Determining Candidacy and Strategies for ART Modification.2019

Determining Candidacy and Strategies for
ART Modification
Supported by an educational grant from ViiV Healthcare

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Slide credit: clinicaloptions.com

Faculty
José R. Arribas, MD
Research Director (HIV and Infectious
Diseases)
Hospital La Paz. IdiPAZ.
Madrid, Spain
Babafemi Taiwo, MBBS
Gene Stollerman Professor of Medicine
Chief, Division of Infectious Diseases
Northwestern University Feinberg
School of Medicine
Chicago, Illinois
Laura Waters, MD
Consultant Physician, HIV/GU Medicine
Mortimer Market Centre
CNWL NHS Trust
London, England
Brian Wood, MD
Associate Professor of Medicine
Division of Allergy and Infectious
Diseases
University of Washington
Seattle, Washington

Faculty Disclosures
The faculty reported the following financial relationships or relationships
to products or devices they or their spouse/life partner have with
commercial interests related to the content of this CME/CE activity:
José R. Arribas, MD, has disclosed that he has received consulting fees from
Gilead Sciences, Janssen, Merck, Teva, and ViiV Healthcare and funds for
research support from Gilead Sciences, Merck, and ViiV Healthcare.
Babafemi Taiwo, MBBS, has disclosed that he has received consulting fees
from Gilead Sciences, Janssen, Merck, and ViiV Healthcare.
Laura Waters, MD, has disclosed that she has received consulting fees from
Cipla, Gilead Sciences, Janssen, Merck, and ViiV Healthcare.
Brian Wood, MD, has no relevant conflicts of interest to report.

Which ARVs to Switch Routinely
vs on an Individualized Basis

Patient Case 1
 45-yr-old black male diagnosed
with HIV infection 13 yrs ago
after a severe case of shingles
‒ Initially received EFV/FTC/TDF
for 8 yrs
‒ Switched to EVG/COBI/FTC/TDF
5 yrs ago
 Other current medications:
daily multivitamin
Parameter
Lab Value at
HIV Diagnosis
HIV-1 RNA, copies/mL 35,000
CD4+ cell count, cells/mm3 124
Anti-HBs Positive
Anti-HCV Negative
HLA-B*5701 Not done
HIV resistance genotype Not done

Patient Case 1
 He comes in for routine 6-mo
visit, no complaints
‒ Physical exam unremarkable
Parameter
Lab Value at
Current Visit
HIV-1 RNA, copies/mL < 20
CD4+ cell count, cells/mm3 543
CBC, Chem 12, lipid profile Normal
Hemoglobin A1C 5.1
Blood pressure, mm Hg 125/75
BMI 23
eGFR, mL/min 120

Questions for Consideration
 What proportion of your patients are like this case patient?
‒ Receiving an older regimen currently listed as an “alternative” option in
DHHS and EACS guidance but in good health with few, if any, complicating
factors
 Is a discussion about ART change appropriate?
 To what regimen would you switch if you were to modify his ART?

Reasons to Consider an ART Switch During Viral
Suppression
Appropriate[1]
 To simplify a regimen (eg, reduce pill
burden or dosing frequency)
 To enhance tolerability or decrease
toxicity
 To prevent or mitigate DDIs
 To eliminate food/fluid requirements
 To allow for optimal ART use during
pregnancy or where pregnancy may occur
 To reduce costs
Inappropriate
 To use the “newest” regimen
 To reduce costs at the price of a toxicity
or intolerance risk for your patient
Slide credit: clinicaloptions.comDHHS Guidelines. October 2018.

Indications for Switch in Virologically Suppressed
Persons
 Documented toxicity or
prevention of long-term toxicity
 Avoidance of DDIs
 Aging and/or comorbidity
 Simplification
 Planned pregnancy or women
wishing to conceive
 Protection from HBV
 Regimen fortification
 Cost reduction
Slide credit: clinicaloptions.comEACS Guidelines. November 2019.
“Clinicians should always review possible AEs or tolerability
issues with current ARV regimens. Just because the viremia is
suppressed, it should not be assumed that the PLWH is well
adapted and tolerating the current regimen”

GS-292-0109: Renal Safety of Switch From TDF to TAF
 Markers of quantitative proteinuria decreased with switch to EVG/COBI/FTC/TAF,
regardless of previous treatment, and increased with continued TDF-based ART
DeJesus. AIDS Res Hum Retroviruses. 2018;34:337. Slide credit: clinicaloptions.com
Switch to
EVG/COBI/FTC/TAF
Continue TDF-based ART
Median∆FromBL,%(IQR)
WkPatients at Risk, n
945
471
928
453
872
426
Urine Albumin:Cr
959
477
940
461
891
431
935
448
Wk
Urine Protein:Cr
P < .001 at all timepoints
for all parameters; Van
Elteren test stratified by
prior treatment regimen.
80
40
0
-40
-80
0 48 96
8.5
11.1
-17.9 -13.7
80
40
0
-40
-80
0 48 96
9.66.6 9.0
-23.4 -20.9
24
-25.5

0
7224
 BMD increased with switch to EVG/COBI/FTC/TAF, regardless of previous
treatment, and remained stable or decreased with continued TDF-based ART
GS-292-0109: Bone Safety of Switch From TDF to TAF
DeJesus. AIDS Res Hum Retroviruses. 2018;34:337. Slide credit: clinicaloptions.com
Switch to
EVG/COBI/FTC/TAF
Continue TDF-based ART
Mean∆FromBL,%(95%CI)
WkPatients at Risk, n
912
457
884
437
821
401
Spine BMD
902
452
872
429
809
396
848
Wk
Hip BMD
P < .001 at all time points
for all parameters; ANOVA
model including treatment
and prior treatment
regimen as fixed effects.
6
4
2
0
-2
0 48 96 0 48 96
875
437
861
416
7224
863
432 412
1.5
1.9 1.9
2.1
-0.1-0.1-0.2-0.2
1.0
1.9
2.3 2.4
-0.2 -0.1 -0.2 -0.5
6
4
2
-2

Switching to a New 3-Drug Regimen:
Weighing the Advantages and Disadvantages
BIC or DTG
FTC
TAF
DOR
3TC
TDF
Goal: Maintain
HIV-1 RNA < 50 copies/mL
DRV/COBI
FTC
TAF
DTG
ABC
3TC

Factors to Evaluate When Switching Regimens
 New AEs or DDIs
 Change in dietary requirements
 Pregnancy
 Potential to exacerbate comorbidities (eg, HBV coinfection)
 Preexisting resistance
‒ Important to get full historical resistance data

Revisiting Patient Case 1
 Following a lengthy discussion, the patient chooses to continue
EVG/COBI/FTC/TDF
 Fast forward to 12 mos from now, the patient has developed arthritis
from an old soccer injury and will begin NSAID therapy
‒ He has become less active and gained weight (BMI 27)
‒ Currently receives lisinopril for mild HTN
‒ Lab values: eGFR of 92 mL/min, hemoglobin A1C of 6.2

 Would you switch his ART regimen now?
 How would you counsel him regarding the risk of weight gain with
ART?

NA-ACCORD: Multivariate Analysis of Weight Gain in
ART-Naive Patients Initiating ART Jan 2007 - Dec 2016
PredictedWeight(kg)
Yrs Since ART Initiation
86
84
82
80
0 1 2 3 4 5
Yr 2
Yr 5
INSTI
PI
NNRTI
+4.9
+4.4
+3.3
+6.0
+5.1
+4.3
PredictedWeight(kg)
86
84
82
80
Yrs Since ART Initiation
0 0.5 1.0 1.5 2.0
Yr 2
DTG
RAL
EVG
+6.0
+4.9
+3.8
PI
NNRTI
Bourgi. CROI 2019. Abstr 670.
 N = 24,001; INSTI-based regimens: n = 4740 (EVG: n = 2124; RAL: n = 1681;
DTG: n = 935); PI-based regimens: n = 7436; NNRTI-based regimens: n = 11,825

3.9
DTG + FTC/TAF
3.5
BIC/FTC/TAF
3.6
BIC/FTC/TAF
2.4
DTG/ABC/3TC
Additional Evidence Regarding Weight Gain Following
ART Initiation: Bictegravir
 Multicenter, randomized, double-blind phase III noninferiority trials
Slide credit: clinicaloptions.com1. Stellbrink. Lancet HIV. 2019;6:e364. 2. Wohl. Lancet HIV. 2019;6:e355.
Study 1490 (N = 645)[1] Study 1489 (N = 629)[2]
0
1
2
3
4
5
MedianWeightGain
atWk96(kg)

*
*
Multivariate Analysis of Weight Gain Following ART
Initiation in RCTs
 Pooled analysis of weight gain across 8 randomized phase III clinical
trials of first-line ART initiation occurring in 2003-2015 (N = 5680)
Slide credit: clinicaloptions.comSax. Clin Infect Dis. 2019;[Epub].
*Color-coded to match respective comparators, denoting P ≤ .05 vs NNRTI (first panel), EVG/COBI (second panel), or ZDV (last panel).
TAF
ABC
TDF
ZDV
BIC
DTG
EVG/COBI
INSTI
PI
NNRTI
1
0
4
3
LSMeanWeightΔ,kg(95%CI)
Wks
12 24 36 48 60 72 84 96
2
*
*
* *
* *
**
Wks
12 24 36 48 60 72 84 96
6
0
5
4
3
2
1
Wks
12 24 36 48 60 72 84 96
6
0
5
4
3
2
1
*
*
*
*
*
*
*
*
*
* *
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*

 Significantly greater weight increase* with DTG vs EFV, with TAF vs TDF; plateauing
in weight gain after Wk 48 observed in men but not in women
ADVANCE: Mean Change in Weight to Wk 96 by Sex
Wk
Women
Hill. IAS 2019. Abstr MOAX0102LB.
MeanWeightChange(kg)
Men
4
2
0
0 4 12 24 36
10
8
6
12
48 60 72 84 96
14
n = 430 418 402 387 376 374 366 292 232 140
+5 kg
+4 kg
+1 kg
NS
*Wilcoxon rank-sum comparison at Wk 96.
WkMeanWeightChange(kg)
4
2
0
0 4 12 24 36
10
8
6
12
48 60 72 84 96
DTG + FTC/TAF
DTG + FTC/TDF
EFV + FTC/TDF
14
n = 549 531 514 488 474 459 441 359 276 175
+10 kg
+5 kg
+3 kg
P<.05P<.001
P<.01
P<.001
P<.01

Cardiovascular Safety of Switch From TDF to TAF
 Retrospective observational study of virologically suppressed PLWH
switching TDF to TAF after ≥ 1 yr of stable ART (N = 110)
‒ Mean age: 50 yrs
‒ 73% male, 65% overweight or obese, 58% black, 49% receiving INSTIs
 In regression analysis comparing values from 1 yr before and after ART
modification, switch to TAF associated with significant increases in:
‒ BMI: 0.45 (95% CI: 0.14-0.76)
‒ ASCVD risk score: 13% (95% CI: 4% to 23%)
‒ Shifted 50.7% of patients to scores indicating use of a statin
Slide credit: clinicaloptions.comSchafer. Open Forum Infect Dis. 2019;[Epub].

Factors to Weigh Before
Switching to 2-Drug Maintenance

Patient Case 2
 53-yr-old white female, initiated DRV + RTV + FTC/TDF many yrs ago
‒ No available records from the time of her diagnosis or during early ART,
no baseline genotype resistance data
‒ Most recently has been stably suppressed for ≥ 12 mos with RPV/FTC/TAF
 She wonders about the possibility of switching to ART without a food
requirement and would like a PPI for GERD
 HBsAg negative; anti-HBc and anti-HBs positive

Question for Consideration
 Would you check a DNA (archive) genotype before offering an ART
switch?

HIV Genotypes: Acquiring Resistance Data
 DNA (archive) genotype[1,2]
‒ Sequences mutations in cell-associated proviral DNA
‒ Can be assessed at any HIV-1 RNA level, including undetectable
‒ Less sensitive than cumulative RNA genotypes
 Concordance between DNA and RNA genotypes varies by study and ARV
class (26% to 84%)[2,3]
 Study 1824: switch to EVG/COBI/FTC/TAF among virologically suppressed
patients with M184V/I mutation on RNA assay[4]
‒ M184V/I detected with DNA assay in only 48% (40/84) of screened patients
1. Delaugerre. HIV Med. 2012;13:517. 2. Wirden. J Antimicrob Chemother. 2011;66:709.
3. Derache. PLoS One. 2015;10:e0117430. 4. Margot. IAS 2019. Abstr MOPEB249. Slide credit: clinicaloptions.com

Guideline Recommendations on Proviral Genotyping
Slide credit: clinicaloptions.com1. EACS Guidelines. November 2019. 2. DHHS Guidelines. October 2018.
DHHS 2018[2]
EACS 2019[1]

Question for Consideration
 Would you offer a switch to 2-drug maintenance ART?

Dual Therapy for Initial or Maintenance ART: Key Trials
Initial ART
 DTG/3TC
(PADDLE, ACTG 5353, GEMINI-1/2)
 Boosted DRV + 3TC, RAL, or RPV
(ANDES, NEAT001, PREZENT)
 Boosted LPV + 3TC
(GARDEL)
Maintenance ART
 DTG/3TC
(LAMIDOL, ASPIRE, TANGO)
 DTG/RPV
(SWORD-1/2)
 Boosted DRV + 3TC or DTG
(DUAL GESIDA, DUALIS)
 Boosted ATV + 3TC
(ATLAS-M, SALT)
 Long-acting IM CAB + RPV
(ATLAS, ATLAS-2M, FLAIR)

 Parallel, randomized, open-label, multicenter phase III noninferiority studies
 Primary endpoint: HIV-1 RNA < 50 copies/mL at Wk 48 by FDA Snapshot
SWORD-1/2: Switch to DTG + RPV in Virologically
Suppressed Adults Receiving Stable 3-Drug ART
Switch to DTG + RPV
(n = 513)
Continue Baseline ART
(n = 511)
Switch to DTG + RPV
Continue DTG + RPV
Early-Switch Phase
Aboud. Lancet HIV. 2019;6:e576. Llibre. Lancet. 2018;391:839. Slide credit: clinicaloptions.com
Adults receiving stable 3-drug ART* with
HIV-1 RNA < 50 copies/mL for ≥ 6 mos;
no previous VF, current HBV, or HCV
requiring therapy; no major RAMs or
R263K; no pregnancy/breastfeeding
(N = 1024)
Late-Switch Phase
Wk 148Wk 52
DTG dosed 50 mg PO QD; RPV dosed 25 mg PO QD.
*INSTI, NNRTI, or PI + 2 NRTIs.
Primary Endpoint
Wk 48
Stratified by BL 3rd agent, age,
BMD substudy participation

SWORD-1/2: Pooled Virologic Outcomes at Wk 48
Llibre. Lancet. 2018;391:839. Slide credit: clinicaloptions.com
Adjusted Treatment Difference,
% (95% CI)
FDA Snapshot at Wk 48
Switch to DTG + RPV
Continue BL ART*
Patients(%)
100
80
60
40
20
0
95 95
< 1 1 5 4
Virologic Success Virologic
Nonresponse
No Virologic
Data
-8 -6 0 4 8
Favors
Continued BL ART
Favors
DTG + RPV
*NNRTI, INSTI, or PI + 2 NRTIs.
-4 -2 2 6
2.5-3.0
-0.2

SWORD-1/2: Renal and Bone Changes Through Wk 48
 70% to 73% of patients were receiving TDF at screening; greater decline in proteinuria
(ie, urine RBP and β2M) with DTG/RPV vs continued BL ART
Llibre. Lancet. 2018;391:839. Slide credit: clinicaloptions.com
Osteocalcin Procollagen Type 1
N-terminal Propeptide
Type 1 Collagen
C-telopeptide
Bone-Specific Alkaline
Phosphatase
*NNRTI, INSTI, or PI + 2 NRTIs. P < .0001 for comparison between arms of change from BL to Wk 48 for each marker.
DTG + RPV Continue BL ART*
BL
Wk 48
BL
Wk 48
MeanSerum
Concentration(µg/L)
60
50
40
30
20
10
0
MeanSerum
Concentration(µg/L)
0.8
0.6
0.4
0.2
0
15.9
12.9
16.2 17.1
23.8
19.0
24.0 23.1
53.0
45.6
55.3 54.7
0.66
0.49
0.69
0.63
Marker of Bone ResorptionMarkers of Bone Formation

 High treatment
satisfaction and low
symptom bother
scores maintained
through Wk 100 with
switch to DTG + RPV[2]
SWORD-1/2: Long-term Efficacy, PROs With DTG + RPV
1. van Wyk. BHIVA 2019. Abstr P008. 2. Oglesby. Glasgow 2018. Abstr P101.
Early-Switch Group (n = 513) Late-Switch Group (n = 477)
Virologic Success With DTG + RPV[1]
0
20
40
60
80
100
HIV-1RNA<50c/mL(%)
95
89
84
93 90
Day 1 to
Wk 100
Day 1 to
Wk 148
Wk 52 to
Wk 100
Wk 52 to
Wk 148
Day 1 to
Wk 48

SWORD-1/2: Resistance Mutations in Patients With CVW
 CVW in DTG + RPV recipients: 11/990 (1%): NNRTI RAMs, n = 6; INSTI RAMs, n = 0
Aboud. Lancet HIV. 2019;6:e576. van Wyk. BHIVA 2019. Abstr P008. Slide credit: clinicaloptions.com
Time of
Failure
Previous Regimen
Mutations at Baseline
by Proviral DNA Test
Mutations at CVW
by Standard Plasma Test
Fold Change
DTG RPV
Wk 24 EFV/FTC/TDF INSTI: G193E INSTI: G193E 1.02 --
Wk 36 EFV/FTC/TDF None NNRTI: K101K/E -- 1.21
Wk 64* DTG/ABC/3TC INSTI: N155N/H, G163G/R INSTI: V151V/I NR† --
Wk 76* ATV, ABC/3TC NNRTI: V108I NR† -- --
Wk 88 DTG/ABC/3TC None NNRTI: E138E/A 0.72 1.61
Wk 88 RPV/FTC/TDF ND NNRTI: K103N, V179I -- 5.24
Wk 100 EFV/FTC/TDF NNRTI: K101E, E138A; INSTI: G193E NNRTI: K101E, E138A, M230M/L; INSTI: NR† -- 31
Wk 100 ATV, RTV, FTC/TDF None None -- --
Wk 112 RAL, FTC/TDF INSTI: E157Q, G193E, T97T/A NNRTI: M230M/L; INSTI: E157Q, G193E 1.47 2
Wk 112 DRV, RTV, FTC/TDF ND ND -- --
Wk 136* EFV/FTC/TDF NR† NNRTI: E138A, L100L/I; INSTI: NR† -- 4.14
*Late switch participant. †Test failed.

DTG/RPV: FDA Indication
 Indicated as a complete regimen for the treatment of HIV infection in
adults to replace current ARV regimen if these criteria met:
‒ Virologically suppressed (HIV-1 RNA < 50 copies/mL)
‒ Receiving stable ART for ≥ 6 mos
‒ No history of treatment failure
‒ No known substitutions associated with resistance to DTG or RPV
DTG/RPV PI. Slide credit: clinicaloptions.com

DTG/RPV: EMA Indication
 Indicated for the treatment of HIV infection in adults if these
criteria met:
‒ Virologically suppressed (HIV-1 RNA < 50 copies/mL)
‒ Receiving stable ART for ≥ 6 mos
‒ No history of virologic failure
‒ No known or suspected resistance to any NNRTI or INSTI
DTG/RPV EPAR. Slide credit: clinicaloptions.com

TANGO: Switch to DTG/3TC in Virologically Suppressed
Adults Receiving Stable TAF-Based ART
 Multicenter, randomized, open-label phase III noninferiority study
Adults with HIV-1 RNA
< 50 copies/mL for > 6 mos on
stable TAF-based ART;
no previous VF, current HBV,
or HCV requiring therapy;
no NRTI or INSTI resistance
(N = 741)
Switch to DTG/3TC
(n = 369)
Continue TAF-Based ART
(n = 372)
Wk 196
Primary Endpoint
Wk 48Stratified by BL 3rd agent
Continuation
of DTG/3TC
permitted
Wk 144
Patients eligible if initial regimen was FTC/TAF plus PI, NNRTI, or INSTI, or TDF switched to TAF ≥ 3 mos prior to screening with no
other regimen changes.
Switch to DTG/3TC
Early-Switch Phase Late-Switch Phase
van Wyk. IAS 2019. Abstr WEAB0403LB. NCT03446573.
 Primary endpoint: HIV-1 RNA ≥ 50 copies/mL at Wk 48 by FDA Snapshot

Difference (%)
-3.4
0.2
-8 -6 -4 -2 0 2 4 6 8
3.9
Key Secondary Endpoint
(HIV-1 RNA < 50 c/mL)
DTG/3TC noninferior to
continued TAF-based ART
-8% NI
margin
TANGO: Virologic Outcomes at Wk 48
TAF-Based ARTDTG/3TC
TAF-Based ART DTG/3TC
-1.2 0.7
-0.3
-8 -6 -4 -2 0 2 4 6 8
Patients(%)
100
80
40
60
20
0
HIV-1 RNA
≥ 50 c/mL
HIV-1 RNA
< 50 c/mL
No Virologic
Data
93.2 93.0
6.5 6.5
Switch to DTG/3TC
(n = 369)
Continue TAF-based ART
(n = 372)
FDA Snapshot at Wk 48 (ITT-E)
Adjusted Treatment Difference (95% CI)*
Primary Endpoint
(HIV-1 RNA ≥ 50 c/mL)
DTG/3TC noninferior to
continued TAF-based ART
4% NI
margin
*Adjusted for baseline third agent class.
van Wyk. IAS 2019. Abstr WEAB0403LB.
0.3 0.5

TANGO: Renal and Bone Changes at Wk 48
38
Continue TAF-based ART (n = 371)Switch to DTG/3TC (n = 369)
Plasma/Serum Markers Serum Bone Turnover Markers
eGFR From Cr
(CKD-EPI),
mL/min/
1.73 m2
Cr,
µmol/L
eGFR From
Cystatin C
(CKD-EPI), mL/
min/1.73 m2
Osteocalcin Procollagen
1 N-terminal
Propeptide
Type 1
Collagen C-
telopeptide
Bone-Specific
Alkaline
Phosphatase
AdjustedMeanΔFromBLatWk48
AdjustedMeanΔfromBLatWk48(μg/L)
10
5
0
-5
-10
6.67
2.19
-7.8
-3.0
0.1
-1.6
Urine Markers
Protein:Cr,
g/mol
RBP:Cr,
µg/mmol
β2M:Cr,
mg/mmol
ΔFromBLatWk48(%)
20
10
0
20
-2.9
1.6
6.3 6.7
-2.7
-7.8
14
12
8
2
-2
-4
P < .05
P < .001
-0.03 -0.34
-1.15
0.69
9.3
6.4
P < .05
0.0602 0.031010
10
6
4
0
P < .001
P < .001
Marker of
Bone
Resorption
Markers of Bone Formation

TANGO: Lipid Parameters and Weight Gain at Wk 48
 Adjusted mean increase from BL in weight: +0.8 kg in both arms
39
TC†
TAF-Based Regimen (n = 277)*
HDL† LDL† TG† TC/HDL TC† HDL† LDL† TG† TC/HDL
DTG/3TC (n = 291)*
*Excludes those with lipid-modifying agent at BL.
†NCEP categories.
Patients(%)
Desirable TC, high HDL, optimal LDL, normal TG, < 3.5 TC/HDL
Borderline high TC, normal HDL, near/above optimal LDL,
borderline high TG, 3.5 to < 4.4 TC/HDL
Borderline high LDL, high TG, 4.4 to < 5 TC/HDL
High TC, low HDL, very high LDL, very high TG, ≥ 5 TC/HDL
Missing
High LDL
0
20
40
60
80
100
BL Wk 48 BL Wk 48 BL Wk 48 BL Wk 48 BL Wk 48 BL Wk 48 BL Wk 48 BL Wk 48 BL Wk 48 BL Wk 48
0
20
40
60
80
100

DTG/3TC: FDA Indication
 Indicated as a complete regimen for the treatment of HIV infection in
adults if these criteria met:
‒ No antiretroviral treatment history
‒ No known substitutions associated with resistance to DTG or 3TC
DTG/3TC PI. Slide credit: clinicaloptions.com

DTG/3TC: EMA Indication
 Indicated for the treatment of HIV infection in adults and adolescents
> 12 yrs of age weighing ≥ 40 kg if this criterion met:
‒ No known or suspected resistance to any INSTI or 3TC
DTG/3TC EPAR. Slide credit: clinicaloptions.com

Revisiting Patient Case 2
 53-yr-old white female, initiated DRV + RTV + FTC/TDF many yrs ago
with consistent HIV-1 RNA < 50 copies/mL
‒ No history of virologic failure or resistance
 Recent diagnosis of osteopenia with increasing LDL and an ASCVD risk
score of 18%

 Would you offer a switch to 2-drug maintenance ART?
 What if she has M184V and K103N?
‒ In the context of treatment failure
‒ Transmitted at baseline

Switching to 2-Drug Maintenance ART
 Best candidates:
‒ Virologically suppressed
patients with history of
excellent adherence
‒ Reason to avoid certain
NRTIs (eg, intolerance, eGFR
< 30 mL/min, osteoporosis)
‒ No documented or suspected
resistance to regimen
components
 Review before switching:
‒ ART and resistance history
‒ HBV infection status
‒ Medication list to assess for
potential DDIs
‒ Pregnancy intent

Key Take-home Messages
 Ongoing vigilance important to ensure that a patient’s current regimen is the best
choice, even if he or she is “happy” with the treatment
‒ Monitor for new comorbidities or circumstances that make the regimen suboptimal
‒ Indiscriminate switching to the newest available regimen is not advised
 When considering a switch from 3-drug to 2-drug maintenance ART, review
resistance history, HBV status, and length of virologic suppression
‒ Multiple regimens with phase III clinical evidence of noninferior efficacy in this setting
‒ As for all switches, review DDIs, conception desire, and insurance coverage
 Although dual ART is an option for select individuals, ARV monotherapy is never
recommended

clinicaloptions.com/hiv
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Determining Candidacy and Strategies for ART Modification.2019

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