GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(三十)
or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL. ‡ Includes subjects who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window. § Includes subjects who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
HIV-1 RNA < 50 copies/mL 87% 85%
Treatment Difference 1.5% (95% CI: –1.7% to 4.8%)
HIV-1 RNA ≥ 50 copies/mL† 5% 4%
No Virologic Data at Week 96 Window 9% 11%
Discontinued Study Drug Due to AE or Death‡ 1% 2%
Discontinued Study Drug Due to Other Reasons and Last Available HIV-1 RNA < 50 copies/mL§ 6% 7%
Missing Data During Window but on Study Drug 2% 1%
Treatment outcomes were similar across subgroups by age, sex, race, baseline viral load, and baseline CD4+ cell count.
In Studies 104 and 111, the mean increase from baseline in CD4+ cell count at Week 96 was 280 cells per mm3 in GENVOYA-treated subjects and 266 cells per mm3 in STRIBILD-treated subjects.
14.3 Clinical Trial Results in HIV-1 Virologically-Suppressed Subjects Who Switched to
In Study 109, the efficacy and safety of switching from ATRIPLA, TRUVADA plus atazanavir (given with either cobicistat or ritonavir), or STRIBILD to GENVOYA once daily were eva luated in a randomized, open-label trial of virologically-suppressed (HIV-1 RNA less than 50 copies per mL) HIV-1 infected adults (N=1436). Subjects must have been suppressed (HIV-1 RNA less than 50 copies per mL) on their baseline regimen for at least 6 months and had no known resistance-associated substitutions to any of the components of GENVOYA prior to study entry. Subjects were randomized in a 2:1 ratio to either switch to GENVOYA at baseline (N=959), or stay on their baseline antiretroviral regimen (N=477). Subjects had a mean age of 41 years (range 21–77), 89% were male, 67% were White, and 19% were Black. The mean baseline CD4+ cell count was 697 cells per mm3 (range 79–1951).
Subjects were stratified by prior treatment regimen. At screening, 42% of subjects were receiving TRUVADA plus atazanavir (given with either cobicistat or ritonavir), 32% were receiving STRIBILD, and 26% were receiving ATRIPLA.
Treatment outcomes of Study 109 through 96 weeks are presented in Table 14.
Table 14 Virologic Outcomes of Study 109 at Week 96* in Virologically-Suppressed Subjects who Switched to GENVOYA
GENVOYA
(N=959) ATRIPLA or TRUVADA+atazanavir +cobicistat or ritonavir or STRIBILD
(N=477)
* Week 96 window was between Day 630 and 713 (inclusive). † Included subjects who had ≥50 copies/mL in the Week 96 window; subjects who discontinued early due to lack or loss of efficacy; subjects who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/mL. ‡ Includes subjects who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window. § Includes subjects who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
HIV-1 RNA < 50 copies/mL&n |
