natgillin/translations-raw huggingface dataset:
In a pooled analysis of antiretroviral-naïve patients receiving emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet in Phase 3 studies GS-US-292-0104 and GS-US-292-0111, genotyping was performed on plasma HIV-1 isolates from all patients with HIV-1 RNA ≥ 400 copies/mL at confirmed virological failure, at Week 144, or at the time of early study drug discontinuation.
Provedeno je genotipiziranje HIV-1 izolata iz plazme svih bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, a primali su fiksnu kombinaciju emtricitabina i tenofoviralafenamida (10 mg) s elvitegravirom i kobicistatom u jednoj tableti u Ispitivanjima faze 3 GS-US-292-0104 i GS-US-292-0111, s HIV-1 RNK ≥ 400 kopija/ml pri potvrđenom virološkom neuspjehu, u 144. tjednu ili u vrijeme ranog prekida primanja ispitivanog lijeka te je provedena analiza objedinjenih podataka.
Descovy film-coated tablets are blue, rectangular-shaped tablets, debossed on one side with “GSI” and the number “225” on the other side of the tablet.
Descovy filmom obložene tablete su plave tablete pravokutnog oblika, s utisnutom oznakom „GSI“ na jednoj strani i „225“ na drugoj strani tablete.
Co-administration of Descovy and carbamazepine is not recommended.
Ne preporučuje se istodobna primjena lijeka Descovy i karbamazepina.
Other HIV antiretrovirals Dolutegravir (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Drugi antiretrovirusni lijekovi za HIV Dolutegravir (50 mg jedanput na dan), tenofoviralafenamid (10 mg jedanput na dan)3
HIV-1 RNA < 50 copies/mL
HIV-1 RNK < 50 kopija/ml
Patients co-infected with HIV and HBV
Bolesnici koji su istodobno zaraženi HIV-om i HBV-om
Indigo carmine aluminium lake (E132)
titanijev dioksid makrogol 3350 talk boja indigo carmine aluminium lake (E132)
Atazanavir/ritonavir (300/100 mg once daily), tenofovir alafenamide (10 mg)
Atazanavir/ritonavir (300/100 mg jedanput na dan), tenofoviralafenamid (10 mg)
4 Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet.
4 Ispitivanje provedeno s fiksnom kombinacijom emtricitabina/rilpivirina/tenofoviralafenamida u jednoj tableti.
1 Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat 150 mg, administered as a fixed-dose combination tablet, was studied in treatment- naive subjects, see section 5.1.
1 U ispitanika koji prethodno nisu bili liječeni ispitivan je lijek Descovy 200/10 mg primjenjen s fiksnom kombinacijom 800 mg darunavira i 150 mg kobicistata u jednoj tableti (vidjeti dio 5.1).
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup Age
Udio (%) bolesnika s HIV-1 RNK < 50 kopija/ml po podskupinama Dob
b Includes patients who had ≥ 50 copies/mL in the Week 48 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
b Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz razloga koji nisu posljedica štetnog događaja, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida imali virusnu vrijednost ≥ 50 kopija/ml.
The safety of emtricitabine and tenofovir alafenamide was evaluated through 144 weeks in an openlabel clinical study (GS-US-292-0112) in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Sigurnost emtricitabina i tenofoviralafenamida procijenjena je tijekom 144 tjedna otvorenog kliničkog Ispitivanja (GS-US-292-0112) u kojem je 248 bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (n = 6) ili im je virus bio suprimiran (n = 242) s blagim do umjerenim oštećenjem funkcije bubrega (procijenjena brzina glomerularne filtracije Cockcroft-Gaultovom metodom [eGFRCG]: 30-69 ml/min) primalo fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti.
In studies in treatment-naïve patients, increases from baseline were observed in both the tenofovir alafenamide fumarate and tenofovir disoproxil fumarate containing treatment groups for the fasting lipid parameters total cholesterol, direct low-density lipoprotein (LDL)- and high-density lipoprotein (HDL)-cholesterol, and triglycerides at Week 144.
U ispitivanjima bolesnika koji prethodno nisu bili liječeni, i u skupini liječenoj tenofoviralafenamidfumaratom i u skupini liječenoj tenofovirdizoproksilfumaratom uočen je porast u odnosu na početne vrijednosti lipida natašte, i to za ukupni kolesterol, lipoproteine niske gustoće (LDL) i lipoproteine visoke gustoće (HDL), te trigliceride, u 144. tjednu.
Rilpivirine (25 mg once daily), tenofovir alafenamide (25 mg once daily)
Rilpivirin (25 mg jedanput na dan), tenofoviralafenamid (25 mg jedanput na dan)
Descovy 200 mg/25 mg film-coated tablets
NAZIV LIJEKA Descovy 200 mg/25 mg filmom obložene tablete
c Includes patients who had ≥ 50 copies/mL in the Week 48 or 144 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
c Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. ili 144. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz razloga koji nisu posljedica štetnog događaja, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida liječenja imali virusnu vrijednost ≥ 50 kopija/ml.
Descovy 200 mg/25 mg film-coated tablets emtricitabine/tenofovir alafenamide
Descovy 200 mg/25 mg filmom obložene tablete emtricitabin/tenofoviralafenamid
d Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
d Obuhvaća bolesnike s prekidom iz razloga koji nisu posljedica štetnog događaja, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
e Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
e Obuhvaća bolesnike s prekidom iz razloga koji nisu posljedica štetnog događaja, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
Co-administration with Descovy is not recommended.
Ne preporučuje se istodobna primjena s lijekom Descovy.
Velpatasvir: AUC: ↔ Cmin: ↑ 46%
Velpatasvir: AUC: ↔ Cmin: ↑ 46% Cmax: ↔
In open-label Study GS-US-292-1249, the efficacy and safety of emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet (E/C/F/TAF), were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior TDF-containing antiretroviral therapy.
U otvorenom Ispitivanju GS-US-292-1249, djelotvornost i sigurnost fiksne kombinacije emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti (E/C/F/TAF) procijenjene su u odraslih bolesnika istodobno zaraženih virusom HIV-1 i kroničnim hepatitisom B. Šezdeset devet od 72 bolesnika prethodno su bili na antiretrovirusnoj terapiji koja je sadržavala TDF.
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine and tenofovir alafenamide, in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (see section 4.8).
Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti (vidjeti dio 4.8).
Table 7: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Farmakokinetika emtricitabina i tenofoviralafenamida u adolescenata i odraslih koji prethodno nisu bili liječeni antiretrovirusnim lijekovima
In Study GS-US-311-1717, patients who were virologically suppressed (HIV-1 RNA <50 copies/mL) on their abacavir/lamivudine containing regimen for at least 6 months were randomised in a 1:1 ratio to either switch to Descovy (N=280) while maintaining their third agent at baseline or stay on their baseline abacavir/lamivudine -containing regimen (N=276).
< 50 kopija/ml) i koji su bili na režimu abakavir/lamivudin najmanje 6 mjeseci randomizirani su u omjeru 1:1 kako bi se prebacili bilo na lijek Descovy (N = 280) uz zadržavanje liječenja trećim lijekom s početka ispitivanja ili ostali na svom početnom režimu koji sadrži abakavir/lamivudin
c Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
c Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. ili 96. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz razloga koji nisu posljedica štetnog događaja, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida imali virusnu vrijednost ≥ 50 kopija/ml.
Le
U
At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet.
U 48. tjednu, 92% bolesnika (66/72) zadržalo je HIV-1 RNK < 50 kopija/ml nakon prebacivanja na fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti.
to 1.5 μM).
(vidjeti dio 5.2).
Descovy film-coated tablets are grey, rectangular-shaped tablets, debossed on one side with “GSI” and the number “210” on the other side of the tablet.
Descovy filmom obložene tablete su sive tablete pravokutnog oblika, s utisnutom oznakom „GSI“ na jednoj strani i „210“ na drugoj strani tablete.
Descovy 200/25 mg once daily
(200/25 mg jedanput na dan)5
The active substances are emtricitabine and tenofovir alafenamide.
Djelatne tvari su emtricitabin i tenofoviralafenamid.
In patients co-infected with HIV and HBV
U bolesnika istodobno zaraženih HIV-om i HBV-om
(M, N, and O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed strain specific activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Tenofoviralafenamid je pokazao antivirusnu aktivnost u staničnoj kulturi na sve skupine virusa HIV-1 (M,N i 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 specifičnu aktivnost na sojeve HIV-2 (vrijednosti EC50 bile su u rasponu od 0,91 do 2,63 nM).
Polyvinyl alcohol
Film ovojnica poli(vinilni alkohol)
Co-administration of rifampicin, rifabutin, and rifapentine, all of which are P-gp inducers, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Istodobna primjena rifampicina, rifabutina i rifapentina, koji su svi induktori P-gp-a, može smanjiti koncentracije tenofoviralafenamida u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
Darunavir/cobicistat (800/150 mg once daily), tenofovir alafenamide (25 mg once daily)5
Darunavir/kobicistat (800/150 mg jedanput na dan), tenofovir alafenamid (25 mg jedanput na dan)5
Sofosbuvir (400 mg once daily)/ velpatasvir (100 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Sofosbuvir (400 mg jedanput na dan)/velpatasvir (100 mg jedanput na dan), emtricitabin (200 mg jedanput na dan)/tenofoviralafenamid (10 mg jedanput na dan)3
Descovy 200 mg/10 mg film-coated tablets
NAZIV LIJEKA Descovy 200 mg/10 mg filmom obložene tablete
ANTICONVULSANTS Oxcarbazepine Phenobarbital Phenytoin
Okskarbazepin Fenobarbital
• tenofovir alafenamide
• tenofovirdizoproksil
In Study GS-US-292-1825, the efficacy and safety of emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet were evaluated in a single arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet.
U otvorenom kliničkom ispitivanju GS-US-292-1825, djelotvornost i sigurnost emtricitabina i tenofoviralafenamida, koji su se davali s elvitegravirom i kobicistatom kao fiksna kombinacija u tableti, procijenjene su u jednoj skupini od 55 odraslih osoba zaraženih virusom HIV-1 sa završnim stadijem bolesti bubrega (eGFRCG < 15 ml/min) na kroničnoj hemodijalizi tijekom najmanje 6 mjeseci prije prebacivanja na emtricitabin i tenofoviralafenamid, koji su davani s elvitegravirom i kobicistatom kao fiksna kombinacija u tableti.
In studies GS-US-292-0104 and GS-US-292-0111, patients were randomised in a 1:1 ratio to receive either emtricitabine 200 mg and tenofovir alafenamide 10 mg (n = 866) once daily or emtricitabine
U Ispitivanjima GS-US-292-0104 i GS-US-292-0111 bolesnici su bili randomizirani u omjeru 1:1 kako bi primali emtricitabin 200 mg i tenofoviralafenamid 10 mg (n = 866) jednom dnevno ili emtricitabin 200 mg i tenofovirdizoproksil (u obliku fumarata) 245 mg (n = 867) jednom dnevno, s time da su obje terapije davane u fiksnoj kombinaciji s elvitegravirom 150 mg i kobicistatom 150 mg u jednoj tableti.
angioedema3, 4, pruritus, urticaria4 Musculoskeletal and connective tissue disorders Uncommon:
angioedem3, 4, svrbež, urtikarija4
• itching (pruritus)
• svrbež (pruritus) • koprivnjača (urtikarija)
SEDATIVES/HYPNOTICS Orally administered midazolam (2.5 mg single dose), tenofovir alafenamide (25 mg once daily)
Peroralno primijenjen midazolam (jednokratna doza od 2,5 mg), tenofoviralafenamid (25 mg jedanput na dan)
E/C/F/TDF (n = 867)
E/C/F/TDF
Lopinavir/ritonavir (800/200 mg once daily), tenofovir alafenamide (10 mg once daily)
Lopinavir/ritonavir (800/200 mg jedanput na dan), tenofoviralafenamid (10 mg jedanput na dan)
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 concentrating tenofovir in peripheral blood mononuclear cells (PBMCs) or HIV target cells including lymphocytes and macrophages.
A djelotvorniji od tenofovirdizoproksilfumarata u koncentriranju tenofovira u mononuklearnim stanicama periferne krvi (PBMC) ili ciljnim stanicama virusa HIV-a koje uključuju limfocite i makrofage.
Tenofovir alafenamide exposure is expected to decrease when tipranavir/ritonavir is used in combination with Descovy.
Kad se tipranavir/ritonavir primjenjuje u kombinaciji s lijekom Descovy, očekuje se smanjenje izloženosti tenofoviralafenamidu
ANTIDEPRESSANTS Sertraline (50 mg once daily), tenofovir alafenamide (10 mg once daily)3
Sertralin (50 mg jedanput na dan), tenofoviralafenamid (10 mg jedanput na dan)3
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in an openlabel clinical study (GS-US-292-0106) in which HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Sigurnost emtricitabina i tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog Ispitivanja (GS-US-292-0106) u kojem su pedijatrijski bolesnici u dobi od 12 do < 18 godina zaraženi virusom HIV-1 koji prethodno nisu bili liječeni primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti.
In Study GS-US-311-1089, the efficacy and safety of switching from emtricitabine/tenofovir disoproxil fumarate to Descovy while maintaining the third antiretroviral agent were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults (n = 663).
U randomiziranom, dvostruko slijepom Ispitivanju GS-US-311-1089 procjenjivane su djelotvornost i sigurnost prebacivanja odraslih bolesnika (n = 663) zaraženih virusom HIV-1 kod kojih je virus bio suprimiran s režima emtricitabin/tenofovirdizoproksilfumarat na lijek Descovy uz zadržavanje liječenja trećim antiretrovirusnim lijekom.
Atazanavir with ritonavir or cobicistat Darunavir with ritonavir or cobicistat1 Lopinavir with ritonavir
Descovy 200/10 mg jedanput na dan atazanavir s ritonavirom ili kobicistatom darunavir s ritonavirom ili kobicistatom1
No dose adjustment of Descovy is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Descovy should generally be avoided but may be used in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2).
Međutim, iako Descovy općenito treba izbjegavati u ovih bolesnika, može ga se primijeniti ako se smatra da su moguće koristi veće od mogućih rizika (vidjeti dijelove 4.4 i 5.2).
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimen Boosted PIs Other third agents
Udio (%) bolesnika s HIV-1 RNK < 50 kopija/ml prema prethodnom režimu liječenja
E/C/F/TDFe (n = 867)
E/C/F/TDFe
Patients should be informed that dizziness has been reported during treatment with Descovy.
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Bolesnike treba obavijestiti da je zabilježena omaglica tijekom liječenja lijekom Descovy.
No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl > 15 mL/min and < 30 mL/min) in a Phase 1 study of tenofovir alafenamide.
Nisu zapažene klinički značajne razlike u farmakokinetici tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl > 15 ml/min i
Darunavir/ritonavir (800/100 mg once daily), tenofovir alafenamide (10 mg once daily)
Darunavir/ritonavir (800/100 mg jedanput na dan), tenofoviralafenamid (10 mg jedanput na dan)
The safety of emtricitabine and tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine and tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet.
Sigurnost emtricitabina i tenofoviralafenamida procijenjena je tijekom 48 tjedana otvorenog kliničkog ispitivanja (GS-US-292-1825) u kojem je jedna skupina od 55 bolesnika zaraženih virusom HIV-1 u kojih je virus bio suprimiran, sa završnim stadijem bolesti bubrega (eGFRCG < 15 ml/min) i na kroničnoj hemodijalizi, primala fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti.
HIV-1 RNA < 20 copies/mL Treatment difference
HIV-1 RNK < 20 kopija/ml Razlika u liječenju
HIV-1 infected patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of emtricitabine and tenofovir alafenamide were evaluated in an open-label clinical study in which 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min) were switched to emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
U otvorenom kliničkom Ispitivanju GS-US-292-0112 procijenjena je djelotvornost i sigurnost emtricitabina i tenofoviralafenamida u 242 bolesnika zaražena virusom HIV-1 s blagim do umjerenim oštećenjem funkcije bubrega (eGFRCG: 30-69 ml/min) koji su bili prebačeni na fiksnu kombinaciju emtricitabina i tenofoviralafenamida (10 mg) s elvitegravirom i kobicistatom u jednoj tableti.
Co-administration of oxcarbazepine, phenobarbital, or phenytoin, all of which are P-gp inducers, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Istodobna primjena okskarbazepina, fenobarbitala i fenitoina, koji su svi induktori P-gp-a, može smanjiti koncentracije tenofoviralafenamida u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
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
Vrijednosti EC50 za tenofoviralafenamid bile su u rasponu od 2,0 do 14,7 nM.
Tenofovir alafenamide
emtricitabin/tenofoviralafenamid
E/C/F/TAF (n = 866)
(n = 866)
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine and tenofovir alafenamide, in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (see section 5.2).
Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali fiksnu kombinaciju emtricitabina i tenofoviralafenamida s elvitegravirom i kobicistatom u jednoj tableti
Co-administration of St. John's wort, a P-gp inducer, may decrease tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Istodobna primjena gospine trave, induktora P-gp-a, može smanjiti koncentracije tenofoviralafenamida u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
Co-administration of carbamazepine, a P-gp inducer, decreases tenofovir alafenamide plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
induktora P-gp-a, smanjuje koncentracije tenofoviralafenamida u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
AUC: ↑ 75%
Cmin: ↑ 58%
Anti-hepatitis C virus medicinal products Ledipasvir (90 mg once daily)/ sofosbuvir (400 mg once daily), emtricitabine (200 mg once daily)/ tenofovir alafenamide (10 mg once daily)3
Lijekovi protiv virusa hepatitsa C Ledipasvir (90 mg jedanput na dan)/ sofosbuvir (400 mg jedanput na dan), emtricitabin (200 mg jedanput na dan)/
Iron oxide black (E172)
titanijev dioksid makrogol 3350 talk željezov oksid, crni (E172)
Co-administration of Descovy with St. John's wort is not recommended.
Ne preporučuje se istodobna primjena lijeka Descovy s gospinom travom.
nausea
Nuspojava
Cmax, Cmin2
Srednja vrijednost postotka promjene AUC, Cmax, Cmin2
3 had missing data.
Podaci iz okvira ispitivanja nedostaju,
Rifampicin Rifapentine
Rifapentin
In Study GS-US-292-0106, the efficacy, safety, and pharmacokinetics of emtricitabine and tenofovir alafenamide were evaluated in an open-label study in which 50 HIV-1 infected, treatment-naïve adolescents received emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet.
U otvorenom Ispitivanju GS-US-292-0106 u kojem je 50 adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni primalo fiksnu kombinaciju emtricitabina i tenofoviralafenamida (10 mg) s elvitegravirom i kobicistatom u jednoj tableti procijenjene su djelotvornost, sigurnost i farmakokinetika emtricitabina i tenofoviralafenamida.