natgillin/translations-raw huggingface dataset:
The prevalence of different subtypes was comparable across treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Prevalencija različitih podtipova bila je usporediva u svim liječenim skupinama, s time da je podtip B prevladavao u obje skupine; 11% bilo je ne-B podtip.
Bictegravir (simultaneous administration, fasted):
Biktegravir (istodobna primjena, natašte):
Biktarvy should not be co-administered simultaneously with magnesium/aluminium-containing antacids or iron supplements under fasted conditions.
Lijek Biktarvy ne smije se davati istodobno s antacidima koji sadrže magnezij/aluminij ili s dodacima prehrani koji sadrže željezo uzetim natašte.
Twenty-four percent of patients identified as Hispanic/Latino.
Kao Hispanoamerikanci/Latinoamerikanci izjasnilo se 24% bolesnika.
Treatment outcomes between treatment groups were similar across subgroups by age, sex, race, baseline viral load, baseline CD4+ cell count, and region.
Ishodi liječenja u terapijskim skupinama bili su slični u svim podskupinama prema dobi, spolu, etničkoj pripadnosti, početnom virusnom optećenju, početnom broju stanica CD4 + te regiji.
headache, dizziness
glavobolja, omaglica
Psychiatric disorders Common:
Psihijatrijski poremećaji
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.
• ako trenutačno uzimate jedan od sljedećih lijekova: rifampicin koji se primjenjuje za liječenje nekih bakterijskih infekcija, kao što je tuberkuloza gospinu travu (Hypericum perforatum), biljni pripravak koji se primjenjuje za depresiju i tjeskobu ili lijekove koji je sadrže.
Treatment outcomes of Studies GS-US-380-1844 and GS-US-380-1878 through Week 48 are presented in Table 4.
Ishodi liječenja u ispitivanjima GS-US-380-1844 i GS-US-380-1878 do 48. tjedna prikazani su u tablici 4.
ANTI-INFECTIVES Antimycobacterials Rifampicin (600 mg once daily), Bictegravir1 (Induction of CYP3A, UGT1A1, and P-gp)
Antivirusni lijekovi za HIV-1 Atazanavir (300 mg jedanput na dan), kobicistat (150 mg jedanput na dan), biktegravir1 (inhibicija CYP3A, UGT1A1 i P-gp/BCRP)
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%).
Nakon peroralne primjene B/F/TAF-a s hranom ili bez nje u odraslih ispitanika zaraženih virusom HIV-1, srednje vrijednosti farmakokinetičkih parametara nakon višestruke doze (CV%) biktegravira bile su Cmax = 6,15 μg/ml (22,9%), AUCtau = 102 μg •h/ml (26,9%) i Ctrough = 2,61 μg/ml (35,2%).
(Inhibition of CYP3A and UGT1A1)
(Inhibira CYP3A i UGT1A1)
Oxcarbazepine Phenobarbital Phenytoin
Okskarbazepin Fenobarbital
4 This study was conducted using emtricitabine/tenofovir alafenamide 200/25 mg once daily.
To je ispitivanje provedeno pomoću emtricitabina/tenofoviralafenamida od 200/25 mg jedanput na dan.
If a patient vomits more than 1 hour after taking Biktarvy they do not need to take another dose of Biktarvy until the next regularly scheduled dose.
Ako bolesnik povraća nakon što je prošao 1 sat od uzimanja lijeka Biktarvy, ne treba uzeti još jednu dozu prije sljedeće redovne doze.
Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food.
Biktarvy treba davati najmanje 2 sata prije dodataka koji sadrže željezo ili zajedno s hranom.
ORAL ANTI-DIABETICS Metformin (500 mg twice daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide
ORALNI ANTIDIJABETICI Metformin (500 mg dva puta na dan), biktegravir/emtricitabin/
B/F/TAF (n = 290)
(n = 290)
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.
U ispitivanjima GS-US-380-1489 i GS-US-380-1490, medijan (Q1-Q3) serumskog kreatinina povećao se od početne vrijednosti do 96. tjedna za 0,09 (0,01-0,16) mg/dl (8,0 [0,9; 14,1] µmol/l) u skupinama liječenima lijekom Biktarvy; 0,09 (0,03, 0,17) mg/dl (8,0 [2,6;
e Study GS-US-380-1490.
e Ispitivanje GS-US-380-1490.
Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1.5-2.0 hours after administration of B/F/TAF.
Nakon peroralne primjene, emtricitabin se brzo i opsežno apsorbira i postiže vršne koncentracije u plazmi 1,5-2,0 sata nakon primjene B/F/TAF-a.
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%).
Nakon peroralne primjene B/F/TAF-a s hranom ili bez nje u odraslih ispitanika zaraženih virusom HIV-1, srednje vrijednosti farmakokinetičkih parametara nakon višestruke doze (CV%) emtricitabina bile su Cmax = 2,13 μg/ml (34,7%), AUCtau = 12,3 μg•h/ml (29.2%) i Ctrough = 0,096 μg/ml (37,4%).
• tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)
• tenofoviralafenamid, antiretrovirusni lijek poznat kao nukleotidni inhibitor reverzne transkriptaze (NtRTI)
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.
Antivirusna aktivnost biktegravira protiv laboratorijskih i kliničkih izolata virusa HIV-1 procijenjena je na limfoblastoidnim staničnim linijama, PBMC-ovima, primarnim monocitnim/makrofagnim stanicama i CD4 + T-limfocitima.
4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
4 Ova nuspojava prepoznata je tijekom praćenja lijekova koji sadrže tenofoviralafenamid nakon njihova stavljanja u promet.
In Study GS-US-380-1490, patients were randomised in a 1:1 ratio to receive either B/F/TAF (n = 320) or dolutegravir + emtricitabine/tenofovir alafenamide (50+200/25 mg) (n = 325) once daily.
U ispitivanju GS-US-380-1490 bolesnici su bili randomizirani u omjeru 1:1 kako bi primali B/F/TAF (n = 320) ili dolutegravir + emtricitabin/tenofoviralafenamid (50 + 200/25 mg) (n = 325) jedanput na dan.
3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products.
3 Ova nuspojava prepoznata je tijekom praćenja lijekova koji sadrže emtricitabin nakon njihova stavljanja u promet.
Metabolism is the major clearance pathway for bictegravir in humans.
Glavni put eliminacije biktegravira u ljudi je metabolizam.
Treatment outcomes of Studies GS-US-380-1489 and GS-US-380-1490 through Weeks 48 and 96 are presented in Table 3.
Ishodi liječenja u ispitivanjima GS-US-380-1489 i GS-US-380-1490 do 48. i 96. tjedna prikazani su u tablici 3.
How to store Biktarvy
Kako čuvati Biktarvy
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.
Antivirusna aktivnost tenofoviralafenamida protiv laboratorijskih i kliničkih izolata virusa HIV-1 podtipa B procijenjena je na limfoblastoidnim staničnim linijama, PBMC-ovima, primarnim monocitnim/makrofagnim stanicama i CD4 + T-limfocitima.
AUC: ↑ 315% Cmax: ↔
Biktegravir: AUC: ↑ 315% Cmax: ↔
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.
Izloženost tenofoviralafenamidu proporcionalna je dozi u rasponu doza od 8 mg to 125 mg.
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%).
Nakon peroralne primjene B/F/TAF-a s hranom ili bez nje u odraslih ispitanika zaraženih virusom HIV-1, srednje vrijednosti farmakokinetičkih parametara nakon višestruke doze (CV%) tenofoviralafenamida bile su Cmax = 0,121 μg/ml (15,4%) i AUCtau = 0,142 μg•h/ml (17,3%).
HIV-1 RNA < 50 copies/mL Treatment difference (95% CI)
HIV-1 RNK < 50 kopija/ml Razlika u liječenju (95% CI)
(Induction of CYP3A, UGT1A1, and P-gp)
(indukcija CYP3A, UGT1A1, i P-gp)
Table 4: Virologic outcomes of Studies GS-US-380-1844 and GS-US-380-1878 at Week 48a
Tablica 4: Virološki ishodi ispitivanja GS-US-380-1844 i GS-US-380-1878 u 48. tjednua Ispitivanje GS-US-380-1844
Missing data during window but on study drug
Podaci iz okvira ispitivanja nedostaju, ali je ispitivani lijek primjenjivan
B/F/TAF (n = 282)
(n = 282)
HIV-1 RNA ≥ 50 copies/mLb Treatment difference (95% CI)
HIV-1 RNK ≥ 50 kopija /mlb Razlika u liječenju (95% CI)
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.
U ispitivanju GS-US-380-1844, srednja vrijednost promjene u odnosu na početni broj stanica CD4 + u 48. tjednu bila je -31 stanica/mm3 u bolesnika koji su prebačeni na B/F/TAF i 4 stanice/mm3 u onih koji su ostali na abakaviru/dolutegraviru/lamivudinu.
Voriconazole (300 mg twice daily), Bictegravir1
Vorikonazol (300 mg dvaput na dan), biktegravir1
ABC/DTG/ 3TC (n = 315)d
ABC/DTG/ 3TC
DTG + F/TAF (n = 325)e
DTG + F/ TAF
The mean baseline CD4+ cell count was 723 cells/mm3 (range 124-2,444).
723 stanice/mm3 (raspon 124-2444).
Sofosbuvir: AUC: ↔
Sofosbuvir: AUC: ↔ Cmax: ↔
HIV-1 infected, virologically -suppressed patients
Bolesnici zaraženi virusom HIV-1 u kojih je virus suprimiran
No dose adjustment is required upon co-administration.
Nije potrebna prilagodba doze nakon istodobne primjene.
In Study GS-US-380-1489, patients were randomised in a 1:1 ratio to receive either bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (n = 314) or abacavir/dolutegravir/lamivudine (600/50/300 mg) (n = 315) once daily.
U ispitivanju GS-US-380-1489 bolesnici su bili randomizirani u omjeru 1:1 kako bi primali biktegravir/emtricitabin/tenofoviralafenamid (B/F/TAF) (n = 314) ili abakavir/dolutegravir/lamivudin (600/50/300 mg) (n = 315) jedanput na dan.
AUC: ↑ 306% Cmax: ↔
Biktegravir: AUC: ↑ 306% Cmax: ↔
Nineteen percent of patients identified as Hispanic/Latino.
Kao Hispanoamerikanci/Latinoamerikanci izjasnilo se 19% bolesnika.
• emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
• emtricitabin, antiretrovirusni lijek poznat kao nukleozidni inhibitor reverzne transkriptaze (NRTI)
Co-administration of oxcarbazepine, phenobarbital, or phenytoin may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Istodobna primjena s okskarbazepinom, fenobarbitalom ili fenitoinom može smanjiti koncentracije biktegravira i tenofoviralafenamida u plazmi.
Baseline ATVor DRV-based regimen (n = 287)
Početni režim na temelju ATV-a ili DRV-a
Co-administration of carbamazepine may decrease bictegravir plasma concentrations.
Istodobna primjena s karbamazepinom može smanjiti koncentracije biktegravira u plazmi.
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.
U ispitivanju GS-US-380-1878, srednja vrijednost promjene u odnosu na početni broj stanica CD4 + u 48. tjednu bila je 25 stanica/mm3 u bolesnika koji su prebačeni na B/F/TAF i 0 stanica/mm3 u onih koji su ostali na početnom režimu liječenja.
The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Tenofoviralafenamid pokazao je antivirusnu aktivnost u staničnoj kulturi protiv svih skupina virusa HIV-1 (M, N, O) uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,10 do 12,0 nM) i aktivnost protiv virusa HIV-2 (vrijednosti EC50 bile su u rasponu od 0,91 do 2,63 nM).
Tenofovir alafenamide: AUC: ↔
Tenofoviralafenamid: AUC: ↔
HIV-1 infected, treatment-naïve patients
Bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni
• abnormal dreams
• abnormalni snovi • glavobolja
Midazolam: AUC: ↔
Midazolam: AUC: ↔ Cmax: ↔
There were no discontinuations due to renal adverse events through Week 96 in patients administered Biktarvy in clinical studies.
U bolesnika koji su u kliničkim ispitivanjima primali lijek Biktarvy, do 96. tjedna nije bilo prekida liječenja uzrokovanih štetnih događajima povezanima s bubrezima.
Antifungals
Antimikotici
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.
Nakon peroralne primjene, tenofoviralafenamid se brzo apsorbira i postiže vršne koncentracije u plazmi 0,5-2,0 sata nakon primjene B/F/TAF-a.
Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Jezgra tablete mikrokristalična celuloza umrežena karmelozanatrij magnezijev stearat
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).
U randomiziranom, otvorenom ispitivanju GS-US-380-1878, procjenjivani su djelotvornost i sigurnost prebacivanja odraslih bolesnika zaraženih virusom HIV-1 (n = 577) s virološkom supresijom s režima abakavir/lamivudin ili emtricitabin/tenofovirdizoproksilfumarat (200/300 mg) plus atazanavir ili darunavir (pojačan kobicistatom ili ritonavirom) na B/F/TAF.
AUC: ↔ Cmin: ↔ Cmax: ↔
Emtricitabin: AUC: ↔ Cmin: ↔ Cmax: ↔
Bictegravir is absorbed following oral administration with peak plasma concentrations occurring at 2.0-4.0 hours after administration of B/F/TAF.
Nakon peroralne primjene, biktegravir se apsorbira i postiže vršne koncentracije u plazmi 2,0-4,0 sata nakon primjene B/F/TAF-a.
AUC: ↑ 61% Cmax: ↔
Biktegravir: AUC: ↑ 61% Cmax: ↔
Co-administration of itraconazole or posaconazole may increase bictegravir plasma concentrations.
Istodobna primjena itrakonazola ili posakonazola može povisiti koncentracije biktegravira u plazmi.
There are no or limited data (less than 300 pregnancy outcomes) from the use of bictegravir or tenofovir alafenamide in pregnant women.
Nema podataka ili su podaci o primjeni biktegravira ili tenofoviralafenamida u trudnica ograničeni
Tabulated summary of adverse reactions The adverse reactions in Table 2 are listed by system organ class and frequency.
Nuspojave u tablici 2 navedene su prema klasifikaciji organskih sustava i učestalosti.
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.
A djelotvorniji od tenofovirdizoproksilfumarata u koncentriranju tenofovira u mononuklearnim stanicama periferne krvi (PBMC), (uključujući limfocite i druge ciljne stanice virusa HIV-a) i makrofagima.
Package leaflet: Information for the user Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za korisnika Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete biktegravir/emtricitabin/tenofoviralafenamid
Talk to your doctor if you are taking: • medicines used for treating HIV and/or hepatitis B, containing:
• lijekove za liječenje infekcije virusom HIV-a i/ili hepatitisa B, koji sadrže:
In Study GS-US-380-1844, the efficacy and safety of switching from a regimen of dolutegravir + abacavir/lamivudine or abacavir/dolutegravir/lamivudine to B/F/TAF were evaluated in a randomised, double-blind study of virologically-suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 563).
U randomiziranom, dvostruko slijepom ispitivanju GS-US-380-1844, procjenjivani su djelotvornost i sigurnost prebacivanja odraslih bolesnika zaraženih s virusom HIV-1 (n = 563) s virološkom supresijom (HIV-1 RNK < 50 kopija/ml) s režima dolutegravir + abakavir/lamivudin ili abakavir/dolutegravir/lamivudin na B/F/TAF.
The active substances are bictegravir, emtricitabine and tenofovir alafenamide.
Djelatne tvari su biktegravir, emtricitabin i tenofoviralafenamid.
AUC: ↓ 54% Cmax: ↓ 57%
Tenofoviralafenamid: AUC: ↓ 54% Cmax: ↓ 57%
• joint pain (arthralgia)
• bol u zglobovima (artralgija)
Tenofovir alafenamide
tenofoviralafenamid
angioedema3,4, rash, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon:
angioedem3, 4, osip, svrbež, urtikarija4
Co-administration of rifampicin may decrease tenofovir alafenamide plasma concentrations.
Istodobna primjena rifampicina može smanjiti koncentracije tenofoviralafenamida u plazmi.
There are limited safety and efficacy data for Biktarvy in patients co-infected with HIV-1 and hepatitis C virus (HCV).
HIV-1 i virusom hepatitisa C (HCV) ograničeni su.
There were no discontinuations due to hepatic adverse events through Week 96 in Biktarvy clinical studies.
U kliničkim ispitivanjima lijeka Biktarvy, do 96. tjedna nije bilo prekida liječenja uzrokovanih štetnim događajima povezanima s jetrom.
• itching (pruritus)
• svrbež (pruritus) • osip
Co-administration with St. John's wort is contraindicated, due to the effect of St. John's wort on the bictegravir component of Biktarvy.
Istodobna primjena lijeka Biktarvy s gospinom travom kontraindicirana je zbog djelovanja gospine trave na biktegravir, sastojak lijeka Biktarvy.
Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir) (see also table below).
(npr. makrolidi, ciklosporin, verapamil, dronedaron, glekaprevir/pibrentasvir) (vidjeti također tablicu u nastavku).
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.
Jedna filmom obložena tableta sadrži 50 mg biktegravira u obliku biktegravirnatrija, 200 mg emtricitabina i 25 mg tenofoviralafenamida u obliku tenofoviralafenamidfumarata.
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.
Jedna filmom obložena tableta lijeka Biktarvy sadrži 50 mg biktegravira u obliku biktegravirnatrija, 200 mg emtricitabina i 25 mg tenofoviralafenamida u obliku tenofoviralafenamidfumarata.
Co-administration of rifabutin may decrease tenofovir alafenamide plasma concentrations.
Istodobna primjena rifabutina može smanjiti koncentracije tenofoviralafenamida u plazmi.
Co-administration of rifapentine may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Istodobna primjena rifapentina može smanjiti koncentracije biktegravira i tenofoviralafenamida u plazmi.
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.
A u PBMC-ovima (uključujući limfocite i druge ciljne stanice HIV-a) i makrofazima te pomoću karboksilesteraze-1 u hepatocitima.
Tablet core
Tablični sažetak nuspojava
AUC: ↔ Cmax: ↔
Sertralin: AUC: ↔ Cmax: ↔
SEDATIVES/HYPNOTICS Midazolam (2 mg, oral syrup, single dose),
Midazolam (jedna doza od 2 mg, sirup), biktegravir/emtricitabin/
Co-administration may decrease bictegravir and tenofovir alafenamide plasma concentrations.
Istodobna primjena može smanjiti koncentracije biktegravira i tenofoviralafenamida u plazmi.
Co-administration may decrease bictegravir plasma concentrations.
Istodobna primjena može smanjiti koncentracije biktegravira u plazmi.
HIV-1 isolates with the K65R mutation have low level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Izolati virusa HIV-1 s mutacijom K65R pokazuju malo smanjenje osjetljivosti na abakavir,
• mineral supplements or vitamins containing magnesium or iron  See section 2 for more information on taking these medicines with Biktarvy.
• vitaminske ili mineralne dodatke prehrani koji sadrže magnezij ili željezo.
Gilead Sciences Poland Sp. z o.o.
Gilead Sciences Belgium SPRL-BVBA
No special hazard for humans was revealed in conventional studies of carcinogenic potential and toxicity to reproduction and development.
Nije otkriven poseban rizik za ljude na temelju konvencionalnih ispitivanja kancerogenog potencijala te reproduktivne i razvojne toksičnosti Ispitivanja reproduktivne toksičnosti u štakora i kunića nisu pokazala učinke na parenje, plodnost, graviditet ili fetalne parametre.
Rifabutin (300 mg once daily), Bictegravir1
Rifabutin (300 mg jedanput na dan),
Get advice from a doctor or pharmacist if you are taking:
Obavijestite svog liječnika ako uzimate:
In 16 HIV/HBV co-infected adults administered Biktarvy (8 HIV/HBV treatment-naïve adults in Study GS-US-380-1490; 8 HIV/HBV suppressed adults in Study GS-US-380-1878), the safety profile of Biktarvy was similar to that in patients with HIV-1 monoinfection (see section 5.1).
GS-US-380-1878), sigurnosni profil lijeka Biktarvy bio je sličan onome u bolesnika zaraženih samo virusom HIV-1 (vidjeti dio 5.1).
Biktarvy [Outer packaging only]
16. PODACI NA BRAILLEOVOM PISMU Biktarvy [Samo vanjsko pakiranje]
Gilead Sciences Netherlands B.V. Tel: + 31 (0) 20 718 36 98
Gilead Sciences, S.L. Tel: + 34 (0) 91 378 98 30
Bictegravir/Emtricitabine/ Tenofovir alafenamide
Sofosbuvir/velpatasvir/
In Studies GS-US-380-1489 and GS-US-380-1490, the mean increase from baseline in CD4+ cell count at Week 96 was 262, 288, and 281 cells/mm3 in the pooled B/F/TAF, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
U ispitivanjima GS-US-380-1489 i GS-US-380-1490, srednja vrijednost promjene u odnosu na početni broj stanica CD4 + u 96. tjednu bila je 262 stanica/mm3 u skupini bolesnika koji su primali
Sofosbuvir/Velpatasvir/ Voxilaprevir (400/100/100 + 100 mg3 once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide (Inhibition of P-gp/BCRP)
(400/100/100 + 100 mg3 jedanput na dan), biktegravir/emtricitabin/
No virologic data at week 48 or 96 window Discontinued study drug due to AE or deathg
HIV-1 RNK ≥ 50 kopija/mlf Bez viroloških podataka u okviru 48. ili 96. tjedna
Cmax, Cmin
Srednja vrijednost postotka promjene za AUC, Cmax, Cmin
ANTIDEPRESSANTS Sertraline (50 mg single dose), Tenofovir alafenamide6
Sertralin (jedna doza 50 mg),
• anticonvulsants used to treat epilepsy, containing: - carbamazepine, oxcarbazepine, phenobarbital or phenytoin
- karbamazepin, okskarbazepin, fenobarbital ili fenitoin
Bictegravir (simultaneous administration with food): AUC: ↔
Biktegravir (otopina antacida 2 sata poslije, natašte): AUC: ↔ Cmax: ↔
At Week 48, 7 patients were HBV suppressed (HBV DNA < 29 IU/mL) and had HIV-1 RNA < 50 copies/mL.
U 48 tjednu, 7 bolesnika imalo je suprimiran HBV (HBV DNK
• ulcer-healing medicines containing sucralfate  Tell your doctor if you are taking any of these medicines.
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Tel.: + 48 (0) 22 262 8702
Gilead Sciences Poland Sp. z o.o. Tel: + 48 (0) 22 262 8702