natgillin/translations-raw huggingface dataset:
Corresponding steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) were 1.1 ± 0.40 µg/mL, 8.3 ± 3.8 µg•h/mL, and 0.05 ± 0.13 µg/mL for cobicistat; 1.9 ± 0.5 µg/mL, 13 ± 4.5 µg•h/mL, and 0.14 ± 0.25 µg/mL for emtricitabine. 
Odgovarajuće srednje vrijednosti Cmax, AUCtau i Ctrough (srednja vrijednost ± SD) u stanju dinamičke ravnoteže bile su 1,1 ± 0,40 µg/ml, 8,3 ± 3,8 µg•h/ml i 0,05 ± 0,13 µg/ml za kobicistat te 1,9 ± 0,5 µg/ml, 13 ± 4,5 µg•h/ml i 0,14 ± 0,25 µg/ml za emtricitabin.
Patients had a mean age of 41 years (range 21-77), 89% were male, 67% were White, and 19% were Black. 
Bolesnici su imali srednju vrijednost dobi od 41 godinu (raspon 21-77), 89% su bili muškarci, 67% bijelci i 19% crnci.
Tenofovir alafenamide is a substrate of OATP in vitro. 
Tenofoviralafenamid je supstrat za OATP in vitro.
Co-administration with Genvoya may increase dabigatran plasma concentrations with similar effects as seen with other strong P-gp inhibitors. 
Koncentracije dabigatrana u plazmi mogu se povećati pri istodobnoj primjeni lijeka Genvoya, s učinkom sličnim kao kod drugih jakih P-gp inhibitora.
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. 
U otvorenom Ispitivanju GS US 292 1249, djelotvornost i sigurnost lijeka Genvoya procijenjene su u odraslih bolesnika istodobno zaraženih virusom HIV-1 i kroničnim hepatitisom B. Šezdeset devet od 72 bolesnika prethodno su bili na tenofovirdizoproksilu koji je sadržavao antiretrovirusnu terapiju.
In a clinical study of HIV virologically suppressed patients co-infected with chronic hepatitis B, who received Genvoya for 48 weeks (GS-US-292-1249, n = 72), 2 patients qualified for resistance analysis. 
U bolesnika istodobno zaraženih HIV-om i HBV-om U kliničkom ispitivanju bolesnika s HIV virološkom supresijom koji su istodobno zaraženi kroničnim hepatitisom B, koji su primali lijek Genvoya tijekom 48 tjedana (GS US 292 1249, n = 72), 2 bolesnika bila su kvalificirana za analizu rezistencije.
Changes in measures of renal function 
Promjene u izmjerenoj funkciji bubrega
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). 
Srednje vrijednosti izloženosti elvitegraviru, kobicistatu, emtricitabinu, tenofoviru i tenofoviralafenamidu postignutih u djece u dobi od 8 do < 12 godina (> 25 kg; n = 23) koja su primala lijek Genvoya u ispitivanju GS-US-292-0106 bile su više (20-80%) od srednjih vrijednosti izloženosti postignutih u odraslih (Tablica 6).
The difference in percentage was 4.2% (95% CI: 0.6% to 7.8%). 
Razlika u postotku bila je 4,2% (95% CI: 0,6% do 7,8%).
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. 
Bolesnici koji su istodobno zaraženi HIV-om i HBV-om Sigurnost lijeka Genvoya je u 72 bolesnika koji su bili zaraženi HIV-om i HBV-om te koji su liječili HIV infekciju u otvorenom kliničkom ispitivanju (GS-US-292-1249) procijenjena tijekom 48. tjedna, u kojem su bolesnici bili prebačeni s drugog antiretrovirusnog režima (koji je uključivao tenofovirdizoproksil u 69 od 72 bolesnika) na lijek Genvoya.
In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite tenofovir diphosphate. 
In vivo se tenofoviralafenamid hidrolizira u stanicama do tenofovira (glavni metabolit), koji se zatim fosforilira u aktivni metabolit tenofovirdifosfat.
2.0% (95% CI: -0.7% to 4.7%) 
2,0% (95% CI: -0,7% do 4,7%)
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. 
Nema podataka o farmakokinetici elvitegravira, kobicistata, emtricitabina ili tenofoviralafenamida u bolesnika sa završnim stadijem bolesti bubrega (procijenjeni CrCl < 15 ml/min) koji nisu na kroničnoj hemodijalizi.
At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya. 
U 48. tjednu, 92% bolesnika (66/72) zadržalo je HIV-1 RNK < 50 kopija/ml nakon prebacivanja na lijek Genvoya.
No clinically relevant differences in elvitegravir, cobicistat, 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 Phase 1 studies of cobicistat-boosted elvitegravir or of tenofovir alafenamide, respectively. 
Nisu zapažene klinički značajne razlike u farmakokinetici elvitegravira, kobicistata, tenofoviralafenamida ili tenofovira između zdravih ispitanika i bolesnika s teškim oštećenjem funkcije bubrega (procijenjeni CrCl ≥ 15 ml/min i < 30 ml/min) u ispitivanjima faze I elvitegravira pojačanog kobicistatom ili tenofoviralafenamida.
The mean baseline CD4+ cell count was 545 cells/mm3 (range 205-1473). 
Srednja vrijednost broja CD4+ stanica na početku ispitivanja iznosila je 545 stanica/mm3 (raspon: 205-1473).
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. 
U HIV-1 izolatima od 12 bolesnika s razvojem virusne rezistencije u skupini liječenoj E/C/F/TDF nastale mutacije bile su M184V/I (n = 9), K65R/N (n = 4) i L210W (n = 1) u RT te E92Q/V (n = 4), Q148R (n = 2) i N155H/S (n = 3) u integrazi.
Elvitegravir: AUC: ↔ 
Sofosbuvir: AUC: ↔
betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. 
• kortikosteroide, koji uključuju: betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon
After switching to Genvoya, 100% (23/23) of patients in Cohort 2 remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48. 
Nakon prelaska na liječenje lijekom Genvoya, 100% (23/23) bolesnika iz kohorte 2 zadržalo je razinu supresije (HIV-1 RNK < 50 kopija/ml) u 48. tjednu.
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. 
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 bilo koju od komponenti lijeka Genvoya prije ulaska u ispitivanje.
There are limited clinical data on the use of Genvoya in HIV/HBV co-infected patients who are treatment-naïve. 
Ograničeni su klinički podaci o primjeni lijeka Genvoya u bolesnika istodobno zaraženim HIV/HBV-om, a koji nisu ranije bili liječeni.
Following oral administration of [14C]-cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively. 
Nakon peroralne primjene [14C]-kobicistata 86% i 8,2% doze izolirano je u stolici, odnosno urinu.
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. 
U HIV-1 izolatima od 12 bolesnika s razvojem virusne rezistencije u skupini liječenoj lijekom Genvoya nastale mutacije bile su M184V/I (n = 11) i K65R/N (n = 2) u RT te T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) i N155H (n = 2) u integrazi.
Mean increases from baseline in the Genvoya group were smaller than in the elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) group at Week 144 (difference -0.04, p < 0.001). 
Srednja vrijednost porasta od početne vrijednosti bila je manja u skupini liječenoj lijekom Genvoya nego u skupini liječenoj elvitegravirom 150 mg/kobicistatom 150 mg/emtricitabinom 200 mg/tenofovirdizoproksilom (u obliku fumarata) 245 mg (E/C/F/TDF) u 144. tjednu (razlika -0,04, p < 0,001).
Patients were virologically suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months before switching to Genvoya. 
Virus je u bolesnika bio suprimiran (HIV-1 RNK < 50 kopija/ml) tijekom najmanje 6 mjeseci prije prebacivanja na lijek Genvoya.
Co-administration with Genvoya may result in increased plasma concentrations of sildenafil and tadalafil, which may result in PDE-5 inhibitor-associated adverse reactions. 
Istodobna primjena lijeka Genvoya može za posljedicu imati povećane koncentracije sildenafila i tadalafila u plazmi, što može dovesti do nuspojava povezanih s inhibitorom PDE-5.
Patients in Cohort 1 had a mean age of 15 years (range 12 to 17), were 44% male, 12% Asian, and 88% Black. 
Bolesnici iz kohorte 1 imali su srednju vrijednost dobi 15 godina (raspon: 12-17), 44% su bili muškog spola, 12% azijati i 88% crnci.
• emtricitabine, an antiretroviral medicine known as a nucleoside reverse transcriptase inhibitor 
• emtricitabin, antiretrovirusni lijek poznat kao nukleozidni inhibitor reverzne transkriptaze
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 zatvaračem sigurnim za djecu s kontinuiranim navojem, otvora prekrivenog omotom od aluminijske folije koja se odvaja s otvaranjem,
Concentrations of these HMG Co-A reductase inhibitors are expected to transiently increase when administered with elvitegravir and cobicistat. 
Koncentracije inhibitora reduktaze HMG-CoA vjerojatno će se kratkotrajno povećati s istodobnom primjenom elvitegravira i kobicistata.
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.
colchicine 
Kolhicin
Steady-state mean Cmax and AUCtau for tenofovir alafenamide were 0.16 ± 0.08 µg/mL and 0.21 ± 0.15 µg•h/mL, respectively. 
Srednje vrijednosti Cmax i AUCtau za tenofoviralafenamid u stanju dinamičke ravnoteže bile su 0,16 ± 0,08 µg/ml odnosno 0,21 ± 0,15 µg•h/ml.
f n = 539 (TAF) or 841 (TFV) adults. 
b n = 22 djece c n = 20 djece d AUClast e n = 19 odraslih f n = 539 (TAF) ili 841 (TFV) odraslih
4 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. 
To je ispitivanje provedeno pomoću elvitegravira/kobicistata/emtricitabina/tenofovirdizoproksilfumarata.
Reproductive toxicity studies in rats and rabbits with cobicistat showed no effects on mating, fertility, pregnancy or foetal parameters. 
Ispitivanja reproduktivne toksičnosti na štakorima i kunićima s kobicistatom nisu pokazala učinke na parenje, plodnost, trudnoću i fetalne parametre.
Concentrations of voriconazole may increase or decrease when co-administered with Genvoya. 
Koncentracije vorikonazola mogu se povećati ili smanjiti s istodobnom primjenom lijeka Genvoya.
Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/ 
voksilaprevir (400 mg/100 mg/100 mg+100 mg jedanput na dan)7/
Animal studies do not indicate direct or indirect harmful effects of elvitegravir, cobicistat, or emtricitabine, administered separately, with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development. 
Ispitivanja na životinjama u kojima su elvitegravir, kobicistat ili emtricitabin primijenivani odvojeno ne ukazuju na izravan ili neizravan štetan učinak na parametre plodnosti, trudnoću, razvoj fetusa, okot ili postnatalni razvoj.
Female 
Kobicistat
At baseline, median CD4+ cell count was 969 cells/mm3 (range: 603 to 1,421), and median CD4+% was 39% (range: 30 to 51%). 
Na početku, medijan broja CD4+ stanica bio je 969 stanica/mm3 (raspon: 603 do 1421), a medijan postotka CD4+ bio je 39% (raspon: 30-51%).
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. 
Pri vršnoj koncentraciji u plazmi omjer srednje vrijednosti lijeka u plazmi i koncentracije lijeka u krvi iznosio je ~1,0, a omjer srednje vrijednosti koncentracije lijeka u spermi i koncentracije lijeka u plazmi iznosio je ~4,0.
The mean baseline CD4+ cell count was 697 cells/mm3 (range 79-1,951). 
Srednja vrijednost početnog broja CD4+ stanica bila je 697 stanica/mm3 (raspon 79-1951).
Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product. 
Istodobna primjena lijeka Genvoya može za posljedicu imati povećane koncentracije ovog lijeka u plazmi.
Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 
Genvoya 150 mg/150 mg/200 mg/10 mg filmom obložene tablete elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid
Concentrations of beta-blockers may be increased when co-administered with cobicistat. 
Koncentracije beta-blokatora mogu se povećati s istodobnom primjenom kobicistata.
After switching to Genvoya, 90% (45/50) of patients remained suppressed (HIV-1 RNA < 50 copies/mL) at Week 48. 
Nakon prelaska na liječenje lijekom Genvoya, 90% (45/50) bolesnika zadržalo je razinu supresije (HIV-1 RNK < 50 kopija/ml) u 48. tjednu.
The mean age was 50 years (range 28-67), 92% of patients were male, 69% were White, 18% were Black, and 10% were Asian. 
Srednja vrijednost dobi je 50 godina (raspon od 28 do 67), 92% bolesnika bili su muškarci, 69% bijelaca, 18% crnaca i 10% azijata.
Gilead Sciences Ireland UC Carrigtohill 
Nositelj odobrenja za stavljanje lijeka u promet Gilead Sciences Ireland UC Carrigtohill
In Study GS-US-292-1825, the efficacy and safety of Genvoya 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 Genvoya. 
U otvorenom kliničkom ispitivanju GS-US-292-1825, djelotvornost i sigurnost lijeka Genvoya 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 lijek Genvoya.
The safety of Genvoya was evaluated through 48 weeks in HIV-1 infected adolescent patients between the ages of 12 to < 18 years weighing ≥ 35 kg, who were either treatment-naïve (GS-US-292-0106, n = 50), or who were virologically suppressed (GS-US-292-1515, n = 50), and in virologically suppressed children between the ages of 8 to < 12 years weighing > 25 kg (GS-US-292-0106, n = 23). 
Pedijatrijska populacija Sigurnost lijeka Genvoya u adolescenata u dobi od 12 do < 18 godina s tjelesnom težinom ≥ 35 kg zaraženih virusom HIV-1 koji prethodno nisu bili liječeni (GS-US-292-0106, n = 50) ili su imali virološku supresiju (GS US 292-1515, n = 50), te u djece s virološkom supresijom u dobi od 8 do < 12 godina s tjelesnom težinom > 25 kg (GS-US-292-0106, n = 23), procijenjena je tijekom
Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity. 
- slabost mišića - slabost koja počinje u šakama i stopalima i pomiče se nagore prema trupu tijela - osjećaj lupanja srca, nevoljnog drhtanja ili hiperaktivnosti
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 pokazuju različit stupanj križne rezistencije za INSTI raltegravir ovisno o tipu i broju mutacija.
Lactose (as monohydrate) Microcrystalline cellulose Croscarmellose sodium Hydroxypropyl cellulose Silicon dioxide Sodium lauryl sulfate Magnesium stearate 
Jezgra tablete laktoza (u obliku hidrata) mikrokristalična celuloza umrežena karmelozanatrij hidroksipropilceluloza silicijev dioksid natrijev laurilsulfat magnezijev stearat
• antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole 
• lijekove protiv gljivica, primjenjuju se za liječenje gljivičnih infekcija, kao što su: ketokonazol, itrakonazol, vorikonazol, posakonazol i flukonazol
However, based on the information retrieved in literature and in the product information of integrase inhibitors containing medicinal products, it could be concluded that the following psychiatric disorders: depression, suicidal ideation and suicidal behaviour (particularly in patients with pre-existing history of psychiatric illness) are class-effect of integrase inhibitors and these are listed in the SmPC of other medicinal products containing integrase inhibitors in monotherapy and in fixed-dose combination (FDC). 
Međutim, na temelju informacija pronađenih u literaturi i informacija o lijeku lijekova koji sadrže inhibitore integraze, moglo bi se zaključiti da su sljedeći psihijatrijski poremećaji: depresija, suicidalne ideacije i suicidalno ponašanje
• PDE-5 inhibitors: sildenafil for the treatment of pulmonary arterial hypertension 
• inhibitori PDE-5: sildenafil za liječenje plućne arterijske hipertenzije • sedativi/hipnotici: midazolam peroralno primijenjen, triazolam.
How to take Genvoya 
Kako uzimati lijek Genvoya
ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan 
RECEPTORA Bosentan
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).
dyspepsia 
dispepsija
The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813). 
Srednja vrijednost početnog broja CD4+ stanica iznosila je 664 stanica/mm3 (raspon 126-1813).
• tenofovir alafenamide, an antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI) 
• tenofoviralafenamid, antiretrovirusni lijek poznat kao nukleotidni inhibitor reverzne transkriptaze (NtRTI).
Clinical monitoring is recommended due to the potential for hyperkalaemia. 
Zbog moguće pojave hiperkalijemije preporučuje se kliničko praćenje.
4.2% (95% CI: 0.6% to 7.8%) 
4,2% (95% CI: 0,6% do 7,8%)
Plasma concentrations of drospirenone may be increased when co-administered with cobicistat-containing products. 
Koncentracije drospirenona u plazmi mogu se povećati s istodobnom primjenom lijekova koji sadrže kobicistat.
Do not store the split tablet. 
Lomljene tablete nemojte čuvati.
Triazolam is primarily metabolised by CYP3A. 
Triazolam prvenstveno metabolizira CYP3A.
Talk to your doctor before taking Genvoya: • If you have liver problems or a history of liver disease, including hepatitis. 
• Ako imate tegobe s jetrom ili ste imali bolest jetre, uključujući hepatitis.
Intravenously administered midazolam (1 mg single dose)/ Tenofovir alafenamide (25 mg once daily) 
Midazolam primijenjen intravenski (jedna doza od 1 mg)/ tenofoviralafenamid (25 mg jedanput na dan)
Midazolam is primarily metabolised by CYP3A. 
Midazolam prvenstveno metabolizira CYP3A.
The mean change from baseline in CD4+ cell count and percentage at Week 48 was -90 cells/mm3 and -1.3%, respectively. 
Srednja vrijednost promjene od početnog broja i postotka CD4+ stanica u 48. tjednu bila je -90 stanica/mm3 odnosno -1,3%.
Recommendation concerning co-administration with Genvoya 
Preporuka za istodobnu primjenu s lijekom Genvoya
Co-administration of Genvoya with carbamazepine is contraindicated (see section 4.3). 
Istodobna primjena lijeka Genvoya s karbamazepinom je kontraindicirana (vidjeti dio 4.3).
Table 5: Pharmacokinetics of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide in antiretroviral-naïve adolescents and adults 
Tablica 5. Farmakokinetika elvitegravira, kobicistata, emtricitabina, tenofovira i tenofoviralafenamida u adolescenata i odraslih koji prethodno nisu bili liječeni antiretrovirusnim lijekovima
Atorvastatin: AUC: ↑ 160% Cmin: NC Cmax: ↑ 132% 
AUC: ↑160% Cmin: NC Cmax: ↑132%
FTC/tenofovir disoproxil plus boosted atazanavir E/C/F/TDF 
FTC/tenofovirdizoproksil plus pojačani atazanavir
The mean increase from baseline in CD4+ cell count at Week 48 was 224 cells/mm3. 
Srednja vrijednost porasta od početnog broja CD4+ stanica u 48. tjednu bila je 224 stanica/mm3.
HIV-1 infected virologically suppressed patients 
Bolesnici zaraženi virusom HIV-1 kod kojih je virus suprimiran
Patients with CrCl between 30 mL/min and 60 mL/min: 
60 ml/min:
Concentrations of ketoconazole and/or cobicistat may increase with co-administration of Genvoya. 
Koncentracije ketokonazola i/ili kobicistata mogu se povećati s istodobnom primjenom lijeka Genvoya.
Ketoconazole (200 mg twice daily)/ Elvitegravir (150 mg once daily)2 
Ketokonazol (200 mg dvaput na dan)/elvitegravir (150 mg jedanput na dan)2
The safety of Genvoya in 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) was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112). 
Sigurnost lijeka Genvoya u 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)
At Week 48, 81.8% (45/55 patients) maintained HIV-1 RNA < 50 copies/mL after switching to Genvoya. 
U 48. tjednu, HIV-1 RNK < 50 kopija/ml zadržala se u 81,8% (45/55 bolesnika) nakon prebacivanja na lijek Genvoya.
Orally administered midazolam (2.5 mg single dose)/ Tenofovir alafenamide (25 mg once daily) 
Midazolam primijenjen peroralno (jedna doza od 2,5 mg)/ tenofoviralafenamid (25 mg jedanput na dan)
It is not known whether elvitegravir, cobicistat, or tenofovir alafenamide are excreted in human milk. 
Nije poznato izlučuju li se elvitegravir, kobicistat ili tenofoviralafenamid u majčino mlijeko.
Sofosbuvir metabolite GS-331007: 
Metabolit sofosbuvira GS-331007: AUC: ↑ 43%
HIV-1 RNA < 50 copies/mL Treatment difference 
HIV-1 RNK < 50 kopija/ml Razlika u liječenju
Caution should be exercised when co-administering Genvoya and a hormonal contraceptive. 
Istodobna primjena lijeka Genvoya i hormonske kontracepcije mora se provoditi s oprezom.
The active substances are elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. 
Djelatne tvari su elvitegravir, kobicistat, emtricitabin i tenofoviralafenamid.
In Study GS-US-292-0109, the efficacy and safety of switching from either efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil, FTC/tenofovir disoproxil plus atazanavir (boosted by either cobicistat or ritonavir), or E/C/F/TDF to Genvoya were evaluated in a randomised, open-label study of virologically suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 1,436). 
U randomiziranom, otvorenom ispitivanju GS-US-292-0109 procjenjivane su djelotvornost i sigurnost prebacivanja odraslih bolesnika (n = 1436) zaraženih virusom HIV-1 kod kojih je virus bio suprimiran (HIV-1 RNK < 50 kopija/ml) bilo sa režima efavirenz (EFV)/emtricitabin (FTC)/tenofovirdizoproksil, FTC/tenofovirdizoproksil plus atazanavir (pojačan ili kobicistatom ili ritonavirom) ili E/C/F/TDF na režim s lijekom Genvoya.