natgillin/translations-raw huggingface dataset:
f 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.
f Vključuje bolnike, ki so sodelovanje prekinili zaradi drugih razlogov kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
HCV infected patients.
pričakovane pri bolnikih, okuženih s HCV.
Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Tenofoviralafenamid se pretežno izloča po presnovi v tenofovir.
Some medicinal products should not be co-administered with Genvoya (see sections 4.3 and 4.5).
Nekaterih zdravil se ne sme uporabljati sočasno z zdravilom Genvoya (glejte poglavji 4.3 in 4.5).
Mean % change of elvitegravir pharmacokinetic parametersa
Povprečni % spremembe farmakokinetičnih parametrov za elvitegravira
Co-administration with Genvoya may lead to decreased elvitegravir and/or cobicistat exposures and loss of therapeutic effect and development of resistance.
Sočasno dajanje z zdravilom Genvoya lahko povzroči znižanje izpostavljenosti elvitegravirju in/ali kobicistatu in izgubo terapevtskega učinka in razvoj rezistence.
Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching to Genvoya.
Bolniki so imeli virološko supresijo (HIV-1 RNA < 50 kopij/ml) vsaj 6 mesecev pred prehodom na zdravilo Genvoya.
Co-administration of Genvoya with dabigatran is contraindicated.
Sočasna uporaba zdravila Genvoya z dabigatranom je kontraindicirana.
• Use effective contraception while taking Genvoya.
• Med jemanjem zdravila Genvoya morate uporabljati učinkovito kontracepcijo.
Patients with end stage renal disease on chronic haemodialysis
Bolniki s končno ledvično odpovedjo na kronični hemodializi
After switching to Genvoya, 100% (23/23) of patients in Cohort 2 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48.
Po prehodu na zdravilo Genvoya je 100 % (23/23) bolnikov v kohorti 2 ohranilo supresijo (HIV-1 RNA < 50 kopij/ml) v 48. tednu.
Both elvitegravir and cobicistat are primarily metabolised and eliminated by the liver.
Elvitegravir in kobicistat v glavnem presnavljajo in izločajo jetra.
Following oral administration of [14C]-cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Po peroralni uporabi [14C]kobicistata so 86 % in 8,2 % odmerka izolirali iz blata oz. urina.
Through 144 weeks of treatment, no subject discontinued Genvoya due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p < 0.001).
Do vključno 144. tedna zdravljenja noben preskušanec ni prekinil z jemanjem zdravila Genvoya zaradi neželenega učinka na ledvice kot posledice zdravljenja, medtem ko je zdravilo E/C/F/TDF (p < 0,001) prenehalo jemati 12 preskušancev.
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.
Protivirusna aktivnost tenofoviralafenamid proti laboratorijskim in kliničnim izolatom virusa HIV-1 podtipa B je bila ocenjena v limfoblastoidnih celičnih linijah, PBMC, primarnih monocitnih/makrofagnih celicah in limfocitih CD4+-T.
Mean exposures of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide achieved in children aged 8 to < 12 years (> 25 kg; n = 23) who received Genvoya in study GS-US-292-0106 were higher (20 to 80%) than the mean exposures achieved in adults (Table 6).
Povprečne izpostavljenosti elvitegravirju, kobicistatu, emtricitabinu, tenofovirju in tenofoviralafenamidu, ki so jih dosegli otroci, stari 8 do < 12 let (> 25 kg; n = 23), ki so prejemali zdravilo Genvoya v študiji GS-US-292-0106, so bile višje (20 do 80 %) od povprečnih izpostavljenosti, doseženih pri odraslih (preglednica 6).
When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Po popravku za vezavo na beljakovine pa je plazemska koncentracija nevezanega (prostega) tenofoviralafenamida pri bolnikih s hudo jetrno okvaro primerljiva s tisto pri osebah z normalnim delovanjem jeter.
In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving tenofovir alafenamide with other medicinal products is low.
Študije in vitro in klinične farmakokinetične študije medsebojnega delovanja zdravil kažejo, da je možnost interakcij, pri katerih posreduje CYP in vključujejo tenofoviralafenamid, z drugimi zdravili majhna.
Patients with CrCl greater than or equal to 60 mL/min:
Bolniki s CrCl 60 ml/min ali več:
• In adults and adolescents aged from 12 years and with body weight at least 35 kg
pri odraslih in mladostnikih, starih 12 let in več, s telesno maso vsaj 35 kg;
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 ~4.0.
Med najvišjo koncentracijo v plazmi je bilo povprečno razmerje med koncentracijo zdravila v plazmi in krvi ~ 1,0 in povprečno razmerje med koncentracijo zdravila v spermi in plazmi ~ 4,0.
Treatment with cobicistat and elvitegravir during pregnancy results in lower elvitegravir exposure (see sections 4.4 and 5.2).
Zdravljenje s kobicistatom in elvitegravirjem med nosečnostjo povzroči manjšo izpostavljenost elvitegravirju (glejte poglavji 4.4 in 5.2).
In patients co-infected with HIV and HBV
Pri bolnikih s sočasno okužbo s HIV in HBV
Patients had a mean age of 41 years (range 21-77), 89% were male, 67% were White, and 19% were Black.
Bolniki so bili povprečno stari 41 let (razpon 21-77), 89 % je bilo moških, 67 % je bilo belcev in 19 % je bilo črncev.
The difference in percentage was 4.2% (95% CI: 0.6% to 7.8%).
Razlika v odstotkih je bila 4,2 % (95-% IZ: 0,6 % do 7,8 %).
Genvoya should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatment of HBV infection (see section 4.5).
Zdravila Genvoya se ne sme dajati sočasno z zdravili, ki vsebujejo tenofoviralafenamid, dizoproksiltenofovirat, lamivudin ali dipivoksiladefovirat, ki se uporabljajo za zdravljenje infekcije s HBV (glejte poglavje 4.5).
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
Of the HIV-1 isolates from 12 patients with resistance development in the Genvoya group, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) and N155H (n = 2) in integrase.
Pri izolatih HIV-1 pri 12 bolnikih z razvojem rezistence v skupini z zdravilom Genvoya so se pojavile mutacije M184V/I (n = 11) in K65R/N (n = 2) v RT ter T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) in N155H (n = 2) v integrazi.
• antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole
• antimikotike, ki se uporabljajo za zdravljenje glivičnih okužb, kot so: ketokonazol, itrakonazol, vorikonazol, posakonazol in flukonazol
The mean age was 36 years (range 18-76), 85% were male, 57% were White, 25% were Black, and 10% were Asian.
Povprečna starost je bila 36 let (razpon 18-76), 85 % je bilo moških, 57 % je bilo belcev, 25 % je bilo črncev in 10 % je bilo Azijcev.
In animal studies there were no effects of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide on mating or fertility parameters (see section 5.3).
V študijah na živalih ni bilo učinkov elvitegravirja, kobicistata, emtricitabina ali tenofoviralafenamid na parjenje ali parametre plodnosti (glejte poglavje 5.3).
Genvoya should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatment of HBV infection.
Zdravila Genvoya se ne sme dajati skupaj z zdravili, ki vsebujejo tenofoviralafenamid, dizoproksiltenofovirat, lamivudin ali dipivoksiladefovirat in se uporabljajo za zdravljenje okužbe s HBV.
HIV-1 infected patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of Genvoya were evaluated in an open-label clinical study of 242 HIV-1 infected patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min).
Bolniki z okužbo HIV-1 z blago do zmerno ledvično okvaro V študiji GS-US-292-0112 so učinkovitost in varnost zdravila Genvoya ocenili v odprti klinični študiji s 242 bolniki, okuženimi s HIV-1, z blago do zmerno ledvično okvaro (eGFRCG: 30-69 ml/min).
If you accidentally take more than the recommended dose of Genvoya you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Če ste vzeli večji odmerek zdravila Genvoya, kot bi smeli Če ste pomotoma zaužili odmerek zdravila Genvoya, višji od priporočenega, obstaja povečano tveganje za pojav možnih neželenih učinkov (glejte poglavje 4, Možni neželeni učinki).
Of the HIV-1 isolates from 12 patients with resistance development in the E/C/F/TDF group, the mutations that emerged were M184V/I (n = 9), K65R/N (n = 4), and L210W (n = 1) in RT and E92Q/V (n = 4), and Q148R (n = 2), and N155H/S (n = 3) in integrase.
Pri izolatih HIV-1 pri 12 bolnikih z razvojem rezistence v skupini E/C/F/TDF so se pojavile mutacije M184V/I (n = 9), K65R/N (n = 4) in L210W (n = 1) v RT ter E92Q/V (n = 4) in Q148R (n = 2) in N155H/S (n = 3) v integrazi.
Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Tenofovir se učinkovito odstrani s hemodializo s koeficientom estrakcije približno
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue of 2'-deoxycytidine.
Emtricitabin je nukleozidni zaviralec reverzne transkriptaze (NRTI- nucleoside reverse transcriptase inhibitor) in nukleozidni analog 2'-deoksicitidina.
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 any of the components of Genvoya prior to study entry.
Bolniki so morali biti pred vstopom v študijo stabilno supresirani (HIV-1 RNA < 50 kopij/ml) na začetnem režimu vsaj 6 mesecev in imeti HIV-1 brez mutacij, povezanih z rezistencami na katero koli od učinkovin zdravila Genvoya.
In these 2 patients, no amino acid substitutions associated with resistance to any of the components of Genvoya were identified in HIV-1 or HBV.
Pri virusih HIV-1 ali HBV pri teh 2 bolnikih niso ugotovili substitucij aminokislin, povezanih z rezistenco na katero koli od učinkovin zdravila Genvoya.
There is insufficient information on the effects of elvitegravir, cobicistat, emtricitabine and tenofovir in newborns/infants.
Podatki o učinku elvitegravirja, kobicistata, emtricitabina in tenofovirja na dojene novorojence/otroke so nezadostni.
Co-administration of rifabutin, a potent CYP3A inducer, may significantly decrease cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Sočasno dajanje rifabutina, močnega induktorja CYP3A, lahko pomembno zniža koncentracije kobicistata in elvitegravirja v plazmi, kar ima lahko za posledico izgubo terapevtskega učinka in razvoj rezistence.
atorvastatin and pitavastatin
atorvastatin in pitavastatin
Table 6: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in virologically suppressed children and adults
Preglednica 6: Farmakokinetika elvitegravirja, kobicistata, emtricitabina, tenofovirja in tenofoviralafenamida pri otrocih in odraslih z virološko supresijo
The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) in HIV-1 infected patients, respectively, were 1.7 ± 0.39 µg/mL, 23 ± 7.5 µg•h/mL, and 0.45 ± 0.26 µg/mL for elvitegravir, which provides inhibitory quotient of ~10 (ratio of Ctrough: protein binding-adjusted IC95 for wild-type HIV-1 virus).
Povprečni Cmax, AUCtau in Ctrough (povprečje ± SD) v stanju dinamičnega ravnovesja po večkratnem odmerjanju bolnikom, okuženim z virusom HIV-1, so bili 1,7 ± 0,39 µg/ml, 23 ± 7,5 µg•h/ml oz. 0,45 ± 0,26 µg/ml za elvitegravir, kar pomeni inhibicijski kvocient ~ 10 (razmerje Ctrough: IC95 prilagojen za vezavo na proteine, za divji tip virusa HIV-1).
Concentrations of these HMG Co-A reductase inhibitors are expected to transiently increase when administered with elvitegravir and cobicistat.
Koncentracije teh zaviralcev reduktaze HMG Co-A se lahko pri dajanju z elvitegravirjem in kobicistatom prehodno zvišajo.
Co-administration with Genvoya may increase dabigatran plasma concentrations with similar effects as seen with other strong P-gp inhibitors.
Koncentracije dabigatrana v plazmi se lahko pri sočasnem dajanju z zdravilom Genvoya zvišajo s podobnimi učinki kot pri drugih močnih zaviralcih P-gp.
Magnesium/aluminium-containing antacid suspension (20 mL single dose)/ Elvitegravir (50 mg single dose)/ Ritonavir (100 mg single dose)
suspenzije antacidov, ki vsebujejo magnezij/aluminij (20 ml enkratni odmerek)/elvitegravir (50 mg enkratni odmerek)/ritonavir (100 mg enkratni odmerek)
Therefore, Genvoya should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5):
Zdravilo Genvoya se zato ne sme dajati sočasno z zdravili, ki med drugim vključujejo naslednje (glejte poglavji 4.4 in 4.5):
The pharmacokinetics of emtricitabine and tenofovir alafenamide have not been fully evaluated in patients co-infected with hepatitis B and/or C virus.
Sočasna okužba z virusom hepatitisa B in/ali hepatitisa C Farmakokinetične lastnosti emtricitabina in tenofoviralafenamida pri bolnikih s hkratno okužbo z virusom hepatitisa B in/ali C niso v celoti ovrednotili.
There are no pharmacokinetic data on elvitegravir, cobicistat, emtricitabine or tenofovir alafenamide in patients with end stage renal disease (estimated CrCl < 15 mL/min) not on chronic haemodialysis.
Farmakokinetičnih podatkov o elvitegravirju, kobicistatu, emtricitabinu in tenofoviralafenamidu pri bolnikih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min), ki niso na kronični hemodializi,
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
In vitro je bila vezava emtricitabina na humane plazemske proteine manj kot 4 % in je neodvisna od koncentracije v razponu med 0,02-200 µg/ml.
No other metabolites were identifiable.
Drugi presnovki niso bili opredeljeni.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odegovornih) za sproščanje serij Gilead Sciences Ireland UC
The safety of Genvoya was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included tenofovir disoproxil in 69 of 72 patients) to Genvoya.
Bolniki s hkratno okužbo s HIV in HBV Varnost zdravila Genvoya so ocenili pri 72 bolnikih s hkratno okužbo s HIV/HBV, ki so se zdravili zaradi HIV v odprti klinični študiji (GS-US-292-1249) do konca 48. tedna, v kateri so bolniki prešli z drugega protiretrovirusnega režima (ki je vključeval dizoproksiltenofovirat pri 69 od 72 bolnikov) na zdravilo Genvoya.
Missing data during window but on study drug Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by subgroup
V oknu podatki manjkajo, a uporablja študijsko zdravilo Delež (%) bolnikov s HIV-1 RNA < 50 kopij/ml po režimu predhodnega zdravljenja
Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Tenofoviralafenamid in vivo ni zaviralec ali induktor CYP3A.
Table 2: Tabulated list of adverse reactions
Preglednica 2: Seznam neželenih učinkov v obliki preglednice Pogostnost
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 Vključuje bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
In studies GS-US-292-0104 and GS-US-292-0111, patients were randomised in a 1:1 ratio to receive either Genvoya (n = 866) once daily or elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) (n = 867) once daily.
V študijah GS-US-292-0104 in GS-US-292-0111 so bolnike randomizirali v razmerju 1:1 za prejemanje zdravila Genvoya (n = 866) enkrat dnevno ali elvitegravir 150 mg/kobicistat
Talk to your doctor before taking Genvoya: • If you have liver problems or a history of liver disease, including hepatitis.
• Če imate težave z jetri ali jetrne bolezni v zdravstveni zgodovini, vključno s hepatitisom.
Co-administration of Genvoya and some medicinal products that induce CYP3A such as St. John's wort (Hypericum perforatum), rifampicin, carbamazepine, phenobarbital, and phenytoin may result in significantly decreased cobicistat and elvitegravir plasma concentrations, which may result in loss of therapeutic effect and development of resistance (see section 4.3).
Sočasno dajanje zdravila Genvoya in nekaterih zdravil, ki inducirajo CYP3A, kot so šentjanževka (Hypericum perforatum), rifampicin, karbamazepin, fenobarbital in fenitoin, lahko povzroči znatno zmanjšanje koncentracij kobicistata in elvitegravirja v plazmi, kar ima lahko za posledico izgubo terapevtskega učinka in razvoj rezistence (glejte poglavje 4.3).
Taking into account the PRAC Assessment Report on the PSUR(s) for cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide, the scientific conclusions of CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za kobicistat/elvitegravir/emtricitabin/tenofoviralafenamid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
 If any of these applies to you, do not take Genvoya and tell your doctor immediately.
 Če to velja za vas, ne jemljite zdravila Genvoya in o tem nemudoma obvestite svojega zdravnika.
Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.
rivaroksabana ali edoksabana in zdravila Genvoya se ne priporoča.
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 5.2).
Novih vprašanj glede varnosti pri bolnikih s končno ledvično odpovedjo na kronični hemodializi, ki so dobivali zdravilo Genvoya, niso prepoznali (glejte poglavje 5.2).
Genvoya should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Zdravila Genvoya se ne sme uporabljati sočasno z drugimi protiretrovirusnimi zdravili (glejte poglavje 4.5).
Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild or moderate hepatic impairment.
Klinično pomembnih sprememb v farmakokinetiki tenofoviralafenamid ali njegovega presnovka tenofovirja pri bolnikih z blago do zmerno jetrno okvaro niso opazili.
Interaction not studied with Genvoya.
Interakcij niso preučili z zdravilom Genvoya.
0.4% (95% CI: -3.0% to 3.8%)
0,4 % (95-% IZ: -3,0 % do 3,8 %)
 If you notice any of these symptoms tell your doctor.
 Če jemljete katero od teh zdravil, obvestite svojega zdravnika.
In open-label Study GS-US-292-1249, the efficacy and safety of Genvoya were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior tenofovir disoproxil-containing antiretroviral therapy.
V odprti študiji GS-US-292-1249 so učinkovitost in varnost zdravila Genvoya ocenili pri odraslih bolnikih s sočasno okužbo s HIV-1 in kroničnim hepatitisom B. Devetinšestdeset od 72 bolnikov se je pred tem zdravilo s protiretrovirusno terapijo, ki je vsebovala dizoproksiltenofovirat.
30 film-coated tablets 30 tablets
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet
In treatment-naïve patients, a mean change from baseline of 0.04 ± 0.12 mg/dL (3.5 ± 10.6 µmol/L) was observed after 144 weeks of treatment.
Pri predhodno nezdravljenih bolnikih so po 144 tednih zdravljenja opazili povprečno spremembo od začetne vrednosti 0,04 ± 0,12 mg/dl (3,5 ± 10,6 μmol/l).
After switching to Genvoya, 90% (45/50) of patients remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48.
Po prehodu na zdravilo Genvoya je 90 % (45/50) bolnikov ohranilo supresijo (HIV-1 RNA < 50 kopij/ml) v 48. tednu.
FOOD SUPPLEMENTS Multivitamin supplements
multivitaminska dopolnila
Triazolam is primarily metabolised by CYP3A.
Triazolam se presnavlja pretežno s CYP3A.
It is recommended that digoxin levels be monitored when digoxin is combined with Genvoya.
Pri uporabi digoksina v kombinaciji z zdravilom Genvoya se priporoča nadziranje ravni digoksina.
ANTI-HYPERTENSIVES Metoprolol
ANTIHIPERTENZIVI metoprolol timolol
The mean age was 50 years (range 28-67), 92% of patients were male, 69% were White, 18% were Black, and 10% were Asian.
Povprečna starost je bila 50 let (razpon 28-67), 92 % bolnikov je bilo moških, 69 % je bilo belcev, 18 % je bilo črncev in 10 % je bilo Azijcev.
Recommendation concerning co-administration with Genvoya
Priporočilo glede sočasne uporabe z zdravilom Genvoya
Cross-resistance in HIV-1 infected, treatment-naïve or virologically suppressed patients Elvitegravir-resistant viruses show varying degrees of cross-resistance to the INSTI raltegravir depending on the type and number of mutations.
Virusi, rezistentni na elvitegravir, kažejo različne stopnje navzkrižne rezistence na INSTI raltegravir, odvisno od vrste in števila mutacij.
Ninety-two percent (66/72 patients) had HBV DNA < 29 IU/mL using missing = failure analysis at Week 48.
Dvaindevetdeset odstotkov (66/72 bolnikov) je imelo v 48. tednu HBV DNA < 29 i.e./ml, izmerjeno z analizo manjkajoče = odpoved.
The antiviral activity of elvitegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cells, monocyte/macrophage cells, and peripheral blood lymphocytes and the 50% effective concentration (EC50) values were in the range of 0.02 to 1.7 nM. Elvitegravir displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, G, and O (EC50 values ranged from 0.1 to 1.3 nM) and activity against HIV-2 (EC50 of 0.53 nM).
Protivirusna aktivnost elvitegravirja proti laboratorijskim in kliničnim izolatom HIV-1 je bila ocenjena v limfoblastoidnih celicah, monocitih/makrofagih in limfocitih v periferni krvi, pri čemer so bile vrednosti 50-odstotno učinkovite koncentracije (EC50) v razponu od 0,02 do 1,7 nM. Elvitegravir je pokazal protivirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F, G in O virusa HIV-1 (vrednosti EC50 so bile v razponu od 0,1 do 1,3 nM) in aktivnost proti HIV-2 (vrednost EC50 je bila 0,53 nM).
Therapy should be initiated by a physician experienced in the management of HIV infection.
4.2 Odmerjanje in način uporabe Terapijo mora začeti zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV.
The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813).
Povprečno število celic CD4+ na začetku je bilo 664 celic/mm3 (razpon 126-1.813).
Midazolam is primarily metabolised by CYP3A.
Midazolam se presnavlja pretežno s CYP3A.
There are limited clinical data on the use of Genvoya in HIV/HBV co-infected patients who are treatment-naïve.
Klinični podatki o uporabi zdravila Genvoya pri bolnikih s sočasno okužbo HIV/HBV, ki se predhodno še niso zdravili, so omejeni.
Caution should be exercised when co-administering Genvoya and a hormonal contraceptive.
Pri sočasnem dajanju zdravila Genvoya in hormonskega kontraceptiva je potrebna previdnost.
2.0% (95% CI: -0.7% to 4.7%)
2,0 % (95-% IZ: -0,7 % do 4,7 %)