natgillin/translations-raw huggingface dataset:
In Study GS-US-380-1878, at Week 48, 100% (8/8) of the patients co-infected with HIV/HBV at baseline in the B/F/TAF arm maintained HBV DNA < 29 IU/mL (missing = excluded analysis) and HIV RNA < 50 copies/mL. 
U ispitivanju GS-US-380-1878, u 48. tjednu, 100% (8/8) bolesnika istodobno zaraženih HIV-om i HBV-om na početku u skupini liječenoj lijekom B/F/TAF-om održalo je HBV DNK < 29 IU/ml (nedostaje = analiza isključena) i HIV RNK < 50 kopija/ml.
It is not known whether bictegravir or tenofovir alafenamide is excreted in human milk. 
Nije poznato izlučuju li se biktegravir ili tenofoviralafenamid u majčino mlijeko.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide 
Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete biktegravir/emtricitabin/tenofoviralafenamid
(Induction of CYP3A and P-gp) 
(indukcija CYP3A i P-gp)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
11. NAZIV I ADRESA NOSTELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
If you vomit more than 1 hour after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet. 
Ako povraćate nakon što je prošao 1 sat od uzimanja lijeka Biktarvy, ne trebate uzeti još jednu tabletu prije sljedeće tablete prema redovitom rasporedu
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). 
Bolesnici su bili randomizirani u omjeru 1:1 kako bi se prebacili na B/F/TAF (n = 282) od početka ispitivanja ili ostali na svom početnom antiretrovirusnom režimu (n = 281).
The prevalence of different subtypes was comparable across all three treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes. 
Prevalencija različitih podtipova bila je usporediva u sve tri terapijske skupine, s time da je podtip B prevladavao u obje skupine; 11% bilo je ne-B podtip.
Emtricitabine has activity against HIV-1, HIV-2 and HBV. 
Emtricitabin je aktivan protiv virusa HIV-1, HIV-2 i HBV.
Bictegravir 
Biktegravir
Bictegravir has activity against HIV-1 and HIV-2. 
Biktegravir je aktivan protiv virusa HIV-1 i HIV-2.
Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine. 
Bubrežna ekskrecija nerazgrađenog tenofoviralafenamida predstavlja put izlučivanja koji je od malog značaja, a kojim se eliminira < 1% doze u mokraći.
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 
Kod vršne koncentracije u plazmi, srednja vrijednost omjera koncentracije lijeka u plazmi i krvi bio je ~1,0, a srednja vrijednost omjera koncentracije lijeka u sjemenu i plazmi bila je ~4,0.
ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1 
Norgestimat (0,180/0,215/0,250 mg jedanput na dan)/ etinilestradiol (0,025 mg jedanput na dan), biktegravir1
Iron oxide red (E172) Iron oxide black (E172) 
makrogol talk željezov oksid, crveni (E172) željezov oksid, crni (E172) 6.2 Inkompatibilnosti
Atazanavir (400 mg once daily), Bictegravir1 
Atazanavir (400 mg jedanput na dan), biktegravir1
Biktarvy should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium. 
Biktarvy treba davati najmanje 2 sata prije ili s hranom 2 sata poslije antacida koji sadrže magnezij i/ili aluminij.
If you vomit less than 1 hour after taking Biktarvy, take another tablet. 
Ako povraćate unutar 1 sata od uzimanja lijeka Biktarvy, uzmite drugu tabletu.
Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide2 
Antivirusni lijekovi za virus hepatitisa C Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan), Biktegravir/emtricitabin/
Name and address of the manufacturer(s) responsible for batch release 
PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje lijeka u promet
Co-administration of azithromycin or clarithromycin may increase bictegravir plasma concentrations. 
Istodobna primjena azitromicina ili klaritromicina može povećati koncentracije biktegravira u plazmi.
Bictegravir displayed antiviral activity in cell culture against HIV-1 group (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from < 0.05 to 1.71 nM), and activity against HIV-2 (EC50 = 1.1 nM). 
Biktegravir je pokazao antivirusnu aktivnost u staničnoj kulturi protiv skupine HIV-1 (M, N, O) uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od < 0,05 do 1,71 nM) i aktivnost protiv virusa HIV-2 (EC50 = 1,1 nM).
2 This study was conducted using bictegravir/emtricitabine/tenofovir alafenamide 75/200/25 mg once daily. 
2 To je ispitivanje provedeno primjenom biktegravira/emtricitabina/tenofoviralafenamida od 75/200/25 mg jedanput na dan.
ANTICONVULSANTS Carbamazepine (titrated from 100 mg to 300 mg twice a day), Emtricitabine/Tenofovir alafenamide4 
Karbamazepin (titriran sa 100 mg na 300 mg dvaput na dan), emtricitabin/tenofoviralafenamid4
Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate. 
Unutar stanice se tenofovir naknadno fosforilira u farmakološki aktivan metabolit tenofovirdifosfat.
AUC: ↑ 39% Cmin: ↑ 36% Cmax: ↔ 
Metformin: AUC: ↑ 39% Cmin: ↑ 36% Cmax: ↔
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. 
Ako bolesnik propusti uzeti dozu lijeka Biktarvy, a proteklo je manje od 18 sati od uobičajenog vremena uzimanja doze, bolesnik mora što prije uzeti lijek Biktarvy i potom ga nastaviti uzimati prema uobičajenom rasporedu.
ANTACIDS, SUPPLEMENTS AND BUFFERED MEDICINES Magnesium/aluminium-containing antacid suspension (20 mL single dose5), Bictegravir 
Otopina antacida koji sadrže magnezij/aluminij (jedna doza od 20 ml5), biktegravir
HIV-1 RNA < 50 copies/mL Treatment difference (95% CI) B/F/TAF vs Comparator 
HIV-1 RNK < 50 kopija/ml Razlika u liječenju (95% CI) B/F/TAF
Do not stop taking Biktarvy Do not stop taking Biktarvy without talking to your doctor. 
Nemojte prestati uzimati lijek Biktarvy bez prethodnog razgovora sa svojim liječnikom.
Co-administration of ciclosporin (IV or oral use) is expected to increase plasma concentrations of both bictegravir and tenofovir alafenamide. 
Očekuje se da će istodobna primjena ciklosporina (i.v. ili peroralno) povećati koncentracije i biktegravira i tenofoviralafenamida u plazmi.
Blood and lymphatic system disorders Uncommon: 
Poremećaji krvi i limfnog sustava
Clinically relevant changes in the pharmacokinetics of bictegravir were not observed in subjects with moderate hepatic impairment. 
Nisu zapažene klinički važne promjene u farmakokinetici biktegravira u bolesnika s umjerenim oštećenjem funkcije jetre.
If the patient vomits within 1 hour of taking Biktarvy another tablet should be taken. 
Ako bolesnik povraća unutar 1 sata od uzimanja lijeka Biktarvy, mora uzeti drugu tabletu.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets 
NAZIV LIJEKA Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete
d Study GS-US-380-1489. 
d Ispitivanje GS-US-380-1489.
Seventeen percent of patients identified as Hispanic/Latino. 
Kao Hispanoamerikanci/Latinoamerikanci izjasnilo se 17% bolesnika.
Table 3: Pooled virologic outcomes of Studies GS-US-380-1489 and GS-US-380-1490 at Weeks 48a and 96b 
Tablica 3: Objedinjeni virološki ishodi u ispitivanjima GS-US-380-1489 i GS-US-380-1490 u 48.a i 96.b tjednu
The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI CCR5 cell line, and PBMCs. 
Antivirusna aktivnost emtricitabina protiv laboratorijskih i kliničkih izolata virusa HIV-1 procijenjena je na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI CCR5 i PBMC-ovima.
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). 
Emtricitabin je pokazao antivirusnu aktivnost u staničnoj kulturi protiv podtipova virusa HIV-1 A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,007 do 0,075 µM) i aktivnost protiv virusa HIV-2 (vrijednosti EC50 bile su u rasponu od 0,007 do 1,5 µM).
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.