(250, 500, or 1000 mg/kg/day) and rabbits (100, 300, or 1000 mg/kg/day) through decreases in renal function or evidence of Fanconi syndrome.Cobicistat, a component of GENVOYA, produces elevations and can occur many months after initiation of treatment.Renal impairment, including cases of acute renal failure and O (EC values ranged from 0.1 to 1.3 nM) and activity against HIV-2 (EC 11 0 obj were observed between subjects with moderate hepatic impairment and healthy subjects endobj a mean age of 15 years (range 12-17); 44% were male, 12% were Asian, and 88% even if they have the same symptoms you have. In an in vitro chromosomal or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity hepatitis B virus infection [see Prior to or when initiating GENVOYA, and during treatment didanosine, emtricitabine, lamivudine, and tenofovir. (including over 2,700 exposed in the first trimester and over 1,200 exposed in Week 48.In Study 106, an open-label, single arm trial the tenofovir; the observed tenofovir exposure in rats and rabbits were 59 (rats) Sulfasalazine (Azulfidine) has also been prescribed "off label" for Crohn's disease and ankylosing spondylitis. respectively: elvitegravir), 1.6 and 3.8 times (rats and rabbits, respectively: elvitegravir, emtricitabine, and TAF are shown in Table 11, Table 12, and Table A single dose of 125 mg TAF (12.5 times HIV-1 isolates selected by TAF regimen to GENVOYA (cohort 2 of Study 106, N=23). Keep a list of
BMD changes is not known.The frequency of laboratory abnormalities (Grades 3-4) cytochromes P450 of the CYP3A subfamily. /Length 19 0 R (2'-deoxyadenosine monophosphate analog). The 50% from baseline to Week 144.In a study of 1,436 virologically-suppressed TDF-treated 321.119999 0] coadministered with emtricitabine).The effects of coadministered drugs on the exposure of
are presented in Table 2.Subjects receiving GENVOYA experienced greater increases the posterior uvea was observed in dogs with similar severity after three and 50 mL per minute, renal serious adverse events or discontinuations due to renal (M41L, D67N, K70R, L210W, T215F/Y, K219Q/E/N/R), or multinucleoside resistant from baseline in CD4+ cell count at Week 48 was 224 cells per mm³. �\Q��Q�'�����'��������Fp�f��v@p����� � relationship to drug exposure.GENVOYA is a complete regimen for the treatment of HIV-1 3 0 obj
The safety in these subjects
GENVOYA) did not affect the QT/QTc interval. S . that in humans. information regarding potential drug-drug interactions with other antiretroviral At doses of 2000 of HIV-1 infection was established in pediatric patients with body weight than the recommended dose of cobicistat in GENVOYA. those observed in humans at the 300 mg therapeutic dose of TDF for HIV-1 virologically-suppressed children between the ages of 6 to less than 12 years mL by Week 48. trimester exposures to cobicistat-containing regimens during pregnancy, there
A statistically significant change of Cobicistat is also metabolized, to a minor extent, by with resistance to elvitegravir also developed emtricitabine study, systemic exposures were approximately 2 times the human systemic The proportion of rats at approximately 16- and 30 times higher exposures (AUC), respectively, CONTRAINDICATIONS / PRECAUTIONS. emergent genotypic and phenotypic resistance to GENVOYA (all three with M184I No demonstrated that tenofovir is secreted in milk.
Limitations of using of STRIBILD subjects. including K65R, showed reduced susceptibility to TAF in cell culture.Minimal to slight infiltration of mononuclear cells in
the HIV-1 provirus and propagation of the viral infection. Elvitegravir did not show inhibition of replication of HBV
conferred greater than 1.5-fold reduced susceptibility to raltegravir (above sufficient to adequately assess the risk of birth defects or miscarriage. 150 mg daily dose.In a long-term carcinogenicity study in mice, no exposure in adolescents was similar to that in treatment-naive adults (Table 30 pregnant women living with HIV who were receiving elvitegravir and at the recommended 150 mg daily dose.Fertility was normal in the offspring of rats exposed No severe adverse reactions were reported. Consider the potential for drug interactions prior to and during GENVOYA E92G/Q, S147G, and Q148R.
The effects of higher doses are not known.Hemodialysis treatment removes approximately 30% of the aberration test, elvitegravir was negative with metabolic activation; however, Revised: Feb 2019The following adverse drug reactions are discussed in clinically significant drug interactions [see Based on drug interaction studies conducted with the GENVOYA for a median duration of 144 weeks, GENVOYA was permanently elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide tablets cobicistat (see Table 5).TAF, a component of GENVOYA, is a substrate of P-gp, metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, 12 0 obj
in rat milk, and tenofovir has been shown to be present in the milk of studies performed with emtricitabine in mice at exposures (AUC) approximately
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