natgillin/translations-raw huggingface dataset:
2 This adverse reaction was not observed in the clinical studies of F/TAF-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
Ova nuspojava nije uočena u kliničkim ispitivanjima lijekova koji sadrže F/TAF, ali je prepoznata u kliničkim ispitivanjima emtricitabina ili tijekom praćenja emtricitabina nakon stavljanja u promet kad se koristio s drugim antiretrovirusnim lijekovima.
ANTI-INFECTIVES Antifungals Ketoconazole Itraconazole
Antimikotici Ketokonazol Itrakonazol
Descovy should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Iako Descovy općenito treba izbjegavati u odraslih sa završnim stadijem bolesti bubrega (procijenjeni CrCl < 15 ml/min) na kroničnoj hemodijalizi, može ga se primijeniti ako se smatra da su moguće koristi veće od mogućih rizika (vidjeti dio 4.2).
The pharmacokinetics of emtricitabine and tenofovir alafenamide have not been fully evaluated in patients co-infected with HBV and/or HCV.
Farmakokinetika emtricitabina i tenofoviralafenamida nije potpuno procijenjena u bolesnika koji su istodobno zaraženi HBV-om i/ili HCV-om.
Most HIV-1 isolates from patients in both treatment groups who developed resistance mutations to elvitegravir in integrase also developed resistance mutations to emtricitabine in RT.
Većina HIV-1 izolata od bolesnika iz obje skupine koji su razvili mutacije u integrazi povezane s rezistencijom na elvitegravir, razvili su i mutacije u RT-u povezane s rezistencijom na emtricitabin.
Patients were randomised in a 1:1 ratio to either switch to Descovy (n = 333), or stay on their baseline emtricitabine/tenofovir disoproxil fumarate containing regimen (n = 330).
Bolesnici su bili randomizirani u omjeru 1:1 kako bi se prebacili bilo na lijek Descovy (n = 333) ili ostali na svom početnom režimu koji sadrži emtricitabin/tenofovirdizoproksilfumarat (n = 330).
Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1 to 2 hours post-dose.
Nakon peroralne primjene, emtricitabin se brzo i opsežno apsorbira i postiže vršne koncentracije u plazmi 1-2 sata nakon doziranja.
Descovy should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Descovy treba izbjegavati u bolesnika čiji HIV-1 nosi mutaciju K65R, a prethodno su liječeni antiretrovirusnim lijekovima (vidjeti dio 5.1).
Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chaintermination.
Tenofovirdifosfat inhibira replikaciju HIV-a ugradnjom u virusnu DNK pomoću HIV RT što dovodi do prekida lanca DNK.
No dose adjustment of sofosbuvir, velpatasvir or voxilaprevir is required.
Nije potrebna prilagodba doze sofosbuvira, velpatasvira ili voksilaprevira.
Table 3: Tabulated list of adverse reactions1
Tablica 3: Tablični prikaz nuspojava1
< 20 copies/mL
< 50 kopija/mle
In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja CART-a može doći do upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, koja može uzrokovati teška klinička stanja ili pogoršanje simptoma.
Descovy 200 mg/25 mg [Outer packaging only]
Descovy 200 mg/25 mg [samo vanjsko pakiranje]
If the patient misses a dose of Descovy within 18 hours of the time it is usually taken, the patient should take Descovy as soon as possible and resume the normal dosing schedule.
Ako je bolesnik propustio uzeti dozu lijeka Descovy, a sjetio se unutar 18 sati od propuštene doze, bolesnik mora što prije uzeti lijek Descovy i potom ga nastaviti uzimati prema uobičajenom rasporedu.
• If you notice within 18 hours of the time you usually take Descovy, you must take the tablet as soon as possible.
• Ako to primijetite unutar 18 sati od propuštene doze lijeka Descovy, tabletu morate uzeti što prije.
EU/1/16/1099/003 EU/1/16/1099/004
EU/1/16/1099/004
Studies of tenofovir alafenamide in animals have shown no evidence of harmful effects on fertility parameters, pregnancy, or foetal development (see section 5.3).
Ispitivanja tenofoviralafenamida na životinjama nisu pokazala nikakve dokaze štetnih učinaka na parametre plodnosti, trudnoću ili razvoj fetusa (vidjeti dio 5.3).
Co-administration of Descovy with other medicinal products that inhibit P-gp and BCRP activity (e.g., cobicistat, ritonavir, ciclosporin) is expected to increase the absorption and plasma concentration of tenofovir alafenamide.
Očekuje se da će istodobna primjena lijeka Descovy s drugim lijekovima koji inhibiraju aktivnost P-gp-a i BCRP-a (npr. kobicistat, ritonavir, ciklosporin) povećati apsorpciju i koncentraciju tenofoviralafenamida u plazmi.
Treatment outcomes of Study GS-US-311-1089 through 48 and 96 weeks are presented in Table 6.
Ishodi liječenja u Ispitivanju GS-US-311-1089 do kraja 48. i 96. tjedna prikazani su u Tablici 6.
The median (Q1, Q3) change from baseline in total cholesterol to HDL-cholesterol ratio at Week 144 was 0.2 (-0.3, 0.7) in the E/C/F/TAF group and 0.1 (-0.4, 0.6) in the E/C/F/TDF group (p = 0.006 for the difference between treatment groups).
Medijan (Q1, Q3) promjene omjera ukupnog kolesterola i HDL kolesterola od početne vrijednosti do vrijednosti u 144. tjednu bio je 0,2 (-0,3; 0,7) u skupini liječenoj E/C/F/TAFom i 0,1 (-0,4; 0,6) u skupini liječenoj E/C/F/TDF-om (p = 0,006 za razliku između liječenih skupina).
While you are taking Descovy
Dok uzimate lijek Descovy
Descovy should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Potrebno je prekinuti liječenje lijekom Descovy u bolesnika u kojih procijenjeni CrCl tijekom liječenja opada na vrijednosti ispod 30 ml/min (vidjeti dio 5.2).
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.
Antivirusno djelovanje emtricitabina na laboratorijske i kliničke izolate virusa HIV-1 procijenjeno je na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI CCR5 i PBMC-ovima.
At 48 weeks, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL, similar to response rates in studies of treatment-naïve HIV-1 infected adults.
U 48. tjednu, njih 92% (46/50) postiglo je HIV-1 RNK < 50 kopija/ml, što je slično stopama odgovora u ispitivanjima odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni.
In a study of virologically suppressed adult patients switching from abacavir/lamivudine to Descovy while maintaining the third antiretroviral agent (Study GS-US-311-1717), there were minimal changes in lipid parameters.
U ispitivanju u odraslih bolesnika kod kojih je virus bio suprimiran i koji su prebačeni s režima abakavir/lamivudin na lijek Descovy uz zadržavanje liječenja trećim antiretrovirusnim lijekom (Ispitivanje GS-US-311-1717) promjene u lipidnim parametrima bile su minimalne.
Table 1: Dose of Descovy according to third agent in the HIV treatment regimen
Tablica 1: Doza lijeka Descovy ovisno o trećem lijeku u režimu liječenja HIV-a
D/C/F/TAF = darunavir/cobicistat/emtricitabine/tenofovir alafenamide a Week 48 window was between Day 294 and 377 (inclusive).
D/C/F/TAF = darunavir/kobicistat/emtricitabin/tenofoviralafenamid a Okvir 48. tjedna bio je između 294. i 377. dana (uključivo).
At baseline, 30% of patients were receiving abacavir/lamivudine in combination with a boosted protease inhibitor and 70% of patients were receiving abacavir/lamivudine in combination with an unboosted third agent.
Na početku je 30% bolesnika primalo abakavir/lamivudin u kombinaciji s pojačanim inhibitorom proteaze, a 70% bolesnika primalo je abakavir/lamivudin u kombinaciji s nepojačanim trećim lijekom.
EU/1/16/1099/001 30 film-coated tablets EU/1/16/1099/002 90 (3 bottles of 30) film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1099/001 30 filmom obloženih tableta EU/1/16/1099/002 90 (3 boce od 30) filmom obloženih tableta
A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Descovy.
U oku pasa bila je prisutna minimalna infiltracija histiocitima kod izloženosti tenofoviralafenamidu i tenofoviru koja je bila približno 4 odnosno 17 puta veća od one očekivane nakon primjene lijeka Descovy.
At the start of treatment with E/C/F/TAF, the 72 patients had been HIV-suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Na početku liječenja E/C/F/TAF-om, 72 bolesnika imali su supresiju HIV-a (HIV-1 RNK < 50 kopija/ml) najmanje 6 mjeseci sa ili bez supresije HBV DNA i imali su kompenziranu funkciju jetre.
EU/1/16/1099/003 30 film-coated tablets EU/1/16/1099/004 90 (3 bottles of 30) film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1099/003 30 filmom obloženih tableta EU/1/16/1099/004 90 (3 boce od 30) filmom obloženih tableta
In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 μg•h/mL) than in subjects with normal renal function (11.8 μg•h/mL).
U zasebnom ispitivanju faze I u kojem se ispitivao samo emtricitabin, srednja vrijednost sistemske izloženosti emtricitabinu bila je viša u bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl < 30 ml/min) (33,7 µg•h/ml) nego u ispitanika s normalnom funkcijom bubrega (11,8 µg•h/ml).
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 strain specific activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 μM).
Emtricitabin je pokazao antivirusnu aktivnost u staničnoj kulturi na podtipove 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 specifičnu aktivnost na sojeve virusa HIV-2 (vrijednosti EC50 bile su u rasponu od 0,007 do 1,5 µM).
Following multiple dose oral administration of emtricitabine to 20 HIV-1 infected subjects, the (mean ± SD) steady state plasma emtricitabine peak concentrations (Cmax) were 1.8 ± 0.7 μg/mL and the area-under the plasma concentration-time curve over a 24-hour dosing interval (AUC) was 10.0 ± 3.1 μg•h/mL.
Nakon peroralne primjene višestruke doze emtricitabina u 20 ispitanika zaraženih virusom HIV-1, vršne koncentracije (Cmax) (srednja vrijednost ± SD) emtricitabina u plazmi pri dinamičkoj ravnoteži bile su 1,8 ± 0,7 µg/ml, a površina ispod krivulje koncentracija-vrijeme tijekom 24-satnog intervala doziranja (AUC) bila je 10,0 ± 3,1 µg•h/ml.
Co-administration of Descovy and rifabutin rifampicin, or rifapentine is not recommended.
Ne preporučuje se istodobna primjena lijeka Descovy i rifabutina, rifampicina ili rifapentina.
If the patient vomits within 1 hour of taking Descovy another tablet should be taken.
Ako bolesnik povraća unutar 1 sata od uzimanja lijeka Descovy, mora uzeti drugu tabletu.
E/C/F/TAF = elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide E/C/F/TDF = elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1049 (inclusive).
E/C/F/TAF = elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid E/C/F/TDF = elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat a Okvir 48. tjedna bio je između 294. i 377. dana (uključivo); Okvir 144. tjedna bio je između 966. i 1049. dana (uključivo).
 If any of the side effects get serious tell your doctor.
Ako neka od ovih nuspojava postane ozbiljna, obavijestite svog liječnika.
Following administration of food in healthy subjects, peak plasma concentrations were observed approximately 1 hour post-dose for tenofovir alafenamide administered as F/TAF (25 mg) or E/C/F/TAF (10 mg).
Nakon primjene hrane u zdravih ispitanika, vršne koncentracije tenofoviralafenamida u plazmi, primijenjenog kao F/TAF (25 mg) ili E/C/F/TAF (10 mg), bile su opažene približno 1 sat nakon doziranja.
Co-administration of ketoconazole or itraconazole, which are potent P-gp inhibitors, is expected to increase plasma concentrations of tenofovir alafenamide.
Očekuje se da će istodobna primjena ketokonazola ili itrakonazola, koji su jaki inhibitori P-gp-a, povisiti koncentracije tenofoviralafenamida u plazmi.
The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL (range: 1.3-7.0) and 23% had baseline viral loads > 100,000 copies/mL.
Srednja početna vrijednost HIV-1 RNK u plazmi bila je 4,5 log10 kopija/ml (raspon: 1,3-7,0), a 23% imalo je početno virusno opterećenje > 100 000 kopija/ml.
Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, iron oxide black (E172).
Poli(vinilni alkohol), titanijev dioksid, makrogol 3350, talk, željezov oksid, crni (E172)
Patients must have been stably suppressed (HIV-1 RNA < 50 copies/mL) on their baseline regimen for at least 6 months and had HIV-1 with no resistance mutations to emtricitabine or tenofovir alafenamide prior to study entry.
U bolesnika je HIV-1 morao biti stabilno suprimiran (HIV-1 RNK < 50 kopija/ml) početnim režimom najmanje 6 mjeseci i biti bez mutacija povezanih s rezistencijom na emtricitabin ili tenofoviralafenamid prije ulaska u ispitivanje.
The safety of emtricitabine and tenofovir alafenamide has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Sigurnost emtricitabina i tenofoviralafenamida nije ustanovljena u bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl ≥ 15 ml/min i < 30 ml/min).
High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Boca od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu s kontinuiranim navojem, otvora prekrivenog zaštitnom aluminijskom folijom, koja sadrži 30 filmom obloženih tableta.
Emtricitabine triphosphate inhibits HIV replication through incorporation into viral deoxyribonucleic acid (DNA) by the HIV reverse transcriptase (RT), which results in DNA chaintermination.
Emtricitabin trifosfat inhibira replikaciju HIV-a ugradnjom u virusnu deoksiribonukleinsku kiselinu (DNK) pomoću reverzne transkriptaze (RT) što dovodi do prekida lanca DNK.
Based on data from an in vitro study, co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g., febuxostat) is not expected to increase systemic exposure to tenofovir in vivo.
Na temelju podataka in vitro ispitivanja, ne očekuje se da će istodobna primjena tenofoviralafenamida i inhibitora ksantin oksidaze (npr. febuksostata) povećati sistemsku izloženost tenofoviru in vivo.
Patients had a mean age of 15 years (range: 12-17), and 56% were female, 12% were Asian, and 88% were Black.
Bolesnici su imali srednju vrijednost dobi 15 godina (raspon: 12-17), a 56% bile su djevojke, 12% azijati i 88% crnci.
There are no or limited data (less than 300 pregnancy outcomes) from the use of tenofovir alafenamide in pregnant women.
Nema podataka ili su podaci o primjeni tenofoviralafenamida u trudnica ograničeni (manje od 300 trudnoća).
Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching.
U bolesnika je virus bio suprimiran (HIV-1 RNK < 50 kopija/ml) tijekom najmanje 6 mjeseci prije prebacivanja.
In Study GS-US-299-0102, patients were randomised in a 2:1 ratio to receive either fixed-dose combination D/C/F/TAF once daily (n = 103) or darunavir and cobicistat and emtricitabine/tenofovir disoproxil fumarate once daily (n = 50).
U Ispitivanju GS-US-299-0102, bolesnici su bili randomizirani u omjeru 2:1 kako bi primali fiksnu kombinaciju D/C/F/TAF jednom dnevno (n = 103) ili darunavir, kobicistat i emtricitabin/tenofovirdizoproksilfumarat jednom dnevno (n = 50).
There were no clinically significant changes in fasting lipid laboratory tests in patients who switched.
Nije bilo klinički značajnih promjena u laboratorijskim vrijednostima lipida izmjerenih natašte u bolesnika koji su prebačeni na tu terapiju.
Based on these limited data, the safety profile of emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet, in patients with HIV/HBV co-infection, was similar to that in patients with HIV-1 monoinfection (see section 4.4).
Na temelju ovih ograničenih podataka, sigurnosni profil emtricitabina i tenofoviralafenamida u fiksnoj kombinaciji s elvitegravirom i kobicistatom u jednoj tableti u bolesnika koji su istodobno bili zaraženi HIV-om i HBV-om bio je sličan onome u bolesnika zaraženih samo virusom HIV-1 (vidjeti dio 4.4).
Film-coating: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine aluminium lake (E132).
Poli(vinilni alkohol), titanijev dioksid, makrogol 3350, talk, boja indigo carmine aluminium lake (E132)
The proportions of patients with plasma HIV-1 RNA < 50 copies/mL and < 20 copies/mL are shown in Table 5.
Udjeli bolesnika s HIV-1 RNK < 50 kopija/ml i < 20 kopija/ml plazme prikazani su u Tablici 5.
There are no efficacy and safety studies conducted in treatment-naïve patients with Descovy.
Nema ispitivanja djelotvornosti i sigurnosti lijeka Descovy provedenih u bolesnika koji prethodno nisu bili liječeni.
Talk to your doctor before taking Descovy: • If you have liver problems or have suffered liver disease, including hepatitis.
• Ako imate tegobe s jetrom ili ste imali bolest jetre, uključujući hepatitis.
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 peripostnatal study were conducted only with tenofovir disoproxil fumarate.
Budući da je izloženost tenofoviru u štakora i miševa nakon primjene tenofoviralafenamida manja nego pri primjeni tenofovirdizoproksilfumarata, ispitivanja kancerogenosti te perinatalno i postnatalno ispitivanje u štakora provedena su samo s tenofovirdizoproksilfumaratom.
Recommendation concerning co-administration with Descovy
Preporuka za istodobnu primjenu s lijekom Descovy
E/C/F/TAF demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
U usporedbi s E/C/F/TDF-om, E/C/F/TAF je pokazao statističku superiornost u postizanju vrijednosti HIV-1 RNK < 50 kopija/ml u 144. tjednu.
Hepatitis B and/or hepatitis C virus co-infection
Istodobna infekcija virusom hepatitisa B i/ili hepatitisa C
Tablet core: Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Mikrokristalična celuloza, umrežena karmelozanatrij, magnezijev stearat.
Through Week 144, the development of one or more primary emtricitabine, tenofovir alafenamide, or elvitegravir resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and E/C/F/TAF treatment-failure isolates (12 of 866 patients [1.4%]) compared with 12 of 20 treatment-failure isolates from patients with evaluable genotypic data in the E/C/F/TDF group (12 of 867 patients [1.4%]).
Do 144. tjedna uočena je jedna ili više primarnih mutacija povezanih s rezistencijom na emtricitabin, tenofoviralafenamid ili elvitegravir, u HIV-1 izolatima 12 od 22 bolesnika s procjenjivim genotipskim podacima iz uparene početne vrijednosti i izolata iz neuspješnog liječenja E/C/F/TAF-om (12 od 866 bolesnika [1,4%]) u usporedbi s 12 od 20 izolata od neuspješno liječenih bolesnika s procjenjivim genotipskim podacima iz skupine liječene E/C/F/TDF-om (12 od 867 bolesnika [1,4%]).
• If you are allergic to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
• ako ste alergični na emtricitabin, tenofoviralafenamid ili neki drugi sastojak ovog lijeka
The mean baseline CD4+ cell count was 427 cells/mm3 (range: 0-1,360) and 13% had a CD4+ cell count < 200 cells/mm3.
Srednja početna vrijednost broja CD4+ stanica bila je 427 stanica/mm3 (raspon: 0-1360), a 13% imalo je broj CD4+ stanica < 200 stanica/mm3.
6 Emtricitabine/tenofovir alafenamide was taken with food in this study.
6 U ovom se ispitivanju emtricitabin/tenofoviralafenamid uzimao s hranom.
There are no data available to make dosing recommendations for co-administration with other protease inhibitors.
Ne mogu se dati preporuke za doziranje kod istodobne primjene s drugim inhibitorima proteaze jer nema dostupnih podataka.
The mean Cmax and AUClast following a single 10 mg dose of tenofovir alafenamide administered in E/C/F/TAF were 0.21 ± 0.10 μg/mL and 0.25 ± 0.08 μg•h/mL, respectively.
Srednje vrijednosti Cmax i AUCzadnji nakon jedne doze od 10 mg tenofoviralafenamida primijenjenog u E/C/F/TAF-u bile su 0,21 ± 0,10 µg/ml odnosno 0,25 ± 0,08 µg•h/ml.
3.3% (95% CI: -11.4% to 18.1%)
3,3% (95% CI: -11,4% do 18,1%)
In human clinical studies, a 10 mg oral dose of tenofovir alafenamide (given with emtricitabine and elvitegravir and cobicistat) resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 245 mg oral dose of tenofovir disoproxil (as fumarate) (given with emtricitabine and elvitegravir and cobicistat).
U kliničkim ispitivanjima u ljudi, peroralna doza od 10 mg tenofoviralafenamida (primijenjenog s emtricitabinom, elvitegravirom i kobicistatom) rezultirala je koncentracijama tenofovirdifosfata > 4 puta većima u PBMC-ovima i > 90% manjim koncentracijama tenofovira u plazmi u usporedbi s peroralnom dozom tenofovirdizoproksila (u obliku fumarata) od 245 mg (primijenjenog s emtricitabinom, elvitegravirom i kobicistatom).
Seventy-nine percent were male, 63% were White, 18% were Black, and 14% were Asian.
Sedamdeset i devet posto su bili muškarci, 63% su bili bijelci, 18% crnci i 14% azijati.
d 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.
d Obuhvaća bolesnike koji su prekinuli liječenje zbog štetnog događaja ili smrti u bilo kojem trenutku od 1. dana do kraja vremenskog okvira, ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.
Cross-resistance in HIV-1 infected, treatment-naïve or virologically suppressed patients 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 sa supstitucijom M184V/I bili su križno rezistentni na lamivudin, ali su zadržali osjetljivost na didanozin, stavudin, tenofovir i zidovudin.
c 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.
c Obuhvaća bolesnike koji su prekinuli liječenje zbog štetnog događaja ili smrti u bilo kojem trenutku od 1. dana do kraja vremenskog okvira, ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.