natgillin/translations-raw huggingface dataset:
2 This adverse reaction was not observed in the clinical studies of emtricitabine + tenofovir alafenamide-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
2 Tega neželenega učinka niso opazili v kliničnih študijah zdravil, ki vsebujejo emtricitabin + alafenamidtenofovirat, temveč je bil opredeljen v kliničnih študijah ali izkušnjah v obdobju trženja za emtricitabin pri uporabi z drugimi protiretrovirusnimi zdravili.
Do not breast-feed during treatment with Biktarvy.
Med zdravljenjem z zdravilom Biktarvy ne dojite.
Each bottle contains silica gel desiccant and polyester coil.
Vsaka plastenka vsebuje silikagelsko sušilno sredstvo in poliestrsko vato.
Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Zadevni primeri vključujejo citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis jirovecii povzročeno pljučnico.
Of these, all single and double mutant isolates lacking Q148H/K/R and 10 of 24 isolates with Q148H/K/R with additional INSTI resistance associated substitutions had ≤ 2.5-fold reduced susceptibility to bictegravir; > 2.5-fold reduced susceptibility to bictegravir was found for 14 of the 24 isolates that contained G140A/C/S and Q148H/R/K substitutions in integrase.
Med njimi so imeli izolati z enojno ali dvojno mutacijo, ki niso imeli Q148H/K/R, in 10 od 24 izolatov s Q148H/K/R z dodatno substitucijo, povezano z rezistenco INSTI, ≤ 2,5-krat zmanjšano občutljivost na biktegravir; > 2,5-krat zmanjšana občutljivost na biktegravir je bila ugotovljena za 14 od 24 izolatov, ki so vsebovali substitucijo G140A/C/S in Q148H/R/K v integrazi.
Patients co-infected with HIV and HBV
Bolniki s sočasno okužbo s HIV in HBV
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Pri nadzoru lipidov in glukoze v krvi je treba upoštevati veljavne smernice za zdravljenje okužbe z virusom HIV.
Adults: one tablet each day with or without food Do not chew, crush or split the tablet.
Odrasli: ena tableta vsak dan s hrano ali brez nje
Macrolides Azithromycin Clarithromycin
Makrolidi azitromicin klaritromicin
Children and adolescents Do not give this medicine to children and adolescents under 18 years of age.
Otrokom in mladostnikom, starim manj kot 18 let, ne dajajte tega zdravila.
Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Nukleozidni in nukleotidni analogi lahko v različnem obsegu vplivajo na mitohondrijsko funkcijo, kar je najbolj izrazito pri stavudinu, didanozinu in zidovudinu.
suicidal behaviour, anxiety, sleep disorders
samomorilno vedenje, anksioznost, motnje spanja
No other metabolites were identifiable.
Drugih presnovkov ni bilo mogoče opredeliti.
The safety and efficacy of Biktarvy in patients with significant underlying liver disorders have not been established.
Varnost in učinkovitost zdravila Biktarvy pri bolnikih s pomembnejšimi sočasnimi jetrnimi boleznimi nista bili dokazani.
Caution is recommended due to the potential effect of these agents on the bictegravir component of Biktarvy.
Priporoča se previdnost zaradi možnih učinkov teh učinkovin na sestavino biktegravir v zdravilu
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.
Populacijske analize z združenimi farmakokinetičnimi podatki iz študij z odraslimi niso razkrile klinično pomembnih razlik zaradi starosti, spola ali rase pri izpostavljenosti biktegravirju, emtricitabinu ali alafenamidtenofoviratu.
There are limited safety and efficacy data for Biktarvy in patients co-infected with HIV-1 and hepatitis C virus (HCV).
Podatki o varnosti in učinkovitosti zdravila Biktarvy pri bolnikih s hkratno okužbo s HIV-1 in virusom hepatitisa C (HCV) so omejeni.
Co-administration is not recommended due to the expected decrease of tenofovir alafenamide.
Sočasno dajanje se ne priporoča zaradi pričakovanega zmanjšanja alafenamidtenofovirata.
Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults.
Zdravilo Biktarvy je ena sama tableta za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti 1 (HIV-1) pri odraslih.
Patients had a mean age of 45 years (range 20-71), 89% were male, 73% were White, and 22% were Black.
Bolniki so bili povprečno stari 45 let (razpon 20-71), 89 % je bilo moških, 73 % je bilo belcev in 22 % je bilo črncev.
Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir (see section 5.1).
Zdravilo Biktarvy je indicirano za zdravljenje odraslih oseb, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1) brez sedanjih ali preteklih dokazov virusne rezistence proti skupini zaviralcev integraze, emtricitabinu ali tenofovirju (glejte poglavje 5.1).
Sofosbuvir metabolite GS-331007: AUC: ↔
presnovek sofosbuvirja GS-331007: AUC: ↔
In Studies GS-US-380-1489 and GS-US-380-1490, the mean age was 35 years (range 18-77), 89% were male, 58% were White, 33% were Black, and 3% were Asian.
V študijah GS-US-380-1489 in GS-US-380-1490 je bila povprečna starost 35 let (razpon 18-77), 89 % je bilo moških, 58 % je bilo belcev, 33 % je bilo črncev in 3 % so bili Azijci.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Poročali so tudi o pojavu avtoimunskih bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis), vendar pa je poročani čas do pojava različen in se ti dogodki lahko pojavijo več mesecev po uvedbi zdravljenja (glejte poglavje 4.4).
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 pokazal ekvivalentno protivirusno aktivnost proti 5 na nenukleozidne zaviralce reverzne transkriptaze (NNRTI)-rezistentnim, 3 na NRTI-rezistentnim in 4 na zaviralce proteaze (PI)-rezistentnim mutiranim klonom HIV-1 v primerjavi s sevom divjega tipa.
Biktarvy should not be co-administered with other antiretroviral medicinal products.
Zdravila Biktarvy se ne sme uporabljati sočasno z drugimi protiretrovirusnimi zdravili.
Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Ledvično izločanje nespremenjenega alafenamidtenofovirata je manj pomembna pot, z < 1 % odmerka, izločenega v urinu.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Biktarvy 50 mg/200 mg/25 mg filmsko obložene tablete
Contents of the pack and other information What Biktarvy contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Biktarvy
Metabolism is the major clearance pathway for bictegravir in humans.
Presnova je glavna pot očistka za biktegravir pri ljudeh.
In human clinical studies, a 25 mg oral dose of tenofovir alafenamide resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 300 mg oral dose of tenofovir disoproxil fumarate.
V kliničnih študijah pri ljudeh je 25 mg peroralni odmerek alafenamidtenofovirata povzročil > 4-krat višje koncentracije tenofovir difosfata v PBMC in > 90 % nižje koncentracije tenofovirja v plazmi v primerjavi s 300 mg peroralnim odmerkom dizoproksiltenofovirijevega fumarata.
Biktarvy comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Zdravilo Biktarvy je na voljo v plastenkah po 30 tablet in v pakiranjih s po 3 plastenkami, od katerih vsaka vsebuje 30 tablet.
B/F/TAF was non-inferior to the control regimen in both studies.
V nobeni od študij ni bila učinkovitost B/F/TAF slabša od kontrolnega režima.
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).
V obeh študijah so bolnike stratificirali glede na HIV-1 RNA ob izhodišču (manj kot ali enako 100.000 kopij/ml, več kot 100.000 kopij/ml do manj kot ali enako 400.000 kopij/ml in več kot 400.000 kopij/ml), na število celic CD4+ (manj kot 50 celic/μl, 50-199 celic/μl ali več kot ali enako 200 celic/μl), ter po regiji (ZDA ali zunaj ZDA).
Emtricitabine is excreted in human milk.
Emtricitabin se izloča v materino mleko.
While taking Biktarvy you may still develop infections or other illnesses associated with HIV infection.
Med jemanjem zdravila Biktarvy se lahko pojavijo okužbe ali druge bolezni, povezane z okužbo z virusom HIV.
Four patients administered Biktarvy (1%) had grade 3 bilirubin increases that were not considered related to study drug.
Biktarvy (1 %), so imeli povečane vrednosti bilirubina 3. stopnje, za katere so ocenili, da niso povezane s študijskim zdravilom.
What Biktarvy is and what it is used for
Kaj je zdravilo Biktarvy in za kaj ga uporabljamo
Patients co-infected with hepatitis B
Bolniki s sočasno okužbo s hepatitisom B
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.
Poleg tega je imelo šest bolnikov predhodno obstoječo mutacijo T97A, povezano z rezistenco na INSTI; vsi so imeli HIV-1 RNA < 50 kopij/ml v 96. tednu ali ob zadnjem obisku.
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 zaviralec prenosa zapisa integraze, (INSTI - integrase strand transfer inhibitor), ki se veže na aktivno mesto integraze in zavira vgradnjo retrovirusne deoksiribonukleinske kisline (DNA), ki je bistvena za replikacijski cikel HIV.
If you forget to take Biktarvy
Če ste pozabili vzeti zdravilo 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.
V ločeni študiji so imele lokacijsko usmerjene mutante z G118R za 3,4-krat, T97A + G118R pa za 2,8-krat zmanjšano občutljivost za biktegravir.
• wind (flatulence)
• vetrovi (flatulenca)
Biktarvy contains three active substances:
Zdravilo Biktarvy vsebuje tri učinkovine:
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).
Zdravila Biktarvy niso preučili pri bolnikih s hudo jetrno okvaro (stopnje C po Child-Pughu), zato se uporaba zdravila Biktarvy pri bolnikih s hudo jetrno okvaro ne priporoča (glejte poglavji 4.4 in 5.2).
Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov emtricitabina na parametre plodnosti, nosečnost, razvoj plodu, porod ali postnatalni razvoj.
However, tenofovir disoproxil fumarate reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses.
Vendar pa je alafenamidtenofovirijev fumarat zmanjšal indeks viabilnosti in telesno maso mladičev v peri- in postnatalni študiji toksičnosti pri odmerkih, toksičnih za mater.
Changes in bilirubin
Spremembe bilirubina
(-8.2% to
(-8,2 % do
Patients should be informed that dizziness has been reported during treatment with the components of Biktarvy (see section 4.8).
Bolnike je treba obvestiti, da so med zdravljenjem z učinkovinami zdravila Biktarvy poročali o omotici (glejte poglavje 4.8).
Tenofovir has activity against HIV-1, HIV-2 and HBV.
Tenofovir je aktiven proti HIV-1, HIV-2 in HBV.
Bictegravir is both a P-gp and a BCRP substrate.
Biktegravir je substrat P-gp in BCRP.
• If you notice within 18 hours of the time you usually take Biktarvy, you must take the tablet as soon as possible.
• Če to opazite v roku 18 ur od časa, ko zdravilo Biktarvy običajno vzamete, morate tableto vzeti čim prej.
• antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or magnesium hydroxide
• antacide za zdravljenje želodčnih razjed, zgage ali refluksa kisline, ki vsebujejo aluminij in/ali magnezijev hidroksid
• If you notice 18 hours or more after the time you usually take Biktarvy, then do not take the missed dose.
• Če to opazite po 18 urah ali več od časa, ko običajno vzamete zdravilo Biktarvy, pozabljenega odmerka ne vzemite.
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.
Ocena neželenih učinkov temelji na podatkih o varnosti vseh študij z zdravilom Biktarvy faze 2 in 3
Do not stop taking Biktarvy Do not stop taking Biktarvy without talking to your doctor.
Ne prenehajte jemati zdravila Biktarvy Ne prenehajte jemati zdravila Biktarvy, ne da bi se posvetovali z zdravnikom.
Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Virusi, rezistentni na emtricitabin, s substitucijo M184V/I, so bili navzkrižno rezistentni na lamivudin, vendar so ohranili občutljivost za didanozin, stavudin, tenofovir in zidovudin.
Medicinal products that induce P-gp activity (e.g. rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of Biktarvy and development of resistance.
Pričakuje se, da zdravila, ki inducirajo aktivnost P-gp (npr. rifabutin, karbamazepin, fenobarbital), zmanjšajo absorpcijo alafenamidtenofovirata, kar povzroči zmanjšanje koncentracije alafenamidtenofovirata v plazmi ter lahko povzroči izgubo terapevtskega učinka zdravila Biktarvy in razvoj rezistence.
Biktarvy may be co-administered with substrates of OCT2 and MATE1.
Zdravilo Biktarvy se lahko uporablja sočasno s substrati OCT2 in MATE1.
Iron oxide red (E172) Iron oxide black (E172)
makrogol smukec rdeči železov oksid (E172) črni železov oksid (E172)
It is not known whether bictegravir or tenofovir alafenamide is excreted in human milk.
Ni znano, ali se biktegravir ali alafenamidtenofovirat izločata v materino mleko.
Biktarvy film-coated tablets are purplish-brown, capsule-shaped, film-coated tablets debossed on one side with “GSI” and “9883” on the other side.
Zdravilo Biktarvy filmsko obložene tablete so vijoličnorjave, filmsko obložene tablete v obliki kapsule, z vtisom »GSI« na eni strani in »9883« na drugi strani.
Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product.
Sočasno dajanje emtricitabina z zdravili, ki se izločajo z aktivnim tubularnim izločanjem, lahko zvišajo koncentracije emtricitabina in/ali sočasno uporabljenih zdravil.
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 Vključuje bolnike, ki so imeli v oknu 48. tedna ≥ 50 kopij/ml; bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
In vitro binding of bictegravir to human plasma proteins was > 99% (free fraction ~0.25%).
In vitro je bila vezava biktegravirja na humane plazemske proteine > 99 % (prosta frakcija ~ 0,25 %).
Discontinuation of Biktarvy therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Prekinitev zdravljenja z zdravilom Biktarvy pri bolnikih s hkratno okužbo s HIV in virusom HBV je lahko povezana s hudimi akutnimi poslabšanji hepatitisa.
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.
Minimalna infiltracija histiocitov je bila prisotna v očesu psov pri izpostavljenosti alafenamidtenofoviratu in tenofovirju, ki je bila približno 14- oz. 43-krat večja od pričakovane po dajanju B/F/TAF .
 If you notice any of these symptoms, tell your doctor immediately.
 Če opazite katerega od teh simptomov, takoj obvestite zdravnika.
There are no pharmacokinetic data on bictegravir or tenofovir alafenamide in patients with creatinine clearance less than 15 mL/min.
Farmakokinetičnih podatkov za biktegravir ali alafenamidtenofovirat pri bolnikih z očistkom kreatinina manj kot 15 ml/min ni na voljo.
Multinucleoside resistant HIV-1 with a T69S double insertion mutation or with a Q151M mutation complex including K65R showed reduced susceptibility to tenofovir alafenamide.
Proti več nukleozidom rezistenten HIV-1 z dvojno insercijsko mutacijo T69S ali mutacijskim kompleksom Q151M, vključno s K65R, je pokazal zmanjšano občutljivost za alafenamidtenofovirat.
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.
Zaradi manjše izpostavljenosti tenofovirju pri podganah in miših po dajanju alafenamidtenofovirata v primerjavi z dizoproksiltenofovirijevim fumaratom so študije kancerogenosti in peri- ter postnatalne študije pri podganah izvedli samo z dizoproksiltenofovirijevim fumaratom.
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.
Toksičen vpliv na kosti so opazili kot zmanjšano mineralno gostoto kosti pri podganah in psih pri izpostavljenostih tenofovirju, ki so bile vsaj 43-krat večje kot izpostavljenost, pričakovana pri dajanju B/F/TAF.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Na voljo so naslednje velikosti pakiranj: škatle z 1 plastenko s po 30 filmsko obloženimi tabletami in škatle s po 90 (3 plastenke po 30) filmsko obloženimi tabletami.
 Get advice from a doctor or pharmacist if you are taking:
 Posvetujte se z zdravnikom ali farmacevtom, če jemljete:
Bictegravir inhibits organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1) in vitro.
Biktegravir in vitro zavira prenašalca organskih kationov 2 (OCT2 - organic cation transporter 2) in prenašalca za ekstruzijo več zdravil in toksinov 1 (MATE1 - multidrug and toxin extrusion transporter).
The use of Biktarvy in children and adolescents under 18 years of age has not yet been studied.
Biktarvy pri otrocih in mladostnikih, starih manj kot 18 let, še niso preučili.
Tablet core Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Jedro tablete Mikrokristalna celuloza, premreženi natrijev karmelozat, magnezijev stearat.
Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet.
Vijoličnorjava filmsko obložena tableta v obliki kapsule, z vtisnjeno oznako “GSI” na eni strani in “9883” na drugi strani tablete.
(Inhibition of P-gp/BCRP)
(zaviranje P-gp/BCRP)
Biktarvy contains tenofovir alafenamide, which is active against hepatitis B virus (HBV).
Zdravilo Biktarvy vsebuje alafenamidtenofovirat, ki učinkuje proti virusu hepatitisa B (HBV).
The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (~9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (~4% of dose).
Biotransformacija emtricitabina vključuje oksidacijo tiolnega dela molekule, pri čemer nastanejo 3'-sulfoksid diastereomere (~ 9 % odmerka), in konjugacijo z glukuronsko kislino, pri čemer nastane
In vitro phenotyping studies showed that bictegravir is primarily metabolised by CYP3A and UGT1A1.
Študije fenotipizacije in vitro so pokazale, da biktegravir primarno presnavljata CYP3A in UGT1A1.
The in vitro human blood to plasma bictegravir concentration ratio was 0.64.
Razmerje med koncentracijo biktegravirja v človeški krvi in plazmi in vitro je bilo 0,64.
Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food (see section 4.5).
Zdravilo Biktarvy je treba dati vsaj 2 uri pred železovimi dodatki ali skupaj s hrano (glejte poglavje 4.5).
Tenofovir alafenamide is permeable into cells and due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in loading tenofovir into peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
Alafenamidtenofovirat prodira v celice in je zaradi večje stabilnosti v plazmi in aktivacije v celici s hidrolizo s pomočjo katepsina A bolj učinkovit kot dizoproksiltenofovirijev fumarat pri koncentriranju tenofovirja v mononuklearnih celicah v periferni krvi (PBMC - peripheral blood mononuclear cells) (vključno z limfociti in drugimi ciljnimi celicami HIV) in makrofagih.
If you vomit less than 1 hour after taking Biktarvy, take another tablet.
Če bruhate manj kot 1 uro po zaužitju zdravila Biktarvy, vzemite še eno tableto.
Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Presnova je glavna pot izločanja alafenamidtenofovirata pri ljudeh in predstavlja > 80 % peroralnega odmerka.
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,
f Vključuje bolnike, ki so imeli v oknu 48. ali 96. tedna ≥ 50 kopij/ml; bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka (n = 0), bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka (B/F/TAF n = 12 in 15; ABC/DTG/3TC n = 2 in 4; DTG+F/TAF n = 3 in
c Pooled from Study GS-US-380-1489 (n = 314) and Study GS-US-380-1490 (n = 320).
c Združeno iz študije GS-US-380-1489 (n = 314) in študije GS-US-380-1490 (n = 320).
Studies of bictegravir in monkeys revealed the liver as the primary target organ of toxicity.
Študije biktegravirja na opicah so pokazale, da so glavni tarčni organ toksičnosti jetra.
Bictegravir is not an inhibitor or inducer of CYP in vivo.
Biktegravir in vivo ni zaviralec ali induktor CYP.
The mean baseline CD4+ cell count was 663 cells/mm3 (range 62-2,582).
Povprečno število celic CD4+ ob izhodišču je bilo 663 celic/mm3 (razpon 62-2582).