FrancophonIA/ELRC3.0 huggingface dataset:
English: RAVs not determined for both NS3 and NS5Aa a. Patients with NS3 and/or NS5A gene sequencing failure.
Slovak: Pacienti so zlyhaním sekvenovania génu NS3 a/alebo NS5A.
English: 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.
Slovak: V štúdiách vývojovej toxicity velpatasviru na myšiach a potkanoch pri expozíciách AUC približne 23-násobne a 4-násobne vyšších ako je expozícia u ľudí pri odporúčanej klinickej dávke, v uvedenom poradí, sa nepozorovali žiadne teratogénne účinky.
English: Table 10 presents the SVR12 by HCV genotype for the POLARIS-1 trial.
Slovak: Tabuľka 10 zobrazuje SVR12 podľa genotypu HCV pre klinické skúšanie POLARIS-1.
English: • St. John's wort (a herbal medicine used to treat depression);
Slovak: • ľubovník bodkovaný (rastlinný liek používaný na liečbu depresie);
English: No dose adjustment of Vosevi, darunavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Vosevi, darunaviru (zosilneného ritonavirom) ani emtricitabínu/tenofovirdizoproxilfumarátu.
English: b. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Slovak: Menovateľom relapsu je počet pacientov s HCV RNA <
English: 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.
Slovak: AUC velpatasviru sa zvyšuje viac než úmerne od 5 do 50 mg a menej než úmerne od 50 do 450 mg, čo naznačuje, že absorpcia velpatasviru je obmedzená rozpustnosťou.
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with once daily sofosbuvir/velpatasvir 400/100 mg for
Slovak: Farmakokinetika sofosbuviru, GS-331007 a velpatasviru sa skúmala u pacientov infikovaných HCV s ESRD vyžadujúcim dialýzu liečených sofosbuvirom/velpatasvirom 400/100 mg raz denne počas 12 týždňov a porovnávala sa s pacientmi bez poruchy funkcie obličiek v skúšaniach 2./3. fázy so sofosbuvirom/velpatasvirom.
English: GT-6 (n = 6)
Slovak: (n = 6)
English: Of the 263 NS5A inhibitor-experienced patients treated with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-1 (see Table 10), 7 of 263 (3%) patients (2 with genotype 1, 4 with genotype 3, and 1 with genotype 4) did not achieve sustained virologic response (SVR12) and qualified for resistance analysis; 6 relapsed and 1 experienced virologic breakthrough with pharmacokinetic data consistent with nonadherence.
Slovak: %) pacientov (2 s genotypom 1, 4 s genotypom 3 a 1 s genotypom 004) nedosiahli trvalú virologickú odpoveď (SVR12) a splnili podmienky na zaradenie do analýzy rezistencie; u 6 došlo k relapsu a u 1 došlo k virologickému zlyhaniu s farmakokinetickými údajmi zodpovedajúcimi s nedodržiavaním predpísanej liečby.
English: No dose adjustment of Vosevi or emtricitabine/rilpivirine/tenofovi r alafenamide is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Vosevi ani emtricitabínu/rilpivirínu/ tenofoviru-alafenamidu.
English: Atorvastatin may be administered with Vosevi at a dose that does not exceed atorvastatin 20 mg.
Slovak: Atorvastatín možno podávať s liekom Vosevi v dávke, ktorá neprekračuje 20 mg.
English: POLARIS-2 (open label)
Slovak: POLARIS-2 (otvorená)
English: Velpatasvir and voxilaprevir are inhibitors of drug transporters P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Slovak: Resistance Protein), transportného polypeptidu organických aniónov (OATP, organic anion-transporting polypeptide) 1B1 a OATP1B3.
English: Studies with DAA-experienced Patients
Slovak: Štúdie s pacientmi liečenými DAA
English: Pravastatin may be administered with Vosevi at a dose that does not exceed pravastatin 40 mg.
Slovak: Pravastatín možno podávať s liekom Vosevi v dávke, ktorá neprekračuje 40 mg pravastatínu.
English: No dose adjustment of Vosevi or dolutegravir is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Vosevi ani dolutegraviru.
English: No NS3 or NS5A RAVs Any NS3 or NS5A RAV NS3 only NS5A only NS3 and NS5A RAVs not determined for both NS3 and NS5Aa a. Patients with NS3 and/or NS5A gene sequencing failure.
Slovak: Len NS3 Len NS5A NS3 a NS5A RAV nie sú stanovené pre NS3 a NS5Aa 100 % (19/19)
English: Relative to patients with normal hepatic function, the voxilaprevir AUCinf was 299% and 500% higher in patients with moderate and severe hepatic impairment, respectively.
Slovak: V porovnaní s pacientmi s normálnou funkciou pečene bola hodnota AUCinf voxilapreviru vyššia o 299
English: After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Slovak: Po jednorazovej 400 mg dávke [14C]-sofosbuviru zdravým jedincom bol pomer [14C]-rádioaktivity v krvi voči plazme približne 0,7.
English: Patients with GT5-6 infection were enrolled into the SOF/VEL/VOX 8 week group only.
Slovak: Pacienti s infekciou GT 5 - 6 boli zaradení len do skupiny SOF/VEL/VOX počas 8 týždňov.
English: Other statins (Inhibition of OATP1B)
Slovak: pravastatín iné statíny (inhibícia OATP1B)
English: i. Administered as emtricitabine, rilpivirine, and tenofovir alafenamide fixed-dose combination.
Slovak: Podávaný ako kombinácia fixnej dávky emtricitabínu, rilpivirínu a tenofovir-alafenamidu.
English: Relapsec
Slovak: Relapsc
English: velpatasvir (400/100 mg once daily)f, h
Slovak: sofosbuvir/velpatasvir (400/100 mg jedenkrát denne)f,h
English: Velpatasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Slovak: Velpatasvir nebol genotoxický v skupine in vitro alebo in vivo testov vrátane bakteriálnej mutagenity, chromozómovej aberácie použitím lymfocytov z ľudskej periférnej krvi a in vivo testoch mikrojadier potkanov.
English: 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.
Slovak: V skupine liečenej sofosbuvirom/velpatasvirom/voxilaprevirom počas 8 týždňov v štúdii POLARIS-3 (pozri tabuľku 14) splnili podmienky na zaradenie do analýzy rezistencie z dôvodu relapsu 2 zo 110 (2
English: Co-administration with such medicinal products is not recommended with Vosevi (see section 4.4 and Table 2).
Slovak: Súbežné podávanie lieku Vosevi s takýmito liekmi sa neodporúča (pozri časť 4.4 a tabuľku 2).
English: Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir, velpatasvir and/or voxilaprevir plasma concentrations leading to reduced therapeutic effect of Vosevi.
Slovak: Lieky, ktoré sú stredne silnými induktormi P-gp a/alebo stredne silnými induktormi CYP (napr. efavirenz, modafinil, oxkarbazepín alebo rifapentín), môžu znížiť plazmatické koncentrácie sofosbuviru, velpatasviru a/alebo voxilapreviru, čo má za následok znížený terapeutický účinok lieku Vosevi.
English: Voxilaprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Slovak: Voxilaprevir nebol genotoxický v skupine in vitro alebo in vivo testov vrátane bakteriálnej mutagenity, chromozómovej aberácie s použitím lymfocytov z ľudskej periférnej krvi a in vivo testoch mikrojadier potkanov.
English: Vosevi contains lactose • Tell your doctor if you are lactose intolerant or intolerant to other sugars.
Slovak: Povedzte svojmu lekárovi, ak neznášate laktózu alebo neznášate iné cukry.
English: Renal impairment No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
Slovak: U pacientov s ľahkou alebo stredne ťažkou poruchou funkcie obličiek sa nevyžaduje úprava dávky lieku Vosevi.
English: Genotype 6
Slovak: Genotyp 6
English: Patients were randomised in a 1:1 ratio to SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks.
Slovak: : 1, aby dostávali SOF/VEL/VOX počas 8 týždňov alebo SOF/VEL počas 12 týždňov.
English: ↔ Rifampicin
Slovak: rilpivirín
English: POLARIS-4 (open label)
Slovak: POLARIS-4 (otvorená)
English: POLARIS-3 (open label)
Slovak: POLARIS-3 (otvorená)
English: l. Administered as elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide fixed-dose combination.
Slovak: %. l. Podávaný ako kombinácia fixnej dávky elvitegraviru, kobicistátu, emtricitabínu a tenofovir-alafenamidu.
English: After a single 100 mg dose of [14C]-voxilaprevir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.8.
Slovak: Po jednorazovej 100 mg dávke [14C]-voxilapreviru zdravým jedincom bol pomer [14C]-rádioaktivity v krvi voči plazme v rozsahu medzi 0,5 až 0,8.
English: Table 10: SVR12 in NS5A-inhibitor experienced patients by HCV genotype in study POLARIS-1*
Slovak: Tabuľka 10: SVR12 u pacientov, ktorí sa už liečili inhibítorom NS5A, podľa genotypu HCV
English: (Inhibition of OATP1B, P-gp/BCRP and CYP3A)
Slovak: (inhibícia OATP1B, P-gp/BCRP a CYP3A)
English: Relapsed 2%
Slovak: % v moči.
English: (Inhibition of OATP1B and BCRP)
Slovak: (inhibícia OATP1B a BCRP)
English: • If you are sick (vomit) less than 4 hours after taking Vosevi, take another tablet.
Slovak: Ak vraciate do 4 hodín po užití lieku Vosevi, užite ďalšiu tabletu.
English: The hydrolysed and dehydrogenated voxilaprevir were the major metabolites identified in human plasma.
Slovak: V ľudskej plazme sa zistili metabolity hydrolyzovaného a dehydrogenovaného voxilapreviru.
English: Musculoskeletal and connective tissue disorders: Common myalgia
Slovak: Poruchy kostrovej a svalovej sústavy a spojivového tkaniva:
English: Site directed mutagenesis of known NS3 RAVs showed that substitutions conferring a > 100-fold reduction in voxilaprevir susceptibility are A156V, A156T or A156L in genotype 1a, 1b, 2a, 3a and 4.
Slovak: NS3 preukázala, že substitúciami vedúcimi k > 100-násobnému zníženiu citlivosti na voxilaprevir sú A156V, A156T alebo A156L v genotype 1a, 1b, 2a, 3a a 4. Žiadne individuálne RAV testované na genotypoch 2b, 5a alebo 6a neviedli k > 100-násobnému zníženiu citlivosti na voxilaprevir.
English: Sofosbuvir Velpatasvir
Slovak: dolutegravir sofosbuvir velpatasvir
English: (Inhibition of OATP1B, P-gp and CYP3A)
Slovak: (inhibícia OATP1B, P-gp a CYP3A)
English: No NS3, NS5A, or NS5B NI RAVs emerged in this patient infected with genotype 1a HCV.
Slovak: U tohto pacienta infikovaného HCV genotypom 1a sa nevyskytli žiadne RAV NI NS3, NS5A ani NS5B.
English: 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.
Slovak: Ak sa režimy obsahujúce sofosbuvir použili v kombinácii s amiodarónom a inými liekmi, ktoré znižujú srdcovú frekvenciu alebo bez nich, pozorovali sa prípady závažnej bradykardie a srdcovej blokády.
English: Breast-feeding Do not breast-feed during treatment with Vosevi.
Slovak: Počas liečby liekom Vosevi nedojčite.
English: There were no patients receiving sofosbuvir/velpatasvir/voxilaprevir for 12 weeks who permanently discontinued treatment due to adverse reactions.
Slovak: U pacientov, ktorí dostávali sofosbuvir/velpatasvir/voxilaprevir počas 8 týždňov bol podiel pacientov, ktorí natrvalo ukončili liečbu z dôvodu nežiaducich reakcií, 0,1
English: 1a 1b 2a 2b 3a 4a
Slovak: POLARIS-1, -2, -3 a -4
English: Ciclosporin ↔ ↓
Slovak: norelgestromín ↔ ↔
English: 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.
Slovak: Po jednorazovej 100 mg dávke [14C]-velpatasviru zdravým účastníkom bol pomer [14C]-rádioaktivity v krvi voči plazme v rozsahu medzi 0,5 až 0,7.
English: GT-4 (n = 22)
Slovak: (n = 22)
English: DAA-naïve adults with genotype 1, 2, 3, 4, 5, or 6 HCV infection (POLARIS-2) Table 12 presents the SVR12 by HCV genotype and virologic outcome for the POLARIS-2 trial.
Slovak: Dospelí, ktorí sa ešte neliečili DAA s infekciou HCV genotypu 1, 2, 3, 4, 5 alebo 6 (POLARIS-2)
English: Co-administration of Vosevi with rifapentine is not recommended (see section 4.4).
Slovak: Súbežné podávanie lieku Vosevi s rifapentínom sa neodporúča (pozri časť 4.4).
English: • The active substances are sofosbuvir, velpatasvir and voxilaprevir.
Slovak: Liečivá sú sofosbuvir, velpatasvir a voxilaprevir.
English: Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate (150/150/200/10 mg once daily)l + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Slovak: Cmin elvitegravir/kobicistát/emtricit abín/tenofoviralafenamidfumarát (150/150/200 mg/ 10 mg jedenkrát denne)l + sofosbuvir/ velpatasvir/voxilaprevir
English: 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).
Slovak: Farmakokinetika voxilapreviru sa skúmala s jednorazovou dávkou 100 mg voxilapreviru u HCV negatívnych pacientov so stredne ťažkou a ťažkou poruchou funkcie pečene (CPT trieda B a C).
English: Close monitoring is recommended if this medicinal product is administered with Vosevi (see sections 4.4 and 4.8).
Slovak: Ak sa tento liek podáva spolu s liekom Vosevi, odporúča sa dôkladné sledovanie (pozri časti 4.4 a digoxín
English: • Placebo 12 weeks (N=152)
Slovak: Placebo 12 týždňov
English: Patients with GT4-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Slovak: Pacienti s infekciou GT 4 - 6 boli zaradení len do skupiny SOF/VEL/VOX počas 12 týždňov.
English: Co-administration of Vosevi with modafinil is not recommended (see section 4.4).
Slovak: Súbežné podávanie lieku Vosevi s modafinilom sa neodporúča (pozri časť 4.4).
English: AUC Cmin
Slovak: Cmin rosuvastatín
English: 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).
Slovak: Farmakokinetika velpatasviru sa skúmala s jednorazovou dávkou 100 mg velpatasviru u HCV negatívnych pacientov so stredne ťažkou a ťažkou poruchou funkcie pečene (CPT trieda B a C).
English: Close monitoring of INR is recommended when Vosevi is co-administered with all vitamin K antagonists.
Slovak: Ak sa liek Vosevi súbežne podáva so všetkými antagonistami vitamínu K, odporúča sa pozorné sledovanie INR.
English: Vosevi is contraindicated with ethinylestradiol-containing medicinal products (see section 4.3).
Slovak: Používanie lieku Vosevi s liekmi obsahujúcimi etinylestradiol je kontraindikované (pozri časť 4.3).
English: Patients receiving tenofovir disoproxil fumarate and Vosevi concomitantly should be monitored for adverse reactions associated with tenofovir disoproxil fumarate.
Slovak: Vosevi sa majú sledovať nežiaduce reakcie spojené s tenofovir-dizoproxilfumarátom.
English: Patients with GT2-6 infection were enrolled into the SOF/VEL/VOX 12 week group only.
Slovak: Pacienti s infekciou GT 2 - 6 boli zaradení len do skupiny SOF/VEL/VOX počas 12 týždňov.
English: Outcome for patients without SVR On-treatment virologic failure
Slovak: Výsledok pre pacientov bez SVR
English: The proportion of patients who permanently discontinued treatment due to adverse reactions was 0.1% for patients receiving sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
Slovak: %. Liečbu natrvalo neukončili z dôvodu nežiaducich reakcií žiadni pacienti, ktorí dostali sofosbuvir/velpatasvir/voxilaprevir počas 12 týždňov.
English: No dose adjustment of Vosevi, raltegravir or emtricitabine/tenofovir disoproxil fumarate is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Vosevi, raltegraviru ani emtricitabínu/tenofovirdizoproxilfumarátu.
English: Studies with DAA-naïve Patients
Slovak: Štúdie s pacientmi liečenými DAA Štúdie s pacientmi neliečenými DAA
English: No dose adjustment of Vosevi or methadone is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Vosevi ani metadónu.
English: Table 9: Demographics and baseline characteristics for patients enrolled into POLARIS-1, -2, -3 and -4
Slovak: Tabuľka 9: Demografické a východiskové charakteristiky pacientov zaradených do štúdií
English: 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).
Slovak: Farmakokinetika voxilapreviru sa navyše skúmala s jednorazovou dávkou 100 mg voxilapreviru u HCV negatívnych pacientov s ťažkou poruchou funkcie obličiek (eGFR <
English: How to take Vosevi
Slovak: Ako užívať liek Vosevi
English: Rifampicin (multiple dose) (Induction of P-gp and CYPs)
Slovak: sofosbuvir rifapentín (indukcia P-gp a CYP)
English: ACID REDUCING AGENTS Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Slovak: Antacidá napr. hydroxid hlinitý alebo horečnatý; uhličitan vápenatý
English: (may affect more than 1 in 10 people) • headache
Slovak: Veľmi časté vedľajšie účinky (môžu postihovať viac ako 1 z 10 ľudí)
English: Digoxin (0.25 mg single dose)e + velpatasvir (100 mg single dose)
Slovak: Digoxín (0,25 mg jednorazová dávka)e
English: Interaction only studied with sofosbuvir Expected:
Slovak: Interakcia sa skúmala len so sofosbuvirom
English: S-methadone ↔ ↔ ↔ Sofosbuvir
Slovak: R-metadón S-metadón sofosbuvir
English: Mild RI (eGFR
Slovak: Ľahká PFO (eGFR ≥
English: In the POLARIS-2 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 12), a total of 21 of 501 (4%) patients (16 with genotype 1, 2 with genotype 2, 2 with genotype 4, and 1 with genotype 5) qualified for resistance analysis due to relapse.
Slovak: V skupine liečenej sofosbuvirom/velpatasvirom/voxilaprevirom počas 8 týždňov v štúdii POLARIS-2 (pozri tabuľku 12) splnilo podmienky na zaradenie do analýzy rezistencie z dôvodu relapsu celkovo 21 z 501 (4
English: Table 15: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of SOF, GS331007, Velpatasvir and Voxilaprevir Compared to Subjects with Normal Renal Function
Slovak: SOF, GS-331007, velpatasviru a voxilapreviru v porovnaní s jedincami s normálnou funkciou obličiek
English: No NS3, NS5A, or NS5B NI RAVs emerged in either of these patients.
Slovak: U žiadneho z týchto pacientov sa nevyvinuli RAV NI NS3, NS5A ani NS5B.
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Slovak: Najväčšia časť dávky sofosbuviru vylúčená v moči bola vo forme GS-331007 (78
English: Clinical studies in DAA-experienced patients
Slovak: Klinické štúdie s pacientmi, ktorí sa už liečili DAA
English: No dose adjustment of Vosevi or voriconazole is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Vosevi ani vorikonazolu.
English: Relative to healthy subjects (n = 137), velpatasvir AUC0-24 and Cmax were 41% lower and 39% lower, respectively, in HCV-infected patients.
Slovak: 137) boli u pacientov infikovaných HCV hodnoty AUC0-24 pre velpatasvir nižšie o 41
English: 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.
Slovak: 1 038) 1 665 ng•h/ml a 678 ng/ml, v uvedenom poradí; priemerné hodnoty AUC0-24 a Cmax v rovnovážnom stave pre GS-331007 (n =
English: Study arms and duration (Number of patients treated)
Slovak: (počet liečených pacientov)
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)k + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir (400/100 mg once daily)f, h
Slovak: + emtricitabín/tenofovirdizoproxilfumarát (200/300 mg jedenkrát denne)j + sofosbuvir/ velpatasvir (400/100 mg jedenkrát denne)f, h
English: In the sofosbuvir/velpatasvir 12-week treatment group, a total of 3 of 440 (1%) patients (2 with genotype 1, 1 with genotype 4) qualified for resistance analysis due to relapse.
Slovak: V skupine liečenej sofosbuvirom/velpatasvirom počas 12 týždňov splnili podmienky na zaradenie do analýzy rezistencie z dôvodu relapsu celkovo 3 zo 440 (1
English: GT = genotype * The most common prior NS5A inhibitors were ledipasvir (LDV) (51%), daclatasvir (27%), and ombitasvir (11%).
Slovak: *Najčastejšie predchádzajúce inhibítory NS5A boli ledipasvir (LDV)
English: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Slovak: Pre sofosbuvir, GS-331007, velpatasvir alebo voxilaprevir sa nezistili žiadne klinicky významné farmakokinetické rozdiely v dôsledku rasy alebo pohlavia.
English: Co-administration with Vosevi is not recommended.
Slovak: Vosevi sa neodporúča.
English: GT-1a (n = 101)
Slovak: (n = 101)
English: j. Administered as emtricitabine, tenofovir disoproxil fumarate fixed-dose combination.
Slovak: Podávaný ako kombinácia fixnej dávky emtricitabínu, tenofovir-dizoproxilfumarátu.
English: No dose adjustment of Vosevi or elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate is required.
Slovak: Nie je potrebná žiadna úprava dávky lieku Vosevi ani elvitegraviru/kobicistátu/ emtricitabínu/tenofoviralafenamidu.
English: ↔ Sofosbuvir ↔ Velpatasvir
Slovak: ↔ modafinil ↓ sofosbuvir ↓ velpatasvir
English: No NS3 or NS5A RAVs Any NS3 or NS5A RAV NS3 Only
Slovak: Žiadne RAV NS3 alebo NS5A Akákoľvek RAV NS3 alebo NS5A 94 % (234/250)
English: Tenofovir
Slovak: PFO
English: Effect on sofosbuvir, velpatasvir and voxilaprevir concentrations not studied Expected:
Slovak: Účinok na koncentrácie sofosbuviru, velpatasviru a voxilapreviru sa neskúmal.
English: Excipients
Slovak: pravastatín
English: Median velpatasvir EC50, nM (range)
Slovak: Medián EC50 velpatasviru,
English: Co-administration of Vosevi with ciclosporin is not recommended (see section 4.4).
Slovak: Súbežné podávanie lieku Vosevi s cyklosporínom sa neodporúča (pozri časť 4.4).
English: Pravastatin
Slovak: PODÁVANIA
English: Rifampicin (600 mg once daily) + velpatasvir (100 mg single dose)f
Slovak: + velpatasvir (100 mg jednorazová dávka)f velpatasvir rifampicín (600 mg jedenkrát denne)
English: Uncommon muscle spasm Laboratory investigations: Common total bilirubin increased
Slovak: Časté zvýšená hladina celkového bilirubínu
English: 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.
Slovak: Na základe populačnej farmakokinetickej analýzy pacientov infikovaných HCV boli priemerné hodnoty AUC0-24 a Cmax v rovnovážnom stave pre voxilaprevir (n =
English: Table 13 presents the SVR12 by HCV genotype by cirrhosis status for the POLARIS-2 trial.
Slovak: SVR12 podľa genotypu HCV podľa stavu cirhózy v klinickom skúšaní POLARIS-2.
English: 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.
Slovak: Na základe populačnej farmakokinetickej analýzy pacientov infikovaných HCV boli priemerné hodnoty AUC0-24 a Cmax v rovnovážnom stave pre velpatasvir (n =
English: Vosevi is contraindicated with rosuvastatin (see section 4.3).
Slovak: Vosevi je kontraindikovaný s ľubovníkom bodkovaným (pozri časť 4.3).
English: No dose adjustment of Vosevi is required for patients with mild hepatic impairment (CPT Class A).
Slovak: Liek Vosevi sa neodporúča podávať pacientom so stredne ťažkou alebo ťažkou poruchou funkcie pečene (trieda