Study sponsors LASA: L ow dose A tazanavir/r vs. S tandard dose A tazanavir/r The LASA study Atazanavir/ritonavir 200/100 mg is Non-inferior to 300/100 mg in Virologic Suppressed HIV-infected Thai Adults a multicentre, randomized, open-label trial Torsak Bunupuradah , Sasisopin Kiertiburanakul, Anchalee Avihingsanon, Ploenchan Chetchotisakd, Malee Techapornroong, Niramon Leerattanapetch, Pacharee Kantipong, Chureeratana Bowonwatanuwong, Sukit Banchongkit , Virat Klinbuayaem, Sripetcharat Mekviwattanawong, Sireethorn Nimitvilai, Supunnee Jirajariyavej, Wisit Prasithsirikul, Warangkana Munsakul, Sorakij Bhakeecheep, Sushada Chaivooth, Praphan Phanuphak, David A Cooper, Tanakorn Apornpong, Stephen J. Kerr, Sean Emery, Kiat Ruxrungtham on behalf of the LASA Study Group
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Study sponsors LASA: Low dose Atazanavir/r vs. Standard dose Atazanavir/r The LASA study Atazanavir/ritonavir 200/100 mg is Non-inferior to 300/100 mg.
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Study sponsors
LASA: Low dose Atazanavir/r vs. Standard dose Atazanavir/r
The LASA studyAtazanavir/ritonavir 200/100 mg is Non-inferior to
300/100 mg in Virologic Suppressed HIV-infected Thai Adults
121 did not satisfy eligibility criteria38% CrCl<60 ml/min32% VL>50 c/ml10% did not use HAART6% history of VL>50 prior screening14% others 559 randomly assigned
ITT = Intention to treat ; PP= per protocol ; NC=F : non-completer=failure or snap shot analyses
680 patients screened
N=279 ATV/r 200/100
N=280 ATV/r 300/100
N=273 (ITT,NC=F)
N=259(PP)
6 not receive study drug
1 died, 1 withdrew consent, 7 had protocol deviation (incorrect therapy given to patient), 5 discontinued randomized therapy due to side effects
3 not receive study drug
N=277(ITT,NC=F)
N=244(PP)
2 died, 3 withdrew consent, 1 LTFU, 11 had protocol deviation (incorrect therapy given to patient), 16 discontinued randomized therapy due to side effects
Baseline characteristics
CharacteristicsATV/r
200/100mgN=273
ATV/r 300/100mg
N=277Age (years) 42 (7.8) 41 (7.1)Male 47% 52%BW (kg) 59 (11) 59 (11)CD4 count (cells/mm3) 549 (256) 528 (222)% Lopinavir/r vs. other PIs 85% vs. 15% 84% vs. 16%Years of prior PI use 5.2 (3.0) 5.1 (3.1)ALT (U/L) 29 (26.8) 28 (24.9)Creatinine clearance* (mL/min) 94.6 (25.9) 95.7 (25.8)
Data are presented as mean (SD) PI: protease inhibitor *by Cockroft-Gault formula
ATV/r 200 is non-inferior to ATV/r 300Favours ATV/r 300 Favours ATV/r 200
NC=F
PP
ITT
-10 0 10 Difference in proportion <200 copies HIV-RNA /mL
P =0.02
HIV-RNA <200 c/ml
Favor ATV 300 Favor ATV 200
Favours ATV/r 300 Favours ATV/r 200
NC=F
PP
ITT
-10 0 10 Difference in proportion <50 copies HIV-RNA /mL
ITT: intention to treat PP: per protocol NC=F: non-completer equal to failure/snap shot
P =0.03
HIV-RNA <50 c/ml
% Patients with suppressed HIV-RNA at week 48
ITT PP NC=F0
20
40
60
80
100 97 99 9696 9991
ATV/r200
ATV/r300
ITT PP NC=F0
20
40
60
80
100 93 95 9292 9486
ATV/r200ATV/r300
HIV-RNA <200 c/ml
HIV-RNA <50 c/ml
P =0.03
P =0.02P =NS
P = NS
P = NS
P = NS
Higher discontinuation in ATV/r 300
Overall Clinical Jaundice
Rash Virologic Failure
Death0
2
4
6
8
2.6
0.4 0.7 0.7 0.4
7.6
2.2 2.5
00.7
ATV/r200ATV/r300
Reason of discontinuation
% p
atien
ts
P =0.01
P =0.06 P = NS
P = NS P = NS
1 patient in ATV/r200 developed I50L, V82A, L90M (history of poor adherence by self-report).