natgillin/translations-raw huggingface dataset:
One patient had missing HBV DNA data at Week 48.
Za jednog su bolesnika nedostajali podaci za HBV DNK u
Patients had a mean age of 46 years (range 20-79), 83% were male, 66% were White, and 26% were Black.
Srednja vrijednost za dob bolesnika bila je 46 godina (raspon 20-79), 83% bili su muškarci, 66% bili su bijelci, a 26% crnci.
• antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or magnesium hydroxide
• antacide za liječenje vrijeda na želucu, žgaravice ili gastroezofagealne refluksne bolesti, koji sadrže aluminijev i/ili magnezijev hidroksid
In both studies, patients were stratified by baseline HIV-1 RNA (less than or equal to 100,000 copies/mL, greater than 100,000 copies/mL to less than or equal to 400,000 copies/mL, or greater than 400,000 copies/mL), by CD4+ cell count (less than 50 cells/µL, 50-199 cells/µL, or greater than or equal to 200 cells/µL), and by region (US or ex-US).
U oba ispitivanja bolesnici su stratificirani prema početnoj vrijednosti HIV-1 RNK (manje ili jednako 100.000 kopija/ml, više od 100.000 kopija/ml do manje ili jednako 400.000 kopija/ml, ili više od 400.000 kopija/ml), prema broju CD4 + stanica (manje od 50 stanica/µl, 50-199 stanica/µl ili više ili jednako 200 stanica/µl) te po regiji (SAD ili izvan SAD-a).
Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development.
Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak emtricitabina na parametre plodnosti, trudnoću, razvoj fetusa, okot ili postnatalni razvoj.
Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Tenofoviralafenamid nije ni inhibitor niti induktor CYP3A in vivo.
Bictegravir demonstrated equivalent antiviral activity against 5 nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant, 3 NRTI-resistant, and 4 protease inhibitor (PI)-resistant HIV-1 mutant clones compared with the wild-type strain.
Biktegravir je pokazao jednaku antivirusnu aktivnost prema 5 mutiranih klonova virusa HIV-1 s rezistencijom na nenukleozidne inhibitore reverzne transkriptaze (NNRTI), 3 s rezistencijom na NRTI i 4 s rezistencijom na inhibitore proteaze (PI) u usporedbi s divljim sojem virusa.
Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food (see section 4.5).
Biktarvy treba davati najmanje 2 sata prije dodataka koji sadrže željezo ili ga treba uzimati s hranom (vidjeti dio 4.5).
The multiple dose pharmacokinetics of bictegravir are dose proportional over the dose range of 25 to 100 mg.
Farmakokinetika višestruke doze biktegravira proporcionalna je dozi u rasponu doza od 25 to 100 mg.
Renal clearance of the unchanged parent was minimal.
Bubrežni klirens nepromijenjenog izvornog lijeka bio je minimalan.
Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least 43 times greater than those expected after administration of B/F/TAF.
Toksičnost za kost uočena je kao smanjena mineralna gustoća kostiju u štakora i pasa pri izloženostima tenofoviru najmanje 43 puta većima od onih očekivanih nakon primjene B/F/TAF-a.
In vitro phenotyping studies showed that bictegravir is primarily metabolised by CYP3A and UGT1A1.
In vitro ispitivanja fenotipa pokazala su da se biktegravir prvenstveno metabolizira putem CYP3A i UGT1A1.
White, high density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Bijela boca od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu s kontinuiranim navojem, otvora prekrivenog zaštitnom aluminijskom folijom, koja sadrži 30 filmom obloženih tableta.
• If you have hepatitis B infection.
• ako ste zaraženi virusom hepatitisa B.
Patients had a mean age of 45 years (range 20-71), 89% were male, 73% were White, and 22% were Black.
Srednja vrijednost za dob bolesnika bila je 45 godina (raspon 20-71), 89% bili su muškarci, 73% bili su bijelci, a 22% crnci.
(Inhibition of CYP3A)
(inhibicija CYP3A)
Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet.
Ljubičastosmeđa, filmom obložena tableta u obliku kapsule s utisnutom oznakom „GSI“ na jednoj strani i „9883“ na drugoj strani tablete.
No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Nije potrebna prilagodba doze lijeka Biktarvy u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
Table 2: Tabulated list of adverse reactions1
Tablica 2: Tablični popis nuspojava1 Učestalost
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
OBLIK I SADRŽAJ 30 filmom obloženih tableta 90 (3 boce od 30) filmom obloženih tableta
Population analyses using pooled pharmacokinetic data from adult studies did not identify any clinically relevant differences due to age, gender or race on the exposures of bictegravir, emtricitabine, or tenofovir alafenamide.
Analize populacije pomoću objedinjenih farmakokinetičkih podataka prikupljenih u ispitivanjima na odraslim bolesnicima nisu identificirale klinički značajne razlike vezane uz dob, spol ili rasnu pripadnost u izloženosti biktegraviru, emtricitabinu ili tenofoviralafenamidu.
The in vitro human blood to plasma bictegravir concentration ratio was 0.64.
In vitro omjer koncentracije biktegravira u ljudskoj krvi i plazmi bio je 0,64.
What you need to know before you take Biktarvy Do not take Biktarvy:
Što morate znati prije nego počnete uzimati Biktarvy Nemojte uzimati Biktarvy:
(may affect up to 1 in 10 people)
Česte nuspojave (mogu se javiti u do 1 na 10 osoba)
b Includes patients who had ≥ 50 copies/mL in the Week 48 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
b Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz razloga koji nisu nedostatak ili gubitak djelotvornosti i koji su u vrijeme prekida liječenja imali virusnu vrijednost ≥ 50 kopija/ml.
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.
U bolesnika je HIV-1 morao biti stabilno suprimiran (HIV-1 RNK < 50 kopija/ml) početnim režimom najmanje 3 mjeseca prije ulaska u ispitivanje.
HIV-1 RNA < 20 copies/mL
HIV-1 RNK < 20 kopija/ml
Bictegravir is not an inhibitor or inducer of CYP in vivo.
Biktegravir nije ni inhibitor niti induktor CYP-a in vivo.
Bictegravir is an integrase strand transfer inhibitor (INSTI) that binds to the integrase active site and blocks the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Biktegravir je inhibitor integraze - integrase strand transfer inhibitor, INSTI koji se veže za aktivno mjesto integraze i blokira korak prijenosa lanca u okviru integracije retrovirusne deoksiribonukleinske kiseline (DNK), što je ključno za replikacijski ciklus HIV-a.
Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“.
(-5.9% to
(-5,9% do
In addition, 6 patients had the pre-existing INSTI resistance-associated mutation T97A; all had HIV-1 RNA < 50 copies/mL at Week 96 or the last visit.
Pored toga, 6 bolesnika imalo je već postojeću mutaciju povezanu s rezistencijom na INSTI, tj. T97A; u svih je bio HIV-1 RNK < 50 kopija/ml u 96. tjednu ili prilikom zadnjeg pregleda.
Biktarvy should not be taken simultaneously with supplements containing magnesium and/or aluminium due to the expected substantial decrease of bictegravir exposure (see section 4.4).
Lijek Biktarvy ne smije se uzimati istodobno s dodacima koji sadrže magnezij i/ili aluminij zbog očekivanog znatnog smanjenja izloženosti biktegraviru (vidjeti dio
The safety and efficacy of Biktarvy in patients with significant underlying liver disorders have not been established.
Bolest jetre Sigurnost i djelotvornost primjene lijeka Biktarvy u bolesnika s prisutnim značajnim bolestima jetre nisu ustanovljene.
In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja CART-a može doći do upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, koja može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Tijekom terapije protiv HIV-a moguće je povećanje tjelesne težine i povišenje razina lipida i glukoze u krvi.
Discontinued study drug due to AE or death and last available HIV-1 RNA < 50 copies/mL Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLc
Prekid primanja ispitivanog lijeka zbog štetnih događaja ili smrti i posljednje dostupne vrijednosti HIV-1 RNK < 50 kopija/ml Prekid primanja ispitivanog lijeka iz drugih razloga i posljednje dostupne vrijednosti HIV-1 RNK
Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults.
Biktarvy je jedna tableta za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1).
Patients co-infected with HIV and HBV
Bolesnici istodobno zaraženi HIV-om i HBV-om
There are no pharmacokinetic data on bictegravir or tenofovir alafenamide in patients with creatinine clearance less than 15 mL/min.
Nema farmakokinetičkih podataka o biktegraviru ili tenofoviralafenamidu u bolesnika s klirensom kreatinina manjim od 15 ml/min.
Biktarvy has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore Biktarvy is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Lijek Biktarvy nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) te se stoga primjena lijeka Biktarvy ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
Co-administration of ciclosporin (IV or oral use) is not recommended.
Ne preporučuje se istodobna primjena ciklosporina (i.v. ili peroralno).
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Za nadzor lipida i glukoze u krvi dane su preporuke u utvrđenim smjernicama za liječenje HIV-a.
Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Poli(vinilni alkohol) titanijev dioksid (E171)
Patients co-infected with HIV and hepatitis B or C virus
Bolesnici s istodobnom infekcijom HIV-om i virusom hepatitisa B ili C
When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist.
Kad Vam se smanji zaliha lijeka Biktarvy, nabavite još lijeka od liječnika ili ljekarnika.
At Week 96, 4 patients were HBV suppressed and had HIV-1 RNA < 50 copies/mL.
U 96. tjednu, 4 bolesnika imalo je suprimiran HBV i imali su HIV-1 RNK < 50 kopija/ml.
No dose adjustment is required upon co-administration in patients with normal renal function.
Nije potrebna prilagodba doze nakon istodobne primjene u bolesnika s normalnom funkcijom bubrega.
Biktarvy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatment of HBV infection.
Biktarvy se ne smije primjenjivati istodobno s lijekovima koji sadrže tenofoviralafenamid, tenofovirdizoproksil, lamivudin ili adefovirdipivoksil koji se primjenjuju u liječenju infekcije HBV-om.
DTG = dolutegravir 3TC = lamivudine a Week 48 window was between Day 295 and 378 (inclusive).
DTG = dolutegravir 3TC = lamivudin a Okvir 48. tjedna bio je između 295. i (uključivo) 378. dana.
Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil fumarate.
Budući da je izloženost tenofoviru u štakora i miševa nakon primjene tenofoviralafenamida manja nego pri primjeni tenofovirdizoproksilfumarata, ispitivanja kancerogenosti te perinatalno i postnatalno ispitivanje u štakora provedena su samo s tenofovirdizoproksilfumaratom.
In HIV infected patients with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme početka CART-a može nastati upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
 If you notice any of these symptoms, tell your doctor immediately.
Ako primijetite bilo koji od ovih simptoma, odmah obavijestite svog liječnika.
• If you notice within 18 hours of the time you usually take Biktarvy, you must take the tablet as soon as possible.
• Ako to primijetite unutar manje od 18 sati od vremena kad obično uzimate lijek Biktarvy, tabletu morate uzeti što prije.
The mean baseline CD4+ cell count was 460 cells/mm3 (range 0-1,636) and 11% had CD4+ cell counts less than 200 cells/mm3.
Srednja početna vrijednost broja CD4 + stanica bila je 460 stanica/mm3 (raspon: 01636), a 11% imalo je broj CD4 + stanica < 200 stanica/mm3.
Bictegravir was not mutagenic or clastogenic in conventional genotoxicity assays.
Biktegravir nije pokazao mutagenost ni klastogenost u konvencionalnim testovima genotoksičnosti.
Interaction not studied with any of the components of Biktarvy.
Interakcija nije ispitana ni s jednom komponentom lijeka Biktarvy.
Bictegravir is primarily eliminated by hepatic metabolism.
Eliminacija Biktegravir se prvenstveno eliminira metabolizmom u jetri.
• anaemia
• anemija
In a second selection, amino acid substitutions T66I and S153F emerged and phenotypic susceptibility to bictegravir was shifted 0.4-, 1.9-, and 0.5-fold for T66I, S153F, and T66I + S153F, respectively.
U drugoj izdvojenoj skupini pojavile su se supstitucije aminokiselina T66I i S153F i fenotipska osjetljivost na biktegravir pomakla se 0,4 puta za T66I; 1,9 puta za S153F i 0,5 puta za T66I + S153F.
Discontinuation of Biktarvy therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Prekid terapije lijekom Biktarvy u bolesnika istodobno zaraženih HIV-om i HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa.
(-5.6% to
(-5,6% do
3.2% (-1.6% to 8.2%)
3,2% (-1,6% do 8,2%)
• St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.
• gospina trava (Hypericum perforatum), biljni pripravak koji se primjenjuje za depresiju i tjeskobu ili lijekovi koji je sadrže.
Biktarvy film-coated tablets are purplish-brown, capsule-shaped, film-coated tablets debossed on one side with “GSI” and “9883” on the other side.
Biktarvy filmom obložene tablete su ljubičastosmeđe filmom obložene tablete u obliku kapsule, s utisnutom oznakom „GSI“ na jednoj strani i „9883“ na drugoj strani tablete.
 If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.
Ako uzimate bilo koji od ovih lijekova, nemojte uzeti lijek Biktarvy i odmah obavijestite liječnika.
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.