natgillin/translations-raw huggingface dataset:
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).
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.
U ispitivanju GS-US-380-1878, u 48. tjednu, 100% (8/8) bolesnika istodobno zaraženih HIV-om i HBV-om na početku u skupini liječenoj lijekom B/F/TAF-om održalo je HBV DNK < 29 IU/ml (nedostaje = analiza isključena) i HIV RNK < 50 kopija/ml.
It is not known whether bictegravir or tenofovir alafenamide is excreted in human milk.
Nije poznato izlučuju li se biktegravir ili tenofoviralafenamid u majčino mlijeko.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide
Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete biktegravir/emtricitabin/tenofoviralafenamid
(Induction of CYP3A and P-gp)
(indukcija CYP3A i P-gp)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11. NAZIV I ADRESA NOSTELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
If you vomit more than 1 hour after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.
Ako povraćate nakon što je prošao 1 sat od uzimanja lijeka Biktarvy, ne trebate uzeti još jednu tabletu prije sljedeće tablete prema redovitom rasporedu
Patients were randomised in a 1:1 ratio to either switch to B/F/TAF at baseline (n = 282), or stay on their baseline antiretroviral regimen (n = 281).
Bolesnici su bili randomizirani u omjeru 1:1 kako bi se prebacili na B/F/TAF (n = 282) od početka ispitivanja ili ostali na svom početnom antiretrovirusnom režimu (n = 281).
The prevalence of different subtypes was comparable across all three treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Prevalencija različitih podtipova bila je usporediva u sve tri terapijske skupine, s time da je podtip B prevladavao u obje skupine; 11% bilo je ne-B podtip.
Emtricitabine has activity against HIV-1, HIV-2 and HBV.
Emtricitabin je aktivan protiv virusa HIV-1, HIV-2 i HBV.
Bictegravir
Biktegravir
Bictegravir has activity against HIV-1 and HIV-2.
Biktegravir je aktivan protiv virusa HIV-1 i HIV-2.
Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Bubrežna ekskrecija nerazgrađenog tenofoviralafenamida predstavlja put izlučivanja koji je od malog značaja, a kojim se eliminira < 1% doze u mokraći.
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
Kod vršne koncentracije u plazmi, srednja vrijednost omjera koncentracije lijeka u plazmi i krvi bio je ~1,0, a srednja vrijednost omjera koncentracije lijeka u sjemenu i plazmi bila je ~4,0.
ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1
Norgestimat (0,180/0,215/0,250 mg jedanput na dan)/ etinilestradiol (0,025 mg jedanput na dan), biktegravir1
Iron oxide red (E172) Iron oxide black (E172)
makrogol talk željezov oksid, crveni (E172) željezov oksid, crni (E172) 6.2 Inkompatibilnosti
Atazanavir (400 mg once daily), Bictegravir1
Atazanavir (400 mg jedanput na dan), biktegravir1
Biktarvy should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium.
Biktarvy treba davati najmanje 2 sata prije ili s hranom 2 sata poslije antacida koji sadrže magnezij i/ili aluminij.
If you vomit less than 1 hour after taking Biktarvy, take another tablet.
Ako povraćate unutar 1 sata od uzimanja lijeka Biktarvy, uzmite drugu tabletu.
Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide2
Antivirusni lijekovi za virus hepatitisa C Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan), Biktegravir/emtricitabin/
Name and address of the manufacturer(s) responsible for batch release
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje lijeka u promet
Co-administration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.
Istodobna primjena azitromicina ili klaritromicina može povećati koncentracije biktegravira u plazmi.
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 pokazao antivirusnu aktivnost u staničnoj kulturi protiv skupine HIV-1 (M, N, O) uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od < 0,05 do 1,71 nM) i aktivnost protiv virusa HIV-2 (EC50 = 1,1 nM).
2 This study was conducted using bictegravir/emtricitabine/tenofovir alafenamide 75/200/25 mg once daily.
2 To je ispitivanje provedeno primjenom biktegravira/emtricitabina/tenofoviralafenamida od 75/200/25 mg jedanput na dan.
ANTICONVULSANTS Carbamazepine (titrated from 100 mg to 300 mg twice a day), Emtricitabine/Tenofovir alafenamide4
Karbamazepin (titriran sa 100 mg na 300 mg dvaput na dan), emtricitabin/tenofoviralafenamid4
Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Unutar stanice se tenofovir naknadno fosforilira u farmakološki aktivan metabolit tenofovirdifosfat.
AUC: ↑ 39% Cmin: ↑ 36% Cmax: ↔
Metformin: AUC: ↑ 39% Cmin: ↑ 36% Cmax: ↔
If the patient misses a dose of Biktarvy within 18 hours of the time it is usually taken, the patient should take Biktarvy as soon as possible and resume the normal dosing schedule.
Ako bolesnik propusti uzeti dozu lijeka Biktarvy, a proteklo je manje od 18 sati od uobičajenog vremena uzimanja doze, bolesnik mora što prije uzeti lijek Biktarvy i potom ga nastaviti uzimati prema uobičajenom rasporedu.
ANTACIDS, SUPPLEMENTS AND BUFFERED MEDICINES Magnesium/aluminium-containing antacid suspension (20 mL single dose5), Bictegravir
Otopina antacida koji sadrže magnezij/aluminij (jedna doza od 20 ml5), biktegravir
HIV-1 RNA < 50 copies/mL Treatment difference (95% CI) B/F/TAF vs Comparator
HIV-1 RNK < 50 kopija/ml Razlika u liječenju (95% CI) B/F/TAF
Do not stop taking Biktarvy Do not stop taking Biktarvy without talking to your doctor.
Nemojte prestati uzimati lijek Biktarvy bez prethodnog razgovora sa svojim liječnikom.
Co-administration of ciclosporin (IV or oral use) is expected to increase plasma concentrations of both bictegravir and tenofovir alafenamide.
Očekuje se da će istodobna primjena ciklosporina (i.v. ili peroralno) povećati koncentracije i biktegravira i tenofoviralafenamida u plazmi.
Blood and lymphatic system disorders Uncommon:
Poremećaji krvi i limfnog sustava
Clinically relevant changes in the pharmacokinetics of bictegravir were not observed in subjects with moderate hepatic impairment.
Nisu zapažene klinički važne promjene u farmakokinetici biktegravira u bolesnika s umjerenim oštećenjem funkcije jetre.
If the patient vomits within 1 hour of taking Biktarvy another tablet should be taken.
Ako bolesnik povraća unutar 1 sata od uzimanja lijeka Biktarvy, mora uzeti drugu tabletu.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
NAZIV LIJEKA Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete
d Study GS-US-380-1489.
d Ispitivanje GS-US-380-1489.
Seventeen percent of patients identified as Hispanic/Latino.
Kao Hispanoamerikanci/Latinoamerikanci izjasnilo se 17% bolesnika.
Table 3: Pooled virologic outcomes of Studies GS-US-380-1489 and GS-US-380-1490 at Weeks 48a and 96b
Tablica 3: Objedinjeni virološki ishodi u ispitivanjima GS-US-380-1489 i GS-US-380-1490 u 48.a i 96.b tjednu
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.
Antivirusna aktivnost emtricitabina protiv laboratorijskih i kliničkih izolata virusa HIV-1 procijenjena je na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI CCR5 i PBMC-ovima.
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 pokazao antivirusnu aktivnost u staničnoj kulturi protiv podtipova virusa HIV-1 A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,007 do 0,075 µM) i aktivnost protiv virusa HIV-2 (vrijednosti EC50 bile su u rasponu od 0,007 do 1,5 µM).