GENVOYA(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)tablets(九)
[N=679]
LDL-cholesterol (fasted) 103
[N=688] +18
[N=688] 107
[N=680] +7
[N=680]
Triglycerides (fasted) 113
[N=692] +31
[N=692] 115
[N=679] +13
[N=679]
Total Cholesterol to HDL ratio 3.7
[N=692] 0.2
[N=692] 3.8
[N=679] 0
[N=679]
Clinical Trials in Pediatric Subjects:
The safety of GENVOYA in HIV-1 infected, treatment-naïve pediatric subjects aged 12 to less than 18 years and weighing at least 35 kg (77 lbs) was eva luated through Week 48 in an open-label clinical trial (Study 106) [see CLINICAL STUDIES (14.5)]. The safety profile in 50 adolescent subjects who received treatment with GENVOYA was similar to that in adults. One 13-year-old female subject developed unexplained uveitis while receiving GENVOYA that resolved and did not require discontinuation of GENVOYA.
Among the 50 pediatric subjects receiving GENVOYA, mean BMD increased from baseline to Week 48, + 4.2% at the lumbar spine and + 1.3% for the total body less head. Mean changes from baseline BMD Z-scores were −0.07 for lumbar spine and −0.20 for total body less head at Week 48. One GENVOYA subject had significant (greater than or equal to 4%) lumbar spine BMD loss at Week 48.
7 DRUG INTERACTIONS
7.1 Not Recommended with Other Antiretroviral Medications
GENVOYA is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration of GENVOYA with other antiretroviral medications for treatment of HIV-1 infection should be avoided. Complete information regarding potential drug-drug interactions with other antiretroviral medications is not provided [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS (5.2) and CLINICAL PHARMACOLOGY (12.3)].
7.2 Potential for GENVOYA to Affect Other Drugs
Cobicistat, a component of GENVOYA, is an inhibitor of CYP3A and CYP2D6 and an inhibitor of the following transporters: p-glycoprotein (P-gp), BCRP, OATP1B1 and OATP1B3. Thus, coadministration of GENVOYA with drugs that are primarily metabolized by CYP3A or CYP2D6, or are substrates of P-gp, BCRP, OATP1B1 or OATP1B3 may result in increased plasma concentrations of such drugs (see TABLE 5). Elvitegravir is a modest inducer of CYP2C9 and may decrease the plasma concentrations of CYP2C9 substrates. TAF is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or UGT1A1. TAF is a weak inhibitor of CYP3A in vitro. TAF is not an inhibitor or inducer of CYP3A in vivo.
7.3 Potential for Other Drugs to Affect One or More Components of GENVOYA
Elvitegravir and cobicistat, components of GENVOYA, are metabolized by CYP3A. Cobicistat is also metabolized, to a minor extent, by CYP2D6.
Drugs that induce CYP3A activity are expected to increase the clearance of elvitegravir and cobicistat, resulting in decreased plasma concentration of cobicistat, elvitegravir, and TAF, which may lead to loss of therapeutic effect of GENVOYA and development of resistance (see TABLE 5).
Coadministration of GENVOYA with other drugs that inhibit CYP3A may decrease the clearance and increase the plasma concentration of cobicistat (see TABLE 5).
TAF, a component of GENVOYA, is a substrate of P-gp, BCRP, OATP1B1 and OATP1B3. Drugs that inhibit P-gp and/or BCRP, such as cobicistat, may increase the absorption of TAF (see TABLE 10). However, when TAF is administered as a component of GENVOYA, its availability is increased by cobicistat and a further inc |
