Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI

Figures & data

Figure 1 STRATEGY-NNRTI trial profile and disposition of subjects at Week 96

* One subject on STB and 4 on the NNRTI arm were randomized and never treated. ^† One subject on STB was excluded from the full analysis set due to protocol-prohibited resistance at or prior to study day 1. ^‡ Disposition included subjects who discontinued study drug before or after week 96. The safety analysis set included subjects who were randomized and received at least one dose of study drug.

Table 1 Analysis of efficacy (HIV-1 RNA < 50 copies/mL) at Week 48 and Week 96 (Snapshot)

Virologic outcomes, n (%)	Week 48*		Week 96*
	Switch group (n = 290)	No-switch group (n = 143)	Switch group (n = 290)	No-switch group (n = 143)
Virologic success (HIV-1 RNA < 50 copies/mL)*	271 (93)	126 (88)	251 (87)	115 (80)
Virologic failure (HIV-1 RNA ≥ 50 copies/mL)	3 (1)	1 (<1)	8 (3)	2 (1)
HIV-1 RNA ≥ 50 copies/mL	2 (<1)	1 (<1)	6 (2)	2 (1)
Discontinued due to lack of efficacy	0	0	1 (<1)	0
Discontinued due to other reasons, last available HIV-1 RNA ≥ 50 copies/mL	1 (<1)	0	1 (<1)	0
No virologic data at Week 48 or Week 96	16 (6)	16 (11)	31 (11)	26 (18)
Discontinued due to AE or death	5 (2)	1 (<1)	9 (3)	2 (1)
Discontinued due to other reasons, last available HIV-1 RNA < 50 copies/mL†	11 (4)	13 (9)	20 (7)	22 (15)
Missing data in window, but on study drug	0	2 (1)	2 (1)	2 (1)

^* At Week 48, the viral load assay used in the study changed from Amplicor to Taqman 2.0, due to the manufacturer’s planned discontinuation of the Amplicor assay. The Week 96 viral load data presented are derived using the Taqman 2.0 assay only.

^† One participant at Week 48 had an AE that caused study drug discontinuation but had plasma HIV-1 RNA < 50 copies/mL in the Week 48 analysis window.

Figure 2 Analysis of efficacy (HIV-1 RNA < 50 copies/mL, Snapshot) by baseline subgroup

*Virologic success and difference for the subgroup with >2 prior regimens were not summarized due to small sample size

Table 2 Treatment emergent adverse events at Week 48 and Week 96

Adverse events, n (%)	Week 48		Week 96
	Switch group (n = 291)	No-switch group (n = 143)	Switch group (n = 291)	No-switch group (n = 143)
Any AE	237 (81)	107 (75)	247 (85)	114 (80)
Grade 3 or 4 AE	19 (7)	9 (6)	26 (9)	11 (8)
Serious AE	14 (5)	6 (4)	24 (8)	7 (5)
Discontinuation due to AE	6 (2)	1 (1)	9 (3)	3 (2)
Death	1 (<1)	0	1 (<1)	0
AEs (any grade) in ≥5% at either Week 48 or Week 96^a^,^b
Upper respiratory tract infection	28 (10)	10 (7)	33 (11)	15 (10)
Nasopharyngitis	27 (9)	14 (10)	30 (10)	17 (12)
Diarrhea	23 (8)	10 (7)	30 (10)	12 (8)
Headache	28 (10)	5 (3)	29 (10)	8 (6)
Nausea^c	23 (8)	4 (3)	25 (9)	4 (3)
Cough	20 (7)	3 (2)	24 (8)	5 (3)
Back pain	13 (4)	6 (4)	23 (8)	8 (6)
Insomnia	17 (6)	7 (5)	22 (8)	11 (8)
Sinusitis	13 (4)	5 (3)	21 (7)	5 (3)
Arthralgia	15 (5)	4 (3)	19 (7)	5 (3)
Fatigue^c	16 (5)	1 (1)	19 (7)	2 (1)
Syphilis	11 (4)	4 (3)	17 (6)	10 (7)

^a AEs in order of decreasing frequency in the switch group at Week 96.

^b AE frequencies at Week 96 are cumulative.

^c Difference of ≥ 5% between groups at Week 96.