FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of emtricitabine were Cmax = 2.13 µg/mL (34.7%), AUCtau = 12.3 µg•h/mL (29.2%), and Ctrough = 0.096 µg/mL (37.4%).
Slovenian: Po peroralnem dajanju B/F/TAF odraslim, okuženim s HIV-1, s hrano ali brez nje, so bili povprečni farmakokinetični parametri večkratnih odmerkov (CV %) za emtricitabin Cmax = 2,13 µg/ml (34,7 %), AUCtau = 12,3 µg•h/ml (29,2 %) in Ctrough = 0,096 µg/ml (37,4 %).
English: In Studies GS-US-380-1489 and GS-US-380-1490, median (Q1, Q3) serum creatinine increased by 0.09 (0.01, 0.16) mg/dL (8.0 [0.9, 14.1] µmol/L), 0.09 (0.03, 0.17) mg/dL (8.0 [2.6, 15.0] µmol/L), and 0.11 (0.04, 0.18) mg/dL (9.7 [3.5, 15.9] μmol/L) from baseline to Week 96 in the Biktarvy, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
Slovenian: 0,09 (0,01; 0,16) mg/dl (8,0 [0,9; 14,1] µmol/l), pri skupini z abakavirjem/dolutegravirjem/lamivudinom za 0,09 (0,03; 0,17) mg/dl (8,0 [2,6; 15,0] µmol/l) in pri skupini z dolutegravirjem + emtricitabinom/alafenamidtenofoviratom za 0,11 (0,04; 0,18) mg/dl (9,7 [3,5; 15,9] μmol/l).
English: 2 This study was conducted using bictegravir/emtricitabine/tenofovir alafenamide 75/200/25 mg once daily.
Slovenian: 2 Ta študija je bila izvedena z biktegravirjem/emtricitabinom/ alafenamidtenofoviratom 75/200/25 mg enkrat dnevno
English: Bictegravir is primarily eliminated by hepatic metabolism.
Slovenian: Biktegravir se primarno izloča z jetrno presnovo.
English: Co-administration not recommended.
Slovenian: Sočasno dajanje se ne priporoča.
English: (-5.9% to
Slovenian: (-5,9 % do
English: Co-administration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.
Slovenian: Sočasno dajanje azitromicina ali klaritromicina lahko poveča koncentracije biktegravirja v plazmi.
English: 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).
Slovenian: Emtricitabin je pokazal protivirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F, in G virusa HIV-1 (vrednosti EC50 so bile v razponu od 0,007 do 0,075 µM) in aktivnost proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,007 do
English: e Study GS-US-380-1490.
Slovenian: e Študija GS-US-380-1490.
English: No virologic data at week 48 or 96 window Discontinued study drug due to AE or deathg
Slovenian: ali 96. tedna Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrtig
English: rifampicin used to treat some bacterial infections such as tuberculosis St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.
Slovenian: • Če trenutno jemljete katero od naslednjih zdravil: rifampicin, ki se uporablja se za zdravljenje nekaterih bakterijskih okužb, kot je tuberkuloza šentjanževka (Hypericum perforatum), zdravilo rastlinskega izvora, ki se uporablja pri depresiji in tesnobi, ali izdelki, ki jo vsebujejo.
English: Talk to your doctor if you are taking: • medicines used for treating HIV and/or hepatitis B, containing:
Slovenian: • zdravila, ki se uporabljajo za zdravljenje okužbe s HIV in/ali hepatitisom B, ki vsebujejo:
English:  If you notice any of these symptoms tell your doctor.
Slovenian: težave pri gibanju  Če opazite katerega koli od teh simptomov, obvestite svojega zdravnika.
English: Discontinued study drug due to other reasons and last available HIV1 RNA < 50 copies/mLh
Slovenian: Prekinitev uporabe študijskega zdravila zaradi drugih razlogov in nazadnje razpoložljivi HIV-1 RNA
English: (Inhibition of CYP3A, UGT1A1, and P-gp/BCRP)
Slovenian: (zaviranje CYP3A, UGT1A1 in Pgp/BCRP)
English: (Inhibition of CYP3A and UGT1A1)
Slovenian: (zaviranje CYP3A in UGT1A1)
English: 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
Slovenian: Med najvišjo koncentracijo v plazmi je bilo povprečno razmerje med koncentracijo zdravila v plazmi in krvi ~ 1,0 in povprečno razmerje med koncentracijo zdravila v spermi in plazmi ~ 4,0.
English: 6 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg once daily.
Slovenian: 6 Ta študija je bila opravljena z elvitegravirjem/kobicistatom/emtricitabinom/ alafenamidtenofoviratom 150/150/200/10 mg enkrat dnevno.
English: Treatment outcomes of Studies GS-US-380-1844 and GS-US-380-1878 through Week 48 are presented in Table 4.
Slovenian: Izidi zdravljenja za študijo GS-US-380-1844 in študijo GS-US-380-1878 do konca 48. tedna so predstavljeni v preglednici 4.
English: How to store Biktarvy
Slovenian: Shranjevanje zdravila Biktarvy
English: • joint pain (arthralgia)
Slovenian: • bolečina v sklepih (artralgija)
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Slovenian: Bolniki s hkratno okužbo z virusom HIV in virusom hepatitisa B ali C Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusno terapijo, obstaja povečano tveganje za hude in potencialno usodne neželene učinke na delovanje jeter.
English: Atazanavir (400 mg once daily), Bictegravir1
Slovenian: atazanavir (400 mg enkrat dnevno), biktegravir1
English: The active substances are bictegravir, emtricitabine and tenofovir alafenamide.
Slovenian: Učinkovine so biktegravir, emtricitabin in alafenamidtenofovirat.
English: Tenofovir alafenamide was not mutagenic or clastogenic in conventional genotoxicity assays.
Slovenian: V običajnih testih genotoksičnosti alafenamidtenofovirat ni bil mutagen ali klastogen.
English: SEDATIVES/HYPNOTICS Midazolam (2 mg, oral syrup, single dose),
Slovenian: midazolam (2 mg, peroralni sirup,
English: HIV-1 isolates with reduced susceptibility to bictegravir have been selected in cell culture.
Slovenian: V celični kulturi so bili selekcionirani izolati HIV-1 z zmanjšano občutljivostjo na biktegravir.
English: ANTACIDS, SUPPLEMENTS AND BUFFERED MEDICINES Magnesium/aluminium-containing antacid suspension (20 mL single dose5), Bictegravir
Slovenian: suspenzije antacidov, ki vsebujejo magnezij/aluminij (20 ml enkratni odmerek5), biktegravir (kelacija s polivalentnimi kationi)
English: • tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Slovenian: • alafenamidtenofovirat, protiretrovirusno zdravilo, znano kot zaviralec nukleotidne reverzne transkriptaze (NtRTI - nucleotide reverse transcriptase inhibitor)
English: Rifabutin (300 mg once daily), Bictegravir1
Slovenian: rifabutin (300 mg enkrat dnevno), biktegravir1
English: Bictegravir was not mutagenic or clastogenic in conventional genotoxicity assays.
Slovenian: V običajnih testih genotoksičnosti biktegravir ni bil mutagen ali klastogen.
English: Biktarvy should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium.
Slovenian: Zdravilo Biktarvy je treba dati vsaj 2 uri pred uporabo antacidov, ki vsebujejo magnezij in/ali aluminij, ali s hrano 2 uri po njihovi uporabi.
English: Table 2: Tabulated list of adverse reactions1
Slovenian: Preglednica 2: Seznam neželenih učinkov v obliki preglednice1 Pogostnost
English: There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir or tenofovir alafenamide in pregnant women.
Slovenian: Podatkov o uporabi biktegravirja ali alafenamidtenofovirata pri nosečnicah ni oziroma jih je malo (manj kot 300 izidov nosečnosti).
English: Table 4: Virologic outcomes of Studies GS-US-380-1844 and GS-US-380-1878 at Week 48a
Slovenian: Preglednica 4: Virološki izidi študij GS-US-380-1844 in GS-US-380-1878 v 48. tednua Študija GS-US-380-1844
English: (-5.6% to
Slovenian: (-5,6 % do
English: Treatment outcomes of Studies GS-US-380-1489 and GS-US-380-1490 through Weeks 48 and 96 are presented in Table 3.
Slovenian: Izidi zdravljenja za študiji GS-US-380-1489 in GS-US-380-1490 do konca 48. in 96. tedna so predstavljeni v preglednici 3.
English: Tenofovir alafenamide: AUC: ↔
Slovenian: alafenamidtenofovirat: AUC: ↔
English: (-5.0% to
Slovenian: (-5,0 % do
English: While you are taking Biktarvy
Slovenian: Med jemanjem zdravila Biktarvy
English: Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of tenofovir alafenamide were Cmax = 0.121 µg/mL (15.4%), and AUCtau = 0.142 µg•h/mL (17.3%).
Slovenian: Po peroralnem dajanju B/F/TAF odraslim, okuženim s HIV-1, s hrano ali brez nje, so bili povprečni farmakokinetični parametri večkratnih odmerkov (CV %) za alafenamidtenofovirat Cmax = 0,121 µg/ml (15,4 %) in AUCtau = 0,142 µg•h/ml (17,3 %).
English: ORAL ANTI-DIABETICS Metformin (500 mg twice daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide
Slovenian: PERORALNI ANTIDIABETIKI metformin (500 mg dvakrat dnevno), biktegravir/emtricitabin/ alafenamidtenofovirat
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells, and CD4+ T-lymphocytes.
Slovenian: Protivirusna aktivnost alafenamidtenofovirata proti laboratorijskim in kliničnim izolatom virusa HIV1 podtipa B je bila ocenjena v limfoblastoidnih celičnih linijah, PBMC, primarnih monocitnih/makrofagnih celicah in T-limfocitih CD4+.
English: Sofosbuvir: AUC: ↔
Slovenian: sofosbuvir: AUC: ↔ Cmax: ↔
English: The antiviral activity of bictegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells, and CD4+ T-lymphocytes.
Slovenian: Protivirusna aktivnost biktegravirja proti laboratorijskim in kliničnim izolatom HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, PBMC, primarnih monocitnih/makrofagnih celicah in T-limfocitih CD4+.
English: Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Slovenian: Jedro tablete mikrokristalna celuloza premreženi natrijev karmelozat magnezijev stearat Filmska obloga polivinilalkohol titanov dioksid (E171)
English: 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.
Slovenian: Podatki o učinku vseh učinkovin zdravila Biktarvy na novorojence so nezadostni, zato se zdravilo
English: No special hazard for humans was revealed in conventional studies of carcinogenic potential and toxicity to reproduction and development.
Slovenian: V običajnih študijah kancerogenega potenciala in vpliva na sposobnost razmnoževanja in razvoja se ni pokazalo posebno tveganje za človeka.
English: Interaction not studied with any of the components of Biktarvy.
Slovenian: Interakcije niso preučili z nobeno od učinkovin zdravila Biktarvy.
English: B/F/TAF (n = 290)
Slovenian: (n = 290)
English: Table 3: Pooled virologic outcomes of Studies GS-US-380-1489 and GS-US-380-1490 at Weeks 48a and 96b
Slovenian: Preglednica 3: Združeni virološki izidi študij GS-US-380-1489 in GS-US-380-1490 v 48. tednua in 96. tednub
English: Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Slovenian: Emtricitabin je aktiven proti HIV-1, HIV-2 in HBV. Alafenamidtenofovirat je nukleotidni zaviralec reverzne transkriptaze (NtRTI - nucleotide reverse transcriptase inhibitor) in fosfonoamidatno predzdravilo tenofovirja (analog 2'-deoksiadenozin monofosfata).
English: IMMUNOSUPPRESSANTS Ciclosporin (IV or oral use)
Slovenian: IMUNOSUPRESIVI ciklosporin (i.v.
English: g Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Slovenian: g Vključuje bolnike, ki so prenehali sodelovati zaradi neželenih učinkov ali smrti, kadar koli od 1. dne do časovnega okna,
English: • emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
Slovenian: • emtricitabin, protiretrovirusno zdravilo, znano kot zaviralec nukleozidne reverzne transkriptaze (NRTI - nucleoside reverse transcriptase inhibitor)
English: Each film-coated tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Slovenian: Ena tableta zdravila Biktarvy vsebuje natrijev biktegravir v količini, ki ustreza 50 mg biktegravirja, 200 mg emtricitabina in alafenamidtenofovirijev fumarat v količini, ki ustreza 25 mg alafenamidtenofovirata.
English: (may affect up to 1 in 10 people)
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Co-administration of itraconazole or posaconazole may increase bictegravir plasma concentrations.
Slovenian: Sočasno dajanje itrakonazola ali posakonazola lahko poveča koncentracije biktegravirja v plazmi.
English: Missing data during window but on study drug
Slovenian: V oknu podatki manjkajo, a uporablja študijsko zdravilo ABC = abakavir
English: Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food.
Slovenian: Zdravilo Biktarvy se daje vsaj 2 uri pred uporabo železovih dodatkov ali skupaj s hrano.
English: B/F/TAF (n = 282)
Slovenian: (n = 282)
English: • feeling sick (nausea)
Slovenian: • občutek tesnobe (anksioznost)
English: Biktarvy should not be co-administered simultaneously with magnesium/aluminium-containing antacids or iron supplements under fasted conditions.
Slovenian: Sočasna uporaba drugih zdravil Zdravila Biktarvy se na tešče ne sme dajati sočasno z antacidi, ki vsebujejo magnezij ali aluminij, ali železovimi dodatki.
English: No dose adjustment is required upon co-administration in patients with normal renal function.
Slovenian: Po sočasni uporabi pri bolnikih z normalnim delovanjem ledvic prilagoditev odmerka ni potrebna.
English: In GS-US-380-1878, the mean change from baseline in CD4+ cell count at Week 48 was 25 cells/mm3 in patients who switched to B/F/TAF and 0 cells/mm3 in patients who stayed on their baseline regimen.
Slovenian: V študiji GS-US-380-1878 je bila povprečna sprememba števila celic CD4+ od izhodišča v 48. tednu 25 celic/mm3 pri bolnikih, ki so prešli na B/F/TAF, in
English: DTG + F/TAF (n = 325)e
Slovenian: DTG + F/TAF
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400/100/100 + 100 mg3 once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide (Inhibition of P-gp/BCRP)
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Biktarvy sofosbuvir/velpatasvir/voksilaprevi r (400/100/100 + 100 mg3 enkrat dnevno), biktegravir/emtricitabin/ alafenamidtenofovirat
English: HIV-1 infected, virologically -suppressed patients
Slovenian: Bolniki z virološko supresijo, okuženi z virusom HIV-1
English: Tenofovir alafenamide is rapidly absorbed following oral administration with peak plasma concentrations occurring at 0.5-2.0 hours after administration of B/F/TAF.
Slovenian: Po peroralnem dajanju se alafenamidtenofovirat hitro absorbira in doseže največjo koncentracijo v plazmi v roku 0,5 do 2,0 uri po dajanju B/F/TAF.
English: Bictegravir is absorbed following oral administration with peak plasma concentrations occurring at 2.0-4.0 hours after administration of B/F/TAF.
Slovenian: Biktegravir se po peroralni uporabi absorbira, z največjo koncentracijo v plazmi 2,0 do 4,0 ure po dajanju B/F/TAF .
English: Co-administration of ciclosporin (IV or oral use) is not recommended.
Slovenian: Ne pričakuje se, da bi sočasna uporaba ciklosporina (i.v.
English: 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.
Slovenian: Ob vstopu v študijo je imel en predhodno nezdravljen bolnik obstoječe mutacije Q148H + G140S, povezane z rezistenco na
English: HIV-1 infected, treatment-naïve patients
Slovenian: Predhodno nezdravljeni bolniki, okuženi z virusom HIV-1
English: Blood and lymphatic system disorders Uncommon:
Slovenian: Bolezni krvi in limfatičnega sistema
English: Bictegravir
Slovenian: HBV. Biktegravir
English: Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup By baseline viral load ≤ 100,000 copies/ mL > 100,000 copies/ mL By baseline CD4+ cell count < 200 cells/mm3 ≥ 200 cells/mm3
Slovenian: < 50 kopij/ml po podskupini Po izhodiščni virusni obremenitvi ≤ 100.000 kopij/ ml > 100.000 kopij/ ml
English: Get advice from a doctor or pharmacist if you are taking:
Slovenian: Obvestite zdravnika, če jemljete:
English: AUC: ↔ Cmin: ↔ Cmax: ↔
Slovenian: emtricitabin: AUC: ↔ Cmin: ↔ Cmax: ↔
English: - adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide, or tenofovir disoproxil
Slovenian: - dipivoksiladefovirat, atazanavir, biktegravir, emtricitabin, lamivudin,
English: Co-administration is not recommended.
Slovenian: ali peroralna uporaba) se ne priporoča.
English: Co-administration of carbamazepine may decrease bictegravir plasma concentrations.
Slovenian: Sočasno dajanje karbamazepina lahko zmanjša koncentracije biktegravirja v plazmi.
English: Bictegravir (simultaneous administration, fasted):
Slovenian: biktegravir (sočasno dajanje, na tešče):
English: Patients should be advised that Biktarvy or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection.
Slovenian: HIV ne ozdravi in da se lahko pri njih še vedno razvijejo oportunistične okužbe ali drugi zapleti zaradi okužbe s HIV.
English: HIV-1 antiviral agents Atazanavir (300 mg once daily), Cobicistat (150 mg once daily), Bictegravir1
Slovenian: atazanavir (300 mg enkrat dnevno), kobicistat (150 mg enkrat dnevno), biktegravir1
English: Co-administration of other medicinal products
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Biktarvy
English: Co-administration with St. John's wort is contraindicated, due to the effect of St. John's wort on the bictegravir component of Biktarvy.
Slovenian: Sočasno dajanje s šentjanževko je kontraindicirano zaradi učinka šentjanževke na sestavino biktegravir v zdravilu Biktarvy.
English: 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.
Slovenian: Sočasno dajanje nekaterih zdravil z zdravilom Biktarvy se ne priporoča: atazanavir, karbamazepin, ciklosporin (i.v.
English: Talk to your doctor before taking Biktarvy:
Slovenian: Pred začetkom jemanja zdravila Biktarvy se posvetujte z zdravnikom:
English: Co-administration of rifampicin may decrease tenofovir alafenamide plasma concentrations.
Slovenian: Sočasno dajanje rifampicina lahko zmanjša koncentracije alafenamidtenofovirata v plazmi.
English: There were no discontinuations due to hepatic adverse events through Week 96 in Biktarvy clinical studies.
Slovenian: Do konca 96. tedna v kliničnih študijah z zdravilom Biktarvy ni bilo prekinitev zdravljenja zaradi neželenih učinkov na jetra.
English: General disorders and administration site conditions Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije
English: Psychiatric disorders Common:
Slovenian: Psihiatrične motnje
English: What Biktarvy is and what it is used for What you need to know before you take Biktarvy How to take Biktarvy
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Biktarvy Kako jemati zdravilo Biktarvy
English: Tenofovir alafenamide:
Slovenian: alafenamidtenofovirat:
English: Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of bictegravir were Cmax = 6.15 µg/mL (22.9%), AUCtau = 102 µg•h/mL (26.9%), and Ctrough = 2.61 µg/mL (35.2%).
Slovenian: Po peroralnem dajanju B/F/TAF odraslim, okuženim s HIV-1, s hrano ali brez nje, so bili povprečni farmakokinetični parametri večkratnih odmerkov (CV %) za biktegravir Cmax = 6,15 µg/ml (22,9 %),
English: respectively) and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Slovenian: 4 v 48. oz. 96. tednu), in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
English: In Study GS-US-380-1878, the efficacy and safety of switching from either abacavir/lamivudine or emtricitabine/tenofovir disoproxil fumarate (200/300 mg) plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) to B/F/TAF were evaluated in a randomised, open-label study of virologically-suppressed HIV-1 infected adults (n = 577).
Slovenian: V študiji GS-US-380-1878 so učinkovitost in varnost prehoda z abakavirja/lamivudina ali emtricitabina/dizoproksiltenofovirijevega fumarata (200/300 mg) plus atazanavir ali darunavir
English: Co-administration may decrease bictegravir plasma concentrations.
Slovenian: Sočasno dajanje lahko zmanjša koncentracije biktegravirja v plazmi.
English: Voriconazole (300 mg twice daily), Bictegravir1
Slovenian: Antimikotiki vorikonazol (300 mg dvakrat dnevno), biktegravir1
English: angioedema3,4, rash, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon:
Slovenian: angioedem3,4, izpuščaj, pruritus, urtikarija4
English: AUC: ↑ 61% Cmax: ↔
Slovenian: biktegravir: AUC: ↑ 61 % Cmax: ↔
English: Co-administration of rifapentine may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Slovenian: Sočasno dajanje rifapentina lahko zmanjša koncentracije biktegravirja in alafenamidtenofovirata v plazmi.
English: The prevalence of different HIV-1 subtypes was comparable between treatment groups, with subtype B predominant in both groups; 5% were non-B subtypes.
Slovenian: Prevalenca različnih podtipov HIV-1 je bila primerljiva v vseh skupinah zdravljenja, pri čemer je v obeh skupinah prevladoval podtip B; 5 % jih ni bilo podtipov B. Povprečno število celic CD4+ ob izhodišču je bilo 723 celic/mm3 (razpon 124-2.444).
English: Co-administration of oxcarbazepine, phenobarbital, or phenytoin may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Slovenian: fenobarbitala ali fenitoina lahko zmanjša koncentracije biktegravija in alafenamidtenofovirata v plazmi.
English: Co-administration may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Slovenian: Sočasno dajanje lahko zmanjša koncentracije biktegravirja in alafenamidtenofovirata v plazmi.
English: Following a single dose oral administration of [14C]-bictegravir, ~60% of the dose from faeces included unchanged parent, desfluoro-hydroxy-BIC-cysteine-conjugate, and other minor oxidative metabolites.
Slovenian: -biktegravirja je ~ 60 % odmerka iz blata vključevalo nespremenjeno izhodno spojino,
English: In GS-US-380-1844, the mean change from baseline in CD4+ cell count at Week 48 was -31 cells/mm3 in patients who switched to B/F/TAF and 4 cells/mm3 in patients who stayed on abacavir/dolutegravir/lamivudine.
Slovenian: -31 celic/mm3 pri bolnikih, ki so prešli na B/F/TAF, in 4 celice/mm3 pri bolnikih, ki so ostali na abakavirju/dolutegravirju/lamivudinu.
English: HIV-1 RNA < 50 copies/mL Treatment difference (95% CI)
Slovenian: < 50 kopij/ml Razlika zdravljenja (95 %
English: The prevalence of different subtypes was comparable across all three treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Slovenian: Prevalenca različnih podtipov je bila primerljiva v vseh treh skupinah zdravljenja, pri čemer je v obeh skupinah prevladoval podtip B; 11 % jih ni bilo podtipov B. Povprečna izhodiščna vrednost HIV-1 RNA v plazmi je bila 4,4 log10 kopij/ml (razpon 1,3-6,6).