natgillin/translations-raw huggingface dataset:
Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected. 
Nakon istodobne primjene s efavirenzom, umjerenim induktorom CYP3A, kao testom, izloženost tenofoviralafenamidu se nije značajno promijenila.
Indigo carmine aluminium lake (E132) Iron oxide yellow (E172) 
boja indigo carmine aluminium lake (E132)
d 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. 
d Obuhvatilo bolesnika 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 nuspojava, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida imali virusnu vrijednost ≥ 50 kopija/ml.
Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya. 
Ne preporučuje se istodobna primjena apiksabana, rivaroksabana ili edoksabana s Genvoyom.
No clinically relevant pharmacokinetic differences due to gender or ethnicity have been identified for cobicistat-boosted elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide. 
Klinički značajne farmakokinetičke razlike vezane uz spol ili etničku pripadnost nisu ustanovljene za kobicistatom pojačani elvitegravir, kobicistat, emtricitabin ili tenofoviralafenamid.
On days of haemodialysis, Genvoya should be administered after completion of haemodialysis treatment. 
Na dane hemodijalize, lijek Genvoya treba primijeniti nakon završetka postupka hemodijalize.
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 na laboratorijske i kliničke izolate virusa HIV-1 procijenjena je na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI CCR5 i PBMC.
• erectile dysfunction medicines, used to treat impotence, such as: 
• kontracepcijske pilule, primjenjuju se za sprječavanje trudnoće • lijekove za erektilnu disfunkciju, primjenjuju se za liječenje impotencije, kao što su:
Disopyramide Flecainide Systemic lidocaine Mexiletine Propafenone 
Flekainid Sistemski lidokain
Co-administration of Genvoya and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, lurasidone, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3). 
Kontraindicirana je i istodobna primjena lijeka Genvoya i drugih lijekova koje prvenstveno metabolizira CYP3A, kao što su amiodaron, kinidin, cisaprid, pimozid, lurasidon, alfuzozin i sildenafil za plućnu arterijsku hipertenziju (vidjeti dio 4.3).
Lactose (as monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate. 
Laktoza (u obliku hidrata), mikrokristalična celuloza, umrežena karmelozanatrij, hidroksipropilceluloza, silicijev dioksid, natrijev laurilsulfat, magnezijev stearat.
Concentrations of calcium channel blockers may be increased when co-administered with cobicistat. 
Koncentracije blokatora kalcijevih kanala mogu se povećati s istodobnom primjenom kobicistata.
Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received Genvoya in Study GS-US-292-1825 were significantly higher than in patients with normal renal function. 
Izloženost emtricitabinu i tenofoviru u 12 bolesnika sa završnim stadijem bolesti bubrega (procijenjeni CrCl < 15 ml/min) na kroničnoj hemodijalizi koji su primali lijek Genvoya u ispitivanju GS-US-292-1825 bila je značajno veća nego u bolesnika s normalnom funkcijom bubrega.
For information on other acid reducing agents (e.g., H2-receptor antagonists and proton pump inhibitors), see “Studies conducted with other medicinal products”. 
Informacije o drugim lijekovima koji reduciraju kiselinu (npr. antagonisti H2-receptora i inhibitori protonske pumpe)
Genvoya should not be co-administered with other antiretroviral medicinal products (see section 4.5). 
Genvoya se ne smije primjenjivati istodobno s drugim antiretrovirusnim lijekovima (vidjeti dio 4.5).
While you are taking Genvoya 
Dok uzimate lijek Genvoya
• Do not breast-feed during treatment with Genvoya. 
• Nemojte dojiti tijekom liječenja lijekom Genvoya.
• medicines used to treat diabetes: 
• lijekove za liječenje dijabetesa:
Genvoya 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 liek Genvoya 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).
Co-administration of Genvoya with dabigatran is contraindicated. 
Istodobna primjena Genvoye s dabigatranom je kontraindicirana.
There were no clinically significant changes in fasting lipid laboratory tests in patients who switched to Genvoya. 
Nije bilo klinički značajnih promjena u laboratorijskim vrijednostima lipida izmjerenih natašte u bolesnika koji su prebačeni na lijek
In animal studies there were no effects of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide on mating or fertility parameters (see section 5.3). 
U ispitivanjima na životinjama nije bilo učinaka elvitegravira, kobicistata, emtricitabina i tenofoviralafenamida na parenje ili parametre plodnosti (vidjeti dio 5.3).
In a clinical study (GS-US-292-0106) in which Genvoya was administered to 23 HIV-1 infected paediatric patients with a mean age of 10 years (range 8 to 11 years), the mean exposures of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide were higher (20 to 80%) than the mean exposures achieved in adults (see sections 4.1 and 5.2). 
U kliničkom ispitivanju (GS-US-292-0106) u kojem su 23 pedijatrijska bolesnika zaražena virusom HIV-1 srednje vrijednosti dobi od 10 godina (u rasponu od 8 do 11 godina) primala lijek Genvoya, srednje vrijednosti izloženosti elvitegraviru, kobicistatu, emtricitabinu, tenofoviru i tenofoviralafenamidu su bile više (od 20% do 80%) od srednjih vrijednosti izloženosti postignutih u odraslih (vidjeti dijelove 4.1 i 5.2).
Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets. 
Genvoya 150 mg/150 mg/200 mg/10 mg filmom obložene tablete.
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 Genvoya. 
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 Genvoya.
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 (raspon1,3-7,0), a 23% imalo je početno virusno opterećenje > 100 000 kopija/ml.
Cobicistat is a strong mechanism-based inhibitor of CYP3A and is also a CYP3A substrate. 
Kobicistat je snažan inhibitor CYP3A temeljeno na mehanizmu te također i supstrat za CYP3A.
If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects. 
potrebno je započeti s primjenom tih lijekova tek nakon medicinske procjene i pod pomnim praćenjem liječnika radi eventualnih nuspojava kortikosteroida.
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 5.2). 
Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali lijek Genvoya (vidjeti dio 5.2).
5.4% (95% CI: 1.5% to 9.2%) 
5,4% (95% CI: 1,5% do 9,2%)
The median increase from baseline for those parameters was greater in the Genvoya group compared with the E/C/F/TDF group at Week 144 (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides). 
Medijan porasta ovih parametara od početnih vrijednosti bio je veći u skupini liječenoj lijekom Genvoya u usporedbi sa skupinom liječenom E/C/F/TDF u 144. tjednu (p < 0,001 za razliku između liječenih skupina u vrijednostima ukupnog kolesterola, LDL i HDL kolesterola te triglicerida natašte).
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 Obuhvaća bolesnike s prekidom iz razloga koji nisu posljedica nuspojava, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
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 nuspojava ili smrti u bilo kojem trenutku od 1. dana tijekom vremenskiog okvira, ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. 
Bolesnici s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom, izloženi su povećanom riziku od teških i potencijalno životno opasnih jetrenih nuspojava.
The use of Genvoya should be accompanied by the use of effective contraception (see sections 4.4 and 4.5). 
Uz primjenu lijeka Genvoya mora se koristiti učinkovita kontracepcija (vidjeti dijelove 4.4 i 4.5).
Genvoya 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 Genvoya u bolesnika u kojih procijenjeni CrCl tijekom liječenja opada na vrijednosti ispod 30 ml/min (vidjeti dio 5.2).
6 This study was conducted using emtricitabine/tenofovir alafenamide. 
To je ispitivanje provedeno pomoću emtricitabina/tenofoviralafenamida.
e 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. 
e Obuhvaća bolesnike koji su prekinuli liječenje zbog nuspojava ili smrti u bilo kojem trenutku od 1. dana tijekom vremenskog okvira, ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.
Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations. 
Istodobna primjena karbamazepina, snažnog induktora CYP3A, može značajno smanjiti koncentracije kobicistata u plazmi.
Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat. 
Koncentracije itrakonazola, flukonazola i posakonazola mogu se povećati s istodobnom primjenom kobicistata.
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). 
Srednje vrijednosti Cmax, AUCtau i Ctrough (srednja vrijednost ± SD) u stanju dinamičke ravnoteže u bolesnika zaraženih virusom HIV-1 bile su 1,7 ± 0,39 µg/ml, 23 ± 7,5 µg•h/ml, i 0,45 ± 0,26 µg/ml za elvitegravir, što omogućuje inhibitorski kvocijent od ~ 10 (omjer Ctrough: IC95 s prilagođenim proteinskim vezivanjem za divlji tip virusa HIV-1).
Treatment with cobicistat and elvitegravir during pregnancy results in lower elvitegravir exposure (see sections 4.4 and 5.2). 
Liječenje kobicistatom i elvitegravirom tijekom trudnoće rezultirat će manjom izloženošću elvitegraviru (vidjeti dijelove 4.4 i 5.2).
As the effect of cationic complexation of elvitegravir cannot be excluded when Genvoya is co-administered with multivitamin supplements, it is recommended to separate Genvoya and multivitamin supplements dosing by at least 4 hours. 
Kako se učinak kationske kompleksacije elvitegravira ne može isključiti kada se Genvoya istodobno primjenjuje s multivitaminskim dodacima,
In studies in treatment-naïve patients, increases from baseline were observed in both 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 u bolesnika koji prethodno nisu bili liječeni, u obje liječene skupine 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.
PDE-5 inhibitors are primarily metabolised by CYP3A. 
Inhibitori PDE-5 prvenstveno se metaboliziraju s CYP3A.
Co-administration with Genvoya may result in increased plasma concentrations of the DOAC, which may lead to an increased bleeding risk. 
Istodobna primjena s Genvoyom može dovesti do povećanih koncentracija DOAC-a u plazmi, što može dovesti do povećane opasnosti od krvarenja.
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. 
In vitro i klinička farmakokinetička ispitivanja interakcija lijekova pokazala su da je mogućnost interakcija posredovanih CYP sustavom za tenofoviralafenamid s drugim lijekovima mala.
In patients treated with Genvoya, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL. 
Od bolesnika liječenih lijekom Genvoya, 92% (46/50) ih je postiglo razinu HIV-1 RNK < 50 kopija/ml.
Skin and subcutaneous tissue disorders Common: 
Poremećaji kože i potkožnog tkiva
Non-black 
Svi osim crnaca
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Ova uputa je zadnji puta revidirana u <{MM/GGGG}> <{mjesec GGGG}> Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
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 liječenja iz razloga koji nisu posljedica nuspojava, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
Some medicinal products should not be co-administered with Genvoya (see sections 4.3 and 4.5). 
Neki lijekovi ne smiju se primjenjivati istodobno s lijekom Genvoya (vidjeti dijelove 4.3 i 4.5).
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). 
Istodobna primjena lijeka Genvoya i nekih lijekova koji induciraju CYP3A, kao što su gospina trava (Hypericum perforatum), rifampicin, karbamazepin, fenobarbital i fenitoin, može dovesti do značajno smanjenih koncentracija kobicistata i elvitegravira u plazmi, što može za posljedicu imati gubitak terapijskog učinka i razvoj rezistencije (vidjeti dio 4.3).
HIV-1 isolates with the K65R mutation have low-level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine. 
Izolati virusa HIV-1 s mutacijom K65R pokazuju malo smanjenje osjetljivosti na abakavir, emtricitabin, tenofovir i lamivudin.
If the patient misses a dose of Genvoya within 18 hours of the time it is usually taken, the patient should take Genvoya with food as soon as possible and resume the normal dosing schedule. 
Ako bolesnik propusti uzeti dozu lijeka Genvoya, a prošlo je manje od 18 sati od uobičajenog vremena uzimanja doze, bolesnik mora što prije uzeti lijek Genvoya s hranom i potom ga nastaviti uzimati prema uobičajenom rasporedu.
 If any of these applies to you, do not take Genvoya and tell your doctor immediately. 
Ako se bilo što od ovoga odnosi na Vas, nemojte uzimati lijek Genvoya i odmah o tome obavijestite liječnika.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and nucleoside analogue of 2'-deoxycytidine. 
Emtricitabin je nukleozidni inhibitor reverzne transkriptaze (NRTI) i nukleozidni analog 2'-deoksicitidina.
The use of Genvoya with oral contraceptives containing other progestogens should be avoided (see section 4.5). 
Primjena lijeka Genvoya i oralnih kontraceptiva koji sadrže druge progestagene mora se izbjegavati (vidjeti dio 4.5).
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). 
Genvoya se ne smije primjenjivati istodobno s lijekovima koji sadrže tenofoviralafenamid, tenofovirdizoproksil, lamivudin ili adefovirdipivoksil koji se primjenjuju u liječenju infekcije HBV-om (vidjeti dio 4.5).
Medicinal products that inhibit CYP3A may decrease the clearance of cobicistat, resulting in increased plasma concentrations of cobicistat. 
Lijekovi koji inhibiraju CYP3A mogu smanjiti klirens kobicistata, što dovodi do povećane koncentracije kobicistata u plazmi.
Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild or moderate hepatic impairment. 
Nisu zapažene klinički važne promjene u farmakokinetici tenofoviraalafenamida ili njegovog metabolita tenofovira u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre.
The pharmacokinetics of emtricitabine and tenofovir alafenamide have not been fully evaluated in patients co-infected with hepatitis B and/or C virus. 
Istodobna infekcija virusom hepatitisa B i/ili hepatitisa C Farmakokinetika emtricitabina i tenofoviralafenamida nije potpuno procijenjena u bolesnika koji su istodobno zaraženi virusom hepatitisa B i/ili C.
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. 
Genvoya se ne smije primjenjivati istodobno s lijekovima koji sadrže tenofoviralafenamid, tenofovirdizoproksil, lamivudin ili adefovirdipivoksil koji se primjenjuju u liječenju infekcije HBV-om.
The most frequently reported adverse reactions in clinical studies through 144 weeks were nausea (11%), diarrhoea (7%), and headache (6%) (pooled data from Phase 3 clinical studies GS-US-292-0104 and GS-US-292-0111 in 866 treatment-naïve adult patients receiving Genvoya). 
Najčešće zabilježene nuspojave u kliničkim ispitivanjima tijekom 144 tjedna bile su mučnina (11%), proljev (7%) i glavobolja (6%) (objedinjeni podaci iz kliničkih ispitivanja faze 3 GS-US-292-0104 i
Studies of tenofovir alafenamide in animals have shown no evidence of harmful effects of tenofovir alafenamide on fertility parameters, pregnancy, or foetal development (see section 5.3). 
Ispitivanja tenofoviralafenamida na životinjama nisu pokazala nikakve dokaze štetnih učinaka tenofoviralafenamida na parametre plodnosti, trudnoću ili razvoj fetusa (vidjeti dio
• wind (flatulence) 
• bol u trbuhu • vjetrovi (flatulencija)
It is recommended to separate Genvoya and antacid administration by at least 4 hours. 
preporučuje se razdvajanje doziranja lijeka Genvoya i multivitaminskih dodataka za najmanje 4 sata.
Magnesium/aluminium-containing antacid suspension (20 mL single dose)/ Elvitegravir (50 mg single dose)/ Ritonavir (100 mg single dose) 
Antacidna suspenzija koja sadrži magnezij i aluminij (jedna doza od 20 ml)/elvitegravir (jedna doza od 50 mg)/ritonavir (jedna doza od 100 mg)
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 na laboratorijske i kliničke izolate virusa HIV-1 podtipa B procijenjeno je na limfoblastoidnim staničnim linijama, PBMC-ovima, primarnim monocitnim/makrofagnim stanicama i CD4+-T limfocitima.
Patients in the study had a median age of 15 years (range: 12 to 17 years), 64% were female and 98% were Black. 
Bolesnici u ispitivanju imali su srednju vrijednost dobi 15 godina (raspon: 12 - 17), 64% njih bilo je ženskog spola a 98% crnci.
• bronchodilators, used to treat asthma and other lung-related problems: salmeterol 
• bronhodilatatore, primjenjuju se za liječenje astme i drugih tegoba s plućima:
Table 6: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in virologically suppressed children and adults 
Tablica 6. Farmakokinetika elvitegravira, kobicistata, emtricitabina, tenofovira i tenofoviralafenamida u djece i odraslih s virološkom supresijom
The mean increase from baseline in CD4+ cell count was 230 cells/mm3 in Genvoya-treated patients and 211 cells/mm3 in E/C/F/TDF-treated patients (p = 0.024) at Week 48, and 326 cells/mm3 in Genvoya-treated patients and 305 cells/mm3 in E/C/F/TDF-treated patients (p = 0.06) at Week 144. 
Srednja vrijednost povećanja od početne vrijednosti broja stanica CD4+ bila je 230 stanica/mm3 u bolesnika liječenih lijekom Genvoya i 211 stanica/mm3 u bolesnika liječenih E/C/F/TDF (p = 0,024) u 48. tjednu te 326 stanica/mm3 u bolesnika liječenih lijekom Genvoya i 305 stanica/mm3 u bolesnika liječenih E/C/F/TDF (p = 0,06) u 144. tjednu.
The mean age was 36 years (range 18-76), 85% were male, 57% were White, 25% were Black, and 10% were Asian. 
Srednja vrijednost dobi bila je 36 godina (raspon 18-76), 85% ih je bilo muškaraca, 57% su bili bijelci, 25% crnci i 10% azijati.
Treatment with cobicistat and elvitegravir during the second and third trimesters of pregnancy has been shown to result in lower elvitegravir exposure (see section 5.2). 
Pokazalo se da liječenje kobicistatom i elvitegravirom tijekom drugog i trećeg tromjesečja trudnoće rezultira manjom izloženošću elvitegraviru (vidjeti dio 5.2).
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. 
Istodobna primjena rifabutina, snažnog induktora CYP3A, može značajno smanjiti koncentracije kobicistata i elvitegravira u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
Patients in Cohort 2 had a mean age of 10 years (range: 8 to 11), a mean baseline weight of 32 kg (range: 26 to 58), were 39% male, 13% Asian, and 78% Black. 
Bolesnici iz kohorte 2 imali su srednju vrijednost dobi 10 godina (raspon: 8-11), srednju vrijednost tjelesne težine na početku ispitivanja 32 kg (raspon: 26-58), 39% su bili muškog spola, 13% azijati i 78% crnci.
0.4% (95% CI: -3.0% to 3.8%) 
0,4% (95% CI: -3,0% do 3,8%)
At baseline, mean plasma HIV-1 RNA was 4.6 log10 copies/mL, median CD4+ cell count was 456 cells/mm3 (range: 95 to 1,110), and median CD4+% was 23% (range: 7 to 45%). 
Na početku je srednja vrijednost HIV-1 RNK u plazmi bila 4,6 log10 kopija/ml, medijan broja CD4+ stanica bio je 456 stanica/mm3 (raspon: 95 do 1110) i medijan postotka CD4+ bio je 23% (raspon: 7-45%).
Co-administration with Genvoya may lead to decreased elvitegravir and/or cobicistat exposures and loss of therapeutic effect and development of resistance. 
Genvoya može dovesti do smanjene izloženosti elvitegraviru i/ili kobicistatu te do gubitka terapijskog učinka i razvoja rezistencije.