Joseph J. Eron Jr., MD W. David Hardy, MD Paul E. Sax, MD How do leading experts select first-line antiretroviral therapy for their HIV-infected patients? Review these downloadable slides for key clinical trial data and the latest DHHS recommendations for first-line antiretroviral therapy.

1. Integrating Recent Data When
Selecting First-line Antiretroviral
Therapy
This activity is supported by an educational grant from Merck.

2. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
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Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Faculty
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
W. David Hardy, MD
Clinical Professor of Medicine
David Geffen School of Medicine
at UCLA
Los Angeles, California
Paul E. Sax, MD
Clinical Director
HIV Program and Division of
Infectious Diseases
Brigham and Women’s Hospital
Professor of Medicine
Harvard Medical School
Boston, Massachusetts

4. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Disclosures
Joseph J. Eron, Jr., MD, has disclosed that he has received consulting
fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences,
GlaxoSmithKline/ViiV, Merck, Tibotec/Janssen, and Tobira; has served
on data and safety monitoring boards for Vertex; and has received funds
for research support from AbbVie and GlaxoSmithKline/ViiV.
W. David Hardy, MD, has disclosed that he has received consulting fees
from Gilead Sciences, GlaxoSmithKline/ViiV, and Janssen; has received
funds for research support from Gilead Sciences, GlaxoSmithKline/ViiV,
Janssen, and Vertex; and has ownership interest (stocks, stock options
or other ownership interest) in Merck.
Paul E. Sax, MD, has disclosed that he has received consulting fees
from AbbVie, Bristol-Myers Squibb, Gilead Sciences,
GlaxoSmithKline/ViiV, Janssen, and Merck and funds for research
support (paid to Brigham and Women’s Hospital) from Bristol-Myers
Squibb, Gilead Sciences, GlaxoSmithKline/ViiV, and Merck.

5. Overview of First-line
Antiretroviral Therapy

6. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS and IAS-USA Guidelines: 2014
Recommended Regimens for First-line ART
1. DHHS Guidelines. May 2014. 2. Günthard HF, et al. JAMA. 2014;312:410-425.
Class
DHHS[1]
IAS-USA[2]
Regardless of
BL VL or CD4+ Count
Pts With Pre-ART
VL < 100,000 c/mL
NNRTI  EFV/TDF/FTC  EFV + ABC/3TC*
 RPV/TDF/FTC
 EFV/TDF/FTC or
 EFV + ABC/3TC*‡
or
 RPV/TDF/FTC‡
Boosted PI  ATV/RTV + TDF/FTC
 DRV/RTV + TDF/FTC
 ATV/RTV + ABC/3TC*  ATV/RTV + TDF/FTC or
 ATV/RTV + ABC/3TC*‡
 DRV/RTV + TDF/FTC
INSTI  RAL + TDF/FTC
 EVG/COBI/TDF/FTC║
 DTG + ABC/3TC*§
 DTG + TDF/FTC
 RAL + TDF/FTC
 EVG/COBI/TDF/FTC║
 DTG + ABC/3TC*§
 DTG + TDF/FTC
*Only for pts who are HLA-B*5701 negative.

Only for those with CD4+ cell counts > 200 cells/mm3
.
‡
Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL.
║
Only for pts with pre-ART CrCl > 70 mL/min.
§
Publication of these guidelines preceded the availability of DTG/ABC/3TC as a single-tablet regimen.

7. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines: 2015 Recommended
Regimens for First-line ART
DHHS Guidelines. April 2015.
Class
DHHS Recommended Therapy
Regardless of BL VL or CD4+ Count
Alternative Regimens
INSTI  RAL + TDF/FTC
 EVG/COBI/TDF/FTC*
 DTG/ABC/3TC†
 DTG + TDF/FTC
Boosted PI  DRV/RTV + TDF/FTC  ATV/RTV + TDF/FTC
 ATV/COBI + TDF/FTC*
 DRV/RTV + ABC/3TC†
 DRV/COBI + ABC/3TC*†
 DRV/COBI + TDF/FTC*
NNRTI  EFV/TDF/FTC
 RPV/TDF/FTC‡
*Only for pts with pre-ART CrCl ≥ 70 mL/min.
†
Only for pts who are HLA-B*5701 negative.
‡
Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL and CD4+ cell counts < 200 cells/mm3
.

8. Selecting Initial
Antiretroviral Therapy

9. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Selected Drug–Drug Interactions of INSTIs
Agent Potential Drug–Drug Interactions
Raltegravir[1]
 Metabolized by UGT1A
 ATV increases RAL concentrations; dose adjustment not recommended
 Avoid aluminum- and/or magnesium-containing antacids
 Rifampin decreases RAL levels; double RAL dose if coadministered with
rifampin
Elvitegravir/
cobicistat[2]
 Metabolized by CYP3A, CYP2D6
 COBI increases levels of drugs metabolized by CYP3A
 Separate dosing with aluminum- and/or magnesium-containing antacids
 Not recommended for use with rifamycins
Dolutegravir[3]  Metabolized by UGT1A, with contribution from CYP3A
 Avoid use with ETR unless coadministered with boosted PI; avoid dosing
with NVP
 Separate dosing with aluminum- and/or magnesium-containing antacids
 DTG may increase metformin concentrations; metformin dose adjustment
may be needed; monitor clinically when starting or stopping DTG
1. Raltegravir [package insert]. 2. EVG/COBI/TDF/FTC [package insert]. 3. Dolutegravir [package insert].

10. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines, April 2015: What to
Start
 An alternative regimen may be the preferred regimen for
some pts
Alternative Regimens
NNRTI
based
 EFV/TDF/FTC
 RPV/TDF/FTC*
PI based  ATV/COBI + TDF/FTC†
 ATV/r + TDF/FTC
 DRV/COBI + ABC/3TC‡
 DRV/r + ABC/3TC‡
 DRV/COBI + TDF/FTC†
*Only for pts with pre-ART HIV RNA < 100,000 copies/mL and CD4 > 200 cells mm3
.
†
Only for pts with pre-ART CrCl ≥ 70 mL/min.
‡
Only for pts who are HLA-B*5701 negative.
DHHS Guidelines. April 2015.

11. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
The International Antiviral Society–USA
Recommended Treatment Regimens
 Currently preferred WHO regimens: EFV/TDF/FTC or
EFV/TDF/3TC due to efficacy and cost of treatment[2]
1. Günthard HF, et al. JAMA. 2014;312:410-425. 2. WHO. The strategic use of antiretrovirals to help end
the HIV epidemic. 2012.
Class IAS-USA[1]
NNRTI  EFV/TDF/FTC or
 EFV + ABC/3TC*†
 RPV/TDF/FTC†
Boosted PI  ATV/RTV + TDF/FTC or
 ATV/RTV + ABC/3TC*†
 DRV/RTV + TDF/FTC
INSTI  RAL + TDF/FTC
 EVG/COBI/TDF/FTC‡
 DTG + ABC/3TC*§
 DTG + TDF/FTC
*Only for pts who are HLA-B*5701 negative.

Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL.
‡
Only for pts with pre-ART CrCl ≥ 70 mL/min.
§
Publication of these guidelines preceded the availability of DTG/ABC/3TC as a single-tablet regimen.

12. Comparing Integrase Inhibitor
Regimens

13. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
FLAMINGO: Wk 96 Subgroup Efficacy
Analysis
Molina JM, et al. Glasgow HIV 2014. Abstract O153.
HIV-1RNA<50c/mL(%)
DTG + NRTIs (n = 242) DRV/RTV + NRTIs (n = 242)
82
75 79
64
52
82
73
80
68
80
100
80
60
40
20
0
TDF/FTC
(n = 325)
ABC/3TC
(n = 159)
> 100,000
(n = 122)
≤ 100,000
(n = 362)
Overall
BL HIV-1 RNA (c/mL) Background NRTI

14. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Difference in 96-Wk Cumulative Incidence
(97.5% CI)
Favors RAL
Favors RAL
Favors DRV/RTV
Lennox JL, et al. Ann Intern Med. 2014;161:461-471.
ACTG 5257: Cumulative Incidence of
Virologic or Tolerability Failure at Wk 96
-20 0-10 10 20
ATV/RTV vs RAL
15% (10.2% to 19.6%)
DRV/RTV vs RAL
7.5% (3.2% to 11.8%)
ATV/RTV vs DRV/RTV
7.5% (2.3% to 12.7%)
1.00
0.75
0.50
0.25
0
CumulativeIncidence
0
Wks Since Study Entry
24 48 64 80 96 112 128 144
ATV/RTV + TDF/FTC
RAL + TDF/FTC
DRV/RTV + TDF/FTC

15. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
STARTMRK: Drug-Related Adverse Events
Rockstroh JK, et al. J Acquir Immune Defic Syndr. 2013;63:77-85.
5-Yr Drug-Related AEs in ≥ 5% of Pts, % RAL + TDF/FTC (n = 281) EFV + TDF/FTC (n = 282)
Gastrointestinal 21.7 29.4
Diarrhea 5.3 9.9
Flatulence 3.6 5.0
Nausea 8.9 11.0
General disorders 10.0 16.7
Fatigue 4.3 8.9
Nervous system disorders 18.5 49.6
Dizziness 7.8 35.1
Headache 9.3 14.2
Somnolence 1.1 7.4
Psychiatric disorders 18.5 30.9
Abnormal dreams 6.8 13.1
Insomnia 7.5 8.2
Nightmares 2.8 5.3
Skin and subcutaneous tissue disorders 6.0 22.3
Rash 1.1 8.2

16. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
EVG/COBI Noninferior to EFV and to
ATV/RTV, With TDF/FTC, Through Wk 144
Wk 48 Wk 144
EVG/COBI/TDF/FTC
(n = 348)
EFV/TDF/FTC
(n = 352)
80
75
0
20
40
60
80
100
88
84
Δ: 3.6%
(-1.6 to 8.8)
Δ: 4.9%
(-1.3 to 11.1)
84 82
Wk 96
Δ: 2.7%
(-2.9 to 8.3)
EVG/COBI/TDF/FTC
(n = 353)
ATV/RTV + TDF/FTC
(n = 355)
Δ: 2.7%
(-2.1 to 7.5)
Δ: 1.1%
(-4.5 to 6.7)
Wk 48 Wk 144
78 75
0
20
40
60
80
100
90 87
Δ: 3.1%
(-3.2 to 9.4)
83 82
Wk 96
Study 102[1] Study 103[2]
1. Wohl DA, et al. J Acquir Immune Defic Syndr. 2014;65:e118-e120.
2. Clumeck N, et al. J Acquir Immune Defic Syndr. 2014;65:e121-e124.

17. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Studies 104 and 111: HIV-1 RNA < 50 c/mL
at Wk 48 (Primary Endpoint)
 CD4+ significantly higher for TAF than TDF (P = .024)
 D/C for adverse events: TAF 0.9%, TDF 1.5%
 Resistance with failure: TAF 7/866 (0.8%), TDF 5/867 (0.6%)
Favors E/C/F/TAF
0
4.7%‒0.7%
2.0%
HIV-1RNA<50c/mL(%)
Treatment Difference (95% CI)Virologic Outcome
‒12% +12%
Favors E/C/F/TDF
Wohl D, et al. CROI 2015. Abstract 113LB.
100
80
60
40
20
0
Success Failure No Data
92 90
4 4 4 6
E/C/F/TAF (n = 866)
E/C/F/TDF (n = 867)

18. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Integrase Inhibitor Options for First-line
Antiretroviral Therapy
Drug Dosing STR Boosting
Required
Any Resistance
in Pts With
Failure
Cross-
Resistance
Raltegravir Twice daily No No Yes Yes
Elvitegravir Once daily Yes Yes Yes Yes
Dolutegravir Once daily Yes No None so far Partial

19. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines: 2015 Recommended and
Alternative Regimens for First-line ART
 An alternative regimen may be the preferred regimen for some pts
DHHS Guidelines. April 2015.
Class
DHHS Recommended Therapy
Regardless of BL VL or CD4+ Count
Alternative Regimens
INSTI  RAL + TDF/FTC
 EVG/COBI/TDF/FTC*
 DTG/ABC/3TC†
 DTG + TDF/FTC
Boosted PI  DRV/RTV + TDF/FTC  ATV/RTV + TDF/FTC
 ATV/COBI + TDF/FTC*
 DRV/RTV + ABC/3TC†
 DRV/COBI + ABC/3TC†
 DRV/COBI + TDF/FTC*
NNRTI  EFV/TDF/FTC
 RPV/TDF/FTC‡
*Only for pts with pre-ART CrCl ≥ 70 mL/min.
†
Only for pts who are HLA-B*5701 negative.
‡
Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL and CD4+ cell counts < 200 cells/mm3
.

20. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
SINGLE: DTG + ABC/3TC Superior to
EFV/TDF/FTC in Tx-Naive Pts To Wk 144
 Emergent resistance in those with VF: 0/39 (DTG) vs 7/33 (EFV)
Virologic
Success*
Virologic
Nonresponse
No Virologic Data
Pts(%)
Favors
EFV/TDF/FTC
95% CI for Difference
0
Wk 48
Wk 96
Wk 144
7.4%
8.0%
8.3%
2.5%
2.3%
2.0% 14.6%
13.8%
12.3%
Favors
DTG + ABC/3TC
15%
Pappa K, et al. ICAAC 2014. Abstract H-647a.
88
81 80
72 71
63
5 6 7 8 10
7 7
13 12
20
30
18
100
80
60
40
20
0
DTG + ABC/3TC QD (n = 414)
EFV/TDF/FTC QD (n = 419)
Wk 48 96 144 Wk 48 96 144 Wk 48 96 144
*HIV-1 RNA < 50 copies/mL as defined by FDA Snapshot algorithm.

-10% noninferiority margin.
Pts with HBV infection were excluded from this study.
15%

21. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Molina JM, et al. Glasgow HIV 2014. Abstract O153.
FLAMINGO: DTG + 2 NRTIs Superior to
DRV/RTV + 2 NRTIs in Tx-Naive Pts at Wk 96
DTG + 2 NRTIs (n = 242)
DRV/RTV + 2 NRTIs (n = 242)
Wk 96
*HIV-1 RNA < 50 copies/mL as defined by FDA
Snapshot algorithm.
Adjusted difference at Wk 96:
12.4% (95% CI: 4.7-20.2; P = .
002)
 Randomized, open-label
phase III study of DTG +
2 NRTIs vs DRV/RTV +
2 NRTIs
 Protocol defined VF: <1%
(2/242) with DTG vs 2%
(4/242) with DRV/RTV
– No treatment-emergent
resistance in either arm Virologic
Success*
Virologic
Nonresponse
Nonresponse
Due to Other
Reasons
Pts(%)
100
80
60
40
20
0
80
68
8
12 12
21

22. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Studies Addressing Abacavir and MI
Study Association Description
D:A:D[1]  Cohort collaboration (prospective)
Danish HIV Cohort[2]  Cohort (linked with registries)
Montreal study[3]  Nested case-control study
SMART[4]  Post hoc subgroup analysis of RCT (use of ABC not
randomized)
STEAL[5]  Preplanned secondary analysis of RCT (use of ABC
randomized)
Swiss HIV Cohort[6]  Cohort (retrospective)
FHDH ANRS CO4[7]
? Nested case-control study
NA-ACCORD[8]
? Cohort (retrospective)
VA Clinical Case Registry[9]
X Cohort (retrospective)
Brothers et al. analysis[10]
X Post hoc meta-analysis of RCTs
ACTG A5001/ALLRT[11]
X Post hoc meta-analysis of RCTs
FDA meta-analysis[12]
X Post hoc meta-analysis of RCTs
1. Friis-Møller N, et al. N Engl J Med. 2003;349:1993-2003. 2. Obel N, et al. HIV Med. 2010;11:130-136. 3. Durand M, et al. J Acquir
Immune Defic Syndr. 2011;57:245-253. 4. Phillips AN, et al. Antiviral Ther. 2008;13:177-187. 5. Martin A, et al. AIDS. 2010;24:2657-2663.
6. Young J, et al. J Acquir Immune Defic Syndr. 2015. [Epub ahead of print] 7. Lang S, et al. AIDS. 2010;24:1228-1230. 8. Palella F, et al.
CROI 2015. Abstract 749LB. 9. Bedimo RJ, et al. Clin Infect Dis. 2011;53:84-91. 10. Brothers CH, et al. J Acquir Immune Defic Syndr.
2009;51:20-28. 11. Ribaudo HJ, et al. Clin Infect Dis. 2011;52:929-940. 12. Ding X, et al. J Acquir Immune Defic Syndr. 2012;61:441-447.

23. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
NA-ACCORD: Recent Abacavir Use and
Risk of MI
 Retrospective analysis of pts in 7
clinical cohorts with recent ABC use
from 1/1/1995 to 12/31/2010
 “Recent” ABC initiation: prescribed
within previous 6 mos
 ABC initiators (n = 1948) vs non-ABC
initiators (n = 14,785):
– “Full” study population: all ART users
excluding persons on ABC at study entry
– “Restricted” population: ART-naive
persons who initiated ART in the cohort
 Endpoint of incident MIs: presence of
clinical diagnosis or elevation of cardiac
enzymes
– All MIs independently adjudicated
Palella F, et al. CROI 2015. Abstract 749LB.
0 2.001.00 4.003.00
Full Study
Restricted
Study
D:A:D
Replication
1.95
1.33
 Recent ABC use significant in restricted
population and D:A:D replication
 Association diminished after adjusting
for additional CVD risk factors in
multivariate analysis
 Significant factors
– Both: age 60+ yrs, HTN, eGFR < 30,
AIDS
– Full: smoking, DM
Adjusted HRs for MI in Those With Recent ABC Use

24. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines: 2015 Recommended and
Other Regimens for First-line ART
DHHS Guidelines. April 2015.
Class
DHHS Recommended Therapy
Regardless of BL VL or CD4+ Count
Other Regimens
INSTI  RAL + TDF/FTC
 EVG/COBI/TDF/FTC*
 DTG/ABC/3TC†
 DTG + TDF/FTC
 RAL + ABC/3TC†
Boosted PI  DRV/RTV + TDF/FTC  ATV/RTV or COBI + ABC/3TC†‡
 LPR/RTV + ABC/3TC†
 LPR/RTV + TDF/FTC
NNRTI  EFV + ABC/3TC†‡
When TDF or ABC cannot be used
 DRV/RTV + RAL§
 LPV/RTV + 3TC
*Only for pts with pre-ART CrCl ≥ 70 mL/min.
†
Only for pts who are HLA-B*5701 negative.
‡
Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL.
§
Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL and CD4+ cell counts < 200 cells/mm3
.

25. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines: 2015 Recommended
and Alternative Regimens for First-line
ART
 An alternative regimen may be the preferred regimen for some pts
DHHS Guidelines. April 2015.
Class
DHHS Recommended Therapy
Regardless of BL VL or CD4+ Count
Alternative Regimens
INSTI  RAL + TDF/FTC
 EVG/COBI/TDF/FTC*
 DTG/ABC/3TC†
 DTG + TDF/FTC
Boosted PI  DRV/RTV + TDF/FTC  ATV/RTV + TDF/FTC
 ATV/COBI + TDF/FTC*
 DRV/RTV + ABC/3TC†
 DRV/COBI + ABC/3TC†
 DRV/COBI + TDF/FTC*
NNRTI  EFV/TDF/FTC
 RPV/TDF/FTC‡
*Only for pts with pre-ART CrCl ≥ 70 mL/min.
†
Only for pts who are HLA-B*5701 negative.
‡
Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL and CD4+ cell counts < 200 cells/mm3
.

26. Evolving Options for First-line
Antiretroviral Therapy

27. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Favors E/C/F/TAF
0
4.7%‒0.7%
2.0%
HIV-1RNA<50c/mL(%)
Treatment Difference (95% CI)Virologic Outcome
‒12% +12%
Favors E/C/F/TDF100
80
60
40
20
0
Success Failure No Data
92 90
4 4 4 6
E/C/F/TAF (n = 866)
E/C/F/TDF (n = 867)
Studies 104 and 111: HIV-1 RNA < 50 c/mL
at Wk 48 (Primary Endpoint)
 CD4 significantly higher for TAF than TDF (P = .024)
 D/C for adverse events: TAF 0.9%, TDF 1.5%
 Resistance with failure: TAF 7/866 (0.8%), TDF 5/867 (0.6%)
Wohl D, et al. CROI 2015. Abstract 113LB.

28. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
TAF vs TDF: Renal Outcomes
 TAF vs TDF
– Significantly smaller decreases in
eGFR (P < .001)
– Significantly less proteinuria,
albuminuria, and tubular
proteinuria (P < .001)
 No cases of tubulopathy/Fanconi
syndrome in either arm
 Discontinuations due to renal
adverse events
– E/C/F/TAF: 0 (0%)
– E/C/F/TDF: 4 (0.5%)
Mean Change in eGFR
MeanChange(mL/min)
-11.2
E/C/F/TAF (n = 866)
E/C/F/TDF (n = 867)
-6.6
0 12 24 36 48
P < .001
Treatment Wk
Sax PE, et al. CROI 2015. Abstract 143LB.
10
5
0
-5
-10
-15
-20

29. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
TAF vs TDF: Changes in Spine and Hip
BMD
E/C/F/TAF, n 845
E/C/F/TDF,
n
850
797
816
784
773
836
848
789
815
780
767
‒0.66
P < .001
‒2.95
‒1.30
P < .001
‒2.86
HipSpine
Mean(SD)%Change
FromBaseline
24 48
Wk
0 24 48
Wk
0
Sax PE, et al. CROI 2015. Abstract 143LB.
2
0
-2
-4
-6
2
0
-2
-4
-6

30. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
TAF-Based Therapies in Development
 Studies all under way or completed
– EVG/COBI/FTC/TAF
– TAF/FTC
– RPV/TAF/FTC
– Darunavir/COBI/FTC/TAF
– TAF for HBV
 TAF/FTC for PrEP: studies planned

31. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines: 2015 Recommended
Regimens for First-line ART
DHHS Guidelines. April 2015.
Class
DHHS Recommended Therapy
Regardless of BL VL or CD4+ Count
Alternative Regimens
INSTI  RAL + TDF/FTC
 EVG/COBI/TDF/FTC*
 DTG/ABC/3TC†
 DTG + TDF/FTC
Boosted PI  DRV/RTV + TDF/FTC  ATV/RTV + TDF/FTC
 ATV/COBI + TDF/FTC*
 DRV/RTV + ABC/3TC†
 DRV/COBI + ABC/3TC*†
 DRV/COBI + TDF/FTC*
NNRTI  EFV/TDF/FTC
 RPV/TDF/FTC‡
*Only for pts with pre-ART CrCl ≥ 70 mL/min.
†
Only for pts who are HLA-B*5701 negative.
‡
Not recommended in pts with baseline HIV-1 RNA > 100,000 copies/mL and CD4+ cell counts < 200 cells/mm3
.

32. clinicaloptions.com/hiv
Integrating Recent Data When Selecting First-line Antiretroviral Therapy
Initial Factors that Influence Selection of
Firstline ART
 Pt preference
– Single vs multi-pill regimens
– Tolerability issues
 Drug–drug interactions
 Comorbidities
 Potential adherence issues
– Adherence to regimen
– Adherence to follow-up care

33. Go Online to Register for an
Interactive CME/CE-Certified Webinar!
Including case discussions on:
Considering stage of disease
Evaluating patient comorbidities
Appraising drug–drug interactions
Assessing potential adherence issues
Applying guideline recommendations
clinicaloptions.com/hiv/live events