natgillin/translations-raw huggingface dataset:
Some medicinal products are not recommended for co-administration with Biktarvy: atazanavir, carbamazepine, ciclosporin (IV or oral use), oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, or sucralfate. 
Neke se lijekove ne preporučuje primjenjivati istodobno s lijekom Biktarvy: atazanavir, karbamazepin, ciklosporin (i.v. ili peroralno), okskarbazepin, fenobarbital, fenitoin, rifabutin, rifapentin ili sukralfat.
Iron supplements: you will need to take Biktarvy at least 2 hours before iron supplements, or you can take them together with food. 
Dodatke prehrani koji sadrže željezo: Morat ćete uzeti lijek Biktarvy najmanje 2 sata prije dodataka prehrani koji sadrže željezo ili ih možete uzimati zajedno s hranom.
Multinucleoside resistant HIV-1 with a T69S double insertion mutation or with a Q151M mutation complex including K65R showed reduced susceptibility to tenofovir alafenamide. 
HIV-1 rezistentan na više nukleozida s mutacijom T69S nastalom dvostrukim umetanjem ili s mutacijskim kompleksom Q151M koji uključuje K65R pokazao je smanjenu osjetljivost na tenofoviralafenamid.
B/F/TAF was non-inferior in achieving HIV-1 RNA < 50 copies/mL at both Weeks 48 and 96 when compared to abacavir/dolutegravir/lamivudine and to dolutegravir + emtricitabine/tenofovir alafenamide, respectively. 
B/F/TAF bio je neinferioran u postizanju HIV-1 RNK < 50 kopija/ml i u 48. i u 96. tjednu u usporedbi s abakavir/dolutegravir/lamivudinom i dolutegravir + emtricitabin/tenofoviralafenamidom.
Bictegravir (simultaneous administration with food): 
Biktegravir (istodobna primjena s hranom):
 If any of these apply to you, do not take Biktarvy and tell your doctor immediately. 
Ako se bilo što od ovoga odnosi na Vas, nemojte uzeti lijek Biktarvy i odmah obavijestite liječnika.
Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations, ATC code: J05AR20 
Farmakoterapijska skupina: antivirusni lijekovi za sistemsku primjenu; antivirusni lijekovi za liječenje HIV-infekcija, kombinacije.
Interaction not studied with tenofovir alafenamide. 
Interakcija nije ispitana s tenofoviralafenamidom.
Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. 
Bolesnici koji imaju bolest jetre uključujući kronični hepatitis B ili C, a liječe se antivirusnim lijekovima, izloženi su većem riziku od teških i potencijalno smrtonosnih komplikacija s jetrom.
Bictegravir: 
Biktegravir:
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine triphosphate. 
Stanični enzimi fosforiliraju emtricitabin u emtricitabin trifosfat.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL. 
In vitro vezanje emtricitabina za proteine ljudske plazme bilo je < 4% i nije ovisilo o koncentraciji u rasponu od 0,02 do 200 μg/ml.
-1.4% (-5.5% to 2.6%) 
-1,4% (-5,5% do 2,6%)
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%). 
U odnosu na stanje natašte, primjena B/F/TAF-a s umjereno masnim obrokom (~600 kcal, 27% masti) ili visokomasnim obrokom (~800 kcal, 50% masti) uzrokovala je povećanje AUC-a biktegravira (24%).
Relative to fasting conditions, the administration of tenofovir alafenamide with a moderate fat meal (~600 kcal, 27% fat) and a high fat meal (~800 kcal, 50% fat) resulted in an increase in AUClast by 48% and 63%, respectively. 
U odnosu na stanje natašte, primjena tenofoviralafenamida s umjereno masnim obrokom (~600 kcal, 27% masti) ili visokomasnim obrokom (~800 kcal, 50% masti) uzrokovala je povećanje AUClast za 48% odnosno 63%.
Bictegravir is both a P-gp and a BCRP substrate. 
Biktegravir je supstrat i P-gp-a i BCRP-a.
Macrolides Azithromycin Clarithromycin 
Makrolidi Azitromicin
In one selection, amino acid substitutions M50I and R263K emerged and phenotypic susceptibility to bictegravir was reduced 1.3-, 2.2-, and 2.9-fold for M50I, R263K, and M50I + R263K, respectively. 
U jednoj izdvojenoj skupini pojavile su se supstitucije aminokiselina M50I i R263K i fenotipska osjetljivost na biktegravir smanjila se 1,3 puta za M50I; 2,2 puta za R263K i 2,9 puta za M50I + R263K.
Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays. 
Tenofoviralafenamid nije pokazao mutagenost ni klastogenost u konvencionalnim pretragama genotoksičnosti.
(may affect up to 1 in 100 people) 
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba)
c Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g. withdrew consent, loss to follow-up, etc. 
c Obuhvaća bolesnike s prekidom liječenja iz razloga koji nisu posljedica štetnih događaja, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
c Pooled from Study GS-US-380-1489 (n = 314) and Study GS-US-380-1490 (n = 320). 
Podaci skupljeni iz ispitivanja GS-US-380-1489 (n = 314) i ispitivanja GS-US-380-1490 (n = 320).
1 This study was conducted using bictegravir 75 mg single dose. 
To je ispitivanje provedeno primjenom jedne doze biktegravira od 75 mg.
 If you notice any of these symptoms tell your doctor. 
 Ako primijetite bilo koji od ovih simptoma, obavijestite svog liječnika.
Patients were randomised in a 1:1 ratio to either switch to B/F/TAF (n = 290), or stay on their baseline antiretroviral regimen (n = 287). 
Bolesnici su bili randomizirani u omjeru 1:1 kako bi se prebacili na B/F/TAF (n = 290) ili ostali na svom početnom antiretrovirusnom režimu (n = 287).
The mean baseline CD4+ cell count was 663 cells/mm3 (range 62-2,582). 
Srednja početna vrijednost broja CD4 + stanica bila je 663 stanica/mm3 (raspon: 62-2582).
A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 14 and 43 times greater, respectively, than those expected after administration of B/F/TAF. 
U oku pasa bila je prisutna minimalna infiltracija histiocitima kod izloženosti tenofoviralafenamidu i tenofoviru koja je bila približno 14 i 43 puta veća od one očekivane nakon primjene B/F/TAF-a.
Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). 
Tenofoviralafenamid se transportira P-glikoproteinom (P-gp) i BCRP-om.
HIV-1 isolates with reduced susceptibility to bictegravir have been selected in cell culture. 
Izolati virusa HIV-1 sa smanjenom osjetljivošću na biktegravir izdvojeni su u staničnoj kulturi.
Tenofovir alafenamide is eliminated following metabolism to tenofovir. 
Tenofoviralafenamid eliminira se nakon metaboličke pretvorbe u tenofovir.
The assessment of adverse reactions is based on safety data from across all Phase 2 and 3 studies with Biktarvy and from post-marketing experience. 
Procjena nuspojava temelji se na podacima o sigurnosti primjene iz svih ispitivanja faze 2 i 3 lijeka
Biktarvy through 96 weeks, the most frequently reported adverse reactions were headache (5%), diarrhoea (5%) and nausea (4%). 
Najčešće prijavljene nuspojave u bolesnika koji prethodno nisu bili liječeni a primali su lijek Biktarvy u kliničkim ispitivanjima tijekom 96 tjedana bile su glavobolja (5%), proljev (5%) i mučnina (4%).
Patients co-infected with hepatitis B 
Bolesnici s istodobnom infekcijom hepatitisom B
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. 
Bolesnici s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom izloženi su povećanom riziku od teških i potencijalno životno opasnih jetrenih nuspojava.
Co-administration of Biktarvy with medicinal products that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption. 
Istodobna primjena lijeka Biktarvy s lijekovima koji jako utječu na aktivnost P-gp-a i BCRP-a može dovesti do promjena u apsorpciji tenofoviralafenamida.
Tenofovir is eliminated by the kidneys by both glomerular filtration and active tubular secretion. 
Tenofovir se eliminira bubrezima putem glomerularne filtracije i aktivne tubularne sekrecije.
Biktarvy may be co-administered with substrates of OCT2 and MATE1. 
Lijek Biktarvy može se primjenjivati istodobno sa supstratima OCT2 i MATE1.
Co-administration of bictegravir and medicinal products that potently induce both CYP3A and UGT1A1, such as rifampicin or St. John's wort, may significantly decrease plasma concentrations of bictegravir, which may result in a loss of therapeutic effect of Biktarvy and development of resistance, therefore co-administration is contraindicated (see section 4.3). 
Istodobna primjena biktegravira i lijekova koji su jaki induktori i CYP3A i UGT1A1, kao što su rifampicin ili gospina trava, može značajno smanjiti koncentracije biktegravira u plazmi, što može dovesti do gubitka terapijskog učinka lijeka Biktarvy i razvoja rezistencije pa je stoga istodobna primjena kontraindicirana (vidjeti dio 4.3).
f Includes patients who had ≥ 50 copies/mL in the Week 48 or 96 window; patients who discontinued early due to lack or loss of efficacy (n = 0); patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy (B/F/TAF n = 12 and 15; ABC/DTG/3TC n = 2 and 4; DTG+F/TAF n = 3 and 4, at Weeks 48 and 96, 
Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. ili 96. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti (n = 0); bolesnike koji su prekinuli liječenje iz razloga koji nisu bili štetni događaj, smrt ili nedostatak ili gubitak djelotvornosti (B/F/TAF n = 12 i 15; ABC/DTG/3TC n = 2 i 4; DTG + F/TAF
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment. 
Zabilježno je da se u stanju imunološke reaktivacije pojavljuju i autoimuni poremećaji (kao što su Gravesova bolest i autoimuni hepatitis); međutim, zabilježeno vrijeme do njihova nastupa prilično je raznoliko i ti se događaji mogu pojaviti mnogo mjeseci nakon početka liječenja.
 If any of the side effects get serious, tell your doctor. 
Ako neka od ovih nuspojava postane ozbiljna, obavijestite svog liječnika.
Ferrous fumarate (324 mg single dose), Bictegravir 
Željezov fumarat (jedna doza od 324 mg), biktegravir
No clinically relevant differences in bictegravir, tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and subjects with severe renal impairment (estimated CrCl < 30 mL/min). 
Nisu zapažene klinički značajne razlike u farmakokinetici biktegravira, tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl < 30 ml/min).
HIV-1 isolates with reduced susceptibility to emtricitabine have been selected in cell culture and had M184V/I mutations in HIV-1 RT. 
Izolati virusa HIV-1 sa smanjenom osjetljivošću na emtricitabin izdvojeni su u staničnim kulturama i imali su M184V/I mutacije u HIV-1 RT.
0.7% (-1.0% to 2.8%) 
0,7% (-1,0% do 2,8%)
At the time of study entry, one treatment-naïve patient had pre-existing INSTI resistance-associated mutations Q148H + G140S and had HIV-1 RNA < 50 copies/mL at Week 4 through Week 96. 
U vrijeme uključivanja u ispitivanje, jedan bolesnik koji prethodno nije bio liječen imao je već postojeće mutacije povezane s rezistencijom na INSTI, tj. Q148H + G140S, i HIV-1 RNK < 50 kopija/ml od 4. do 96. tjedna.
Emtricitabine is primarily excreted by the kidneys by both glomerular filtration and active tubular secretion. 
Emtricitabin se uglavnom eliminira bubrezima putem glomerularne filtracije i aktivne tubularne sekrecije.
Studies of bictegravir and tenofovir alafenamide, administered separately, in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development (see section 5.3). 
Ispitivanja na životinjama kojima su biktegravir i tenofoviralafenamid davani odvojeno nisu pokazala nikakve dokaze štetnih učinaka na parametre plodnosti, trudnoću ili razvoj fetusa (vidjeti dio 5.3).
How to take Biktarvy 
Kako uzimati Biktarvy
0.0% (-2.5% to 2.5%) 
0,0% (-2,5% do 2,5%)
Nervous system disorders Common: 
Poremećaji živčanog sustava
h Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g. withdrew consent, loss to follow-up, etc. 
h Obuhvaća bolesnike s prekidom liječenja iz razloga koji nisu bili štetni događaj, smrt ili nedostatak ili gubitak djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
If you do miss a dose: 
Ako ipak propustite uzeti dozu:
Uncommon: 
Često:
Co-administration of other medicinal products 
Istodobna primjena drugih lijekova
In treatment-naïve (Studies GS-US-380-1489 and GS-US-380-1490) and virologically-suppressed patients (Studies GS-US-380-1844 and GS-US-380-1878), no patient receiving Biktarvy had HIV-1 with treatment-emergent genotypic or phenotypic resistance to bictegravir, emtricitabine, or tenofovir alafenamide in the final resistance analysis population (n = 10) with HIV-1 RNA ≥ 200 copies/mL at the time of confirmed virologic failure, Week 48, Week 96 (treatment naïve studies only) or early study drug discontinuation. 
U bolesnika koji prethodno nisu bili liječeni (ispitivanja GS-US-380-1489 i GS-US-380-1490) i bolesnika s virološkom supresijom (ispitivanja GS-US-380-1844 i GS-US-380-1878), niti jedan bolesnik koji je primao lijek Biktarvy nije imao HIV-1 s genotipskom ili fenotipskom rezistencijom na biktegravir, emtricitabin, ili tenofoviralafenamid nastalom za vrijeme liječenja u populaciji za završnu analizu rezistencije (n = 10) s HIV-1 RNK ≥ 200 kopija/ml u vrijeme potvrđenog virološkog neuspjeha, u 48. tjednu, 96. tjednu (samo ispitivanja bez prethodnog liječenja) ili u vrijeme ranog prestanka uzimanja ispitivanog lijeka.
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. 
Klinički značajne razlike u farmakokinetici tenofoviralafenamida ili njegovog metabolita tenofovira nisu ustanovljene kod bolesnika s blagim, umjerenim ili teškim oštećenjima jetre.
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. 
Ako bolesnik propusti uzeti dozu lijeka Biktarvy, a proteklo je više od 18 sati, bolesnik ne smije uzeti propuštenu dozu nego jednostavno treba nastaviti uzimati doze prema uobičajenom rasporedu.
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. 
Izolati virusa HIV-1 sa smanjenom osjetljivošću na tenofoviralafenamid izdvojeni su u staničnim kulturama i imali su mutaciju K65R u HIV-1 RT; dodatno je kratkotrajno opažena i mutacija K70E u HIV-1 RT.
Antacids and magnesium supplements: you will need to take Biktarvy at least 2 hours before antacids or supplements containing aluminium and/or magnesium. 
Antacide ili dodatke prehrani koji sadrže magnezij: Morat ćete uzeti Biktarvy najmanje 2 sata prije antacida ili dodataka koji sadrže aluminij i/ili magnezij.
Tablet core Microcrystalline cellulose, croscarmellose sodium, magnesium stearate. 
Jezgra tablete mikrokristalična celuloza, umrežena karmelozanatrij, magnezijev stearat
Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination. 
Emtricitabin trifosfat inhibira replikaciju HIV-a ugradnjom u virusnu DNK pomoću reverzne transkriptaze (RT) što dovodi do prekida lanca DNK.
Co-administration of bictegravir with medicinal products that potently inhibit both CYP3A and UGT1A1, such as atazanavir, may significantly increase plasma concentrations of bictegravir, therefore co-administration is not recommended. 
Istodobna primjena biktegravira i lijekova koji su jaki inhibitori i CYP3A i UGT1A1, kao što je atazanavir, može znatno povećati koncentracije biktegravira u plazmi pa se stoga istodobna primjena ne preporučuje.
• bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI) 
• biktegravir, antiretrovirusni lijek poznat kao inhibitor integraze (INSTI)
Caution is recommended due to the potential effect of these agents on the bictegravir component of Biktarvy. 
Savjetuje se oprez zbog mogućeg djelovanja tih lijekova na biktegravir, sastojak lijeka Biktarvy.
Calcium carbonate (1,200 mg single dose), Bictegravir 
Kalcijev karbonat (jedna doza od 1200 mg), biktegravir
The frequencies were derived from Phase 3 Biktarvy clinical studies in treatment-naïve patients through 96 weeks (GS-US-380-1489 and GS-US-380-1490). 
Učestalosti su izvedene iz podataka kliničkih ispitivanja faze 3 lijeka Biktarvy, a tijekom 96 tjedana liječenja bolesnika koji prethodno nisu bili liječeni (GS-US-380-1489 i GS-US-380-1490).
Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue). 
Tenofoviralafenamid je nukleotidni inhibitor reverzne transkriptaze (engl. nucleotide reverse transcriptase inhibitor, NtRTI) i fosforoamidatni prolijek tenofovira (analog 2'-deoksiadenozin monofosfata).
• Signs of inflammation or infection • Joint pain, stiffness or bone problems 
• znakove upale ili infekcije • bol u zglobovima, ukočenost ili tegobe s kostima.
In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL. 
In vitro vezanje tenofovira za proteine ljudske plazme bilo je < 0,7% i nije ovisilo o koncentraciji u rasponu od 0,01 do 25 μg/ml.
Co-administration of Biktarvy with other medicinal products that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide. 
Istodobna primjena lijeka Biktarvy s drugim lijekovima koji inhibiraju P-gp i BCRP može povećati apsorpciju i koncentraciju tenofoviralafenamida u plazmi.
Study GS-US-380-1878 
Ispitivanje GS-US-380-1878
Co-administration is contraindicated due to the effect of rifampicin on the bictegravir component of Biktarvy. 
Istodobna primjena kontraindicirana je zbog djelovanja rifampicina na biktegravir, sastojak lijeka Biktarvy.
B/F/TAF (n = 634)c 
(n = 634)c
Emtricitabine is excreted in human milk. 
Emtricitabin se izlučuje u majčino mlijeko.
Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose. 
Glavni put eliminacije tenofoviralafenamida u ljudi je metabolizam kojim se razgradi > 80% peroralne doze.
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/tenofoviralafenamid a Okvir 48. tjedna bio je između 295. i (uključivo) 378. dana.
6 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg once daily. 
To je ispitivanje provedeno pomoću elvitegravira/kobicistata/emtricitabina/tenofoviralafenamida od 150/150/200/10 mg jedanput na dan.
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). 
Djelotvornost i sigurnost lijeka Biktarvy u odraslih virološki suprimiranih bolesnika zaraženih virusom HIV-1 temelje se na podacima prikupljenim tijekom 48 tjedana u randomiziranom, dvostruko slijepom, aktivno kontroliranom ispitivanju GS-US-380-1844 (n = 563) i randomiziranom, otvorenom, aktivno kontroliranom ispitivanju GS-US-380-1878 (n = 577).
In Study GS-US-380-1490, 8 patients with HIV/HBV co-infection at baseline were randomised to receive B/F/TAF. 
U ispitivanju GS-US-380-1490, 8 bolesnika istodobno zaraženih HIV-om i HBV-om na početku bilo je randomizirano da primaju B/F/TAF.
Recommendation concerning co-administration with Biktarvy 
Preporuka za istodobnu primjenu s lijekom Biktarvy
In a separate study, site-directed mutants with G118R and T97A+G118R had 3.4- and 2.8-fold reduced susceptibility to bictegravir, respectively. 
U zasebnom ispitivanju, mutanti s ciljanom mutagenezom G118R i T97A + G118R imali su
In Studies GS-US-380-1489 and GS-US-380-1490, total bilirubin increases were observed in 15% of treatment-naïve patients administered Biktarvy through Week 96. 
U ispitivanjima GS-US-380-1489 i GS-US-380-1490, povećanje ukupnog bilirubina opaženo je u 15% bolesnika koji prethodno nisu bili liječeni, a primali su lijek Biktarvy do 96. tjedna.
 Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first. 
 Nemojte prestati uzimati lijek Biktarvy ako imate hepatitis B.
Tenofovir has activity against HIV-1, HIV-2 and HBV. 
Tenofovir je aktivan protiv virusa HIV-1, HIV-2 i HBV.
Animal studies indicate no effects of bictegravir, emtricitabine or tenofovir alafenamide on mating or fertility (see section 5.3). 
Ispitivanja na životinjama pokazala su da biktegravir, emtricitabin i tenofoviralafenamid nemaju učinke na parenje ili plodnost (vidjeti dio 5.3).
The prevalence of different HIV-1 subtypes was comparable between treatment groups, with subtype B predominant in both groups; 5% were non-B subtypes. 
Prevalencija različitih podtipova virusa HIV-1 bila je usporediva u terapijskim skupinama, s time da je podtip B prevladavao u obje skupine; 5% bilo je ne-B podtip.
In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate. 
In vivo, tenofoviralafenamid se hidrolizira u stanicama do tenofovira (glavni metabolit), koji se zatim fosforilira u aktivni metabolit tenofovirdifosfat.
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 jedanput na dan), etinilestradiol (0,025 mg jedanput na dan) emtricitabin/tenofoviralafenamid4
Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chaintermination. 
Tenofovirdifosfat inhibira replikaciju HIV-a ugradnjom u virusnu DNK pomoću HIV-RT-a, što dovodi do prekida lanca DNK.
Bictegravir is a substrate of CYP3A and UGT1A1. 
Biktegravir je supstrat CYP3A i UGT1A1.
Interaction not studied with bictegravir. 
Interakcija s biktegravirom nije ispitana.
There is insufficient information on the effects of all the components of Biktarvy in newborns/infants, therefore Biktarvy should not be used during breast-feeding. 
Nema dovoljno podataka o učincima svih komponenti lijeka Biktarvy na novorođenčad/dojenčad;
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine. 
Emtricitabin je nukleozidni inhibitor reverzne transkriptaze (engl. nucleoside reverse transcriptase inhibitor, NRTI) i nukleozidni analog 2'-deoksicitidina.
The efficacy and safety of Biktarvy in HIV-1 infected, treatment-naïve adults are based on 48-week and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-380-1489 (n = 629) and GS-US-380-1490 (n = 645). 
Djelotvornost i sigurnost lijeka Biktarvy u odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni temelje se na podacima prikupljenim tijekom 48 odnosno 96 tjedana u dva randomizirana, dvostruko slijepa, aktivno kontrolirana ispitivanja GS-US-380-1489 (n = 629) i GS-US-380-1490 (n = 645).