All subjects received a weight-based dose of TIVICAY [see These 46 subjects had a mean age of 12 years (range: 6 to 17), were 54% female and 52% black. Visit the Copyright © 2020 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. patients to report to their healthcare provider the use of any other
who are taking TIVICAY to consistently use effective contraception.The safety, virologic, and immunologic responses in
take it as soon as they remember. should consider factors such as feasibility of switching, tolerability, ability
or take more than the prescribed dose [see Instruct patients to store the TIVICAY 10-mg tablets in
Virologic responses at Week 48 by baseline genotypic and phenotypic INSTIresistance categories and the INSTI resistance-associated substitutions that emerged on dolutegravir treatment in VIKING-4 were consistent with those seen in VIKING-3.The susceptibility of dolutegravir was tested against 60 INSTI-resistant site-directed mutant HIV-1 viruses (28 with single substitutions and 32 with 2 or more substitutions) and 6 INSTIresistant site-directed mutant HIV-2 viruses. Therefore, TIVICAY is not recommended for use in patients
mitigated, please see Table 6 for steps to prevent or manage these possible and
At 48 weeks, the rates of adverse events leading to discontinuation were 3% in subjects receiving TIVICAY 50 mg once daily + background regimen and 4% in subjects receiving raltegravir 400 mg twice daily + background regimen.The only treatment-emergent AR of moderate to severe intensity with at least 2% frequency in either treatment group was diarrhea, 2% (6 of 354) in subjects receiving TIVICAY 50 mg once daily + background regimen and 1% (5 of 361) in subjects receiving raltegravir 400 mg twice daily + background regimen.In a multicenter, open-label, single-arm trial (ING112574, VIKING-3), 183 HIV-1–infected, antiretroviral treatment-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received TIVICAY 50 mg twice daily with the current failing background regimen for 7 days and with optimized background therapy from Day 8. Call your doctor or get medical breast milk, affects human milk production, or has effects on the breastfed
In addition, a diminished virologic response of 40% (6 of 15) was observed when the substitution E157Q or K was present at baseline with other INSTI-resistance substitutions but without a Q148H or R substitution.Response rates by baseline phenotype were analyzed in an as-treated analysis using all subjects with available baseline phenotypes through Week 48 (n = 163) (see Table 12).
Amino acid substitutions E92Q, G118R, S153F or Y, G193E or R263K emerged in different passages and conferred decreased susceptibility to dolutegravir of up to 4-fold. The tablet film-coating contains the inactive ingredients iron oxide yellow (25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.Perform pregnancy testing before initiation of TIVICAY in
Revised: Oct 2019The following serious adverse drug reactions are discussed in other sections of the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety assessment of TIVICAY in HIV-1–infected treatmentnaive subjects is based on the analyses of data from 2 international, multicenter, double-blind trials, SPRING-2 (ING113086) and SINGLE (ING114467) and data from the international, multicenter, open-label FLAMINGO (ING114915) trial.In SPRING-2, 822 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg once daily or raltegravir 400 mg twice daily, both in combination with fixed-dose dual nucleoside In SINGLE, 833 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg with fixed-dose abacavir sulfate and lamivudine (EPZICOM) once daily or fixed-dose efavirenz/emtricitabine/tenofovir (ATRIPLA) once daily (study treatment was blinded through Week 96 and open-label from Week 96 through Week 144). These recommendations are based on either drug interaction trials or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy.
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