Contemporary Management of HIV. New Data From AIDS 2018

Contemporary Management of HIV:
New Data From AIDS 2018
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ViiV Healthcare.

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Program Directors
Joseph J. Eron, Jr., MD
Professor of Medicine and
Epidemiology
University of North Carolina School of
Medicine
Director, AIDS Clinical Trials Unit
University of North Carolina
Chapel Hill, North Carolina
Princy N. Kumar, MD
Professor of Medicine and
Microbiology
Division of Infectious Diseases
Georgetown University Hospital
Division Chief
Division of Infectious Diseases and
Travel Medicine
Department of Internal Medicine
Medstar Georgetown University
Hospital
Washington, DC

Core Faculty
Eric S. Daar, MD
Chief, Division of HIV Medicine
Harbor-UCLA Medical Center
Professor of Medicine
David Geffen School of Medicine at UCLA
Los Angeles, California

Faculty Disclosures
Joseph J. Eron, Jr., MD, has disclosed that he has received consulting fees from
Gilead Sciences, Janssen, Merck, and ViiV Healthcare and funds for research
support from AbbVie, Gilead Sciences, Janssen, and ViiV Healthcare.
Princy N. Kumar, MD, has disclosed that she has received consulting fees from
Gilead Sciences, Theratechnologies, and ViiV Healthcare; has received funds for
research support from Gilead Sciences, Merck, and ViiV Healthcare; and has
ownership interest in Gilead Sciences, Johnson & Johnson, Merck, and Pfizer.
Eric S. Daar, MD, has disclosed that he has received consulting fees from Gilead
Sciences, Merck, and Theratechnologies and funds for research support from
Gilead Sciences, Merck, and ViiV Healthcare.

Outline
 HIV Prevention
 ART and Pregnancy
 First-line Therapy
 Second-line Therapy
 Switching ART in Virologically Suppressed Patients
 New and Investigational Strategies

PARTNER2: HIV Risk in Serodiscordant MSM Partners
 Multicenter, observational, prospective study of HIV serodiscordant couples in
which the HIV-positive partners received suppressive ART
‒ PARTNER1: 2010-2014 (MSM and heterosexuals)
‒ PARTNER2: 2014-2018 (MSM only)
 Primary aim: estimate within-couple HIV transmission risk for serodiscordant MSM
having condomless sex while HIV-positive partner had HIV-1 RNA < 200 copies/mL
‒ No PEP or PrEP use reported by HIV-negative partner
‒ Linked infections established by phylogenetic analysis of HIV-1 pol and env sequences
isolated from plasma or PBMCs
Rodger A, et al. AIDS 2018. Abstract WEAX0104LB. Slide credit: clinicaloptions.com
783 MSM couples contributed 1596 CYFU

PARTNER2: HIV Transmission
 No linked transmissions documented in ~ 77,000 condomless sex acts when
HIV-positive MSM partner suppressed to HIV-1 RNA < 200 copies/mL
 Unlinked transmissions occurred in 15 initially HIV-negative MSM partners
Sexual Behavior Reported by
HIV-Negative Partner
Linked
Transmissions, n
Upper 95% CL*
Condomless
Sex Acts, n
CYFU
Any sex 0 0.23† 76991 1596
Anal sex 0 0.24 70743 1546
Insertive anal sex 0 0.27 52572 1345
Receptive anal sex without ejaculation 0 0.43 23153 867
Receptive anal sex with ejaculation 0 0.57 20770 652
Any sex with an STI 0 2.74 6301 135
*For rate of within-couple HIV transmission per 100 CYFU. †Compared with 0.84 for MSM and 0.46 for heterosexuals in PARTNER1.
Rodger A, et al. AIDS 2018. Abstract WEAX0104LB. Slide credit: clinicaloptions.com

Discussion: HIV Transmission
 How do you counsel your virologically suppressed patients about
U(ndetectable) = U(ntransmittable)?
 How do you counsel them about considerations beyond HIV
transmission, such as STDs?

1. Molina JM, et al. N Engl J Med. 2015;373:2237-2246. 2. Molina JM, et al.
Lancet HIV. 2017;4:e402-e410. 3. Antoni G, et al. IAS 2017. Abstract TUAC0102.
ANRS IPERGAY: Placebo vs On-Demand TDF/FTC Oral
PrEP
 On-demand PrEP* efficacy high for MSM, including those with frequent sex
(15-18 pills/mo) or less frequent sex (9.5 pills/mo)
Study Phase N
Total
Follow-
up, PY
Median
Pills/Mo
HIV Incidence/
100 PY
Risk
Reduction,
%
P
Value
TDF/FTC Placebo
Placebo controlled,
randomized[1] 400 431.3 15 0.91 6.60 86 .002
Open-label extension[2] 361 518 18 0.19 6.60 97 NR
Substudy (patients with
less frequent sex)[3] 269 134 9.5 0 9.3 100 NR
*On-demand PrEP strategy not FDA approved.

ANRS Prevenir: Daily vs On-Demand TDF/FTC Oral PrEP
HIV-negative adults at high risk of
HIV infection with inconsistent
condom use; CrCl ≥ 50 mL/min;
HBsAg negative in on-demand arm
(N = 1594)*
Daily TDF/FTC PrEP†
(n = 724)
On-Demand TDF/FTC PrEP†
(n = 870)
*Participants enrolled in arm of their choice with ability to switch; target enrollment, N = 3000 (85% MSM).
†Plus condoms, gels, risk reduction and adherence counseling, questionnaire on sexual behavior. Follow-up every 3 mos with STI and/or HIV testing,
plasma creatinine measurement.
End of Study
May 31, 2020
Current Analysis
July 2, 2018
Molina J-M, et al. AIDS 2018. Abstract WEAE0406LB. Slide credit: clinicaloptions.com
Beginning of Study
May 3, 2017
HIV Incidence/100 PY
(95% CI)
0 (0-0.8)
0 (0-0.7)
 Multicenter, open-label, prospective cohort study in Paris
 Predominantly MSM (98.8%), white (85.2%); median age: 36 yrs; mean follow-up: 7 mos
 Overall HIV infections averted, n = 85
‒ Assuming incidence of 9.17/100 PY as reported for ANRS IPERGAY study among participants in Paris

ANRS Prevenir: PrEP Adherence, Sexual Behavior
 Median episodes of condomless sex in previous 4 wks: 3-6 with daily PrEP,
2-4 with on-demand PrEP
 Median sexual partners in previous 3 mos: 10-15 with daily PrEP, 6-10 with
on-demand PrEP
At Last Sexual Encounter, n (%)
Daily PrEP
(1088 Acts)
On-Demand PrEP
(1191 Acts)
PrEP use
 Total
 Correct*
1068 (98.2)
1024 (95.8)
967 (81.2)
931 (96.2)
Condom use 206 (18.9) 258 (21.6)
Participants with adherence data, n = 1102.
*Per protocol, or at least 1 pill before and after within 24 hrs.

ANRS Prevenir: Safety
 Most drug-related AEs were gastrointestinal
 No discontinuations due to drug-related AEs
Incidence/100 PY (95% CI)
Daily PrEP
(443 PYFU)
On-Demand PrEP
(506 PYFU)
Drug-related AEs 11.5 (8.6-15.1) 12.5 (9.6-15.9)
Grade 3/4 AEs 3.6 (2.1-5.9) 4.7 (3.0-7.1)
Viral hepatitis 1.1 (0.4-2.6) 1.2 (0.4-2.6)
ALT abnormality
 Grade 3/4
45.6 (39.5-52.3)
2.3 (0.1-12.6)
40.3 (35.0-46.3)
2.0 (0.1-11.0)
Grade 1 creatinine 15.6 (12.1-19.7) 17.6 (14.1-21.7)
CrCl 50-70 mL/min 15.1 (11.7-19.2) 17.6 (14.1-21.7)

Effect of PrEP Uptake on HIV Diagnoses: United States
 Comparison of HIV diagnoses in people 13 yrs of age or older* vs PrEP
uptake rates† from 2012 to 2016
Sullivan PS, et al. AIDS 2018. Abstract LBPEC063. Slide credit: clinicaloptions.com
States Grouped by Quintiles of PrEP Uptake
EstimatedAnnualChange
inHIVDiagnoses(%)
*Calculated using data from the National HIV Surveillance System, US Census, and intercensal estimates.
†CDC method estimated PrEP indications; national database covering > 83% of prescriptions supplied via commercial pharmacies and validated
algorithm excluding non-PrEP FTC/TDF quantified unique persons using PrEP.
 For 38 jurisdictions with
available viral suppression data,
significant association between
PrEP uptake and decrease in HIV
diagnoses persisted after
controlling for state viral
suppression level
4
2
0
-2
-4
-6
0.93
-4.65
-0.94-0.41
1.53
Low Medium
Low
Medium Medium
High
High

PrEP Uptake in Adolescents: United States
 National pharmacy claims of people starting TDF/FTC for PrEP from 2012 to 2017 (n = 149,893 aged
25 yrs or older; n = 27,330 aged 12-24 yrs)
Magnuson D, et al. AIDS 2018. Abstract TUAC0305. Slide credit: clinicaloptions.com
IndividualsStartingPrEP
Aged 12-17 yrs (n = 2590)
Aged 18-24 yrs (n = 24,740)
Year
Where PrEP Was Prescribed
269 425 546 818
222 310
1093
1544
3150
5845 5417
7691
0
2000
4000
6000
8000
10,000
2012 2013 2014 2015 2016 2017
0 20 40 60 80 100 120
Aged ≥ 25
Aged 18-24
Aged 12-17
Emergency medicine
Family practice
Pediatrics
Internal medicine
Infectious diseases
Other

Discussion: PrEP
 Are there certain patients in whom you would recommend on-demand
PrEP?
 What are your PrEP recommendations for women?
 For adolescents and young adults?

Tenofovir and Emtricitabine Tissue Penetration
 TFV and FTC concentrations in mucosal
tissues determined after single dose of
TDF/FTC (N = 15 healthy volunteers;
8 men, 7 women)
‒ Median age: men, 26 yrs; women,
22 yrs
 TFV vaginal and cervical concentrations
~ 2 logs lower than rectal
concentrations (6.8-50 vs 1877 ng/g)
 Despite high FTC concentrations in
vagina and cervix, FTC-TP detected for
≤ 2 days in both tissues
TFV
TFV-DP
MedianConcentration
(ng/g)
MedianConcentration
(fmol/g)
Patterson KB, et al. Sci Transl Med. 2011;3:112re4.
10000
1000
100
10
1
0.1
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Rectal tissue
Vaginal tissue
Cervical tissue
106
105
104
103
102
101
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Days After Single TDF/FTC Dose

 Randomized, open-label phase II/III pilot study in South Africa and
Uganda
 Primary endpoint: maternal pharmacokinetics of DTG
 Secondary endpoints: HIV-1 RNA < 50 copies/mL at 2 wks postpartum,
safety
DolPHIN-1: DTG or EFV + NRTIs in Pregnant Women
Initiating ART During Third Trimester
*EFV-based regimen begun immediately at diagnosis per national guidelines, randomization at a median of 3 days (range: 1-8) later.
†TDF/FTC in South Africa; TDF/3TC in Uganda.
2 wks postpartum
All patients
subsequently received
EFV + 2 NRTIs;
post-switch follow-up
for up to 6 mos
Orrell C, et al. AIDS 2018. Abstract THAB0307LB. Waitt C, et al. CROI 2018. Abstract 807. ClinicalTrials.gov. NCT02245022. Slide credit: clinicaloptions.com
DTG 50 mg QD + 2 NRTIs†
(n = 29)
EFV 600 mg QD + 2 NRTIs†
(n = 31)
Adult women with untreated HIV presenting to
antenatal clinics at ≥ 28-36 wks of gestation;
no ARVs in prior 6 mos or INSTI experience;
no depression; Hb ≥ 8 g/dL, eGFR ≥ 50 mL/min,
ALT ≤ 5 x ULN; no active HBV*
(N = 60)

DolPHIN-1: Maternal Plasma PK of DTG
 DTG exposure at or below target
(ie, 324 ng/mL)
‒ Third trimester: 32% (9/28)
‒ Postpartum: 22% (6/27)
 DTG accumulation in breast milk: 3% with
rapid elimination upon cessation
‒ Prolonged infant washout
Participant with undetectable DTG throughout excluded, n = 1. *Sampling 2-18 days after delivery, median: 8 days.
Orrell C, et al. AIDS 2018. Abstract THAB0307LB. Slide credit: clinicaloptions.com
DTG Parameter (Range) Third Trimester (n = 28) Postpartum (n = 27)* GMR (90% CI)
AUC0-24h, ng·h/mL 35,322 (19,196-67,922) 37,575 (14,933-59,633) 0.95 (0.74-1.23)
Cmax, ng/mL 2534 (1462-3986) 2843 (1398-4224) 0.91 (0.82-1.01)
Ctrough, ng/mL 642 (188-3088) 696 (204-1443) 0.93 (0.76- 1.14)
324 ng/mL
64 ng/mL
Third trimester
Postpartum
Hrs
DTG(ng/mL)
DTG PK Profile (Geometric Mean ± 90% CI)
500
1000
0
3000
2000
2500
0 4 8 12 16 20 24
1500

DolPHIN-1: Virologic Response
 Median time to virologic
suppression approximately
halved with DTG vs EFV
Orrell C, et al. AIDS 2018. Abstract THAB0307LB. Slide credit: clinicaloptions.com
HIV-1 RNA < 50
copies/mL, n (%)
DTG
+ 2 NRTIs
(n = 29)
EFV
+ 2 NRTIs
(n = 31)
P
Value
2 wks
postpartum
20 (69.0) 12 (38.7) .02
ProportionWithHIV-1
RNA>50copies/mL
Days From Screening
P = .0001
DTG + 2 NRTIs
EFV + 2 NRTIs
0.50
0.25
0.00
1.00
0.75
0 20 40 60 80 100

ARV Surveillance During Pregnancy
 Limited data available on safety of ART during pregnancy and lactation
‒ Approximately 5-yr mean lag between ARV approval and availability of data in
pregnancy, with no pregnancy data available for 3/7 ARVs approved since 2010
 Current data on newer ARVs (ie, INSTIs, ETR, TAF) insufficient to exclude
even a 2-fold increase in overall birth defects or rare events such as neural
tube defects
 Risk of serious birth defects associated with any drug exposure
at conception greater than for exposure during pregnancy, although clinical
trials may not distinguish between the two
‒ Neural tube defects likely to occur before Day 28 post conception
Mofenson L. AIDS 2018. Session TUSY15. Slide credit: clinicaloptions.com

Tsepamo: Neural Tube Defects and DTG Exposure
 Unplanned analysis of ongoing birth
outcomes surveillance study among
Botswanan women ± HIV infection[1,2]
 At latest analysis on July 15, 2018[2]
‒ NTD prevalence with DTG exposure
at conception: 4/596
(0.67%; 95% CI: 0.26% to 1.7%)
‒ NTD prevalence with DTG started
during pregnancy: 1/3104
(0.03%; 95% CI: 0.01% to 0.18%)
 Next formal analysis to occur after
March 31, 2019, which will include
72% of national births
1. Zash R, et al. N Engl J Med. 2018;[Epub ahead of print]. 2. Zash R, et al. AIDS 2018. Session TUSY15. Slide credit: clinicaloptions.com
DTG Any Non-
DTG ART
EFV HIV
Negative
Pregnancy
NeuralTubeDefects*
(%,95%CI)
DTG
Conception
*In 89,064 births as of May 1, 2018.
0.94
0.12 0.05 0.00 0.09
2.5
1.5
0.5
2
1
0

*DHHS: < 8 wks from last menstrual period; BHIVA and WHO: first trimester.
†DHHS: ≥ 8 wks from last menstrual period; BHIVA and WHO: second and third trimesters.
Guidance on the Use of DTG in Women
References in slidenotes. Adapted from Doherty M, et al. AIDS 2018. Session TUSY15. Slide credit: clinicaloptions.com
Currently
Receiving DTG?
Pregnancy Status
Recommendation on DTG
DHHS[1] BHIVA[2] WHO[3]
No
Early pregnancy*
Late pregnancy†
Childbearing potential, no contraception
Childbearing potential, effective contraception
Yes
Early pregnancy*
Late pregnancy†
Childbearing potential, no contraception
Childbearing potential, effective contraception
DTG may be used Use DTG or another option Do not use DTG

Discussion: HIV and Pregnancy
 How do you counsel and test pregnant women at high risk for HIV
infection during pregnancy and postpartum?
 How do you counsel HIV-infected women of childbearing age who are
not using contraception or have pregnancy intention?
 In HIV-infected women, how do you weigh the options for selection of
ART?

Class DHHS[1] IAS-USA[2]
INSTI  BIC/TAF/FTC
 DTG/ABC/3TC
 DTG + (TAF or TDF)/FTC
 EVG/COBI/(TAF or TDF)/FTC
 RAL + (TAF or TDF)/FTC
 BIC/TAF/FTC
 DTG/ABC/3TC
 DTG + TAF/FTC
DHHS, IAS-USA Guidelines: Recommended Regimens for
First-line ART
 Recommendations may differ based on baseline HIV-1 RNA, CD4+ cell count, CrCl, eGFR,
HLA-B*5701 status, HBsAg status, osteoporosis status, and pregnancy status
 Data are lacking for women of child-bearing age not using contraception
 IAS-USA now lists EVG/COBI/TAF/FTC and RAL + TAF/FTC as alternative regimens owing to their
lower resistance barriers and, respectively, more drug interactions and higher pill burden[2]
Bold text identifies single-tablet regimens.
1. DHHS Guidelines. May 2018. 2. Saag MS, et al. JAMA. 2018;320:379-396. Slide credit: clinicaloptions.com

GEMINI-1 and -2: DTG + 3TC vs DTG + TDF/FTC in
Treatment-Naive Patients
 Parallel, international, randomized, double-blind phase III noninferiority studies
 Primary endpoint: HIV-1 RNA < 50 copies/mL at Week 48 by FDA Snapshot analysis
‒ Noninferiority margin: -10%
ART-naive adults with HIV-1 RNA
1000-500,000 copies/mL, ≤ 10 days on
previous ART, no major resistance
associated mutation, no HBV infection
or HCV requiring therapy
(N = 1433)
DTG + 3TC PO QD
(n = 716)
DTG + TDF/FTC PO QD
(n = 717)
Wk 144
Primary Analysis
Wk 48
Stratified by HIV-1 RNA (≤ vs > 100,000 copies/mL),
CD4+ cell count (≤ vs > 200 cells/mm³)
Cahn P, et al. AIDS 2018. Abstract TUAB0106LB. ClinicalTrials.gov. NCT02831673. ClinicalTrials.gov. NCT02831764. Slide credit: clinicaloptions.com
Screening within 28 days of study start; studies double-blinded until Wk 96, open-label until Wk 144.
Continuation of
DTG + 3TC
permitted

GEMINI-1 and -2: Baseline Characteristics
Cahn P, et al. AIDS 2018. Abstract TUAB0106LB. Slide credit: clinicaloptions.com
Characteristic
DTG + 3TC
(n = 716)
DTG +
TDF/FTC
(n = 717)
Median HIV-1 RNA,
log10 c/mL (range)
 ≤ 100,000 c/mL, n (%)
 > 100,000 c/mL, n (%)
4.43
(1.59-6.27)
576 (80)
140 (20)
4.46
(2.11-6.37)
564 (79)
153 (21)
Median CD4+ cell count,
cells/mm3 (range)
 > 200 cells/mm3, n (%)
 ≤ 200 cells/mm3, n (%)
427.0
(19-1399)
653 (91)
63 (9)
438.0
(19-1497)
662 (92)
55 (8)
Characteristic
DTG + 3TC
(n = 716)
DTG +
TDF/FTC
(n = 717)
Median age, yrs (range)
 ≥ 50 yrs of age, n (%)
32.0 (18-72)
65 (9)
33.0 (18-70)
80 (11)
Female, n (%) 113 (16) 98 (14)
Race, n (%)
 Black/African heritage
 Asian
 White
 Other
99 (14)
71 (10)
480 (67)
66 (9)
76 (11)
72 (10)
497 (69)
72 (10)
Hispanic/Latino, n (%) 215 (30) 232 (32)

Cahn P, et al. AIDS 2018. Abstract TUAB0106LB.
*Adjusted for HIV-1 RNA (≤ vs > 100,000 copies/mL), CD4+ cell count(≤ vs > 200 cells/mm3), and study (GEMINI-1 vs GEMINI-2).
†PP = the ITT-E population excluding significant protocol violations.
DTG + 3TC (n = 716)
DTG + TDF/FTC (n = 717)
Virologic
Success
Virologic
Nonresponse
No Virologic
Data
HIV-1RNA
<50copies/mL(%)
ITT-E
100
80
60
40
20
0
91 93
3 2 6 5
Treatment Difference*
ITT-E: -1.7% (95% CI: -4.4% to 1.1%)
PP† : -1.3% (95% CI: -3.9% to 1.2%)
 No treatment-emergent INSTI or NRTI
mutations in patients with VF in either arm
 Confirmed VF with DTG + 3TC: n = 6
 Confirmed VF with DTG + TDF/FTC: n = 4
 Bone and kidney safety markers more
favorable with DTG + 3TC vs DTG + TDF/FTC
DTG + 3TC was noninferior vs 3-drug therapy, no resistance in either arm
GEMINI-1 and -2: DTG + 3TC Noninferior to DTG +
TDF/FTC in Treatment-Naive Patients at Wk 48

GEMINI-1 and -2: Virologic Response at Wk 48 by
Baseline HIV-1 RNA and CD4+ Cell Count
 TRDF includes confirmed virologic withdrawal, withdrawal for lack of efficacy or treatment-related
AEs, and participants meeting protocol-defined stopping criteria
Cahn P, et al. AIDS 2018. Abstract TUAB0106LB. Slide credit: clinicaloptions.com
Virologic Outcomes by TRDF Analysis
DTG + 3TC DTG + TDF/FTC
PatientsWithoutTRDF(%)
Baseline CD4+
Cell Count, cells/mm3
100
80
60
40
20
98 98 99 97 98 100
≤ 100,000 > 100,000
Baseline HIV-1
RNA, c/mL
> 200 ≤ 200
566/
576
553/
564
138/
140
149/
153
642/
653
647/
662
62/
63
55/
55
98 98
Virologic Outcomes by FDA Snapshot Analysis
Baseline CD4+
Cell Count, cells/mm3
100
80
60
40
20
91 94 92 90 93 93
79
93
≤ 100,000 > 100,000
Baseline HIV-1
RNA, c/mL
> 200 ≤ 200
526/
576
531/
564
129/
140
138/
153
605/
653
618/
662
50/
63
51/
55
PatientsWith
HIV-1RNA<50c/mL(%)
n/N =n/N =
00

DIAMOND: Rapid ART Initiation With
DRV/COBI/FTC/TAF in Treatment-Naive Patients
 Interim analysis of open-label, prospective, multicenter phase III study
 Primary endpoint: HIV-1 RNA < 50 copies/mL at Wk 48 by FDA Snapshot analysis
 Median time from diagnosis to screening/BL: 5 days (range: 0-14)
ART-naive adults diagnosed with HIV within
2 wks of screening/BL visit; ART initiated
immediately without BL lab results
(N = 109)
DRV/COBI/FTC/TAF PO QD
Wk 48:
Primary
Endpoint
Huhn GD, et al. AIDS 2018. Abstract WEPEC200. ClinicalTrials.gov. NCT03227861. Slide credit: clinicaloptions.com
Day 3*:
BL lab
results
Wk 4†:
BL review of
resistance
Wk 24:
Current Interim
Analysis
*± 1 wk. Safety stopping criteria: eGFR < 50 mL/min, AST or ALT ≥ 2.5 x ULN, serum lipase ≥ 1.5 x ULN, + pregnancy test, HCV
requiring treatment immediately or with drugs incompatible with DRV/COBI/FTC/TAF, or any other lab result considered by
investigator to necessitate discontinuation of study drugs.
†± 7 days. Patients without genotypic sensitivity to all DRV/COBI/FTC/TAF components required to stop, except M184I/V alone.

DIAMOND: Wk 24 Results
 99/109 patients on study at Wk 24
‒ Met safety stopping rule: n = 3; met
resistance stopping rule: n = 0; d/c for other
reasons: n = 7 (none for lack of efficacy)
 No grade 4 AEs or deaths, no study drug–
related serious AEs
 Grade 3/4 AST elevation: n = 4
 1 d/c for AEs: grade 3 allergic dermatitis,
grade 2 pyrexia and lip swelling
 HIVTSQ total treatment satisfaction scores
high at Wk 4 (mean: 56.5 out of 60) and
Wk 24 (mean: 57.9 out of 60)
Slide credit: clinicaloptions.comHuhn GD, et al. AIDS 2018. Abstract WEPEC200.
Virologic Outcomes
219/
312
81
13
88/109 14/109 7/109 88/98
6
90
Patients(%)
100
80
60
40
20
0
n/N =
HIV-1 RNA
< 50 c/mL
FDA Snapshot
HIV-1 RNA
≥ 50 c/mL
No Data HIV-1 RNA
< 50 c/mL
HIV-1 RNA
≥ 50 c/mL
10
10/98
Observed

Discussion: First-line Therapy
 How do new options fit into the current treatment landscape for
treatment-naive patients starting ART?
 Whom would you consider a candidate for initial therapy with a 2-drug
regimen?
 How might recent data on rapid ART initiation affect how you counsel
newly diagnosed patients?

DAWNING: NRTIs + DTG or LPV/RTV as Second-line ART
 International, randomized, open-label phase IIIb noninferiority study
 Primary endpoint: HIV-1 RNA < 50 copies/mL at Wk 48 by FDA
Snapshot algorithm with noninferiority margin of 12%
*Investigator-selected NRTIs; included ≥ 1 fully active NRTI according to HIV genotypic resistance testing at screening.
†Based on recommendation by monitoring committee, protocol amended to allow discontinuation of LPV/RTV arm and crossover to
DTG arm due to superior efficacy.
DTG + 2 NRTIs*
(n = 312)
LPV/RTV + 2 NRTIs*†
(n = 312)
Aboud M, et al. AIDS 2018. Abstract THPEB040. Slide credit: clinicaloptions.com
Stratified by number of fully active NRTIs
(2 vs < 2), HIV-1 RNA (≤ vs > 100,000 c/mL)
Patients with HIV infection and VF (2 instances
of HIV-1 RNA ≥ 400 copies/mL) on first-line
NNRTI + 2 NRTIs; receiving first-line regimen
≥ 6 mos; no primary resistance to INSTIs or PIs
(N = 624)
Primary Endpoint
Wk 48
DTG + 2 NRTIs
continuation phase
Wk 52

DAWNING: Virologic Response at Wk 48
DTG + 2 NRTIs
LPV/RTV + 2 NRTIs
Virologic Outcomes Treatment Difference, % (95% CI)
*P < .001 for superiority.
13.8*
219/
312
84
70
261/
312
219/
312
246/
283
204/
274
87
74
HIV-1RNA<50c/mL(%)
100
80
60
40
20
0
n/N =
ITT-E PP
DTGLPV/RTV
-12 -8 -4 0 4 8 12 16 20 24
ITT-E
PP
7.3 20.3
5.8 18.7
12.3

DAWNING: Virologic Response at Wk 48 by BL Strata
1. Aboud M, et al. AIDS 2018. Abstract THPEB040. 2. Wang R, et al. AIDS 2018. Abstract THPEB071. Slide credit: clinicaloptions.com
DTG + 2 NRTIs
LPV/RTV + 2 NRTIs
89
71
64 65
216/
242
178/
249
45/
70
41/
63
84
73
84
59
80
69
51/
61
38/
64
210/
251
181/
248
133/
166
104/
151
≤ 100,000
c/mL
> 100,000
c/mL
2 < 2 < 200
cells/mm3
88
72
128/
146
115/
160
HIV-1 RNA[1] Fully Active NRTIs[1]
CD4+ Cell Count[1]
≥ 200
cells/mm3
HIV-1RNA<50c/mL(%)
100
80
60
40
20
0
n/N =
Others† None
83
56
84
72
80
55
220/
261
182/
252
5/
6
5/
9
24/
30
18/
33
NRTI Mutations[2]
M184I/V
± Others*
*Including K65R. †IAS major NRTI mutations, excluding K65R and M184I/V.

DAWNING: Virologic Withdrawal and
Treatment-Emergent Mutations
 Met criteria for virologic withdrawal: DTG, n = 11; LPV/RTV, n = 30
‒ Treatment-emergent resistance: DTG, n = 2; LPV/RTV, n = 3
 Fewer drug-related AEs with DTG vs LPV/RTV
VW and Treatment-Emergent
Mutations by BL NRTI Resistance
DTG + 2 NRTIs (n = 314)* LPV/RTV + 2 NRTIs (n = 310)
VW, n/N INSTI, n NRTI, n VW, n/N PI, n NRTI, n
M184I/V only 3/77 0 0 10/85 0 0
M184I/V + others, including K65R 4/184 2† 1† 10/167 0 2‡
K65R ± others, but not M184I/V 1/16 0 0 2/17 0 0
Others, excluding K65R and M184I/V 1/7 0 0 0 0 0
None 2/30 0 0 8/33 0 1§
*Includes 2 subjects randomized to LPV/RTV but treated with DTG.
†Emergent G118R (INSTI) + D67N (NRTI) in n = 1; H51H/Y, G118R, E138E/K, and R263R/K (all INSTI) in n = 1.
‡BL K65R + M184I/V in both with emergent K219K/Q or K219K/E + K70K/Q/R. §Emergent K70K/R + M184V.
Wang R, et al. AIDS 2018. Abstract THPEB071. Aboud M, et al. AIDS 2018. Abstract THPEB040. Slide credit: clinicaloptions.com

Discussion: Second-line Therapy
 How often do you see failure with resistance after first-line therapy?
 How does M184V affect your recommendations for the next treatment
regimen?

Switching ART in
Virologically Suppressed Patients

SWORD-1 and -2: Switch to DTG + RPV vs Continuation
of Baseline ART in Virologically Suppressed Adults
 Parallel, randomized, open-label, multicenter phase III noninferiority studies[1,2]
 Primary endpoint: HIV-1 RNA < 50 copies/mL maintained in 95% of patients in each arm at Wk 48;
adjusted treatment difference: -0.2% (95% CI: -3.0 to 2.5)[2]
 10/990 (1%) confirmed virologic withdrawals through Wk 100 (Treatment-emergent NNRTI
resistance mutations documented in 3/10, all from early switch arm)
Switch to DTG + RPV
(n = 513)
Continue Baseline ART
(n = 511)
Switch to DTG + RPV
Continue DTG + RPV
Early Switch Phase
1. Aboud M, et al. AIDS 2018. Abstract THPEB047. 2. Llibre JM, et al. Lancet. 2018;391:839-849. Slide credit: clinicaloptions.com
Adults on stable ART
(INSTI, NNRTI, or PI +
2 NRTIs) with HIV-1 RNA
< 50 copies/mL for ≥ 6 mos
at screening; no previous
VF or current HBV infection
(N = 1024)
Late Switch Phase
Wk 148Wk 52
Current Analysis
Wk 100
DTG dosed 50 mg PO QD; RPV dosed 25 mg PO QD.
Primary Endpoint
Wk 48
*70% to 73% of patients receiving TDF at baseline.
Virologic Response With DTG
+ RPV by FDA Snapshot
89%
93%
(HIV-1 RNA < 50 copies/mL
at Wk 100)

SWORD-1 and -2: Bone and Lipid Markers
 All bone turnover markers
significantly lower at Wk 100 vs BL
except procollagen 1 N-terminal
propeptide in early switch arm
 No changes in lipid levels (total
cholesterol, LDL-C, HDL-C,
triglycerides, total cholesterol:HDL-C
ratio) or atherogenesis and
inflammation biomarkers at Wk 100
vs BL in either group
 Early switch group maintained
improvements in markers of renal
tubular function (urine retinol-
binding protein/creatinine ratio and
urine β2-microglobulin/creatinine
ratio) observed from BL to Wk 48
through Wk 100
P Value for Change
From BL in Mean
Serum Concentration
Early Switch
Late
Switch
Wk 48 Wk 100 Wk 100
Osteocalcin < .001 < .001 < .001
Bone-specific alkaline
phosphatase
< .001 < .001 < .001
Procollagen 1 N-
terminal propeptide
< .001 - .05
Type 1 collagen-C
telopeptide
< .001 < .001 .05

Study 1824: Switch to EVG/COBI/FTC/TAF in
Virologically Suppressed Adults With M184V/I
 Ongoing, international, multicenter, open-label, single-arm phase IIIb pilot study
 Primary endpoint: HIV-1 RNA < 50 copies/mL at Wk 12 by PVR, defined as
‒ No confirmed VF (HIV-1 RNA ≥ 50 copies/mL on 2 consecutive visits) before Wk 12
‒ No premature d/c with last available HIV-1 RNA ≥ 50 copies/mL
‒ EVG/COBI/FTC/TAF d/c before Wk 12 for reasons other than viral rebound considered to have PVR
HIV-infected adults with HIV-1 RNA < 50 copies/mL for
≥ 6 mos on TDF/FTC or ABC/3TC + third agent*; M184V and/or
M184I on historical genotypic resistance test†; no previous VF
on PI- or INSTI-based regimen; eGFR ≥ 30 mL/min
(N = 37)
EVG/COBI/FTC/TAF PO QD
Primary Endpoint
Wk 12 Wk 48
Perez-Valero I, et al. AIDS 2018. Abstract TUAB0104. Slide credit: clinicaloptions.com
*At baseline, 54% of patients receiving PI, 32% INSTI, 11% NNRTI.
†51% (19/37) of patients also had evidence of baseline NNRTI resistance.

Study 1824: Efficacy and Safety
 HIV-1 RNA < 50 copies/mL
‒ Wk 12: 37/37 (100%)
‒ Wk 24: 37/37 (100%)
 No evidence of virologic failure
or treatment-emergent
resistance at Wks 12 or 24
 Single viral blips in 2 patients:
HIV-1 RNA 69 or 93 copies/mL,
respectively
Perez-Valero I, et al. AIDS 2018. Abstract TUAB0104. Slide credit: clinicaloptions.com
AE, n (%)
E/C/F/TAF
(n = 37)
Any AE
 Drug related
29 (78)
8 (22)†
Grade 2-4 AE
 Drug related
15 (40)
5 (14)
Grade 3/4 AE* 5 (14)
AE leading to premature study drug d/c
 Drug related
1 (3)
1 (3)
Serious AE* 4 (11)‡
*None deemed related to study drugs.
†Asthenia, fatigue, headache, each n = 2; diarrhea, skin
burning sensation, HTN, muscle spasms, each n = 1.
‡Tonsillar carcinoma, pleural adenocarcinoma, proteinuria,
acute kidney injury/renal failure, each n = 1.

Discussion: Switching in Virologically Suppressed
Patients
 How does Study 1824 affect your approach to maintenance therapy in
people with underlying resistance?
 Whom would you consider a candidate for maintenance dual therapy?

New and Investigational Strategies

DRIVE-FORWARD: NRTIs + Either Doravirine or DRV/RTV
in Treatment-Naive Adults
 Multicenter, randomized, double-blind phase III study[1]
 Primary endpoint: HIV-1 RNA < 50 copies/mL at Wk 48[2]
‒ Doravirine vs DRV/RTV: 84% vs 80% (difference: 3.9%; 95% CI: -1.6% to 9.4%)
Stratified by HIV-1 RNA (> vs ≤ 100,000 copies/mL)
and NRTI selection (TDF/FTC or ABC/3TC)
Current Analysis
Wk 96
*Investigator choice prior to randomization of open-label TDF/FTC or ABC/3TC.
†Option for eligible participants to receive doravirine + 2 NRTIs in extension phase.
1. Molina JM, et al. AIDS 2018. Abstract LBPEB017. 2. Molina JM, et al. CROI 2017. Abstract 45LB. Slide credit: clinicaloptions.com
ART-naive adults with HIV-1
RNA ≥ 1000 copies/mL within
45 days; no resistance to
study drugs by genotype test
(N = 766)
Open-label extension
for 96 wks†
Doravirine 100 mg QD + 2 NRTIs*
+ DRV/RTV Placebo
(n = 383)
DRV/RTV 800/100 mg QD + 2 NRTIs*
+ Doravirine Placebo
(n = 383)
Primary Analysis
Wk 48

DRIVE-FORWARD: Virologic Outcomes at Wk 96
Molina JM, et al. AIDS 2018. Abstract LBPEB017. Slide credit: clinicaloptions.com
HIV-1 RNA < 50 copies/mL by
Observed Failure Analysis, % (n)*
DOR DRV/RTV
All participants 81.0 (342) 76.8 (323)
BL HIV-1 RNA, copies/mL
 ≤ 100,000
 > 100,000
 ≤ 500,000
 > 500,000
85.6 (264)
65.4 (78)
81.8 (325)
64.7 (17)
79.7 (282)
65.2 (72)
78.1 (311)
36.4 (11)
BL CD4+ cell count, cells/mm3
 ≤ 50
 51-200
 > 200
80.0 (5)
71.0 (31)
82.0 (306)
52.9 (17)
65.8 (38)
79.9 (268)
NRTI
 TDF/FTC
 ABC/3TC
80.3 (295)
85.1 (47)
76.3 (283)
80.0 (40)
FDA Snapshot Analysis
Treatment Difference:
7.1% (95% CI: 0.5% to 13.7%)
*Discontinuation for lack of efficacy considered failure, other missing
data excluded; n refers to total number of participants per subgroup.
100
80
60
40
20
0
73.1
66.0
HIV-1RNA<50copies/mL(%)
DOR
+ 2 NRTIs
DRV/RTV +
2 NRTIs
280/
383
252/
383n/N =

DRIVE-FORWARD: Resistance at Wk 96
 Resistance in DOR arm, n = 2
‒ V106I, H221Y, F227C (DOR) and
M184V (FTC), > 96-fold reduction in
phenotypic susceptibility to DOR at
Wk 24
‒ V106A, P225Y/H (DOR) and V118I,
M184I (FTC), > 95-fold reduction in
phenotypic susceptibility to DOR at
Wk 72
 Resistance in DRV/RTV arm, n = 1
‒ Phenotypic resistance to FTC and 3TC
(> 79-fold reduction), genotype test
failed
Outcome
DOR
(n = 383)
DRV/RTV
(n = 383)
PDVF, n (%)
 Nonresponse, n
 Rebound, n
34 (9)
3
31
43 (11)
5
38
Early d/c without PDVF, n (%) 61 (16) 71 (19)
Successful genotype test, n
 DOR resistance
 NRTI resistance
 PI resistance
15
2
2
-
20
-
1
0

Fold Change by Virus NRTI NNRTI
ZDV d4T ddI ABC FTC 3TC TFV DOR EFV ETR RPV
WT 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0
A98G/F227C/M184V 0.1 0.7 1.2 2.7 > 100 > 100 0.5 > 93 9.0 2.8 3.8
A98G/V106I/H221Y/F227C/
M184V
0.1 0.6 1.2 3.2 > 100 > 100 0.6 > 110 19 7.9 10
V106A/P225H/Y318F/K65R 1.0 1.4 1.8 2.4 7.7 12 1.6 > 210 4.8 0.7 1.0
V106I/F227C 0.2 0.7 1.0 0.7 2.8 3.1 0.3 > 105 2.5 4.0 3.4
V106I/H221Y/F227C/M184V 0.2 0.8 1.1 3.9 > 100 > 100 0.4 > 96 1.7 1.5 1.2
V106M/F227C/K65R/M184V 0.1 0.5 1.5 2.8 > 100 > 100 0.4 > 98 11.0 0.6 0.4
Y188L/M184V 0.5 0.8 1.6 2.9 > 100 > 100 0.8 > 181 > 120 3.4 11
DRIVE-FORWARD and DRIVE-AHEAD: Resistance
 Susceptibility analysis of the 7 doravirine-resistant clinical mutants
from DRIVE-FORWARD and DRIVE-AHEAD phase III studies
Lai M-T, et al. AIDS 2018. Abstract THPDB101. Slide credit: clinicaloptions.com
Orange shading denotes resistance. Green shading denotes susceptibility. Bolded italics indicate partial sensitivity.

0
DRIVE-FORWARD: Safety at Wk 96
 Grade 2 bilirubin elevation: DOR, 1.8%;
DRV/RTV, 0.3%
‒ In DOR arm, all except 1 patient had elevated
predose bilirubin at BL
*Most occurred before Wk 48; no AE caused > 3 d/c in either arm.
AE, n (%)
DOR
(n = 383)
DRV/RTV
(n = 383)
Any AE
 Drug related
324 (84.6)
123 (32.1)
317 (82.8)
123 (32.1)
AE in > 10% in ≥ 1 arm
 Diarrhea
 Nausea
 Headache
 Upper RTI
 Viral upper RTI
65 (17.0)
45 (11.7)
57 (14.9)
51 (13.3)
44 (11.5)
91 (23.8)
52 (13.6)
46 (12.0)
30 (7.8)
50 (13.1)
Serious AE 27 (7.0) 33 (8.6)
AE leading to d/c*
 Rash
6 (1.6)
2 (< 1)
13 (3.4)
1 (< 1)
AE of clinical interest
 Rash
 Neuropsychiatric
36 (9.4)
60 (15.7)
37 (9.7)
72 (18.8)
mg/dL
25
20
15
10
5
14.0
-0.5
17.7
4.1
21.9
-1.1
22.5
-0.4
-5
4.5 4.2
DOR DRV/RTV
LDL-C Non-HDL-C Total
Cholesterol
Triglycerides HDL-C

BRIGHTE: Fostemsavir in Heavily Treatment–
Experienced Adults
 Randomized cohort of phase III trial
HIV-infected, heavily treatment–
experienced adults failing current
ART with confirmed HIV-1 RNA
≥ 400 c/mL; have 1-2 remaining
ARV classes (≥ 1 fully active
available agent/class) and not
able to construct viable regimen
with remaining agents
(n = 272)
Primary
Analysis
Day 8Randomized 3:1
Blinded Phase
Wks 24-96 counted from start of open-label FTR 600 mg BID + OBT.
*Mean adjusted by HIV-1 RNA log10 c/mL on Day 1.
†Excluded 2 patients due to data entry errors.
‡OBT permitted to include investigational agents.
§Study to be conducted until another option, rollover study, or marketing approval available.
Adjusted* Mean Δ in HIV-1
RNA at Day 8 vs Day 1,
log10 c/mL (95% CI)
-0.79
(-0.88 to -0.70)†
-0.17
(-0.33 to -0.01)
Wk 96§Day 9
Current
Analysis
Wk 24
Open-Label Extension
Pialoux G, et al. AIDS 2018. Abstract THPEB045. Slide credit: clinicaloptions.com
FTR 600 mg BID +
Failing Regimen
(n = 203)
Placebo BID +
Failing Regimen
(n = 69)
FTR 600 mg BID +
OBT‡
FTR 600 mg BID +
OBT‡
Treatment Difference,
% (95% CI)
-0.63 (-0.81 to -0.44)
Primary Endpoint

Outcome by
Disease Characteristics
HIV-1 RNA
< 40 c/mL,
n (%)
Mean Δ in CD4+
Cell Count vs BL,
cells/mm3 (n)
BL HIV-1 RNA, c/mL
 < 103
 103 to < 104
 104 to < 105
 ≥ 105
21 (68)
28 (64)
67 (57)
30 (38)
22 (28)
91 (38)
89 (108)
119 (73)
BL CD4+ cell count, cells/mm3
 < 20
 20 to < 50
 50 to < 100
 100 to < 200
 ≥ 200
24 (33)
12 (48)
20 (51)
40 (63)
50 (68)
97 (64)
107 (22)
83 (34)
103 (58)
71 (66)
Fully active ARVs in OBT
 1
 2
79 (60)
58 (50)
91 (123)
88 (107)
BRIGHTE: Fostemsavir + OBT Virologic Efficacy, CD4+ Cell
Count at Wk 24
Pialoux G, et al. AIDS 2018. Abstract THPEB045. Slide credit: clinicaloptions.com
Outcome by
Demographic Characteristics
HIV-1 RNA
< 40 c/mL,
n (%)
Mean Δ in CD4+
Cell Count vs BL,
cells/mm3 (n)
Age, yrs
 < 35
 35 to < 50
 ≥ 50
29 (48)
52 (51)
65 (59)
113 (55)
92 (94)
76 (99)
Sex
 Male
 Female
105 (53)
41 (57)
83 (182)
109 (66)
Race
 White
 Black
92 (50)
36 (60)
89 (162)
94 (58)
Region
 North America
 Europe
 South America
56 (52)
29 (56)
57 (54)
74 (97)
106 (46)
92 (98)

Discussion: Investigational Strategies
 How might the new and emerging investigational strategies discussed
here fit into the current HIV treatment landscape?

RIVER: ART ± Vorinostat With Prime/Boost Vaccine in
Primary HIV Infection
 Background: total HIV DNA predicts time to viral rebound after stopping treatment
 Current study: proof-of-concept, randomized phase II trial of ART +
HDAC inhibitor (vorinostat) + vaccine (ChAdV63.HIVconsv and MVA.HIVconsv)
 Predominantly MSM (92%); median age: 32 yrs
 Primary endpoint: difference between arms in mean log10 HIV-1 DNA copies/million CD4+ T-cells
averaged across Wks 16 and 18
 Secondary endpoint: HIV-specific T-cell responses by intracellular cytokine staining
Persons with primary HIV
infection treated with
immediate triple-drug
ART with INSTI until
undetectable HIV-1 RNA
(N = 60)
ART + Vorinostat 400 mg PO q72h x 10 + Vaccine*
(n = 30)
ART Alone
(n = 30)
Wk 18
*Prime: ChAdV63.HIVconsv at randomization, boost: MVA.HIVconsv at Wk 8.
Fidler S, et al. AIDS 2018. Abstract TUAA0202LB. Slide credit: clinicaloptions.com

RIVER: HIV-1 DNA in CD4+ T-Cells
 No significant difference in proviral DNA reservoir in CD4+ T-cells at Wks 16-18
 Combination of HDAC inhibitor vorinostat + vaccine + ART safe and immunogenic
and had no significant effect on proviral DNA reservoir vs ART alone
 More research needed
Fidler S, et al. AIDS 2018. Abstract TUAA0202LB. Slide credit: clinicaloptions.com
P = .95
HIV-1DNA
(log10copies/million
CD4+T-cells)
Enrollment Wk 8 Wk 12 Wk 16 Wk 18Randomization
Primary endpoint: 0.04 (95% CI: -0.03 to 0.11; P = .26)
ART alone ART + vorinostat + vaccine
5.00
4.00
3.00
2.00
P = .77 P = .30 P = .25 P = .49

HIV Cure Research: α4β7 Integrin
 Promising signals in SIV-infected
nonhuman primates[2]
‒ Treatment with ART + primatized mAb
against α4β7 integrin associated with
durable virologic suppression and normal
CD4+ cell count, even after stopping
treatment
‒ However, confirmatory study with same
design showed no effect on virologic
suppression after stopping treatment[3]
 Vedolizumab: humanized mAb
against α4β7 integrin[4]
‒ FDA approved for Crohn’s disease and
ulcerative colitis in adults
1. Cicala C, et al. Proc Natl Acad Sci U S A. 2009;106:20877-20882. 2. Byrareddy SN, et al. Science. 2016;354:197-202.
3. Di Mascio M, et al. AIDS 2018. Abstract TUAA0206LB. 4. Vedolizumab [package insert]. 2018. Slide credit: clinicaloptions.com
 In vitro, CD4+ T-cells with high vs low levels of α4β7 integrin more susceptible to
HIV infection[1]

Vedolizumab in Virologically Suppressed Adults
 Open-label, single-arm, exploratory study of adults with virologic suppression on ART, CD4+ cell
count > 450 copies/mm3 (N = 18)
‒ ART discontinued at Wk 22
‒ Vedolizumab infusions at Wks 0 and 2, and then every 4 wks through Wk 30
 Primary endpoint: no infusion-related AEs or vedolizumab-related serious AEs before or after ART
interruption
 Secondary endpoint: no difference in plasma viral rebound necessitating ART restart* with
vedolizumab vs historical untreated controls through Wk 48
‒ HR: 0.95 (95% CI: 0.42-2.13)
‒ Historical untreated control data from published studies of ART interruption for post hoc analysis
Fauci AS, et al. AIDS 2018. Abstract WESS0102. Slide credit: clinicaloptions.com
*ART restart criteria: > 4 wks of HIV-1 RNA > 1000 copies/mL, decrease in CD4+ cell count by > 30% from baseline or decrease to
< 350 cells/mm3, HIV-related symptoms, or pregnancy.

Summary
 PARTNER2 provides evidence that U(ndetectable) does indeed equal
U(ntransmittable)
 ANRS Prevenir provides additional data on efficacy of on-demand PrEP
‒ More data to come
 DTG has been shown to maintain levels throughout pregnancy and rapidly reduce
HIV-1 RNA
‒ Important safety signal (neural tube defects) when taken at the time of conception
 Novel strategies for treatment-naive and treatment-experienced patients continue
to expand
‒ Demonstrated efficacy, safety of 2-drug regimen of DTG + 3TC in treatment naive
 The search for innovative strategies for HIV cure continues

clinicaloptions.com/AIDS2018
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