integrating recent data when selecting first-line antiretroviral therapy.2015 [dhhs recommendations...
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Integrating Recent Data When Selecting First-line Antiretroviral Therapy
This activity is supported by an educational grant from Merck.
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Faculty
Joseph J. Eron, Jr., MDProfessor of Medicine and EpidemiologyUniversity of North Carolina School of MedicineDirector, AIDS Clinical Trials UnitUniversity of North CarolinaChapel Hill, North Carolina
W. David Hardy, MDClinical Professor of MedicineDavid Geffen School of Medicine at UCLALos Angeles, California
Paul E. Sax, MDClinical DirectorHIV Program and Division of Infectious DiseasesBrigham and Women’s HospitalProfessor of MedicineHarvard Medical SchoolBoston, Massachusetts
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DisclosuresJoseph 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.
Overview of First-line Antiretroviral Therapy
clinicaloptions.com/hivIntegrating 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.
clinicaloptions.com/hivIntegrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines: 2015 Recommended Regimens for First-line ART
DHHS Guidelines. April 2015.
Class DHHS Recommended TherapyRegardless 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/mm 3.
Selecting Initial Antiretroviral Therapy
clinicaloptions.com/hivIntegrating Recent Data When Selecting First-line Antiretroviral Therapy
Selected Drug–Drug Interactions of INSTIs
Agent Potential Drug–Drug InteractionsRaltegravir[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].
clinicaloptions.com/hivIntegrating 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.
clinicaloptions.com/hivIntegrating 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.
Comparing Integrase Inhibitor Regimens
clinicaloptions.com/hivIntegrating Recent Data When Selecting First-line Antiretroviral Therapy
FLAMINGO: Wk 96 Subgroup Efficacy Analysis
Molina JM, et al. Glasgow HIV 2014. Abstract O153.
HIV
-1 R
NA
< 5
0 c/
mL
(%)
DTG + NRTIs (n = 242) DRV/RTV + NRTIs (n = 242)
8275 79
6452
8273
8068
80
100
80
60
40
20
0TDF/FTC(n = 325)
ABC/3TC(n = 159)
> 100,000(n = 122)
≤ 100,000(n = 362)
Overall
BL HIV-1 RNA (c/mL) Background NRTI
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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 RAL15% (10.2% to 19.6%)
DRV/RTV vs RAL7.5% (3.2% to 11.8%)
ATV/RTV vs DRV/RTV7.5% (2.3% to 12.7%)
1.00
0.75
0.50
0.25
0
Cum
ulat
ive
Inci
denc
e
0
Wks Since Study Entry
24 48 64 80 96 112 128 144
ATV/RTV + TDF/FTCRAL + TDF/FTCDRV/RTV + TDF/FTC
clinicaloptions.com/hivIntegrating 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
clinicaloptions.com/hivIntegrating 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)
8075
0
20
40
60
80
10088
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
10090 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.
clinicaloptions.com/hivIntegrating 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
-1 R
NA
<50
c/m
L (%
)
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
0Success Failure No Data
92 90
4 4 4 6
E/C/F/TAF (n = 866)E/C/F/TDF (n = 867)
clinicaloptions.com/hivIntegrating Recent Data When Selecting First-line Antiretroviral Therapy
Integrase Inhibitor Options for First-line Antiretroviral TherapyDrug Dosing STR Boosting
RequiredAny Resistance
in Pts With Failure
Cross- Resistance
Raltegravir Twice daily No No Yes YesElvitegravir Once daily Yes Yes Yes YesDolutegravir Once daily Yes No None so far Partial
clinicaloptions.com/hivIntegrating 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 TherapyRegardless 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/mm 3.
clinicaloptions.com/hivIntegrating 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
(%)
FavorsEFV/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%
FavorsDTG + ABC/3TC
15%
Pappa K, et al. ICAAC 2014. Abstract H-647a.
8881 80
72 7163
5 6 7 8 10 7 713 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%
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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
NonresponseNonresponse Due to Other
Reasons
Pts
(%)
100
80
60
40
20
0
8068
8 12 1221
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Studies Addressing Abacavir and MIStudy Association DescriptionD: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.
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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:DReplication
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
clinicaloptions.com/hivIntegrating 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 TherapyRegardless 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/mm 3.
clinicaloptions.com/hivIntegrating 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 TherapyRegardless 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/mm 3.
Evolving Options for First-line Antiretroviral Therapy
clinicaloptions.com/hivIntegrating Recent Data When Selecting First-line Antiretroviral Therapy
Favors E/C/F/TAF
0
4.7%‒0.7%2.0%
HIV
-1 R
NA
<50
c/m
L (%
)
Treatment Difference (95% CI) Virologic Outcome
‒12% +12%
Favors E/C/F/TDF100
80
60
40
20
0Success 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.
clinicaloptions.com/hivIntegrating 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
Mea
n C
hang
e (m
L/m
in)
-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
clinicaloptions.com/hivIntegrating Recent Data When Selecting First-line Antiretroviral Therapy
TAF vs TDF: Changes in Spine and Hip BMD
E/C/F/TAF, n 845E/C/F/TDF, n 850
797816
784773
836848
789815
780767
‒0.66
P < .001
‒2.95
‒1.30
P < .001
‒2.86
HipSpine
Mea
n (S
D) %
Cha
nge
From
Bas
elin
e
24 48
Wk0 24 48
Wk0
Sax PE, et al. CROI 2015. Abstract 143LB.
2
0
-2
-4
-6
2
0
-2
-4
-6
clinicaloptions.com/hivIntegrating 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
clinicaloptions.com/hivIntegrating Recent Data When Selecting First-line Antiretroviral Therapy
DHHS Guidelines: 2015 Recommended Regimens for First-line ART
DHHS Guidelines. April 2015.
Class DHHS Recommended TherapyRegardless 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/mm 3.
clinicaloptions.com/hivIntegrating 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
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
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