Genvoya (Page 9 of 11)

14.2 Clinical Trial Results in HIV-1 Treatment-Naïve Subjects

In both Study 104 and Study 111, subjects were randomized in a 1:1 ratio to receive either GENVOYA (N=866) once daily or STRIBILD (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, TDF 300 mg) (N=867) once daily. The mean age was 36 years (range 18–76), 85% were male, 57% were White, 25% were Black, and 10% were Asian. Nineteen percent of subjects identified as Hispanic/Latino. The mean baseline plasma HIV-1 RNA was 4.5 log₁₀ copies per mL (range 1.3–7.0) and 23% of subjects had baseline viral loads greater than 100,000 copies per mL. The mean baseline CD4+ cell count was 427 cells per mm³ (range 0–1360) and 13% had CD4+ cell counts less than 200 cells per mm³.

Pooled treatment outcomes of Studies 104 and 111 through Week 144 are presented in Table 16.

Table 16 Pooled Virologic Outcomes of Randomized Treatment in Studies 104 and 111 at Week 144* in Treatment-Naïve Subjects

	GENVOYA(N=866)	STRIBILD(N=867)
* Week 144 window was between Day 966 and 1049 (inclusive). † The primary endpoint was assessed at Week 48 and the virologic success rate was 92% in the GENVOYA group and 90% in the STRIBILD group, with a treatment difference of 2.0% (95% CI: -0.7% to 4.7%). The difference at Week 144 was primarily driven by discontinuations due to other reasons with last available HIV-1 RNA <50 copies/mL. ‡ Included subjects who had ≥50 copies/mL in the Week 144 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 †	84%	80%
HIV-1 RNA ≥ 50 copies/mL ‡	5%	4%
No Virologic Data at Week 144 Window	11%	16%
Discontinued Study Drug Due to AE or Death §	2%	3%
Discontinued Study Drug Due to Other Reasons and Last Available HIV-1 RNA < 50 copies/mL ¶	9%	11%
Missing Data During Window but on Study Drug	1%	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 144 was 326 cells per mm³ in GENVOYA-treated subjects and 305 cells per mm³ in STRIBILD-treated subjects.

14.3 Clinical Trial Results in HIV-1 Virologically-Suppressed Adults Who Switched to GENVOYA

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 evaluated 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 17.

Table 17 Virologic Outcomes of Study 109 at Week 96* in Virologically-Suppressed Adults 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	93%	89%
HIV-1 RNA ≥ 50 copies/mL †	2%	2%
No Virologic Data at Week 48 Window	5%	9%
Discontinued Study Drug Due to AE or Death ‡	1%	3%
Discontinued Study Drug Due to Other Reasons and Last Available HIV-1 RNA < 50 copies/mL §	3%	6%
Missing Data During Window but on Study Drug	1%	<1%

Treatment outcomes were similar across subgroups receiving ATRIPLA, TRUVADA plus atazanavir (given with either cobicistat or ritonavir), or STRIBILD prior to randomization. In Study 109, the mean increase from baseline in CD4+ cell count at Week 96 was 60 cells per mm³ in GENVOYA-treated subjects and 42 cells per mm³ in subjects who stayed on their baseline regimen.