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GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(八)
line for both those continuing baseline treatment and those switching to GENVOYA.
Bone Mineral Density Effects
Treatment-Naïve Adults:
In a pooled analysis of Studies 104 and 111, the effects of GENVOYA compared to STRIBILD on bone mineral density (BMD) change from baseline to Week 96 were assessed by dual-energy X-ray absorptiometry (DXA). Mean BMD decreased from baseline to Week 96 by −0.96% with GENVOYA compared to −2.79% with STRIBILD at the lumbar spine and −0.67% compared to −3.28% at the total hip. BMD declines of 5% or greater at the lumbar spine were experienced by 12% of GENVOYA subjects and 26% of STRIBILD subjects. BMD declines of 7% or greater at the femoral neck were experienced by 11% of GENVOYA subjects and 26% of STRIBILD subjects. The long-term clinical significance of these BMD changes is not known.
Virologically Suppressed Adults:
In Study 109, TDF-treated subjects were randomized to continue their TDF-based regimen or switch to GENVOYA; changes in BMD from baseline to Week 96 were assessed by DXA. Mean BMD increased in subjects who switched to GENVOYA (2.12% lumbar spine, 2.44% total hip) and decreased slightly in subjects who continued their baseline regimen (−0.09% lumbar spine, −0.46% total hip). BMD declines of 5% or greater at the lumbar spine were experienced by 2% of GENVOYA subjects and 6% of subjects who continued their TDF-based regimen. BMD declines of 7% or greater at the femoral neck were experienced by 2% of GENVOYA subjects and 7% of subjects who continued their TDF-based regimen. The long-term clinical significance of these BMD changes is not known.
Laboratory Abnormalities:
The frequency of laboratory abnormalities (Grades 3–4) occurring in at least 2% of subjects receiving GENVOYA in Studies 104 and 111 are presented in Table 3.
Table 3 Laboratory Abnormalities (Grades 3–4) Reported in ≥ 2% of Subjects Receiving GENVOYA in Studies 104 and 111 (Week 96 analysis)
Laboratory Parameter Abnormality* GENVOYA
N=866 STRIBILD
N=867
* Frequencies are based on treatment-emergent laboratory abnormalities.
Amylase 2% 4%
AST 2% 2%
Creatine Kinase (≥10.0 × ULN) 9% 7%
Urine RBC (Hematuria) (>75 RBC/HPF) 3% 3%
LDL-cholesterol (fasted) (>190 mg/dL) 8% 4%
Total cholesterol (fasted) (>300mg/dL) 3% 2%
Serum Lipids:
Subjects receiving GENVOYA experienced greater increases in serum lipids compared to those receiving STRIBILD.
Changes from baseline in total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and total cholesterol to HDL ratio are presented in Table 4.
Table 4 Lipid Values, Mean Change from Baseline, Reported in Subjects Receiving GENVOYA or STRIBILD in Studies 104 and 111*
GENVOYA
N=866 STRIBILD
N=867
Baseline Week 96 Baseline Week 96
mg/dL Change† mg/dL Change†
* Excludes subjects who received lipid lowering agents during the treatment period. † The change from baseline is the mean of within-subject changes from baseline for subjects with both baseline and Week 96 values.
Total Cholesterol (fasted) 162
[N=692] +31
[N=692] 166
[N=679] +15
[N=679]
HDL-cholesterol (fasted) 46
[N=692] +7
[N=692] 46
[N=679] +4 |
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