
(HIV-1 RNA
< 50 copies/mL)
91 (105) 92 (106) 89 (50)
Virologic
nonresponse
< 1 (1) 7 (8) 2 (1)
No virologic data 8 (9) < 1 (1) 9 (5)

17. LATTE-2: Wk 48 Pt Satisfaction With IM
and PO Regimens
Slide credit: clinicaloptions.comMargolis DA, et al. AIDS 2016. Abstract THAB0206LB.
Wk 48 Patient-Reported
Outcomes, %
IM CAB + RPV
Q4W
(n = 103)
IM CAB + RPV
Q8W
(n = 109)
PO CAB +
ABC/3TC
(n = 49)
How satisfied are you with
your current treatment?
 6 79 83 67
 5 20 14 29
 < 5 1 3 4
How satisfied would you be to
continue with your present
form of treatment?
 6 85 88 55
 5 13 11 33
 < 5 2 1 12
 Pt satisfaction assessed using 0 to 6 scoring (0 = very dissatisfied, 6 = very
satisfied)

18. Dual Therapy Studies

19. Switch to DTG + RPV in Suppressed Pts
With Multiple Previous Treatment Failures
 Open-label cohort study based in clinical practice setting (N = 38)
– DTG 50 mg/day + RPV 25 mg/day for pts with long-term virologic
suppression but virologic failure on > 1 previous ART regimens
 HIV-1 RNA suppressed to < 35 copies/mL in 92% (35/38) at Wk 48
– No virologic failures; 3 pts d/c (GI toxicity, DDI, physician decision, n = 1)
 DTG + RPV associated with improved liver function tests, improved
lipid profile, and stable kidney function at Wk 48
Slide credit: clinicaloptions.comDíaz A, et al. AIDS 2016. Abstract TUPDB0106.
Baseline Characteristic , % Switch to DTG + RPV (N = 38)
Regimen at time of switch  NRTI + NNRTI + PI
 NRTI + NNRTI + PI + INSTI
85
53
Reasons for switch to DTG + RPV  Drug–drug interaction
 Toxicity
 Simplification
38
33
25
Pre-existing resistance mutations  NRTI: 65; NNRTI: 37; PI: 32; INSTI: NA

20. PADDLE: Dolutegravir + Lamivudine for
Treatment-Naive Pts
 Open-label, single-arm phase IV exploratory trial
 18/20 pts achieved HIV-1 RNA < 50 c/mL at Wk 48
– 1 pt committed suicide (deemed unrelated to study drugs)
– 1 pt experienced PDVF at Wk 36 (BL HIV-1 RNA > 100,000 c/mL);
resuppressed HIV-1 RNA without ART change by discontinuation visit
(Wk 52)
– 3 other pts with BL HIV-1 RNA > 100,000 c/mL suppressed at Wk 48
Slide credit: clinicaloptions.comCahn P, et al. AIDS 2016. Abstract FRAB0104LB.
Treatment-naive pts
with HIV-1 RNA
> 5000-100,000 c/mL,
CD4+ cell count ≥ 200
cells/mm3
, HBsAg negative
(N = 20)
DTG 50 mg QD + 3TC 300 mg QD
(N = 20*)
*10 pts enrolled initially; additional 10 pts enrolled after confirming virologic success of first cohort at Wk 8.
†
Primary endpoint.
Wk 48†

21. Prevention and Vaccine Studies

22. Slide credit: clinicaloptions.com
MTN-020/ASPIRE: Dapivirine Vaginal Ring
for HIV Prevention in Women
 Multicenter, double-blind, placebo-controlled, randomized phase III
trial in Malawi, South Africa, Uganda, and Zimbabwe
 Silicone elastomer vaginal matrix ring containing NNRTI dapivirine
25 mg; ring replaced every 4 wks
 Primary endpoints: efficacy and safety
 HIV protection efficacy vs placebo: 27% (P = .046)
Brown E, et al. AIDS 2016. Abstract TUAC0105LB.
Baeten JM, et al. N Engl J Med. 2016;[Epub ahead of print].
Dapivirine 25 mg Vaginal Ring Q4W
+ HIV Prevention Service Package
(n = 1313)
Placebo Vaginal Ring Q4W
+ HIV Prevention Service Package
(n = 1316)
Sexually active HIV-
uninfected adult
women
(N = 2629)
≥ 1 yr; endpoint-
driven duration

23. Slide credit: clinicaloptions.com
MTN-020/ASPIRE Subcohort: Adherence
by Residual DAP Levels in Vaginal Ring
Brown E, et al. AIDS 2016. Abstract TUAC0105LB. Reproduced with permission.
Outcome Placebo Nonadherent
(≥ 23.5 mg*)
Low-High Adherence
(< 23.5 mg*)
Med-High Adherence
(< 22 mg*)
Infections, n 50 13 14 7
HIV incidence/100 PY 4.6 3.6 1.9 1.5
Risk reduction vs
PBO, % (95% CI; P
value)
--
31
(-28 to 63; .24)
56
(20 to 76; .007)
65
(22 to 84; .01)
*Residual levels of DAP remaining in returned rings.
 Lower residual DAP
levels in returned rings
indicate higher
adherence
16 18 20 22 24 26 28
DAP Remaining (mg)
Expected level of ring
used for 28 days: 20-21 mg
Expected level of
unused ring: 24-25 mg

24.  Sustained adherence associated with 92% reduction in risk of HIV infection
MTN-020/ASPIRE Subcohort: Adherence
vs HIV Protection 3 Mos Before Detection
No use Bottom third Top thirdMiddle third
HIVInfectionRiskReduction(%)
Slide credit: clinicaloptions.com
Adherence*
*For seroconversions, adherence level taken from visit with lowest adherence of 3 months (3 visits)
before HIV detection.
100
50
0
-50
Risk reduction
92%
(95% CI: 38 to 99)
Risk reduction
58%
(95% CI: -7 to 83)
Risk reduction
29%
(95% CI: -52 to 66)Risk reduction
11%
(95% CI: -78 to 55)
Brown E, et al. AIDS 2016. Abstract TUAC0105LB.
Reproduced with permission.

25. ATN 113: Daily Oral TDF/FTC as PrEP for
Adolescent MSM in US
 Observational, open-label, single-arm feasibility study
– HIV-negative US MSM aged 15-17 yrs who demonstrated high-risk behavior for
acquiring HIV prescribed daily oral TDF/FTC; 2864 individuals prescreened, N = 79
enrolled
 Wk 48 outcomes
– 3 seroconversions; all 3 had low TFV-DP drug levels at time of seroconversion
– HIV incidence: 6.41/100 PY (95% CI: 4.9-25.8)
– Median adherence declined over time for all race/ethnic groups
– Drop off in TFV-DP levels between Wk 12 and Wk 24 corresponded to reduced
frequency of scheduled study visits (from every 4 wks to every 12 wks)
Slide credit: clinicaloptions.comHosek S, et al. AIDS 2016. Abstract TUAX0104LB.
Characteristic, % Wk 4 Wk 8 Wk 12 Wk 24 Wk 36 Wk 48
TFV-DP levels > 700 fmol/punch* 60.0 52.4 55.0 31.5 22.7 28.2
*Equivalent to adherence for ≥ 4 days.

26. Slide credit: clinicaloptions.com
HVTN100: Investigational HIV-1 Vaccine
for HIV-Uninfected South African Adults
 Double-blind, randomized, placebo-controlled phase I/II trial
– South African adults (N = 252) randomized to vaccination (n = 210) or placebo (n = 42)
– Vaccine: clade C ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59
– Vaccination schedule: ALVAC-HIV at mos 0 and 1; ALVAC-HIV + gp120/MF59 at mos 3, 6,
and 12 (booster)
 Goal: after 6.5 mos, meet 4 prespecified immunogenetic criteria required to move into
phase IIb efficacy studies
1. Develop IgG-binding Abs to ≥ 2 of 3 gp120 vaccine antigens (LL of 95% CI ≥ 75%)
2. Exhibit noninferior IgG-binding Ab magnitude to 2 of 3 gp120 vaccine antigens vs RV144
(previous vaccine trial)
3. Exhibit noninferior response rate of Env-specific CD4+ T cells expressing IL-2, IFN-gamma, or
CD40L vs RV144 (difference within 30%)
4. Develop IgG-binding Abs to ≥ 1 clade C V1V2 Ags/tags (LL of 95% CI ≥ 56%)
 All criteria met; vaccine will move into phase IIb efficacy studies
Bekker LG, et al. AIDS 2016. Abstract TUAX0102LB.

27. HIV/HCV-Coinfection Studies

28.  ASTRAL-5: multicenter, open-label, single-arm phase III study[1]
– 12 wks of SOF/VEL in HIV/HCV-coinfected, GT 1-6 HCV , tx naive or experienced,
stably suppressed on ART (N = 106)
Sofosbuvir/Velpatasvir in HIV/HCV-
Coinfected Pts
Slide credit: clinicaloptions.com
1. Bräu N, et al. AIDS 2016. Abstract WEAB0301. Reproduced with
permission.
2. Mogalian E,et al. AIDS 2016. Abstract WEAB0302.
Total
(n = 106)
HCV Genotype
BL
NS5A
RAVs
(n = 12)
1a
(n = 66)
1b
(n = 12)
2
(n = 11)
3
(n = 12)
4
(n = 5)
SVR12, % 95 95* 92†
100 92‡
100 100*Relapse, n = 2; LTFU, n = 1. †
LTFU, n = 1. ‡
Withdrew consent, n = 1.
 Drug-drug interaction study in healthy volunteers[2]
– 50% reduction in VEL exposure when EFV/TDF/FTC and SOF/VEL coadministered;
EFV not recommended with SOF/VEL
– FTC, EFV, RPV, DTG, RAL, EVG, ATV, RTV, DRV, LPV, not affected by SOF/VEL;
TDF exposure increased ~20% to 81%

29. Additional Studies Assessing HCV
Therapy in Pts With HIV/HCV Coinfection
 TURQUOISE-I, Part 2: multicenter phase III trial in which HIV/HCV-
coinfected pts with GT1 or GT4 HCV treated with OBV/PTV/RTV ±
DSV ± RBV (N = 228)[1]
– SVR12 (ITT): GT1, 97% (n/N = 190/195); GT4, 96% (n/N = 27/28)
– Intermittent HIV viremia in 10/228 (4%) pts; HIV-1 RNA < 200 copies/mL
– 4% of pts in each arm had BL HIV-1 RNA ≥ 40 copies/mL
 6 wks of SOF/LDV for HIV-infected pts with acute GT1/4 HCV
infection[2]
– SVR12: 77% (n/N = 20/26); 4 virologic failures (1 reinfection), 2 LTFU
– 3 relapsed pts had BL HCV RNA ≥ 7.0 log10 IU/mL
Slide credit: clinicaloptions.com
1. Rockstroh JK, et al. AIDS 2016. Abstract WEAB0304LB.
2. Nelson M, et al. AIDS 2016. Abstract WEPEB059.

30. Comorbidities and
Opportunistic Infections

31.  Prospective, randomized trial conducted in in Zimbabwe, Malawi, Uganda, and
Kenya
– Primary endpoint: mortality at 24 wks
Slide credit: clinicaloptions.com
REALITY: Enhanced OI Prophylaxis at
ART Initiation in Immunocompromised Pts
Hakim J, et al. AIDS 2016. Abstract FRAB0101LB.
Enhanced Prophylaxis
initiated at time of ART†
(n = 906)
Standard Prophylaxis
initiated at time of ART‡
(n = 899)
ART-naive HIV-infected adults
and children older than 5 yrs
of age with CD4+ cell counts
< 100 cells/mm3
(N = 1805)
Additional randomizations
conducted in factorial fashion*
*Raltegravir added to ART for 12 wks; food supplementation for 12 wks.
†
Cotrimoxazole, isoniazid/vitamin B6 300/25 mg/day for 12 wks (IPT), fluconazole 100 mg/day for
12 wks, azithromycin 500 mg/day for 5 days, albendazole 400 mg (single dose).
‡
Cotrimoxazole, IPT added after 12 wks (except in Malawi).
In both prophylaxis regimens, cotrimoxazole and IPT given at half doses if younger than 12 yrs of age.

32. Slide credit: clinicaloptions.com
REALITY: Mortality Benefit With Enhanced
OI Prophylaxis for Pts Initiating ART
1. Hakim J, et al. AIDS 2016. Abstract FRAB0101LB.
2. Kityo C, et al. AIDS 2016. Abstract FRAB0102LB.
 3.3 lives saved for every 100 treated with enhanced prophylaxis[1]
 Additional REALITY factorial randomization assessed mortality for
ART initiation with 2 NRTIs + NNRTI + RAL vs 2 NRTIs + NNRTI[2]
– Addition of RAL to standard 3-drug ART did not affect all-cause mortality
at 24 or 48 wks
Deaths, %[1]
Enhanced
Prophylaxis
(n = 906)
Standard
Prophylaxis
(n = 899)
HR
(95% CI)
P Value
Wk 24* 8.9 12.2
0.73
(0.54-0.97)
.03
Wk 48 11.0 14.4
0.75
(0.58-0.98)
.04
*Primary endpoint.

33. Slide credit: clinicaloptions.com
REALITY: Additional Outcomes Favor
Enhanced OI Prophylaxis
Hakim J, et al. AIDS 2016. Abstract FRAB0101LB.
Reproduced with permission.
WHO stage 4 disease or death
WHO stage 3/4 disease or death
New TB disease
AE causing OI drug modification
Hospitalizations
New cryptococcal disease
New candida disease
Presumptive severe bacterial infection
Grade 4 AE
Serious AE
Grade 3/4 AE
Grade 4 AE definitely/probably related to prophylaxis
Grade 4 AE definitely/probably/possibly related to prophylaxis
Favors Enhanced Prophylaxis Favors Standard Prophylaxis
.006
.007
.01
.01
.02
.04
.06
.07
.35
.21
.60
.21
.97
0.3 0.5 0.7 1.0 1.5 2.0
HR (Enhanced Prophylaxis:Standard Prophylaxis)
P Value

34.  Multicenter, open-label, randomized phase III trial
– Pts in Benin, Guinea, and Senegal
– Primary outcome: mortality at 12 mos post-randomization
Slide credit: clinicaloptions.com
RAFA: ART With Standard- vs High-Dose
Rifampicin in HIV/TB-Coinfected Pts
Merle CS, et al. AIDS 2016. Abstract WEAB0205LB.
Pactr.org. PACTR201105000291300. EDCTP Project Portfolio.
Standard-Dose Rifampicin,†
Start ART at Wk 8
(n = 258)
Standard-Dose Rifampicin,†
Start ART at Wk 2
(n = 262)
ART-naive
HIV/TB-coinfected
adults with CD4+
cell count ≥ 50
cells/mm3
(N = 778)
High-Dose Rifampicin,* Start ART at Wk 8
(n = 258)
*Rifampicin 15 mg/kg plus ethambutol, isoniazid, pyrazinamide.
†
Rifampicin 10 mg/kg plus ethambutol, isoniazid, pyrazinamide.
ART regimen: EFV 600 mg + 2 NRTIs.
All pts received
rifampicin 10 mg/kg
+ isoniazid
Intensive Phase Continuation PhaseWk 8

35. Slide credit: clinicaloptions.com
RAFA: Survival Outcomes With High- vs
Standard-Dose Rifampicin
 Overall survival not improved, but high-dose rifampicin may benefit severely
immunocompromised pts
Merle CS, et al. AIDS 2016. Abstract WEAB0205LB.
Reproduced with permission.
Overall Survival, %
HD RIF, ART Wk 8
(n = 249)
SD RIF, ART Wk 8
(n = 247)
SD RIF, ART Wk 2
(n = 251)
12 mos 90 86 89
18 mos 90 85 88
Mortality for Pts With CD4+ Cell Count < 100 cells/mm3
(n = 159)
SD RIF, ART Wk 8 (n = 47)
SD RIF, ART Wk 2 (n = 60)
HD RIF, ART Wk 8 (n = 52)
HD RIF vs SD RIF, ART Wk 2:
HR: 0.20 (95% CI: 0.04-0.90)
HD RIF vs SD RIF, ART Wk 8:
HR: 0.12 (95% CI: 0.03-0.55)
1.00
0.75
0.50
0.25
0
0 2 4 6 8 10 12 14 16 18
Mos Since Randomization
Survival

36. HIV Testing and Monitoring
Strategies and Tools

37. ANRS 12249: Test and Treat Strategies in
Rural South Africa (KwaZulu-Natal)
 Test and treat trial; treatment cluster-randomized by site
– Rapid HIV testing during home visits every 6 mos; if HIV infected, pts
moved to randomized treatment
 Similar HIV incidence between randomized groups
Slide credit: clinicaloptions.comIwuji C, et al. AIDS 2016. Abstract FRAC0105LB.
Intervention Arm
Immediate ART
(n = 13,236)
Control Arm (Guideline-Based ART)
ART if CD4+ cell count ≤ 350/500 cells/mm3
* or stage WHO 3/4
(n = 14,917)
HIV-infected adults
(N = 28,153)
Outcome Intervention Control Adjusted RR P Value
Mean HIV prevalence, % 30 31 -- --
12-mo linkage to care for HIV-
infected pts,†
% 47 47 -- --
HIV incidence/100 PY 2.13 2.27 0.95 .5821
*Guidelines for ART initiation cutoff changed during study. †
Pts not previously receiving care.

38. FORTH: HIV Self-Testing in Australian
MSM
 HIV-uninfected Australian MSM who had > 5 male partners or condomless anal
intercourse in past 3 mos (N = 362) randomized to free access to HIV self-testing
(n = 182) or standard care (n = 180)
Slide credit: clinicaloptions.comJamil MS, et al. AIDS 2016. Abstract FRAC0102. Reproduced with permission.
5.0
1.0
0
MeanHIVTests/Yr
3.0
2.0
4.0
Self-testing
(n = 178)
Standard care
(n = 165)
Self-testing
(n = 148)
Standard care
(n = 141)
Self-testing
(n = 30)
Standard care
(n = 24)
Overall Recent HIV Test at BL
(≤ Last 2 Yrs)
Nonrecent HIV Test at BL
(> Last 2 Yrs)
Self tests
Facility-based testing
RR: 2.1 (P < .001)
RR: 2.0 (P < .001)
RR: 3.95 (P < .001)
1.7 1.9 1.8 2.1
0.8 0.7
2.4
2.4
2.1
 No decline in STI testing for self-testing group vs standard care group

39. Further Studies Assessing HIV Testing
Strategies
 Strategies to improve male HIV testing for those in relationships in Kenya[1]
– Pregnant or postpartum women with male HIV-uninfected or HIV-unknown partners
randomized to groups in which they gave partner an HIV self-test (HIVST group,
n = 284) or HIV clinic referral voucher (comparison group, n = 286)
Slide credit: clinicaloptions.com
1. Agot K, et al. AIDS 2016. Abstract FRAC0104.
2. Patel VV, et al. AIDS 2016. Abstract FRAC0101.
Outcome, n (%) HIVST Comparison Difference, % (95% CI)
Male partner testing 258 (90.8) 148 (51.7) 39.1 (32.4 to 45.8)
Discuss HIV testing 271 (95.4) 276 (96.5) -1.1 (-4.3 to 2.2)
Couples testing 214 (75.4) 95 (33.2) 42.1 (34.7 to 49.6)
Learned partner’s HIV status 255 (89.8) 145 (50.7) 39.1 (32.3 to 45.9)
Partner violence due to testing 1 (0.4) 1 (0.3) 0.0 (-1.0 to 1.0)
 CHALO: e-messaging reminders for HIV testing for MSM in India[2]
– Of pts who completed follow-up (N = 130), intervention increased recent HIV testing
vs baseline (44% vs 32%; P < .05); “avoidance” language emphasizing negative
outcomes was associated with higher rate of testing or intention to test vs
“approach” language highlighting a benefit (82% vs 65%, P =.03)

40.  Validation of Cepheid GeneXpert HIV-1 Quant for monitoring HIV-1
RNA in pts on ART[1]
– Point-of-care, PCR-based testing system
– Compared with Abbott Real Time HIV-1 assay,
 LAg-Avidity for detecting viral breakthrough for pts on ART[2]
Studies Assessing Tools for Monitoring
ART Efficacy and Failure
Slide credit: clinicaloptions.com
1. Kulkarni S, et al. AIDS 2016. Abstract THPDB0205. 2. Nicholas S, et al. AIDS
2016. Abstract THPEB046. 3. Wendel SK, et al. AIDS 2016. Abstract THPEB039.
Study Findings
Validation of GeneXpert HIV-1 Quant for
monitoring HIV-1 RNA in pts on ART[1]
Point-of-care, PCR-based testing system
Assessed samples from Indian pts with varying
HIV-1 RNA levels (N = 219) and controls
 Similar detection with GeneXpert
vs standard Real Time assay:
R2
= 0.784
 Sensitivity/specificity for detecting
HIV-1 RNA > 200 c/mL: 97%/100%
Assessment of SAMBA-1 for routine
monitoring of HIV-1 RNA in pts on ART[2]
Nearly point-of-care, PCR-based testing system
Assessed pts on first-line ART at hospital/health
centers in Malawi from Aug 2013 to Dec 2015
 13675/19036 (72%) received ≥ 1 test
 > 80% of tests reviewed the same day
at health centers
LAg-Avidity for detecting viral breakthrough
for pts on ART[3]
Antigen avidity enzyme immunoassay
Assessed samples from US pts pre/post ART
(n = 72) and suppressed pts who had
breakthrough (n = 179)
 Sensitivity/specificity for detecting
viral breakthrough: 65%/86%

41. Go Online for More CCO
Coverage of AIDS 2016!
Capsule Summaries of all the key data
CME-certified text module with expert
faculty commentary on all the key studies
clinicaloptions.com/HIV