natgillin/translations-raw huggingface dataset:
The efficacy and safety of Biktarvy in virologically-suppressed HIV-1 infected adults are based on 48-week data from a randomised, double-blind, active-controlled study, GS-US-380-1844 (n = 563); and a randomised, open label, active-controlled study, GS-US-380-1878 (n = 577).
Učinkovitost in varnost zdravila Biktarvy pri odraslih bolnikih z virusno supresijo, okuženih z virusom HIV-1, temelji na 48-tedenskih podatkih iz randomizirane, dvojno slepe študije, nadzorovane z učinkovino, GS-US-380-1844 (n = 563); in iz randomizirane, odprte študije, nadzorovane z učinkovino, GS-US-380-1878 (n = 577).
Oxcarbazepine Phenobarbital Phenytoin
okskarbazepin fenobarbital fenitoin
(Induction of CYP3A and P-gp)
(indukcija CYP3A in P-gp)
Co-administration is contraindicated due to the effect of rifampicin on the bictegravir component of Biktarvy.
Sočasno dajanje je kontraindicirano zaradi učinka rifampicina na sestavino biktegravir v zdravilu
Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide
Biktarvy 50 mg/200 mg/25 mg filmsko obložene tablete biktegravir/emtricitabin/ alafenamidtenofovirat
Interactions between Biktarvy or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”; all No
Interakcije med zdravilom Biktarvy ali posamičnimi učinkovinami in sočasno uporabljenimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom »↑«, zmanjšanje z »↓«, brez spremembe z »↔«; vse meje brez učinka (No Effect Boundaries) so 70 %-143 %).
If a patient misses a dose of Biktarvy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Če bolnik izpusti odmerek zdravila Biktarvy za več kot 18 ur, naj ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1
PERORALNI KONTRACEPTIVI norgestimat (0,180/0,215/0,250 mg enkrat dnevno)/etinilestradiol (0,025 mg enkrat dnevno), biktegravir1
No dose adjustment is required upon co-administration.
Prilagoditev odmerka pri sočasni uporabi ni potrebna.
Bictegravir has activity against HIV-1 and HIV-2.
Biktegravir deluje proti HIV-1 in HIV-2.
In Study GS-US-380-1489, patients were randomised in a 1:1 ratio to receive either bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (n = 314) or abacavir/dolutegravir/lamivudine (600/50/300 mg) (n = 315) once daily.
V študiji GS-US-380-1489 so bolnike randomizirali v razmerju 1:1 za biktegravir/emtricitabin/ alafenamidtenofovirat (B/F/TAF) (n = 314) ali abakavir/dolutegravir/lamivudin (600/50/300 mg) (n = 315) enkrat dnevno.
headache, dizziness
glavobol, omotičnost
HIV-1 isolates with reduced susceptibility to tenofovir alafenamide have been selected in cell culture and had the K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
V celični kulturi so bili izbrani izolati HIV-1 z zmanjšano občutljivostjo na alafenamidtenofovirat in mutacijo K65R v RT HIV-1; poleg tega so prehodno opazili mutacijo K70E v HIV-1 RT. Izolati
• bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI)
• biktegravir, protiretrovirusno zdravilo, znano kot zaviralec prenosa zapisa integraze (INSTIintegrase strand transfer inhibitor)
If you vomit more than 1 hour after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.
Če bruhate več kot 1 uro po zaužitju zdravila Biktarvy, vam ni treba vzeti še ene tablete, dokler ni čas za naslednjo tableto po vašem urniku.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
Emtricitabin je nukleozidni zaviralec reverzne transkriptaze (NRTI - nucleoside reverse transcriptase inhibitor) in analog 2'-deoksicitidina.
DTG = dolutegravir 3TC = lamivudine F/TAF = emtricitabine/tenofovir alafenamide a Week 48 window was between Day 295 and 378 (inclusive).
DTG = dolutegravir 3TC = lamivudin F/TAF = emtricitabin/alafenamidtenofovirat a Okno v 48. tednu je med 295. in 378. dnevom (vključno z njima).
If you do miss a dose:
Če ste pozabili vzeti odmerek:
Biktarvy can cause dizziness.
Zdravilo Biktarvy lahko povzroči omotičnost.
Thirty-five percent of the dose was recovered from urine and consisted primarily of the glucuronide of bictegravir and other minor oxidative metabolites and their phase II conjugates.
Pretežno so ga sestavljali glukuronidi biktegravirja in drugi manj pomembni oksidativni presnovki in njihovi konjugati faze II.
• itching (pruritus)
• srbečica (pruritus)
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja,
(Inhibition of CYP3A)
(zaviranje CYP3A)
HIV-1 RNA ≥ 50 copies/mLb Treatment difference (95% CI)
HIV-1 RNA ≥ 50 kopij/mlb Razlika zdravljenja (95-% IZ)
HIV-1 isolates with reduced susceptibility to emtricitabine have been selected in cell culture and had M184V/I mutations in HIV-1 RT.
V celični kulturi so bili izbrani izolati HIV-1 z zmanjšano občutljivostjo na emtricitabin in mutacijo M184V/I v RT HIV-1 .
The prevalence of different subtypes was comparable across treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Prevalenca različnih podtipov je bila primerljiva v vseh skupinah zdravljenja, pri čemer je v obeh skupinah prevladoval podtip B; 11 % jih ni bilo podtipov B. Bolniki so bili stratificirani glede na predhodni režim zdravljenja.
Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Študije o vplivu na sposobnost razmnoževanja pri podganah in kuncih niso pokazale učinkov na parjenje, plodnost, nosečnost ali plod.
The protein-adjusted EC95 of bictegravir was 361 nM (0.162 µg/mL) for wild type HIV-1 virus.
Vrednosti 50-odstotno učinkovite koncentracije (EC50) za biktegravir so bile v razponu od < 0,05 do 6,6 nM. Za protein prilagojena vrednost EC95 biktegravirja je bila 361 nM (0,162 µg/ml) za divji tip virusa HIV-1.
ANTICONVULSANTS Carbamazepine (titrated from 100 mg to 300 mg twice a day), Emtricitabine/Tenofovir alafenamide4
ANTIKONVULZIVI karbamazepin (titriran s 100 mg na 300 mg dvakrat dnevno), emtricitabin/ alafenamidtenofovirat4
Norgestimate (0.180/0.215/0.250 mg once daily), Ethinylestradiol (0.025 mg once daily), Emtricitabine/Tenofovir alafenamide4
norgestimat (0,180/0,215/0,250 mg enkrat dnevno), etinilestradiol (0,025 mg enkrat dnevno), emtricitabin/ alafenamidtenofovirat
Patients had a mean age of 46 years (range 20-79), 83% were male, 66% were White, and 26% were Black.
(razpon 20-79), 83 % je bilo moških, 66 % je bilo belcev in 26 % je bilo črncev.
In Study GS-US-380-1844, the efficacy and safety of switching from a regimen of dolutegravir + abacavir/lamivudine or abacavir/dolutegravir/lamivudine to B/F/TAF were evaluated in a randomised, double-blind study of virologically-suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 563).
V študiji GS-US-380-1844 so učinkovitost in varnost prehoda z režima dolutegravir + abakavir/lamivudin ali abakavir/dolutegravir/lamivudin na B/F/TAF ocenili v randomizirani, dvojno slepi študiji odraslih z virološko supresijo (HIV-1 RNA < 50 kopij/ml), okuženih z virusom HIV-1 (n = 563).
No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Odmerka zdravila Biktarvy pri bolnikih z blago (stopnje A po Child-Pughu) ali zmerno (stopnje B po
In Studies GS-US-380-1489 and GS-US-380-1490, the mean increase from baseline in CD4+ cell count at Week 96 was 262, 288, and 281 cells/mm3 in the pooled B/F/TAF, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
V študijah GS-US-380-1489 in GS-US-380-1490 je bilo povprečno povečanje števila celic CD4+ od izhodišča do 96. tedna 262, 288 oz. 281 celic/mm3 za združene skupine B/F/TAF , abakavirja/dolutegravirja/lamivudina oz. dolutegravirja + emtricitabina/alafenamidtenofovirata.
Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Alafenamidtenofovirat Alafenamidtenofovirat se prenaša s P-glikoproteinom (P-gp) in proteinom, odpornim na raka dojke
Co-administration of Biktarvy with other medicinal products that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide.
Sočasno dajanje zdravila Biktarvy z drugimi zdravili, ki zavirajo P-gp in BCRP, lahko poveča absorpcijo in koncentracije alafenamidtenofovirata v plazmi.
If a patient vomits more than 1 hour after taking Biktarvy they do not need to take another dose of Biktarvy until the next regularly scheduled dose.
Če bolnik bruha več kot 1 uro po jemanju zdravila Biktarvy, mu do naslednjega rednega odmerka ni treba vzeti drugega odmerka.
The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Vrednosti EC50 za alafenamidtenofovirat so bile v razponu od 2,0 do 14,7 nM. Alafenamidtenofovirat je pokazal protivirusno aktivnost v celični kulturi vseh skupin HIV-1 (M, N in O), vključno s podtipi A, B, C, D, E, F in G (vrednosti EC50 so bile v razponu od 0,10 do 12,0 nM) in je pokazal aktivnost proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,91 do 2,63 nM).
Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1.5-2.0 hours after administration of B/F/TAF.
Emtricitabin se po peroralni uporabi hitro in obsežno absorbira, z največjimi koncentracijami v plazmi od 1,5 do 2,0 uri po uporabi B/F/TAF.
No human data on the effect of Biktarvy on fertility are available.
Podatkov o učinkih uporabe zdravila Biktarvy na sposobnost razmnoževanja pri ljudeh ni.
Relative to fasting conditions, the administration of B/F/TAF with either a moderate fat (~600 kcal, 27% fat) or high fat meal (~800 kcal, 50% fat) resulted in an increase in bictegravir AUC (24%).
Glede na pogoje na tešče je dajanje B/F/TAF z obrokom z zmerno vsebnostjo maščobe (~ 600 kcal, 27 % maščobe) ali veliko vsebnostjo maščobe (~ 800 kcal, 50 % maščobe)
(may affect up to 1 in 100 people)
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI CCR5 cell line, and PBMCs.
Protivirusna aktivnost emtricitabina proti laboratorijskim in kliničnim izolatom HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, celični liniji MAGI CCR5 in PBMC.
Bictegravir displayed antiviral activity in cell culture against HIV-1 group (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from < 0.05 to 1.71 nM), and activity against HIV-2 (EC50 = 1.1 nM).
Biktegravir je pokazal protivirusno aktivnost v celični kulturi proti skupini HIV-1 (M, N, O), vključno s podtipi A, B, C, D, E, F in G (vrednosti EC50 so bile v razponu < 0,05 do 1,71 nM), in aktivnost proti HIV-2 (EC50 = 1,1 nM).
Tenofovir alafenamide is eliminated following metabolism to tenofovir.
Alafenamidtenofovirat se pretežno izloča po presnovi v tenofovir.
Ferrous fumarate (324 mg single dose), Bictegravir
železov fumarat (324 mg enkratni odmerek), biktegravir (kelacija s polivalentnimi kationi)
Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild, moderate, or severe hepatic impairment.
Klinično pomembnih sprememb v farmakokinetiki alafenamidtenofovirata ali njegovega presnovka tenofovirja pri bolnikih z blago do zmerno jetrno okvaro niso opazili.
In 16 HIV/HBV co-infected adults administered Biktarvy (8 HIV/HBV treatment-naïve adults in Study GS-US-380-1490; 8 HIV/HBV suppressed adults in Study GS-US-380-1878), the safety profile of Biktarvy was similar to that in patients with HIV-1 monoinfection (see section 5.1).
Pri 16 bolnikih, sočasno okuženih s HIV/HBV, ki so dobivali zdravilo Biktarvy (8 predhodno nezdravljenih bolnikov s HIV/HBV v študiji GS-US-380-1490; 8 odraslih s supresijo HIV/HBV v študiji GS-US-380-1878), je bil profil varnosti zdravila Biktarvy podoben kot pri bolnikih, okuženih samo s HIV-1 (glejte poglavje 5.1).
4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
4 Ta neželeni učinek je bil opredeljen v okviru nadzora za zdravila, ki vsebujejo alafenamidtenofovirat, v obdobju trženja zdravil.
In Study GS-US-380-1878, at Week 48, 100% (8/8) of the patients co-infected with HIV/HBV at baseline in the B/F/TAF arm maintained HBV DNA < 29 IU/mL (missing = excluded analysis) and HIV RNA < 50 copies/mL.
V študiji GS-US-380-1878 je v 48. tednu 100 % (8/8) bolnikov s sočasno okužbo s HIV/HBV ob izhodišču v kraku z B/F/TAF ohranilo HBV DNA < 29 i.e./ml (manjkajoče = izključena analiza) in
[Outer packaging only]
[Samo na zunanji ovojnini]
d Study GS-US-380-1489.
d Študija GS-US-380-1489.
Tenofovir is eliminated by the kidneys by both glomerular filtration and active tubular secretion.
Tenofovir se iz telesa izloča z ledvicami, s pomočjo glomerularne filtracije in aktivnega tubularnega izločanja.
Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Predklinični podatki za emtricitabin na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement
togost sklepov bolečine v sklepih (zlasti v kolkih, kolenih in ramenih)
4 This study was conducted using emtricitabine/tenofovir alafenamide 200/25 mg once daily.
4 Ta študija je bila opravljena z emtricitabinom/ alafenamidtenofoviratom 200/25 mg enkrat dnevno.
In clinical studies of treatment-naïve patients receiving
V kliničnih študijah pri bolnikih, ki so prejemali zdravilo Biktarvy, do konca
Package leaflet: Information for the user Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide This medicine is subject to additional monitoring.
Navodilo za uporabo Biktarvy 50 mg/200 mg/25 mg filmsko obložene tablete biktegravir/emtricitabin/alafenamidtenofovirat Za to zdravilo se izvaja dodatno spremljanje varnosti.
3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products.
3 Ta neželeni učinek je bil opredeljen v okviru nadzora za zdravila, ki vsebujejo emtricitabin, v obdobju trženja zdravil.
Patients must have been stably suppressed (HIV-1 RNA < 50 copies/mL) on their baseline regimen for at least 3 months prior to study entry.
Bolniki so morali biti na izhodiščnem režimu pred vstopom v študijo vsaj 3 mesece stabilno supresirani (HIV-1 RNA < 50 kopij/ml).
Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of emtricitabine were Cmax = 2.13 µg/mL (34.7%), AUCtau = 12.3 µg•h/mL (29.2%), and Ctrough = 0.096 µg/mL (37.4%).
Po peroralnem dajanju B/F/TAF odraslim, okuženim s HIV-1, s hrano ali brez nje, so bili povprečni farmakokinetični parametri večkratnih odmerkov (CV %) za emtricitabin Cmax = 2,13 µg/ml (34,7 %), AUCtau = 12,3 µg•h/ml (29,2 %) in Ctrough = 0,096 µg/ml (37,4 %).
In Studies GS-US-380-1489 and GS-US-380-1490, median (Q1, Q3) serum creatinine increased by 0.09 (0.01, 0.16) mg/dL (8.0 [0.9, 14.1] µmol/L), 0.09 (0.03, 0.17) mg/dL (8.0 [2.6, 15.0] µmol/L), and 0.11 (0.04, 0.18) mg/dL (9.7 [3.5, 15.9] μmol/L) from baseline to Week 96 in the Biktarvy, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
0,09 (0,01; 0,16) mg/dl (8,0 [0,9; 14,1] µmol/l), pri skupini z abakavirjem/dolutegravirjem/lamivudinom za 0,09 (0,03; 0,17) mg/dl (8,0 [2,6; 15,0] µmol/l) in pri skupini z dolutegravirjem + emtricitabinom/alafenamidtenofoviratom za 0,11 (0,04; 0,18) mg/dl (9,7 [3,5; 15,9] μmol/l).
2 This study was conducted using bictegravir/emtricitabine/tenofovir alafenamide 75/200/25 mg once daily.
2 Ta študija je bila izvedena z biktegravirjem/emtricitabinom/ alafenamidtenofoviratom 75/200/25 mg enkrat dnevno
Bictegravir is primarily eliminated by hepatic metabolism.
Biktegravir se primarno izloča z jetrno presnovo.
Co-administration not recommended.
Sočasno dajanje se ne priporoča.
(-5.9% to
(-5,9 % do
Co-administration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.
Sočasno dajanje azitromicina ali klaritromicina lahko poveča koncentracije biktegravirja v plazmi.
Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Emtricitabin je pokazal protivirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F, in G virusa HIV-1 (vrednosti EC50 so bile v razponu od 0,007 do 0,075 µM) in aktivnost proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,007 do
e Study GS-US-380-1490.
e Študija GS-US-380-1490.
No virologic data at week 48 or 96 window Discontinued study drug due to AE or deathg
ali 96. tedna Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrtig
rifampicin used to treat some bacterial infections such as tuberculosis St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.
• Če trenutno jemljete katero od naslednjih zdravil: rifampicin, ki se uporablja se za zdravljenje nekaterih bakterijskih okužb, kot je tuberkuloza šentjanževka (Hypericum perforatum), zdravilo rastlinskega izvora, ki se uporablja pri depresiji in tesnobi, ali izdelki, ki jo vsebujejo.
Talk to your doctor if you are taking: • medicines used for treating HIV and/or hepatitis B, containing:
• zdravila, ki se uporabljajo za zdravljenje okužbe s HIV in/ali hepatitisom B, ki vsebujejo:
 If you notice any of these symptoms tell your doctor.
težave pri gibanju  Če opazite katerega koli od teh simptomov, obvestite svojega zdravnika.
Discontinued study drug due to other reasons and last available HIV1 RNA < 50 copies/mLh
Prekinitev uporabe študijskega zdravila zaradi drugih razlogov in nazadnje razpoložljivi HIV-1 RNA
(Inhibition of CYP3A, UGT1A1, and P-gp/BCRP)
(zaviranje CYP3A, UGT1A1 in Pgp/BCRP)
(Inhibition of CYP3A and UGT1A1)
(zaviranje CYP3A in UGT1A1)
At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~1.0 and the mean semen to plasma drug concentration ratio was
Med najvišjo koncentracijo v plazmi je bilo povprečno razmerje med koncentracijo zdravila v plazmi in krvi ~ 1,0 in povprečno razmerje med koncentracijo zdravila v spermi in plazmi ~ 4,0.
6 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg once daily.
6 Ta študija je bila opravljena z elvitegravirjem/kobicistatom/emtricitabinom/ alafenamidtenofoviratom 150/150/200/10 mg enkrat dnevno.
Treatment outcomes of Studies GS-US-380-1844 and GS-US-380-1878 through Week 48 are presented in Table 4.
Izidi zdravljenja za študijo GS-US-380-1844 in študijo GS-US-380-1878 do konca 48. tedna so predstavljeni v preglednici 4.
How to store Biktarvy
Shranjevanje zdravila Biktarvy
• joint pain (arthralgia)
• bolečina v sklepih (artralgija)
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Bolniki s hkratno okužbo z virusom HIV in virusom hepatitisa B ali C Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusno terapijo, obstaja povečano tveganje za hude in potencialno usodne neželene učinke na delovanje jeter.
Atazanavir (400 mg once daily), Bictegravir1
atazanavir (400 mg enkrat dnevno), biktegravir1
The active substances are bictegravir, emtricitabine and tenofovir alafenamide.
Učinkovine so biktegravir, emtricitabin in alafenamidtenofovirat.
Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
V običajnih testih genotoksičnosti alafenamidtenofovirat ni bil mutagen ali klastogen.
SEDATIVES/HYPNOTICS Midazolam (2 mg, oral syrup, single dose),
midazolam (2 mg, peroralni sirup,
HIV-1 isolates with reduced susceptibility to bictegravir have been selected in cell culture.
V celični kulturi so bili selekcionirani izolati HIV-1 z zmanjšano občutljivostjo na biktegravir.
ANTACIDS, SUPPLEMENTS AND BUFFERED MEDICINES Magnesium/aluminium-containing antacid suspension (20 mL single dose5), Bictegravir
suspenzije antacidov, ki vsebujejo magnezij/aluminij (20 ml enkratni odmerek5), biktegravir (kelacija s polivalentnimi kationi)
• tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)
• alafenamidtenofovirat, protiretrovirusno zdravilo, znano kot zaviralec nukleotidne reverzne transkriptaze (NtRTI - nucleotide reverse transcriptase inhibitor)
Rifabutin (300 mg once daily), Bictegravir1
rifabutin (300 mg enkrat dnevno), biktegravir1
Bictegravir was not mutagenic or clastogenic in conventional genotoxicity assays.
V običajnih testih genotoksičnosti biktegravir ni bil mutagen ali klastogen.
Biktarvy should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium.
Zdravilo Biktarvy je treba dati vsaj 2 uri pred uporabo antacidov, ki vsebujejo magnezij in/ali aluminij, ali s hrano 2 uri po njihovi uporabi.
Table 2: Tabulated list of adverse reactions1
Preglednica 2: Seznam neželenih učinkov v obliki preglednice1 Pogostnost
There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir or tenofovir alafenamide in pregnant women.
Podatkov o uporabi biktegravirja ali alafenamidtenofovirata pri nosečnicah ni oziroma jih je malo (manj kot 300 izidov nosečnosti).
Table 4: Virologic outcomes of Studies GS-US-380-1844 and GS-US-380-1878 at Week 48a
Preglednica 4: Virološki izidi študij GS-US-380-1844 in GS-US-380-1878 v 48. tednua Študija GS-US-380-1844
(-5.6% to
(-5,6 % do
Treatment outcomes of Studies GS-US-380-1489 and GS-US-380-1490 through Weeks 48 and 96 are presented in Table 3.
Izidi zdravljenja za študiji GS-US-380-1489 in GS-US-380-1490 do konca 48. in 96. tedna so predstavljeni v preglednici 3.
Tenofovir alafenamide: AUC: ↔
alafenamidtenofovirat: AUC: ↔
(-5.0% to
(-5,0 % do
While you are taking Biktarvy
Med jemanjem zdravila Biktarvy
Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of tenofovir alafenamide were Cmax = 0.121 µg/mL (15.4%), and AUCtau = 0.142 µg•h/mL (17.3%).
Po peroralnem dajanju B/F/TAF odraslim, okuženim s HIV-1, s hrano ali brez nje, so bili povprečni farmakokinetični parametri večkratnih odmerkov (CV %) za alafenamidtenofovirat Cmax = 0,121 µg/ml (15,4 %) in AUCtau = 0,142 µg•h/ml (17,3 %).
ORAL ANTI-DIABETICS Metformin (500 mg twice daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide
PERORALNI ANTIDIABETIKI metformin (500 mg dvakrat dnevno), biktegravir/emtricitabin/ alafenamidtenofovirat