natgillin/translations-raw huggingface dataset:
f. Lack of pharmacokinetics interaction bounds 70-143%. 
f. Območje 70-143 %, znotraj katerega ni farmakokinetičnih interakcij.
(Induction of P-gp and CYPs) 
(indukcija P-gp in CYP)
Interaction only studied with velpatasvir and voxilaprevir. 
Preučevane so bile samo interakcije z velpatasvirjem in voksilaprevirjem.
Table 9: Demographics and baseline characteristics for patients enrolled into POLARIS-1, -2, -3 and -4 
Preglednica 9: Demografske in izhodiščne značilnosti za bolnike, vključene v študije POLARIS
The highest documented doses of sofosbuvir, velpatasvir and voxilaprevir were single doses of 1,200 mg, 500 mg, and 900 mg, respectively. 
Največji dokumentirani odmerki so bili enkratni odmerek 1.200 mg sofosbuvirja, enkratni odmerek 500 mg velpatasvirja in enkratni odmerek 900 mg voksilaprevirja.
b. One patient without cirrhosis had genotype 1 subtype other than genotype 1a or genotype 1b; the patient achieved SVR12. 
b. En bolnik brez ciroze je imel podvrsto genotipa 1, ki ni bila genotip 1a ali genotip 1b; bolnik je dosegel SVR12.
Cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5). 
Pri uporabi režimov, ki vključujejo sofosbuvir, v kombinaciji z amiodaronom in/ali drugimi zdravili, ki upočasnjujejo srčni utrip, so opazili primere hude bradikardije in srčnega bloka (glejte poglavji 4.4
In vitro, slow metabolic turnover of velpatasvir primarily by CYP2B6, CYP2C8 and CYP3A4 and of voxilaprevir primarily by CYP3A4 was observed. 
In vitro so zabeležili počasno presnovo velpatasvirja, primarno s citokromi CYP2B6, CYP2C8 in CYP3A4, ter voksilaprevirja, primarno s citokromom CYP3A4.
Vosevi should not affect your ability to drive or use any tools or machinery. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Vosevi ne bi smelo vplivati na vašo sposobnost upravljanja vozil ali strojev.
GS-331007 AUC0-inf did not change and Cmax was 19% to 35% lower when Vosevi or its components together were administered with food. 
vrednost Cmax pa je bila za 19 % do 35 % nižja pri jemanju zdravila Vosevi ali njegovih učinkovin skupaj s hrano.
Efavirenz/emtricitabine/ 
Elvitegravir/kobicistat/ emtricitabin/
DAA-naïve patients, GT 1, 2, 4, 5, or 6, with or without cirrhosis GT 3 without cirrhosis 
1, 2, 4, 5 ali 6, ki predhodno še niso bili zdravljeni z DAA, s cirozo ali brez, in GT 3 brez ciroze
b. Four patients had genotype 1 subtypes other than genotype 1a or genotype 1b; all 4 patients achieved SVR12. 
b. Štirje bolniki so imeli podvrste genotipa 1, ki niso bile genotip 1a ali genotip 1b; vsi 4 bolniki so dosegli SVR12.
Omeprazole dosed 4 hours after Vosevi 
Omeprazol uporabljen 4 ure po zdravilu Vosevi
No dose adjustment of Vosevi or ketoconazole is required. 
Odmerka zdravila Vosevi ali ketokonazola ni treba prilagajati.
(Inhibition of OATP1B) 
(zaviranje OATP1B)
Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis. 
Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) in pri bolnikih z ESRD, zaradi katere je potrebna hemodializa.
Population pharmacokinetic analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) had no clinically relevant effect on the exposure of velpatasvir. 
Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza (stopnja A po CPT) ni imela klinično pomembnega učinka na izpostavljenost velpatasvirju
Lansoprazoled Rabeprazoled Pantoprazoled Esomeprazoled 
Pantoprazold Esomeprazold
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Vosevi. 
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Vosevi,
Digoxin (0.25 mg single dose)e + velpatasvir (100 mg single dose) 
Digoksin (0,25 mg enkratni odmerek)e + velpatasvir (100 mg enkratni odmerek)
Co-administration of strong OATP1B inhibitors with Vosevi is not recommended (see section 4.5). 
Sočasna uporaba močnih zaviralcev OATP1B z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.5).
Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 and Cmax for sofosbuvir (n = 1038) were 1665 ng•hr/mL and 678 ng/mL, respectively; mean steady-state AUC0-24 and Cmax for GS-331007 (n = 1593) were 12834 ng•hr/mL and 744 ng/mL, respectively. 
Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV so bile povprečne vrednosti AUC0-24 in Cmax v stanju dinamičnega ravnovesja za sofosbuvir (n = 1.038) 1.665 ng•h/ml in 678 ng/ml; povprečne vrednosti AUC0-24 in Cmax v stanju dinamičnega ravnovesja za GS331007 (n = 1.593) so bile 12.834 ng•h/ml in 744 ng/ml.
Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for voxilaprevir (n = 1591) were 2577 ng•hr/mL and 192 ng/mL, respectively. 
Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV so bile povprečne vrednosti AUC0-24 in Cmax v stanju dinamičnega ravnovesja za voksilaprevir (n = 1.591) 2.577 ng•h/ml in 192 ng/ml.
Interaction only studied with sofosbuvir/ velpatasvir. 
Preučevane so bile samo interakcije s sofosbuvirjem/velpatasvirjem.
Liver transplant patients 
Bolniki s presajenimi jetri
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir, voxilaprevir or Vosevi in pregnant women. 
Podatkov o uporabi sofosbuvirja, velpatasvirja, voksilaprevirja ali zdravila Vosevi pri nosečnicah ni oziroma jih je malo (manj kot 300 izpostavljenih nosečnosti).
The use of such medicinal products with Vosevi is contraindicated (see section 4.3 and Table 2). 
Uporaba takšnih zdravil skupaj z zdravilom Vosevi je kontraindicirana (glejte poglavje 4.3 in preglednico 2).
Table 6: SVR12 in DAA-experienced patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 12 weeks POLARIS-1 (n = 260) 
Preglednica 6: SVR12 pri bolnikih, ki so bili predhodno že zdravljeni z DAA, z izhodiščnimi RAV NS3 ali NS5A ali brez njih po študiji sofosbuvir/velpatasvir/voksilaprevir 12 tednov POLARIS-1 (n = 260)
Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1200 mg. Velpatasvir AUC increases in a greater than proportional manner from 5 to 50 mg and in a less than proportional manner from 50 to 450 mg, indicating velpatasvir absorption is solubility limited. 
Vrednost AUC za velpatasvir se poviša več kot sorazmerno od 5 do 50 mg in manj kot sorazmerno od 50 do 450 mg, kar pomeni, da je absorpcija velpatasvirja omejena glede na topnost.
DAA-experienced patients (who have not received an NS5A inhibitor), GT1-6, with or without cirrhosis 
1-6, ki so bili predhodno že zdravljeni z DAA (vendar niso prejemali zaviralcev NS5A), s cirozo ali brez
Relapseb 
Relapsd
Patients with GT5-6 infection were enrolled into the SOF/VEL/VOX 8 week group only. 
Bolniki z okužbo GT 5-6 so bili vključeni samo v skupino za 8tedensko zdravljenje s SOF/VEL/VOKS.
Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in patients with moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively. 
V primerjavi z bolniki z normalnim delovanjem jeter je bila vrednost AUC0-24 za sofosbuvir za 126 % višja pri bolnikih z zmerno jetrno okvaro in za 143 % višja pri bolnikih s hudo jetrno okvaro, medtem ko je bila vrednost
SOF/VEL/VOX 8 weeks (n = 110) 
SOF/VEL/VOKS 8 tednov (n = 110)
If you are sick (vomit) after taking Vosevi it may affect the amount of Vosevi in your blood. 
Če bruhate po uporabi zdravila Vosevi, lahko to vpliva na količino zdravila Vosevi v vaši krvi.
Breast-feeding Do not breast-feed during treatment with Vosevi. 
Dojenje Med zdravljenjem z zdravilom Vosevi ne smete dojiti.
b. Two patients had genotype 1 subtypes other than genotype 1a or genotype 1b; both patients achieved SVR12. 
b. Dva bolnika sta imela podvrsto genotipa 1, ki ni bila genotip 1a ali genotip 1b; oba bolnika sta dosegla SVR12
No dose adjustment of Vosevi or tacrolimus is required at initiation of co-administration. 
Odmerka zdravila Vosevi ali takrolimusa ob uvedbi sočasnega dajanja ni treba prilagajati.
Following a single dose of 100 mg [14C]-voxilaprevir, the majority (approximately 91%) of radioactivity in plasma was parent drug. 
Po enkratnem 100-miligramskem odmerku [14C]-voksilaprevirja je večina (približno 91 %) radioaktivnosti v plazmi posledica izhodiščne spojine.
(Inhibition of P-gp and CYP3A) 
(zaviranje P-gp in CYP3A)
The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir/voxilaprevir, its components (sofosbuvir, velpatasvir, and/or voxilaprevir), or are predicted medicinal product interactions that may occur with Vosevi. 
Opisane interakcije med zdravili temeljijo na študijah, izvedenih z bodisi sofosbuvirjem/velpatasvirjem/voksilaprevirjem, njegovimi učinkovinami
Medicinal products that may decrease plasma exposure of Vosevi Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir, velpatasvir and/or voxilaprevir leading to reduced therapeutic effect of Vosevi. 
Zdravila, ki so močni induktorji P-gp in/ali citokromov CYP2B6, CYP2C8 ali CYP3A4 (npr. karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin in šentjanževka), lahko zmanjšajo koncentracije sofosbuvirja, velpatasvirja in/ali voksilaprevirja v plazmi, kar zmanjša terapevtski učinek zdravila Vosevi.
Ciclosporin (600 mg single dose)f + 
Ciklosporin (600 mg enkratni odmerek)f +
Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with DAAs. 
Med zdravljenjem z zdravili z DAA in po njem so poročali o primerih reaktivacije virusa HBV, tudi takih s smrtnim izidom.
Rifapentine (Induction of P-gp and CYPs) 
Rifapentin (indukcija P-gp in CYP)
Both of these patients had virus with emergent NS5A RAV Y93H at failure. 
Oba bolnika sta imela virus, pri katerem je prišlo do NS5A RAV Y93H
Adults previously treated with sofosbuvir/velpatasvir-containing regimens Vosevi for 12 weeks was evaluated in patients who were previously treated with a sofosbuvir/velpatasvir-containing regimen. 
12-tedensko zdravljenje z zdravilom Vosevi so ocenili pri bolnikih, ki so predhodno prejemali zdravljenje z režimom na osnovi sofosbuvirja/velpatasvirja.
Otherd 
Drugoe
Potential for Vosevi to affect other medicinal products 
Farmakokinetične interakcije Možnost vpliva zdravila Vosevi na druga zdravila
Following a single 100 mg oral dose of [14C]-voxilaprevir, mean total recovery of the [14C]-radioactivity was 94%, with all radioactivity measured in the faeces and none in the urine. 
Po enkratnem 100-miligramskem peroralnem odmerku [14C]-voksilaprevirja je bil povprečni skupni delež [14C]-radioaktivnosti, ki so jo izolirali, višji kot 94 %, pri čemer je bila vsa radioaktivnost izmerjena v blatu in nobene v urinu.
POLARIS-1 (randomised double blind) 
(randomizirana, dvojno slepa)
Table 7: SVR12 in DAA-naïve patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 8 weeks POLARIS-2 (n = 498) 
Preglednica 7: SVR12 pri bolnikih, ki predhodno še niso bili zdravljeni z DAA, z izhodiščnimi RAV NS3 ali NS5A ali brez njih po študiji sofosbuvir/velpatasvir/voksilaprevir 8 tednov POLARIS-2 (n = 498)
Additionally, the pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault). 
Dodatno so farmakokinetiko voksilaprevirja preučili z enkratnim 100-miligramskim odmerkom voksilaprevirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi Cockcroft-Gault).
Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 400 mg sofosbuvirja, 100 mg velpatasvirja in 100 mg voksilaprevirja.
Vosevi 400 mg/100 mg/100 mg film-coated tablets sofosbuvir/velpatasvir/voxilaprevir 
Navodilo za uporabo Vosevi 400 mg/100 mg/100 mg filmsko obložene tablete sofosbuvir/velpatasvir/voksilaprevir
Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for velpatasvir (n = 1595) were 4041 ng•hr/mL and 311 ng/mL, respectively. 
Na podlagi analize populacijske farmakokinetike pri bolnikih z okužbo s HCV so bile povprečne vrednosti AUC0-24 in Cmax v stanju dinamičnega ravnovesja za velpatasvir (n = 1.595) 4.041 ng•h/ml in 311 ng/ml.
Famotidine dosed simultaneously with Vosevi 
Famotidin uporabljen sočasno z zdravilom Vosevi Cimetidind Nizatidind
(Inhibition of OATP1B, P-gp and CYP3A) 
(zaviranje prenašalcev OATP1B, P-gp in CYP3A)
With Cirrhosis 
S cirozo
In the POLARIS-3 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 14), 2 of 110 (2%) patients (genotype 3) qualified for resistance analysis due to relapse. 
V študiji POLARIS-3 sta bila v skupini, ki je prejemala 8-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem/voksilaprevirjem (glejte preglednico 14), 2 od 110 (2 %) bolnikov (genotip 3) primerna za analizo odpornosti zaradi relapsa.
SOF/VEL 12 weeks (n = 151) 
SOF/VEL 12 tednov (n = 151)
How to store Vosevi 
Shranjevanje zdravila Vosevi
↔ Velpatasvir ↔ Voxilaprevir 
↔ Velpatasvir ↔ Voksilaprevir
Studies with DAA-experienced Patients 
Študije pri bolniki, ki so bili predhodno zdravljeni z DAA
Patients with GT4-6 infection were enrolled into the SOF/VEL/VOX 12 week group only. 
Bolniki z okužbo GT 46 so bili vključeni samo v skupino za 12tedensko zdravljenje s SOF/VEL/VOKS.
SOF/VEL/VOX 12 weeks (n = 263) 
SOF/VEL/VOKS 12 tednov (n = 263)
No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with voxilaprevir at AUC exposures approximately 141- and 4-times higher, respectively, than the human exposure at the recommended clinical dose. 
V študijah razvojne toksičnosti z voksilaprevirjem pri izpostavljenostih na podlagi AUC, ki so bile približno 141-krat večje pri podganah in 4-krat večje pri kuncih od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso zabeležili nobenih teratogenih učinkov.
Darunavir boosted with ritonavir (800 + 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f 
Darunavir, okrepljen z ritonavirjem (800 + 100 mg enkrat na dan) + emtricitabin/ dizoproksiltenofovirijev fumarat (200/300 mg enkrat na dan)j +
Pravastatin may be administered with Vosevi at a dose that does not exceed pravastatin 40 mg. 
Pravastatin se lahko daje z zdravilom Vosevi v odmerku, ki ne presega odmerka pravastatina 40 mg.
Biliary excretion of parent drug was the major route of elimination for voxilaprevir. 
Glavna pot izločanja voksilaprevirja je bilo izločanje izhodiščne spojine skozi žolč.
Omeprazole dosed 2 hours prior to Vosevi 
Omeprazol uporabljen 2 uri pred zdravilom Vosevi Lansoprazold
No dose adjustment of Vosevi or methadone is required. 
Odmerka zdravila Vosevi ali metadona ni treba prilagajati.
Co-administration of such medicinal products with Vosevi is not recommended (see section 4.5). 
Sočasna uporaba teh zdravil z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.5).
SOF/VEL 12 weeks (n = 440) 
SOF/VEL 12 tednov (n = 440)
ACID REDUCING AGENTS Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate 
Antacidi npr. aluminijev hidroksid ali magnezijev hidroksid;
Musculoskeletal and connective tissue disorders: Common myalgia 
Bolezni mišično-skeletnega sistema in vezivnega tkiva:
sofosbuvir (400 mg single dose)e 
sofosbuvir (400 mg enkratni odmerek)f
Voxilaprevir ↔ ↔ ↔ 
R-metadon ↔ ↔ ↔ S-metadon ↔ ↔ ↔
SOF/VEL 12 weeks (n = 109) 
SOF/VEL 12 tednov (n = 109)
Table 12: SVR12 by HCV genotype and virologic outcome in study POLARIS-2* 
Preglednica 12: SVR12 po genotipu HCV in virološki izid v študiji POLARIS-2* SOF/VEL/VOKS
No dose adjustment of Vosevi, raltegravir or emtricitabine/tenofovir disoproxil fumarate is required. 
Odmerka zdravila Vosevi, raltegravirja ali emtricitabina/dizoproksil tenofovirijevega fumarata ni treba prilagajati.
The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault). 
Farmakokinetiko velpatasvirja so preučili z enkratnim 100-miligramskim odmerkom velpatasvirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi CockcroftGault).
Median sofosbuvir EC50, nM (range) 
Sofosbuvir EC50, nMa
Cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate. 
Pri uporabi režimov, ki vključujejo sofosbuvir, v kombinaciji z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
Median voxilaprevir EC50, nM (range) 
Povprečna vrednost EC50 za voksilaprevir, nM (razpon)
HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Tenofovir disoproxil fumarate 
ZDRAVILA ZA ZDRAVLJENJE OKUŽBE Z VIRUSOM HIV: ZAVIRALCI REVERZNE TRANSKRIPTAZE
NS5A inhibitorexperienced patients, GT1-6, with or without cirrhosis 
1-6, ki so bili predhodno že zdravljeni z zaviralci NS5A, s cirozo ali brez
• The other ingredients are 
• Druge sestavine zdravila so Jedro tablete:
The median time between prior DAA failure and first dose of Vosevi or sofosbuvir/velpatasvir for patients enrolled into POLARIS-4 was 76 weeks (range: 10 to 549 weeks). 
Mediana časa med predhodnim neuspehom zdravljenja z DAA in prvim odmerkom zdravila Vosevi ali sofosbuvirja/velpatasvirja za bolnike, vključene v študijo POLARIS-4, je bila
No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 23- and 4-fold higher, respectively, than the human exposure at the recommended clinical dose. 
V študijah razvojne toksičnosti z velpatasvirjem pri izpostavljenostih na podlagi AUC, ki so bile približno 23-krat večje pri miših in 4-krat večje pri podganah od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso zabeležili nobenih teratogenih učinkov.
Rifampicin (600 mg once daily) + sofosbuvir (400 mg single dose)f 
Rifampicin (600 mg enkrat na dan) + sofosbuvir (400 mg enkratni odmerek)f
Ketoconazole (200 mg twice daily) + velpatasvir (100 mg single dose)f 
Ketokonazol (200 mg dvakrat na dan) + velpatasvir (100 mg enkratni odmerek)f
Patients with GT1-4 were randomised in a 1:1 ratio to SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks. 
Bolniki z okužbo GT 1-4 so bili randomizirani v razmerju 1 : 1 za 8tedensko zdravljenje s SOF/VEL/VOKS
At clinically relevant concentrations, voxilaprevir is not an inhibitor of hepatic transporters OCT1, renal transporters OCT2, OAT1, OAT3 or MATE1, or CYP or UGT1A1 enzymes. 
V klinično pomembnih koncentracijah voksilaprevir ni zaviralec jetrnih prenašalcev OCT1, ledvičnih prenašalcev
Severe RI (eGFR <30 mL/min/1.73 m2) 
≥ 50 in < 80 ml/mi n/1,73 m2)
No dose adjustment of Vosevi or voriconazole is required. 
Odmerka zdravila Vosevi ali vorikonazola ni treba prilagajati.
Analyses were conducted to explore the association between pre-existing baseline NS3 and NS5A RAVs and treatment outcome for patients that had not previously been treated with DAA regimens and received sofosbuvir/velpatasvir/voxilaprevir for 8 weeks in POLARIS-2 and POLARIS-3. 
V študijah POLARIS-2 in POLARIS-3 so opravili analize, da bi raziskali povezavo med predhodno obstoječimi izhodiščnimi RAV NS3 in NS5A in izidom zdravljenja pri bolnikih, ki predhodno še niso bili zdravljeni z režimi, ki vsebujejo DAA, in ki so prejemali 8-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem/voksilaprevirjem.
Analyses were conducted to explore the association between pre-existing baseline NS3 and NS5A RAVs and treatment outcome for patients that had previously been treated with DAA regimens and received sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-1 and POLARIS-4. 
V študijah POLARIS-1 in POLARIS-4 so opravili analize, da bi raziskali povezavo med predhodno obstoječimi izhodiščnimi RAV NS3 in NS5A in izidom zdravljenja pri bolnikih, ki so bili predhodno že zdravljeni z režimi, ki vsebujejo DAA, in ki so prejemali 12-tedensko zdravljenje s sofosbuvirjem/velpatasvirjem/voksilaprevirjem.
↔ Voxilaprevir 
↔ voksilaprevir
ANTIMYCOBACTERIALS Rifampicin (single dose) 
ZDRAVILA ZA ZDRAVLJENJE OKUŽB Z MIKOBAKTERIJAMI Rifampicin (enkratni odmerek) (zaviranje OATP1B)
mL/min/1. 
ml/min/1,7 3m2)
No dose adjustment of Vosevi or elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate is required. 
Odmerka zdravila Vosevi ali elvitegravirja/kobicistata/ emtricitabina/ tenofoviralafenamidijevega fumarata ni treba prilagajati.
Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study. 
V študiji razvoja pri podganah pred kotitvijo in po njej sofosbuvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
Norgestrel Ethinyl estradiol 
Norgestimat/etinilestradiol (norgestimat
ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol (norgestimate 0.180 mg/0.215 mg/0.25 m g/ethinyl estradiol 0.025 mg) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f 
0,180 mg/0,215 mg/0,25 mg/ etinilestradiol 0,025 mg) +
Patient disposition 
Razporeditev bolnikov
After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.7. 
Po enkratnem 100-miligramskem odmerku [14C]-velpatasvirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi 0,5-0,7.
l. Administered as elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fixed-dose combination. 
l.Uporabljeno kot fiksna kombinacija elvitegravirja, kobicistata, emtricitabina in tenofoviralafenamida.
Genotype 1b 
Genotip 1b Genotip 2
Co-administration with such medicinal products is not recommended with Vosevi (see section 4.4 and Table 2). 
Sočasna uporaba teh zdravil z zdravilom Vosevi ni priporočljiva (glejte poglavje 4.4 in preglednico 2).
The safety assessment of Vosevi was based on data from Phase 2 and 3 clinical trials in which 1383 patients received sofosbuvir/velpatasvir/voxilaprevir or sofosbuvir/velpatasvir + voxilaprevir for 8 or 12 weeks. 
1.383 bolniki, ki so prejemali sofosbuvir/velpatasvir/voksilaprevir ali sofosbuvir/velpatasvir +
No dose adjustment of Vosevi, darunavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required. 
darunavirja (okrepljenega z ritonavirjem) ali emtricitabina/dizoproksil tenofovirijevega fumarata ni treba prilagajati.
The pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C). 
Farmakokinetiko voksilaprevirja so proučili z enkratnim 100-miligramskim odmerkom voksilaprevirja pri bolnikih, negativnih za HCV, z zmerno in hudo jetrno okvaro (stopnja B in C po CPT).
The pharmacokinetics of velpatasvir were studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C). 
Farmakokinetiko velpatasvirja so proučili z enkratnim 100-miligramskim odmerkom velpatasvirja pri bolnikih, negativnih za HCV, z zmerno in hudo jetrno okvaro (stopnja B in C po CPT).
No dose adjustment of Vosevi or dolutegravir is required. 
Odmerka zdravila Vosevi ali dolutegravirja ni treba prilagajati.