natgillin/translations-raw huggingface dataset:
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.
Glede na pogoje na tešče je dajanje alafenamidtenofovirata z obrokom z zmerno vsebnostjo maščobe (~ 600 kcal, 27 % maščobe) in veliko vsebnostjo maščobe (~ 800 kcal, 50 % maščobe) povzročilo povečanje AUClast za 48 % oz.
Biktarvy may interact with other medicines.
Zdravilo Biktarvy lahko medsebojno deluje z drugimi zdravili.
Animal studies indicate no effects of bictegravir, emtricitabine or tenofovir alafenamide on mating or fertility (see section 5.3).
Študije na živalih ne kažejo na učinke biktegravirja, emtricitabina ali alafenamidtenofovirata na parjenje ali plodnost (glejte poglavje 5.3).
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
4.9 Preveliko odmerjanje V primeru prevelikega odmerka je treba pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8).
Based on drug interaction studies conducted with Biktarvy or the components of Biktarvy, no clinically significant drug interactions are expected with: amlodipine, atorvastatin, buprenorphine, drospirenone, famciclovir, famotidine, fluticasone, methadone, naloxone, norbuprenorphine, omeprazole or rosuvastatin.
Po podatkih iz študij medsebojnega delovanja, opravljenih z učinkovinami zdravila Biktarvy, se ne pričakujejo nobena klinično pomembna medsebojna delovanja, kadar se zdravilo Biktarvy uporablja v kombinaciji z naslednjimi zdravili: amlodipin, atorvastatin, buprenorfin, drospirenon, famciklovir, famotidin, flutikazon, metadon, nalokson, norbuprenorfin, omeprazol ali rosuvastatin.
• St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.
• šentjanževka (Hypericum perforatum), zdravilo rastlinskega izvora, ki se uporablja pri depresiji in tesnobi, ali izdelki, ki jo vsebujejo
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.
Pri bolnikih z boleznijo jeter, vključno s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusnimi zdravili, je tveganje resnih in potencialno smrtnih zapletov z jetri večje.
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.
Bela plastenka iz polietilena visoke gostote (HDPE) s polipropilensko, za otroke varno zaporko z navojem in zatesnjena z indukcijsko aktivirano aluminijasto folijo, ki vsebuje 30 filmsko obloženih tablet.
The K65R and K70E mutations result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Mutaciji K65R in K70E povzročita manjšo občutljivost za abakavir, didanozin, lamivudin, emtricitabin in tenofovir, vendar ohranita občutljivost za zidovudin.
Four patients had missing HBV DNA data at Week 96 (one lost to follow-up from Week 48, 1 lost to follow-up after Week 72, 1 with missing HBV data but HIV-1 RNA < 50 copies/mL, and 1 with missing data in Week 96 window).
DNA v 96. tednu za štiri bolnike so manjkali (1 je bil izgubljen za spremljanje od 48. tedna, 1 je bil izgubljen za spremljanje po 72. tednu, 1 ni imel podatkov o HBV, vendar je imel HIV-1 RNA < 50 kopij/ml, in 1 je imel manjkajoče podatke v oknu 96. tedna).
Seventeen percent of patients identified as Hispanic/Latino.
Sedemnajst odstotkov bolnikov je bilo hispanskega/latinskoameriškega porekla.
Bictegravir was not carcinogenic in a 6-month rasH2 transgenic mouse study (at doses of up to 100 mg/kg/day in males and 300 mg/kg/day in females, which resulted in exposures of approximately 15 and 23 times, in males and females, respectively, the exposure in humans at the recommended human dose) nor in a 2-year rat study (at doses of up to 300 mg/kg/day, which resulted in exposures of approximately 31 times the exposure in humans).
100 mg/kg/dan pri samcih in 300 mg/kg/dan pri samicah, kar je povzročilo približno 15-kratno izpostavljenost pri samcih in 23-kratno izpostavljenost pri samicah v primerjavi z izpostavljenostjo pri ljudeh ob priporočenem odmerku), niti v 2-letni študiji na podganah (z odmerki do 300 mg/kg/dan, kar je povzročilo približno 31-kratno izpostavljenost pri ljudeh).
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 plastenke po 30) filmsko obloženimi tabletami
Biktarvy through 96 weeks, the most frequently reported adverse reactions were headache (5%), diarrhoea (5%) and nausea (4%).
V kliničnih študijah s predhodno nezdravljenimi bolniki, ki so dobivali zdravilo Biktarvy do konca 96. tedna, so bili neželeni učinki, o katerih so najpogosteje poročali, glavobol (5 %), driska (5 %) in navzea (4 %).
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.
V drugi selekcionirani kulturi so se pojavile aminokislinske substitucije T66I in S153F; fenotipska občutljivost na biktegravir se je spremenila za 0,4-krat za T66I, 1,9-krat za S153F in 0,5-krat za T66I + S153F.
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 je bila vezava tenofovirata na humane plazemske proteine < 0,7 % in je neodvisna od koncentracije v razponu od 0,01 do 25 µg/ml.
What you need to know before you take Biktarvy Do not take Biktarvy:
Kaj morate vedeti, preden boste vzeli zdravilo Biktarvy Ne jemljite zdravila Biktarvy:
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.
V eni selekcionirani kulturi so se pojavile aminokislinske substitucije M50I in R263K; fenotipska občutljivost na biktegravir je bila zmanjšana za 1,3-krat za M50I, 2,2-krat za R263K in 2,9-krat za M50I + R263K.
Although kidney problems have not been observed with Biktarvy, there is a possibility that you may experience kidney problems when taking Biktarvy over a long period of time.
Čeprav v povezavi z zdravilom Biktarvy niso opazili težav z ledvicami, se vam lahko po dolgotrajnem jemanju zdravila Biktarvy pojavijo težave z ledvicami.
vomiting, abdominal pain, dyspepsia, flatulence
bruhanje, bolečine v trebuhu, dispepsija, flatulenca
Bictegravir (antacid suspension 2 hours prior, fasted):
biktegravir (suspenzija antacida 2 uri prej, na tešče):
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).
Študije biktegravirja in alafenamidtenofovirata, uporabljenih ločeno, na živalih niso pokazale škodljivih učinkov na parametre plodnosti, nosečnost ali razvoj plodu (glejte poglavje 5.3).
3.2% (-1.6% to 8.2%)
3,2 % (-1,6 % do 8,2 %)
Iron supplements: you will need to take Biktarvy at least 2 hours before iron supplements, or you can take them together with food.
Železovi dodatki: Zdravilo Biktarvy boste morali vzeti vsaj 2 uri pred železovimi dodatki ali pa jih vzemite skupaj s hrano.
Treatment outcomes between treatment groups were similar across subgroups by age, sex, race, baseline viral load, baseline CD4+ cell count, and region.
Izidi zdravljenja med skupinami zdravljenja so bili podobni v podskupinah glede na starost, spol, raso, virusno obremenitev ob izhodišču, število celic CD4+ ob izhodišču in regijo.
In offspring from rat and rabbit dams treated with bictegravir during pregnancy, there were no toxicologically significant effects on developmental endpoints.
Pri potomcih samic podgan in kuncev, ki so jim dajali biktegravir med brejostjo, ni bilo opaziti toksikološko pomembnih učinkov na opazovane dogodke, kar zadeva razvoj ploda.
Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity
oslabelost mišic oslabelost, ki se začne v dlaneh in stopalih in se premika proti trupu razbijanje srca (palpitacije), tresavica ali hiperaktivnost
 If any of these apply to you, do not take Biktarvy and tell your doctor immediately.
 Če kar koli od tega velja za vas, ne jemljite zdravila Biktarvy in o tem nemudoma obvestite zdravnika.
No virologic data at Week 48 window
Brez viroloških podatkov v oknu
• Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection.
• Po začetku jemanja zdravil za okužbo s HIV se lahko pojavijo tudi avtoimunske bolezni, če imunski sistem napada zdravo telesno tkivo.
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).
Klinično pomembnih razlik v farmakokinetičnih lastnostih biktegravirja, alafenamidtenofovirata ali tenofovirja med zdravimi osebami in preskušanci s hudo ledvično okvaro (ocenjeni CrCl < 30 ml/min)
Interaction not studied with bictegravir.
Interakcije niso preučili z biktegravirjem.
At Week 96, 4 patients were HBV suppressed and had HIV-1 RNA < 50 copies/mL.
V 96. tednu so bili 4 bolniki HBV-supresirani in so imeli HIV-1 RNA < 50 kopij/ml.
Bictegravir (simultaneous administration with food):
biktegravir (sočasno dajanje s hrano):
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).
Pogostnosti so izpeljali iz kliničnih študij zdravila Biktarvy 3. faze pri predhodno nezdravljenih bolnikih do konca 96. tedna (GS-US-380-1489 in GS-US-380-1490).
No dose adjustment of Biktarvy is required in elderly patients (see section 5.2).
Biktarvy pri starejših bolnikih ni treba prilagoditi (glejte poglavje 5.2).
Bictegravir (antacid suspension after 2 hours, fasted):
biktegravir (suspenzija antacida po 2 urah, na tešče):
-1.4% (-5.5% to 2.6%)
-1,4 % (-5,5 % do 2,6 %)
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).
Bolniki so bili randomizirani v razmerju 1:1 za prehod na B/F/TAF (n = 290) ali za nadaljevanje izhodiščnega protiretrovirusnega režima (n = 287).
Interaction not studied with tenofovir alafenamide.
Interakcije z alafenamidtenofoviratom niso preučili.
At Week 48, 7 patients were HBV suppressed (HBV DNA < 29 IU/mL) and had HIV-1 RNA < 50 copies/mL.
V 48. tednu je bilo 7 bolnikov HBV-supresiranih (HBV DNA < 29 i.e./ml) in so imeli HIV-1 RNA < 50 kopij/ml.
 If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.
 Če jemljete katero od teh zdravil, ne jemljite zdravila Biktarvy in o tem nemudoma obvestite zdravnika.
Calcium carbonate (1,200 mg single dose), Bictegravir
kalcijev karbonat (1.200 mg enkratni odmerek), biktegravir
Bictegravir is a substrate of CYP3A and UGT1A1.
Biktegravir je substrat CYP3A in UGT1A1.
ANTIDEPRESSANTS Sertraline (50 mg single dose), Tenofovir alafenamide6
ANTIDEPRESIVI sertralin (50 mg enkratni odmerek), alafenamidtenofovirat6
Twenty-four percent of patients identified as Hispanic/Latino.
Štiriindvajset odstotkov bolnikov je bilo španskega/latinskoameriškega porekla.
Other medicines and Biktarvy Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chaintermination.
Tenofovir difosfat zavira podvajanje HIV z vgraditvijo v virusno DNA z RT HIV, kar povzroči prekinitev verige DNA.
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.
Pri ugotovljeni imunski reaktivaciji so poročali tudi o pojavu avtoimunskih bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis), vendar pa je poročani čas do njihovega pojava bolj variabilen in se ti dogodki lahko pojavijo več mesecev po uvedbi zdravljenja.
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 je bila vezava emtricitabina na humane plazemske proteine manj kot 4 % in je neodvisna od koncentracije v razponu od 0,02 do 200 µg/ml.
DTG = dolutegravir 3TC = lamivudine a Week 48 window was between Day 295 and 378 (inclusive).
DTG = dolutegravir 3TC = lamivudin a Okno v 48. tednu je med 295. in 378. dnevom (vključno z njima).
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 Vključuje bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
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 Vključuje bolnike, ki so sodelovanje prekinili zaradi drugih razlogov kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
Tabulated summary of adverse reactions The adverse reactions in Table 2 are listed by system organ class and frequency.
Neželeni učinki v preglednici 2 so našteti po organskih sistemih in pogostnosti.
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).
Učinkovitost in varnost zdravila Biktarvy pri predhodno nezdravljenih odraslih bolnikih, okuženih z virusom HIV-1, temelji na 48-tedenskih in 96-tedenskih podatkih iz dveh randomiziranih, dvojno slepih študij, nadzorovanih z učinkovino, GS-US-380-1489 (n = 629) in GS-US-380-1490 (n = 645).
If Biktarvy is stopped for any reason, speak to your doctor before you restart taking Biktarvy tablets.
Če zaradi katerega koli razloga prenehate jemati zdravilo Biktarvy, se pogovorite z zdravnikom, preden ga začnete ponovno jemati.
In Study GS-US-380-1490, 8 patients with HIV/HBV co-infection at baseline were randomised to receive B/F/TAF.
V študiji GS-US-380-1490 je bilo 8 bolnikov s sočasno okužb s HIV/HBV ob izhodišču randomiziranih za prejemanje B/F/TAF.
Antacids and magnesium supplements: you will need to take Biktarvy at least 2 hours before antacids or supplements containing aluminium and/or magnesium.
Antacidi ali magnezijevi dodatki: Zdravilo Biktarvy boste morali vzeti vsaj 2 uri pred antacidi ali dodatki, ki vsebujejo aluminij in/ali magnezij, ali pa vzemite zdravilo Biktarvy s hrano vsaj 2 uri po tem.
Emtricitabine is primarily excreted by the kidneys by both glomerular filtration and active tubular secretion.
Emtricitabin se primarno izloča z ledvicami, z glomerularno filtracijo in aktivno tubularno sekrecijo.
Emtricitabine triphosphate inhibits HIV replication through incorporation into viral DNA by the HIV reverse transcriptase (RT), which results in DNA chain-termination.
Emtricitabin trifosfat zavira podvajanje HIV z vgraditvijo v virusno DNA z reverzno transkriptazo (RT) HIV, kar povzroči prekinitev verige DNA.
If the patient vomits within 1 hour of taking Biktarvy another tablet should be taken.
Če bolnik v roku 1 ure od jemanja zdravila Biktarvy bruha, naj vzame drugo tableto.
Co-administration of Biktarvy with medicinal products that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption.
Sočasno dajanje zdravila Biktarvy z zdravili, ki močno vplivajo na aktivnost P-gp in BCRP, lahko povzroči spremembe v absorpciji alafenamidtenofovirata.
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).
Sočasna uporaba biktegravirja in zdravil, ki močno inducirajo CYP3A in UGT1A1, kot sta rifampicin ali šentjanževka, lahko močno zmanjša koncentracije biktegravirja v plazmi, kar lahko povzroči izgubo terapevtskega učinka zdravila Biktarvy in razvoj odpornosti, zato je sočasna uporaba kontraindicirana (glejte poglavje 4.3).
Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Znotrajcelični tenofovir se nato fosforilira v farmakološko aktivni presnovek tenofovir difosfat.
0.7% (-1.0% to 2.8%)
0,7 % (-1,0 % do 2,8 %)
Study GS-US-380-1878
Študija GS-US-380-1878
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.
Sočasna uporaba biktegravirja in zdravil, ki močno zavirajo CYP3A in UGT1A1, kot je atazanavir, lahko močno poveča koncentracije biktegravirja v plazmi, zato sočasna uporaba ni priporočljiva.
Biktarvy [Outer packaging only]
Biktarvy [samo na zunanji ovojnini]
The multiple dose pharmacokinetics of emtricitabine are dose proportional over the dose range of 25 to 200 mg. Tenofovir alafenamide exposures are dose proportional over the dose range of 8 mg to 125 mg.
Farmakokinetika večkratnega odmerjanja biktegravirja je sorazmerna z odmerkom v razponu odmerka od 25 do 100 mg. Farmakokinetika večkratnega odmerjanja emtricitabina je sorazmerna z odmerkom v razponu odmerka od 25 do 200 mg. Izpostavljenosti alafenamidtenofoviratu so sorazmerne z odmerkom v razponu odmerka od 8 mg do 125 mg.
When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist.
Ko se vaše zaloge zdravila Biktarvy manjšajo, si ga priskrbite pri zdravniku ali farmacevtu.
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine triphosphate.
Celični encimi fosforilirajo emtricitabin v emtricitabin trifosfat.
HIV-1 RNA < 20 copies/mL
HIV-1 RNA < 50 kopij/ml
Nineteen percent of patients identified as Hispanic/Latino.
Devetnajst odstotkov bolnikov je bilo hispanskega/latinskoameriškega porekla.
- azithromycin, clarithromycin, rifabutin or rifapentine
- azitromicin, klaritromicin, rifabutin ali rifapentin
What Biktarvy looks like and contents of the pack
Izgled zdravila Biktarvy in vsebina pakiranja
0.0% (-2.5% to 2.5%)
0,0 % (-2,5 % do 2,5 %)
No dose adjustment of Biktarvy is required in patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Ledvična okvara Odmerka zdravila Biktarvy pri bolnikih z ocenjenim očistkom kreatinina (CrCl - creatinine clearance) ≥ 30 ml/min ni treba prilagoditi.
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.
Pri predhodno nezdravljenih bolnikih (študiji GS-US-380-1489 in GS-US-380-1490) in bolnikih z virološko supresijo (študiji GS-US-380-1844 in GS-US-380-1878), ni imel noben bolnik, ki je dobival zdravilo Biktarvy, HIV-1 z genotipsko ali fenotipsko rezistenco na biktegravir, emtricitabin ali alafenamidtenofovirat v končni populacijski analizi rezistence (n = 10) s HIV-1 RNA ≥ 200 kopij/ml v času potrjenega virološkega neuspeha, v 48. tednu, 96. tednu (samo študije s predhodno nezdravljenimi bolniki) ali predčasne prekinitve zdravljenja z zdravilom.
In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
Študije in vitro so pokazale, da se alafenamidtenofovirat presnavlja v tenofovir (glavni presnovek) s pomočjo katepsina A v PBMC (vključno z limfociti in drugimi ciljnimi celicami HIV) in makrofagih ter s karboksilesterazo-1 v hepatocitih.
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.
Učinkovitost B/F/TAF pri doseganju HIV-1 RNA < 50 kopij/ml tako v 48. kot tudi 96. tednu ni bila slabša v primerjavi z abakavirjem/dolutegravirjem/lamivudinom in dolutegravirjem + emtricitabinom/alafenamidtenofoviratom.
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.
Če bolnik izpusti odmerek zdravila Biktarvy v roku 18 ur od časa, ko ga običajno vzame, naj vzame zdravilo Biktarvy takoj, ko je mogoče, nato pa nadaljuje z običajnim režimom odmerjanja.
Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Alafenamidtenofovirat in vivo ni zaviralec ali induktor CYP3A.
HIV-1 isolates with the K65R mutation have low level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
HIV-1 z mutacijo K65R imajo nizko zmanjšano občutljivost za abakavir, emtricitabin, tenofovir in lamivudin.
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.
V študijah GS-US-380-1489 in GS-US-380-1490 so opazili povečane vrednosti skupnega bilirubina pri 15 % predhodno nezdravljenih bolnikov, ki so dobivali zdravilo Biktarvy do konca 96. tedna.
Clinically relevant changes in the pharmacokinetics of bictegravir were not observed in subjects with moderate hepatic impairment.
Jetrna okvara Klinično pomembnih sprememb v farmakokinetiki biktegravirja pri preskušancih z zmerno jetrno okvaro niso opazili.
Non-clinical studies of tenofovir alafenamide in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Predklinične študije alafenamidtenofovirata pri podganah in psih so pokazale, da sta primarna ciljna organa toksičnosti kosti in ledvice.
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).
Bolniki so bili randomizirani v razmerju 1:1 za prehod na B/F/TAF ob izhodišču (n = 282) ali za nadaljevanje izhodiščnega protiretrovirusnega režima (n = 281).
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.
Zdravila Biktarvy se ne sme dajati skupaj z zdravili, ki vsebujejo alafenamidtenofovirat, dizoproksiltenofovirat, lamivudin ali dipivoksiladefovirat in se uporabljajo za zdravljenje okužbe s
In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
In vivo se alafenamidtenofovirat hidrolizira v celicah v tenofovir (glavni presnovek), ki se fosforilizira v aktivni presnovek tenofovir difosfat.