/
Switch to DTG/ABC/3TC Switch to DTG/ABC/3TC

Switch to DTG/ABC/3TC - PowerPoint Presentation

karlyn-bohler
karlyn-bohler . @karlyn-bohler
Follow
435 views
Uploaded On 2017-04-15

Switch to DTG/ABC/3TC - PPT Presentation

STRIIVING Study Design Endpoints Primary proportion of patients maintaining HIV RNA lt 50 cmL at W48 ITTE snapshot noninferiority if lower margin of the twosided 95 CI for the difference 10 90 power ID: 537597

dtg abc switch 3tc abc dtg 3tc switch striiving w24 study adverse art continuation virologic 2015 w48 arm baseline

Share:

Link:

Embed:

Download Presentation from below link

Download Presentation The PPT/PDF document "Switch to DTG/ABC/3TC" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.


Presentation Transcript

Slide1

Switch to DTG/ABC/3TC

STRIIVING

NEAT 022Slide2

Design

Endpoints

Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W24

(ITT-E, snapshot) ; non-inferiority if lower margin of the two-sided 95% CI for the difference = - 10%, 90% power Secondary: CD4 cell count changes, safety, lipid, renal, bone and cardiovascular changes, development of resistance, treatment satisfaction

Switch to DTG/ABC/3TC

Continue current ART

Randomisation *

1 : 1Open-label

HIV+ ≥ 18 yearsHIV RNA < 50 c/mL On 2 NRTI + PI/r or NNRTI or INSTI stable ≥ 6 monthsHLA-B*5701 negativeHBs Ag negative

N = 278

N = 275

W24

W48

STRIIVING

Study

: switch to DTG/ABC/3TC

Switch to DTG/ABC/3TC

STRIIVING

Trottier

B.

Antivir Ther. 2017;22(4):295-305.

* Randomisation

was

stratified

by 3rd agent (PI, INSTI or NNRTI)Slide3

STRIIVING Study: switch to DTG/ABC/3TC

DTG/ABC/3TC

N = 275

Continuation of current ART (deferred switch)

N = 278

Median age, years

45

47

Female, %

14

14

Hepatitis C

coinfection

, %

8

5

Median time on current ART, months

54

51

CD4 cell count (/mm

3

), median

618

597ART at randomisation, %PINNRTIINSTITDF/FTC backbone4332257642312779Discontinuation, NW0-W24 / W24-W48For adverse eventFor protocol deviationLost to follow-upFor other reasons36 / 910 / 015 / 03 / 58 / 433 / 140 / 417 / 13 / 313 / 6

Baseline characteristics and patient disposition

STRIIVING

Trottier

B.

Antivir

Ther

. 2017;22(4):295-305.Slide4

HIV RNA < 50 c/

mL

(

ITT-e)STRIIVING

* Analysis restricted to patients with deferred switch

85

1

14

88

1

10

83

< 1

1792 17

0

20

406080100%

DTG/ABC/3TC

Immediate

switch D1-W24 (N = 275)

Continuation

cART

D1-W24 (N = 278)

DTG/ABC/3TCImmediate switch D1-W48 (N = 275)DTG/ABC/3TCDeferred switch W24-W48 (N = 244 *) No subjects met protocol-defined virologic failure in either study arm ; 4 subjects with HIV RNA > 50 c/mL at W48 (1 early switch, 3 deferred switch) ; all 4 resuppressed < 50 c/mLVirologic successVirologic non responseNo virologic dataSTRIIVING Study: switch to DTG/ABC/3TCAt week 24- Lower bound for theadjusted difference : - 9.1 %(non-inferiority), by ITT-E- Success in 93 % in bothgroups in the per-protocolanalysis (difference : - 0.2;95% CI : - 5.0 to 4.6)Trottier B. Antivir Ther. 2017;22(4):295-305.Slide5

DTG/ABC/3TC

(N = 276)

Continuation of

cART

(N = 277)

Any adverse event

183 (66)

129 (47)

Drug-related

adverse event

59 (21)

4 (1)

Adverse event grade 3-4

8 (3)

5 (2)

Serious adverse event

6

(2)

5

(2)

Discontinuation for adverse event

11 (4)

0

Adverse event in ≥ 5% in either groupCough14 (5)8 (3)Diarrhea17 (6)4 (1)Fatigue19 (7)3 (1)Headache13 (5)4 (1)Nausea27 (10)3 (1)Upper respiratory tract infection

21 (8)

20 (7)

Psychiatric

35 (13)

8 (3)

Adverse events at W24, n (%)

111

STRIIVING

Trottier

B.

Antivir

Ther

. 2017;22(4):295-305.

STRIIVING

Study

: switch to DTG/ABC/3TCSlide6

Grade

Onset

Prior ARV

(3

rd

drug)

1

Insomnia

2

W1

LPV/r

2

Diarrhea, flatulence, rash,

Abdominal

pain

, anxiety,

nausea, body ache

1

2W1W1

RPV

3

Euphoric

mood

, Headache12W1ATV/r4Abdominal cramps, chills, diarrhea, dizziness, headache2W1RAL5Pruritus2W1NFV6Upper abdominal pain, diarrheaFatigue1, malaiseFlu-like syndrome DepressionProfuse sweating, change in body odor12121W1W1W9W12W17NVP7Nasal congestionWorsening fatigueNausea12

3

W2

EVG/c

8

Alopecia              

1

W4

ATV/r

9

Fatigue

1

1

W8

DRV/r

10

Homicide

1

NA

W10

RAL

1

Not drug-related

Adverse events leading to discontinuation of DTG/ABC/3TC (N = 10)

112

STRIIVING

Study

: switch to DTG/ABC/3TC

STRIIVING

Trottier

B.

Antivir

Ther

. 2017;22(4):295-305.Slide7

Total

cholesterol

HDL -

cholesterol

LDL-

cholesterol

Triglycerides

Total cholesterol:

HDL ratio

DTG/ABC/3TC

ART

DTG/ABC/3TC

ART

DTG/ABC/3TC

ART

DTG/ABC/3TC

ART

DTG/ABC/3TC

ART

Change

from baseline

at

W

24 (SD)3.33 (31.88)-0.59 (25.05)-0.47 (8.77)-1.45 (8.43)4.47 (24.08)0.93 (21.95)0.17 (99.59)-5.74(76.93)0.14 (0.88)0.05 (0.78)Fasting Lipids, mean mg/dLSTRIIVING Study: switch to DTG/ABC/3TCSTRIIVINGDTG/ABC/3TC at W24Continuation ART at W24DTG/ABC/3TC at BaselineContinuation ART at Baseline3.52.51050.5

1.5

2

3

4

4.5

Total cholesterol:HDL ratio

140

100

40

0

200

20

60

80

120

160

180

Total cholesterol

HDL

LDL

Triglycerides

Trottier

B.

Antivir

Ther

. 2017;22(4):295-305.Slide8

Mean change from baseline in serum

creatinine

(mg/

dL

) through 24 weeksSTRIIVING Study: switch to DTG/ABC/3TCSTRIIVING

Trottier B. Antivir Ther. 2017;22(4):295-305.

Small, non-progressive changes in serum creatinine were observed in the DTG/ABC/3TC arm due to known inhibition of tubular creatinine secretion by DTG

256

257

262

257

275

276

237246240249DTG/ABC/3TCART

Number of patients

8

4

BL

16

24

Week

-0,2

-0,1

00,10,20,3DTG/ABC/3TCContinuation ART0,0870,010,087Slide9

Treatment Satisfaction (HIVTSQ)

Adjusted mean change in total score at W24

STRIIVING

Study

: switch to DTG/ABC/3TCSTRIIVING

At baseline, overall treatment satisfaction scores were similar between groups

Adjusted mean difference at W24 (95% CI): 2.4 (1.3, 3.5) ; p < 0.001

DTG/ABC/3TC

Continuation ART

0

1

2

3

4

DTG/ABC/3TC (N = 269)

ART (N = 276)

Trottier

B.

Antivir

Ther. 2017;22(4):295-305.Slide10

STRIIVING Study: switch to DTG/ABC/3TC

Conclusion

Efficacy

Similar virologic response for DTG/ABC/3TC and continuation of current ART at W24, with non-inferioritySuccess rate was maintained through 48 weeks in the early switch groupIn the late switch group, virologic suppression was observed in 92% of subjects on DTG/ABC/3TC (24 weeks post-switch)There were no protocol-defined virologic failure in the study Tolerability 4% of subjects discontinued due to adverse events by W24 in the DTG/ABC/3TC arm vs 0% in the continuation groupThere were no further discontinuations due to adverse events in the early switch arm post-week 24Rates of discontinuation for adverse events in the late switch arm was 2%

113STRIIVINGTrottier B. Antivir Ther. 2017;22(4):295-305.