GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(三十一)
bsp;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.
14.4 Clinical Trial Results in HIV-1 Infected Subjects with Renal Impairment
In Study 112, the efficacy and safety of GENVOYA once daily were eva luated in an open-label clinical trial of 248 HIV-1 infected subjects with renal impairment (eGFR of 30 to 69 mL per minute by Cockcroft-Gault method). Of the 248 enrolled, 6 were treatment-naïve and 242 were virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months before switching to GENVOYA [see USE IN SPECIFIC POPULATIONS (8.6) and CLINICAL PHARMACOLOGY (12.3)].
The mean age was 58 years (range 24–82), with 63 subjects (26%) who were 65 years of age or older. Seventy-nine percent were male, 63% were White, 18% were Black, and 14% were Asian. Thirteen percent of subjects identified as Hispanic/Latino. The mean baseline CD4+ cell count was 664 cells per mm3 (range 126–1813). At Week 96, 88% (214/242 virologically suppressed subjects) maintained HIV-1 RNA less than 50 copies per mL after switching to GENVOYA. All six treatment-naïve subjects were virologically suppressed at Week 96. Five subjects among the entire study population had virologic failure at Week 96.
14.5 Clinical Trial Results in HIV-1 Treatment-Naïve Adolescent Subjects Aged 12 to Less than 18
In Study 106, the efficacy, safety, and pharmacokinetics of GENVOYA were eva luated in an open-label trial in HIV-1 infected treatment-naïve adolescents aged 12 to less than 18 years weighing at least 35 kg (77 lbs) (N=50). Subjects treated with GENVOYA once daily had a mean age of 15 years (range 12-17); 44% were male, 12% were Asian, and 88% were Black. At baseline, mean plasma HIV-1 RNA was 4.6 log10 copies per mL (22% had baseline plasma HIV-1 RNA greater than 100,000 copies per mL), median CD4+ cell count was 456 cells per mm3 (range: 95 to 1110), and median CD4+ percentage was 23% (range: 7% to 45%).
In subjects treated with GENVOYA, 92% (46/50) achieved HIV-1 RNA less than 50 copies per mL at Week 48. The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells per mm3. Three of 50 subjects had virologic failure at Week 48; no emergent resistance to GENVOYA was detected through Week 48.
16 HOW SUPPLIED/STORAGE AND HANDLING
GENVOYA tablets are green, capsule-shaped, film-coated tablets, debossed with "GSI" on one side of the tablet and the number "510" on the other side. Each bottle contains 30 tablets (NDC 61958-1901-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure.
Store below 30 °C (86 °F).
Keep container tightly closed.
Dispense only in original container.
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17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-ap |
