natgillin/translations-raw huggingface dataset:
c There were 17 new virologic failures between the Week 48 primary analysis and Week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL). 
c Med primarno analizo v 48. tednu in 96. tednom se je pojavilo 17 novih viroloških neuspehov (6 bolnikov z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 11 bolnikov z začetno virusno obremenitvijo > 100.000 kopij/ml).
No dose adjustment of Odefsey is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis; however, Odefsey should generally be avoided but may be used with caution in these patients if the potential benefits are considered to outweigh the potential risks (see sections 4.4 and 5.2). 
Odmerka zdravila Odefsey pri odraslih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min) na kronični hemodializi ni treba prilagoditi; vendar pa se je treba zdravilu Odefsey načeloma izogniti, a se lahko uporablja pri teh bolnikih, če prevlada mnenje, da so možne koristi večje od možnih tveganj
The active substances are emtricitabine, rilpivirine and tenofovir alafenamide. 
Učinkovine so emtricitabin, rilpivirin in tenofoviralafenamid.
Patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Odefsey (see section 4.8). 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Bolnike je treba opozoriti, da se lahko v času zdravljenja z učinkovinami zdravila Odefsey pojavijo utrujenost, omotičnost in somnolenca (glejte poglavje 4.8).
In studies in treatment-naïve patients receiving emtricitabine + tenofovir alafenamide (FTC + TAF) or emtricitabine + tenofovir disoproxil fumarate (FTC + TDF), both given with elvitegravir + cobicistat as a fixed-dose combination tablet, 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. 
V študijah pri predhodno nezdravljenih bolnikih, ki so prejemali emtricitabin + tenofoviralafenamid (FTC + TAF) ali emtricitabin + dizoproksiltenofovirijev fumarat (FTC + TDF), oba skupaj z elvitegravirjem + kobicistatom v obliki tablete s fiksno kombinacijo odmerkov, so v 144. tednu povečanje od začetne vrednosti opazili v obeh skupinah zdravljenja, pri parametrih maščob na tešče za skupni holesterol, direktni LDL holesterol in HDL holesterol, ter trigliceride.
(may affect up to 1 in 100 people) 
Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
If a patient vomits more than 4 hours after taking Odefsey they do not need to take another dose of Odefsey until the next regularly scheduled dose. 
Če bolnik bruha več kot 4 ure po jemanju zdravila Odefsey, naj ne vzame naslednjega odmerka zdravila Odefsey pred naslednjim predvidenim odmerkom ob običajnem času.
Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLf 
Prekinitev uporabe študijskega zdravila zaradi drugih razlogov in nazadnje razpoložljivi HIV-1 RNA
HIV-1 infected adult patients with mild to moderate renal impairment In Study GS-US-292-0112, the efficacy and safety of E/C/F/TAF FDC tablet were evaluated in an open-label clinical study of 242 HIV-1 infected, virologically suppressed patients with mild to moderate renal impairment (eGFRCG: 30-69 mL/min). 
Odrasli bolniki z okužbo HIV-1 z blago do zmerno ledvično okvaro V študiji GS-US-292-0112 so učinkovitost in varnost E/C/F/TAF v obliki tablete FDC ocenili z odprto klinično študijo pri 242 bolnikih z virološko supresijo, okuženih z virusom HIV-1 in z blago do zmerno ledvično okvaro (eGFRCG: 30-69 ml/min).
Virologically suppressed HIV-1 infected adult patients In Study GS-US-366-1216, the efficacy and safety of switching from FTC/RPV/TDF to Odefsey were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults. 
Odrasli bolniki, okuženi z virusom HIV-1, z virološko supresijo V študiji GS-US-366-1216 so učinkovitost in varnost prehoda s FTC/RPV/TDF na zdravilo Odefsey ocenili v randomizirani, dvojno slepi študiji pri odraslih bolnikih, okuženih z virusom HIV-1, z virološko supresijo.
In the Week 144 pooled analysis of antiretroviral-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in the Phase 3 studies GS-US-292-0104 and GS-US-292-0111, the development of one or more primary resistance-associated mutations was observed in HIV-1 isolates from 12 of 866 (1.4%) patients treated with E/C/F/TAF. 
V združeni analizi v 144. tednu v študijah faze III GS-US-292-0104 in GS-US-292-0111 pri bolnikih, ki se predhodno niso zdravili s protiretrovirusnimi zdravili in so prejemali elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid (E/C/F/TAF), so opazili razvoj ene ali več primarnih mutacij pri izolatih HIV-1 pri 12 od 866 (1,4 %) bolnikov, ki so prejemali zdravljenje z zdravilom E/C/F/TAF.
d There were 10 new virologic failures between the Week 48 primary analysis and Week 96 (3 patients with baseline viral load ≤ 100,000 copies/mL and 7 patients with baseline viral load > 100,000 copies/mL). 
d Med primarno analizo v 48. tednu in 96. tednom se je pojavilo 10 novih viroloških neuspehov (3 bolniki z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 7 bolnikov z začetno virusno obremenitvijo > 100.000 kopij/ml).
Odefsey should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes (see section 4.4). 
Zdravila, ki podaljšujejo interval QT: Zdravilo Odefsey je treba uporabljati previdno, če se uporablja sočasno z zdravili z znanim tveganjem za Torsade de Pointes (glejte poglavje 4.4).
The most frequently reported adverse reactions in clinical studies of treatment-naïve patients taking rilpivirine hydrochloride in combination with emtricitabine + tenofovir disoproxil fumarate were nausea (9%), dizziness (8%), abnormal dreams (8%), headache (6%), diarrhoea (5%) and insomnia (5%). 
Pri predhodno nezdravljenih bolnikih, ki so prejemali rilpivirinijev klorid v kombinaciji z emtricitabinom + dizoproksiltenofovirijevim fumaratom, so bili najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah, navzea (9 %), omotičnost (8 %), nenavadne sanje (8 %),
HIV-1 RNA < 20 copies/mL Treatment difference 
< 20 kopij/ml Razlika zdravljenja
What you need to know before you take Odefsey Do not take Odefsey: 
Kaj morate vedeti, preden boste vzeli zdravilo Odefsey
More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1). 
Rezistenca, povezana z lamivudinom/emtricitabinom, se je pojavila pri več bolnikih z virološkim neuspehom na zdravilo rilpivirin kot pri bolnikih z virološkim neuspehom na efavirenz (glejte poglavje 5.1).
In the pooled Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients, at Week 96, there was an overall mean change from baseline in basal cortisol of -19.1 (-30.85; -7.37) nmol/L in the rilpivirine arm and of -0.6 (-13.29; 12.17) nmol/L in the efavirenz arm. At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine arm (+18.4 ± 8.36 nmol/L) than in the efavirenz arm (+54.1 ± 7.24 nmol/L). 
V združenih študijah fazi III TMC278-C209 in TMC278-C215 predhodno nezdravljenih bolnikov je bila v 96. tednu splošna povprečna sprememba od začetne vrednosti za bazalni kortizol -19,1 (-30,85;-7,37) nmol/l v kraku z rilpivirinom in -0,6 (-13,29; 12,17) nmol/l v kraku z efavirenzom.
Package leaflet: Information for the user Odefsey 200 mg/25 mg/25 mg film-coated tablets emtricitabine/rilpivirine/tenofovir alafenamide This medicine is subject to additional monitoring. 
Navodilo za uporabo Odefsey 200 mg/25 mg/25 mg filmsko obložene tablete emtricitabin/rilpivirin/tenofoviralafenamid Za to zdravilo se izvaja dodatno spremljanje varnosti.
 If any of these applies to you, talk to your doctor before taking Odefsey. 
 Če kar koli od navedenega velja za vas, se pred jemanjem zdravila Odefsey posvetujte z zdravnikom.
Co-administration of Odefsey with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of virologic response to Odefsey (see section 4.3) and possible resistance to rilpivirine and to the NNRTI class. 
Opazili so, da sočasna uporaba zdravila Odefsey z zaviralci protonske črpalke povzroči zmanjšane koncentracije rilpivirina v plazmi (zaradi povečanja vrednosti pH v želodcu), kar lahko potencialno povzroči izgubo virološkega odziva na zdravilo Odefsey (glejte poglavje 4.3) in možno rezistenco na rilpivirin in na razred NNRTI.
HYPNOTICS/SEDATIVES Midazolam (2.5 mg, orally, single dose)/ Tenofovir alafenamide 
HIPNOTIKI/SEDATIVI midazolam (2,5 mg, peroralno, enkratni odmerek)/ tenofoviralafenamid midazolam (1 mg, intravensko, enkratni odmerek)/ tenofoviralafenamid midazolam:
• feeling sleepy (somnolence) 
• zaspanost (somnolenca)
Adults 
Starejši
Titanium dioxide (E171) Iron oxide black (E172) 
Filmska obloga makrogol polivinilalkohol smukec titanov dioksid (E171)
Treatment-naïve HIV-1 infected adult patients The efficacy of rilpivirine is based on the analyses of 96 weeks data from two randomised, double-blind, controlled studies in treatment-naïve patients (TMC278-C209 and emtricitabine + tenofovir disoproxil fumarate subset of TMC278-C215). 
Učinkovitost rilpivirina temelji na analizah podatkov 96 tednov iz dveh randomiziranih, dvojno slepih, kontroliranih študij pri predhodno nezdravljenih bolnikih (TMC278-C209 in podskupina TMC278-C215, ki je prejemala emtricitabin + dizoproksiltenofovirijev fumarat).
FTC/RPV /TDF 
FTC/RPV/
ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin 
ANTIEPILEPTIKI karbamazepin okskarbazepin fenobarbital fenitoin
• increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood 
Preiskave lahko kažejo tudi: • zvišane ravni holesterola in/ali pankreatične amilaze (prebavnega encima) v krvi
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. 
Klinično pomembnih razlik v farmakokinetiki tenofoviralafenamida ali tenofovirja med zdravimi osebami in bolniki s hudo ledvično okvaro (ocenjeni CrCl ≥ 15 ml/min in < 30 ml/min) v študiji
Up to 30% of the emtricitabine dose can be removed by haemodialysis. 
Specifičnega antidota za preveliko odmerjanje zdravila Odefsey ni. Do 30 % odmerka emtricitabina se lahko odstrani s hemodializo.
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.
Rifabutin (300 mg once daily)/ Rilpivirine1 
rifabutin (300 mg enkrat dnevno)/rilpivirin1
Therapy should be initiated by a physician experienced in the management of HIV infection. 
4.2 Odmerjanje in način uporabe Zdravljenje mora začeti zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV.
If you are taking an antacid, take it at least 2 hours before or at least 4 hours after Odefsey. 
Če jemljete antacid, ga vzemite vsaj 2 uri pred zdravilom Odefsey ali najmanj 4 ure po tem.
Non-clinical data on rilpivirine hydrochloride reveal no special hazard for humans based on studies of safety pharmacology, drug disposition, genotoxicity, carcinogenic potential, toxicity to reproduction and development. 
Predklinični podatki za rilpivirinijev klorid na osnovi študij farmakološke varnosti, porazdelitve zdravila, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Seventy-nine percent were male, 63% were White, 18% were Black, and 14% were Asian. 
Devetinsedemdeset odstotkov je bilo moških, 63 % je bilo belcev, 18 % je bilo črncev in 14 % je bilo
The most frequently reported adverse reactions in clinical studies of treatment-naïve patients taking emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat were nausea (11%), diarrhoea (7%), and headache (6%). 
Povzetek varnostnega profila Pri predhodno nezdravljenih bolnikih, ki so prejemali emtricitabin + tenofoviralafenamid v kombinaciji z elvitegravirjem + kobicistatom, so bili najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah, navzea (11 %), driska (7 %) in glavobol (6 %).
Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. 
Ena filmsko obložena tableta vsebuje 200 mg emtricitabina, 25 mg rilpivirina v obliki rilpivirinijevega klorida in 25 mg tenofoviralafenamida v obliki tenofoviralafenamidijevega fumarata.
Discontinued study drug due to AE or death and last available HIV-1 RNA < 50 copies/mL Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLe 
< 50 kopij/ml Prekinitev uporabe študijskega zdravila zaradi drugih razlogov in nazadnje razpoložljivi HIV-1 RNA
Proportion (%) of patients with HIV-1 RNA < 50 copies/mL by prior treatment regimend EFV/FTC/TDF FTC/TDF plus boosted atazanavir E/C/F/TDF 
< 50 kopij/ml po režimu predhodnega zdravljenjad EFV/FTC/TDF FTC/TDF z ojačanim atazanavirjem
• wind (flatulence) 
• vetrovi (flatulenca) • driska
Paracetamol: AUC: ↔ Cmin: N/A 
paracetamol: AUC: ↔ Cmin: N/A Cmax: ↔
0.4% (95% CI: -3.0% to 3.8%) 5.4% (95% CI: 1.5% to 9.2%) 
5,4 % (95 % IZ: 1,5 % do 9,2 %)
In a study of virologically suppressed patients switching from EFV/FTC/TDF to Odefsey (Study GS-US-366-1160), decreases from baseline were observed in the fasting values of total cholesterol and HDL-cholesterol in the Odefsey arm; no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio, direct LDL-cholesterol or triglycerides were observed in either treatment arm at Week 96. 
V študiji pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval EFV/FTC/TDF, na zdravilo Odefsey (študija GS-US-366-1160), so v kraku z zdravilom Odefsey opazili zmanjšanje skupnega holesterola in HDL holesterola na tešče glede na začetne vrednosti; v 96. tednu niso v nobenem kraku opazili klinično pomembnih sprememb mediane vrednosti razmerja med skupnim holesterolom in HDL holesterolom, vrednosti direktnega LDL holesterola ali trigliceridov na tešče glede na začetne vrednosti.
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 
- oslabelost, ki se začne v dlaneh in stopalih in se premika proti trupu
No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, rilpivirine or tenofovir alafenamide. 
Za emtricitabin, rilpivirin ali tenofoviralafenamid ni bilo identificirane klinično pomembne farmakokinetične razlike glede na starost, spol ali etnično pripadnost.
In virologically suppressed patients 
Pri bolnikih z virusno supresijo
There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 4.8). 
Novih varnostnih vprašanj pri bolnikih s končno ledvično odpovedjo na kronični hemodializi, ki so prejemali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov, niso prepoznali (glejte poglavje 4.8).
had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262). 
Do konca 96. tedna se je pri manj bolnikih v kraku z rilpivirinom z začetno virusno obremenitvijo ≤ 100.000 kopij/ml pojavila z rezistenco povezana substitucija in/ali fenotipska rezistenca na rilpivirin (7/288) kot pri bolnikih z začetno virusno obremenitvijo > 100.000 kopij/ml (30/262).
In Study GS-US-366-1216, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 16 cells/mm3 in those who remained on FTC/RPV/TDF. 
V študiji GS-US-366-1216 je bila pri bolnikih, ki so prešli na zdravilo Odefsey, povprečna sprememba števila celic CD4+ glede na začetno vrednost v 96. tednu 12 celic/mm3, pri bolnikih, ki so nadaljevali z jemanjem FTC/RPV/TDF, pa 16 celic/mm3.
Non-response Virologic failure (all patients) 
Neodzivni Virološki neuspeh
Rilpivirine-containing regimen 
Režimi, ki vsebujejo rilpivirin
6 Adverse reaction identified through post-marketing surveillance for tenofovir alafenamide-containing products. 
6 Neželeni učinek, opredeljen v okviru nadzora v obdobju trženja zdravil za zdravila, ki vsebujejo tenofoviralafenamid.
A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Odefsey should be used. 
Pri jemanju antagonistov receptorjev H2 je treba dosledno upoštevati načrt odmerjanja vsaj 12 ur pred uporabo zdravila Odefsey ali najmanj 4 ure po njej.
No emergent resistance to E/C/F/TAF was detected through Week 48. 
Pojava rezistence proti E/C/F/TAF do vključno
In Study GS-US-366-1160, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 6 cells/mm3 in those who stayed on EFV/FTC/TDF. 
V študiji GS-US-366-1160 je bila pri bolnikih, ki so prešli na zdravilo Odefsey, povprečna sprememba števila celic CD4+ glede na začetno vrednost v 96. tednu 12 celic/mm3, pri bolnikih, ki so nadaljevali z jemanjem EFV/FTC/TDF, pa 6 celic/mm3.
Odefsey [Outer packaging only] 
PODATKI V BRAILLOVI PISAVI Odefsey [samo na zunanji ovojnini]
Odefsey 200 mg/25 mg/25 mg film-coated tablets emtricitabine/rilpivirine/tenofovir alafenamide 
IME ZDRAVILA Odefsey 200 mg/25 mg/25 mg filmsko obložene tablete emtricitabin/rilpivirin/tenofoviralafenamid
headache1, 3, dizziness1, 3 
glavobol1,3, omotičnost1,3
Simeprevir (150 mg once daily)/ Rilpivirine 
simeprevir (150 mg enkrat dnevno)/rilpivirin simeprevir:
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine. 
Mehanizem delovanja in farmakodinamični učinki Emtricitabin je nukleozidni zaviralec reverzne transkriptaze (NRTI-nucleoside reverse transcriptase inhibitor) in analog 2'-deoksicitidina.
If you are taking an H2-antagonist, take it at least 12 hours before or at least 4 hours after Odefsey. 
Če jemljete antagonist receptorjev H2, ga vzemite vsaj 12 ur pred zdravilom Odefsey ali najmanj 4 ure po tem.
Patients had a mean age of 48 years (range 19-76), 87% were male, 67% were White, and 27% were Black. 
Bolniki so bili povprečno stari 48 let (razpon 19-76), 87 % je bilo moških, 67 % je bilo belcev in 27 % je bilo črncev.
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 (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and showed activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM). 
Tenofoviralafenamid je pokazal protivirusno aktivnost v celični kulturi vseh skupin HIV-1 (M, N in O), vključno s podtipi A, B, C, D, E, F in G (vrednosti EC50 so bile v razponu od 0,10 do 12,0 nM) in je pokazal aktivnost proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,91 do
In a study of virologically suppressed patients switching from FTC/RPV/TDF to Odefsey (Study GS-US-366-1216), increases from baseline were observed in fasting values of total cholesterol, direct LDL-cholesterol, HDL-cholesterol, and triglycerides in the Odefsey arm; and no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio were observed in either treatment arm at Week 96. 
V študiji pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval FTC/RPV/TDF, na zdravilo Odefsey (študija GS-US-366-1216), so v kraku z zdravilom Odefsey opazili povečanja skupnega holesterola, direktnega LDL holesterola, HDL holesterola in trigliceridov na tešče glede na začetne vrednosti; v 96. tednu niso v nobenem kraku zdravljenja opazili klinično pomembnih sprememb mediane vrednosti razmerja med skupnim holesterolom in holesterolom HDL na tešče glede na začetne vrednosti.
How to store Odefsey 
Shranjevanje zdravila Odefsey
Co-administration may cause significant decreases in rilpivirine plasma concentrations (reduced absorption, increase in gastric pH). 
Sočasna uporaba lahko povzroči pomembno zmanjšanje koncentracij rilpivirina v plazmi (zmanjšana absorpcija,
Patients had a mean age of 45 years (range 23-72), 90% were male, 75% were White, and 19% were Black. 
Bolniki so bili povprečno stari 45 let (razpon 23−72), 90 % je bilo moških, 75 % je bilo belcev in 19 % je bilo črncev.
The safety of emtricitabine + 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 + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet. 
Varnost emtricitabina in tenofoviralafenamida so ocenili v 48-tedenski odprti klinični študiji z eno skupino (GS-US-292-1825) pri 55 bolnikih z virološko supresijo z okužbo s HIV-1 in končno ledvično odpovedjo (eGFRCG < 15 ml/min) na kronični hemodializi, ki so prejemali emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
Emtricitabine + tenofovir alafenamide containing regimens Treatment-naïve and virologically suppressed HIV-1 infected adult patients In Study GS-US-292-0104 and Study GS-US-292-0111, patients received either E/C/F/TAF (n = 866) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) (n = 867) once daily, both given as FDC tablets. 
V študiji GS-US-292-0104 in v študiji GS-US-292-0111 so bolniki prejeli bodisi E/C/F/TAF (n = 866) bodisi elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat (E/C/F/TDF) (n = 867) enkrat dnevno v obliki tablet FDC.
Antacids should only be administered either at least 2 hours before or at least 4 hours after Odefsey. 
Antacide je treba dati bodisi vsaj 2 uri pred uporabo zdravila Odefsey ali vsaj 4 ure po njej.
While you are taking Odefsey 
Med jemanjem zdravila Odefsey
HIV-1 RNA < 50 copies/mL Treatment difference 
< 50 kopij/ml Razlika zdravljenja
Ketoconazole (400 mg once daily)/ Rilpivirine1 
Antimikotiki ketokonazol (400 mg enkrat dnevno)/rilpivirin1
It is possible that in the future, long-term users of Odefsey may get kidney problems. 
Obstaja možnost, da se v primeru dolgotrajne uporabe pri bolnikih kasneje pojavijo ledvične težave.
Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1 
famotidin (40 mg enkratni odmerek, vzet 12 ur pred rilpivirinom)/rilpivirin1
No virologic data in Week 48 or 96 window 
Brez viroloških podatkov v oknu
Co-administration of ketoconazole is expected to increase plasma concentrations of tenofovir alafenamide (inhibition of P-gp). 
Pričakuje se, da bo sočasna uporaba ketokonazola povzročila povečanje koncentracij tenofoviralafenamida v plazmi (zaviranje P-gp).