natgillin/translations-raw huggingface dataset:
Famotidine dosed simultaneously with Epclusad
Famotidin uporabljen sočasno z zdravilom Epclusad
Epclusa + RBV 12 weeks (87) Epclusa 24 weeks (90)
Zdravilo Epclusa + RBV 12 tednov (87) Zdravilo Epclusa 24 tednov (90)
TN and TE, with CPT Class B decompensated cirrhosis
PN in PZ, z dekompenzirano cirozo stopnje B po CPT
HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS
ZDRAVILA ZA ZDRAVLJENJE OKUŽBE Z VIRUSOM HIV: ZAVIRALCI INTEGRAZE
Safety data are limited in patients with severe renal impairment (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 boleznijo ledvic v končni fazi (ESRD), zaradi katere je potrebna hemodializa.
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Sočasna okužba z virusoma HCV in HBV (virus hepatitisa B) Med zdravljenjem ali po zdravljenju z zdravili z direktnim delovanjem na viruse so poročali o reaktivaciji virusa hepatitisa B (HBV), nekateri primeri so bili smrtni.
These data indicate that biliary excretion of parent drug was a major route of elimination for velpatasvir.
Ti podatki kažejo, da je glavna pot izločanja velpatasvirja izločanje izhodiščne spojine skozi žolč.
Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
Pri bolnikih s kompenzirano cirozo, ki so okuženi z genotipom 3, se lahko razmisli o dodajanju ribavirina (glejte poglavje 5.1).
Of the 267 treated patients, the median age was 59 years (range: 40 to 73); 70% of the patients were male; 90% were White, 6% were Black; 42% had a baseline body mass index of at least 30 kg/m2.
Mediana starosti 267 zdravljenih bolnikov je bila 59 let (razpon: 40-73 let); 70 % bolnikov je bilo moških; 90 % je bilo belcev; 6 % je bilo črncev; 42 % je imelo indeks telesne mase najmanj 30 kg/m2.
Note: Baseline frequency of ascites was: 20% none, 77% mild/moderate, 3% severe Baseline frequency of encephalopathy was: 38% none, 62% grade 1-2.
Opomba: Izhodiščna pogostost ascitesa je bila: 20 % brez, 77 % blag/zmeren, 3 % hud.
Genotype 2, 4, and 6 HCV-infected patients had a higher prevalence of NS5A RAVs (70%, 63% and 52%, respectively) compared to genotype 1 (23%), genotype 3 (16%), and genotype 5 (18%) HCV-infected patients.
2, 4 in 6 je bila večja prevalenca RAV NS5A (70 %, 63 % in 52 %) kot pri bolnikih z okužbo s HCV genotipa 1 (23 %), 3 (16 %) in 5 (18 %).
Studies in patients with decompensated cirrhosis
Študije pri bolnikih z dekompenzirano cirozo
TN and TE, without cirrhosis or with compensated cirrhosis
PN in PZ, brez ciroze ali s kompenzirano cirozo
Rosuvastatin (10 mg single dose)/ velpatasvir (100 mg once daily)d (Inhibition of OATP1B and BCRP)
Rosuvastatin (10 mg enkratni odmerek)/velpatasvir (100 mg enkrat na dan)d (zaviranje prenašalcev OATP1B in BCRP)
Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Epclusa.
Zdravila, ki so zmerni induktorji P-gp in/ali citokroma CYP (npr. efavirenz, modafinil, okskarbazepin ali rifapentin), lahko zmanjšajo koncentracije sofosbuvirja ali velpatasvirja v plazmi, kar zmanjša terapevtski učinek zdravila Epclusa.
Effect on velpatasvir exposure not studied.
Učinka na izpostavljenost velpatasvirju niso preučevali.
Steady-state Cmax for sofosbuvir, GS-331007 and velpatasvir were 566, 868 and 259 ng/mL, respectively.
Vrednosti Cmax v stanju dinamičnega ravnovesja so bile 566 ng/ml za sofosbuvir, 868 ng/ml za GS-331007 in 259 ng/ml za velpatasvir.
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.
Velpatasvir v nizu raziskav in vitro ali in vivo ni bil genotoksičen, vključno z bakterijskim testom mutagenosti, testom kromosomske aberacije z uporabo limfocitov humane periferne krvi in in vivo v testu mikronukleusa pri podganah.
(400/ 100 mg single dose fed)c
(400/100 mg enkratni odmerek po obroku)c
After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Po enkratnem 400-miligramskem odmerku [14C]-sofosbuvirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi približno 0,7.
Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
Kadar se to zdravilo uporablja sočasno z zdravilom Epclusa, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Epclusa.
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Epclusa,
Epclusa + RBV 12 weeks
Zdravilo Epclusa + RBV 12 tednov
Clinical studies in patients with decompensated cirrhosis - ASTRAL-4 (study 1137) ASTRAL-4 was a randomised, open-label study in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and CPT Class B cirrhosis.
Klinične študije pri bolnikih z dekompenzirano cirozo- ASTRAL-4 (študija 1137) ASTRAL-4 je bila randomizirana, odprta študija pri bolnikih z okužbo s HCV genotipa 1, 2, 3, 4, 5 ali 6 in cirozo stopnje B po CPT.
The 1 virologic failure patient with genotype 1 HCV had no NS5A or NS5B RAVs at failure.
Bolnik z okužbo s HCV genotipa 1, ki je doživel virološki neuspeh, ob neuspehu ni imel RAV NS5A ali NS5B.
Epclusa 12 weeks (59)
Zdravilo Epclusa 12 tednov (59)
Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Uporaba z močnimi induktorji P-gp in citokromov CYP Zdravila, ki so močni induktorji P-glikoproteina (P-gp) in/ali citokromov P450 (CYP) (karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin in šentjanževka).
Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Začetni odmerek znaša 600 mg in če ga bolniki dobro prenašajo, ga je mogoče povečevati do največ 1.000-1.200 mg (1.000 mg za bolnike s telesno maso < 75 kg in 1.200 mg za bolnike s telesno maso ≥ 75 kg).
Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je bil povprečni skupni delež [14C]-radioaktivnosti, ki so jo izolirali, višji kot 92 %, pri čemer se je 80 % izoliralo v urinu, 14 % v blatu in 2,5 % v izdihanem zraku.
No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 31- and 6-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 31-krat večje pri miših in 6krat večje pri podganah od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, niso zabeležili nobenih teratogenih učinkov.
Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital and phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of sofosbuvir/velpatasvir.
Zdravila, ki so močni induktorji P-gp in/ali citokromov CYP2B6, CYP2C8 ali CYP3A4 (npr. karbamazepin, fenobarbital in fenitoin, rifampicin, rifabutin in šentjanževka), lahko zmanjšajo koncentracije sofosbuvirja ali velpatasvirja v plazmi, kar zmanjša terapevtski učinek sofosbuvirja/velpatasvirja.
Of the 2 genotype 1 virologic failure patients, one patient had virus with emergent NS5A RAV Y93N and the other patient had virus with emergent NS5A RAVs L31I/V and Y93H at virologic failure.
Od 2 bolnikov z okužbo s HCV genotipa 1, ki sta dosegla virološki neuspeh, se je pri enem bolniku pojavil virus z RAV NS5A Y93N, pri drugem pa virus z RAV NS5A L31I/V in Y93H v času virološkega neuspeha.
If you are not sure talk to your doctor or pharmacist.
Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Table 8: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (study ASTRAL-4)
Preglednica 8: SVR12 pri bolnikih z izhodiščnimi RAV NS5A ali brez njih po genotipu HCV (študija ASTRAL-4)
Both patients had virus at baseline harboring NS5A RAVs.
Oba bolnika sta imela ob izhodišču virus, pri katerem je bil prisoten RAV NS5A.
↔ ↔ ↔ No dose adjustment of oral contraceptives is required.
↔ ↔ ↔ Odmerka peroralnih kontraceptivov ni treba prilagajati.
No dose adjustment of Epclusa or ketoconazole is required.
Odmerka zdravila Epclusa ali ketokonazola ni treba prilagajati.
Velpatasvir is a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Velpatasvir je substrat citokromov CYP2B6, CYP2C8 in CYP3A4 in se presnavlja počasi.
The pharmacokinetics of sofosbuvir, GS-331007 and velpatasvir in paediatric patients have not been established (see section 4.2).
Pediatrična populacija Farmakokinetike sofosbuvirja, GS-331007 in velpatasvirja pri pediatričnih bolnikih niso ugotavljali
Epclusa 12 weeks (106)
Zdravilo Epclusa 12 tednov (106)
In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed.
In vitro so zabeležili počasno presnovo velpatasvirja s citokromi CYP2B6, CYP2C8 in CYP3A4.
The use of such medicinal products with Epclusa is contraindicated (see section 4.3).
Uporaba takšnih zdravil skupaj z zdravilom Epclusa je kontraindicirana (glejte poglavje 4.3).
Digoxin (0.25 mg single dose)f/ velpatasvir (100 mg single dose)
Digoksin (0,25 mg enkratni odmerek)f/velpatasvir (100 mg enkratni odmerek)
• light-headedness;
• zasoplost;
Omeprazole dosed simultaneously with Epclusad
Omeprazol uporabljen sočasno z zdravilom Epclusad
100% (8/8)a
Genotip 2, 4 in 6 100 % (8/8)a
Interaction only studied with sofosbuvir Expected:
Preučevane so bile samo interakcije s sofosbuvirjem
Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
S cirozo jeter stopnje B po Child-Pugh
The pharmacokinetics of velpatasvir was 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).
Epclusa 24 weeks (n = 90)
Zdravilo Epclusa 24 tednov (n = 90)
With any baseline NS5A RAVs Without baseline NS5A RAVs
Brez izhodiščnih RAV NS5A
Table 7: SVR12 in patients with and without baseline Y93H, 1% Cut-off (Resistance Analysis Population Set) ASTRAL 3
Preglednica 7: SVR12 pri bolnikih z izhodiščnim Y93H ali brez njega z mejno vrednostjo 1 % (populacija za analizo odpornosti) v študiji ASTRAL-3
Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Rifampicin (600 mg enkrat na dan)/velpatasvir (100 mg enkratni odmerek)
Studies in patients with decompensated cirrhosis (CPT Class B) Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients with decompensated cirrhosis in one Phase 3 study (ASTRAL-4).
V eni klinični študiji 3. faze (ASTRAL-4) so opravili analize, da bi raziskali povezavo med predhodno obstoječimi izhodiščnimi RAV NS5A in izidom zdravljenja pri bolnikih z dekompenzirano cirozo.
Table 15: Virologic outcome for patients with genotype 1 and 3 HCV infection in study ASTRAL-4
Preglednica 15: Virološki izid za bolnike z okužbo s HCV genotipa 1 ali 3 v študiji ASTRAL-4
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women.
Podatkov o uporabi sofosbuvirja, velpatasvirja ali zdravila Epclusa pri nosečnicah ni oziroma so omejeni (manj kot 300 izpostavljenih nosečnosti).
At clinically relevant plasma concentration, velpatasvir is not an inhibitor of hepatic transporters bile salt export pump (BSEP), sodium taurocholate cotransporter protein (NTCP), OATP2B1, OATP1A2 or organic cation transporter (OCT) 1, renal transporters OCT2, OAT1, OAT3, multidrug resistance-associated protein 2 (MRP2) or multidrug and toxin extrusion protein (MATE) 1, or CYP or uridine glucuronosyltransferase (UGT) 1A1 enzymes.
(OCT, organic cation transporter) 1, ledvičnih prenašalcev OCT2, OAT1, OAT3, beljakovine, povezane z odpornostjo proti več zdravilom 2 (MRP2, multidrug resistance-associated protein 2), beljakovine za ekstruzijo več zdravil in toksinov (MATE, multidrug and toxin extrusion protein) 1, encimov CYP ali uridin-difosfatglukuroniltransferaze (UGT, uridine glucuronosyltransferase) 1A1.
Genotypes 2 or 4
Genotip 2 ali 4 Skupaj
Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Defosforilacija povzroči nastanek nukleozidnega presnovka GS-331007, ki ga ni mogoče učinkovito ponovno refosforilati in ki in vitro ni aktiven proti HCV. Sofosbuvir in GS-331007 nista substrata ali zaviralca encimov UGT1A1 ali CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP2D6.
Epclusa 24 weeks
Zdravilo Epclusa 24 tednov
Table 11 presents the SVR12 for the ASTRAL-2 study.
V preglednici 11 je predstavljen SVR12 za študijo ASTRAL-2.
The safety profile of Epclusa has been evaluated in one open-label study in which patients with CPT Class B cirrhosis received Epclusa for 12 weeks (n = 90), Epclusa + RBV for 12 weeks (n = 87) or Epclusa for 24 weeks (n = 90).
CPT prejemali zdravilo Epclusa 12 tednov (n = 90), zdravilo Epclusa + RBV 12 tednov (n = 87) ali zdravilo Epclusa 24 tednov (n = 90).
At baseline, 29% of patients had cirrhosis, 22% were treatment experienced, 32% had received a kidney transplant, 92% were on haemodialysis, and 8% were on peritoneal dialysis; mean duration on dialysis was 7.3 years (range: 0 to 40 years).
Ob izhodišču je imelo 29 % bolnikov cirozo, 22 % se jih je predhodno zdravilo, 32 % je imelo presaditev ledvice, 92 % jih je bilo na hemodializi in 8 % jih je bilo na peritonealni dializi;
Dolutegravir ↔ ↔ ↔ No dose adjustment of Epclusa or dolutegravir is required.
Dolutegravir ↔ ↔ ↔ Odmerka zdravila Epclusa ali dolutegravirja ni treba prilagajati.
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
After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.52 and 0.67.
Po enkratnem 100-miligramskem odmerku [14C]-velpatasvirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi 0,52-0,67.
Genotype 3 infected patients with the NS5A RAV Y93H at baseline had a lower SVR12 rate than patients without Y93H after treatment with Epclusa for 12 weeks, as summarised in Table 7.
Epclusa je bila pri bolnikih z okužbo s HCV genotipa 3 z RAV NS5A Y93H ob izhodišču stopnja SVR12 nižja kot pri bolnikih brez Y93H, kot je povzeto v preglednici 7.
Table 12 presents the SVR12 for the ASTRAL-3 study.
V preglednici 12 je predstavljen SVR12 za študijo ASTRAL-3.
Total (all GTs) (n = 624)
Skupaj (vsi GT) (n = 624)
Co-administration of Epclusa with efavirenz-containing regimens is not recommended (see section 4.4).
Sočasna uporaba zdravila Epclusa z režimi, ki vključujejo efavirenz, ni priporočljiva (glejte poglavje 4.4).
Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Famotidin (40 mg enkratni odmerek)/sofosbuvir/velpatasvi r (400/100 mg enkratni odmerek)c
Of the 2 genotype 3 virologic failure patients, one had NS5A RAV Y93H emerge at failure.
Od 2 bolnikov z okužbo s HCV genotipa 3, ki sta doživela virološki neuspeh, se je pri enem pojavil RAV NS5A Y93H ob neuspehu.
Ribavirin was discontinued in 15% of patients treated with Epclusa + RBV for 12 weeks due to adverse events.
15 % bolnikov, ki so prejemali zdravljenje z zdravilom Epclusa + RBV 12 tednov.
Median velpatasvir EC50, nM (range)
Povprečna vrednost EC50 za velpatasvir, nM (razpon)
Median sofosbuvir EC50, nM (range)
Povprečna vrednost EC50 za sofosbuvir, nM (razpon)
Epclusa + RBV 12 weeks (n = 87)
Zdravilo Epclusa + RBV 12 tednov (n = 87)
Genotype 1, 2, 3, 4, 5 and 6
Genotip 1, 2, 3, 4, 5 in 6
Of the 106 treated patients, the median age was 57 years (range: 25 to 72); 86% of the patients were male; 51% were white; 45% were black; 22% had a baseline body mass index ≥ 30 kg/m2; 19 patients (18%) had compensated cirrhosis; and 29% were treatment experienced.
Povprečna starost 106 zdravljenih bolnikov je bila 57 let (razpon: 25 do 72); 86 % bolnikov je bilo moških; 51 % je bilo belcev; 45 % je bilo črncev; 22 % bolnikov je imelo osnovni indeks telesne mase ≥ 30 kg/m2; 19 bolnikov (18 %) je imelo kompenzirano cirozo, 29 % bolnikov pa se je predhodno že zdravilo.
g Lack of pharmacokinetics interaction bounds 50-200%.
g. Območje 50-200 %, znotraj katerega ni farmakokinetičnih interakcij.
In clinical studies, headache, fatigue and nausea were the most common (incidence ≥ 10%) treatment emergent adverse events reported in patients treated with 12 weeks of Epclusa.
V kliničnih študijah so bili najpogostejši (pojavili so se pri ≥ 10 % bolnikov) neželeni učinki, o katerih so poročali pri bolnikih, ki so 12 tednov prejemali zdravljenje z zdravilom Epclusa, glavobol, utrujenost in slabost.
Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Odrasli bolniki z okužbo s HCV genotipa 2 - ASTRAL-2 (študija 1139) ASTRAL-2 je bila randomizirana, odprta študija, v kateri so ocenili 12-tedensko zdravljenje z zdravilom Epclusa v primerjavi z 12-tedenskim zdravljenjem s SOF + RBV pri bolnikih z okužbo s
(Induction of P-gp and CYPs)
(indukcija P-gp in citokromov CYP)
It is unknown whether sofosbuvir, metabolites of sofosbuvir or velpatasvir are excreted in human milk.
Dojenje Ni znano, ali se sofosbuvir in njegovi presnovki ali velpatasvir izločajo v materino mleko.
Total (all GTs) (n = 106)
Skupaj (vsi GT) (n = 106)
Table 13: SVR12 for selected subgroups in study ASTRAL-3 (HCV genotype 3)
Preglednica 13: SVR12 za izbrane podskupine v študiji ASTRAL-3 (HCV genotipa 3) Zdravilo Epclusa
Genotype 3 HCV-infected adults - ASTRAL-3 (study 1140) ASTRAL-3 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 24 weeks of treatment with SOF+RBV in patients with genotype 3 HCV infection.
Odrasli bolniki z okužbo s HCV genotipa 3 - ASTRAL-3 (študija 1140) ASTRAL-3 je bila randomizirana, odprta študija, v kateri so ocenili 12-tedensko zdravljenje z zdravilom Epclusa v primerjavi s 24-tedenskim zdravljenjem s SOF + RBV pri bolnikih z okužbo s
Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Jedro tablete kopovidon mikrokristalna celuloza premrežen natrijev karmelozat magnezijev stearat
Co-administration of Epclusa with oxcarbazepine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of Epclusa.
Pričakuje se, da bo sočasno dajanje zdravila Epclusaz okskarbazepinom zmanjšalo koncentracije sofosbuvirja in velpatasvirja, kar zmanjša terapevtski učinek zdravila Epclusa.
Epclusa should not be administered concurrently with other medicinal products containing sofosbuvir.
4.4 Posebna opozorila in previdnostni ukrepi Zdravila Epclusa se ne sme dati sočasno z drugimi zdravili, ki vsebujejo sofosbuvir.
Without cirrhosis 98% (160/163) With cirrhosis a Five patients with missing cirrhosis status in the SOF+RBV 24 week group were excluded from this subgroup analysis.
S cirozo a. 5 bolnikov brez statusa ciroze v skupini, ki je prejemala 24-tedensko zdravljenje s SOF + RBV, je bilo izključenih iz te analize podskupin.
Epclusa 12 weeks (90)
Zdravilo Epclusa 12 tednov (90)
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Zdravljenje z zdravilom Epclusa v skladu s priporočenim odmerjanjem (glejte poglavje 4.2.)
CPT Class C cirrhosis pre-transplant CPT Class B or C post-transplant
S cirozo jeter stopnje B ali C po CPT po presaditvi
Severe RI (eGFR <30 mL/min/1.7 3m2)
(eGFR < 30 ml/min/1,73
It is recommended to separate antacid and Epclusa administration by 4 hours.
Priporoča se, da med uporabo antacida in zdravila Epclusa minejo 4 ure.
• St. John's wort (herbal medicine used to treat depression);
• šentjanževko (zdravilo rastlinskega izvora, ki se uporablja za zdravljenje depresije);
Epclusa 12 weeks (624) Placebo 12 weeks (116)
Placebo 12 tednov (116)
Outcome for patients without SVR12 On-treatment virologic failure Relapsea
Izid za osebe brez SVR Virološki neuspeh med zdravljenjem 0/106 Relapsa
• palpitations;
• omotico;
Patients were randomised in a 1:1:1 ratio to treatment with Epclusa for 12 weeks, Epclusa + RBV for 12 weeks or Epclusa for 24 weeks.
Bolniki so bili randomizirani v razmerju 1 : 1 : 1 za 12-tedensko zdravljenje z zdravilom Epclusa, 12-tedensko zdravljenje z zdravilom Epclusa + RBV ali za 24tedensko zdravljenje z zdravilom Epclusa.
Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Epclusa.
Pri sočasni uporabi z zdravilom Epclusa je potrebna previdnost, priporoča se tudi spremljanje terapevtske koncentracije digoksina.
Co-administration of Epclusa with rifapentine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of
Pričakuje se, da bo sočasno dajanje zdravila Epclusa z rifapentinom zmanjšalo koncentracije sofosbuvirja in velpatasvirja, kar zmanjša terapevtski učinek zdravila Epclusa.
Epclusa 12 weeks (n = 277)
12 tednov (n = 277)
Effect of baseline HCV resistance-associated variants on treatment outcome Studies in patients without cirrhosis and patients with compensated cirrhosis Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients without cirrhosis or with compensated cirrhosis in three Phase 3 clinical studies (ASTRAL-1, ASTRAL-2 and ASTRAL-3).
Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja Študije pri bolnikih brez ciroze in bolnikih s kompenzirano cirozo V treh kliničnih študijah 3. faze (ASTRAL-1, ASTRAL-2 in ASTRAL-3) so opravili analize, da bi raziskali povezavo med predhodno obstoječimi izhodiščnimi RAV NS5A in izidom zdravljenja pri bolnikih brez ciroze ali s kompenzirano cirozo.
Film-coating Polyvinyl alcohol Titanium dioxide Polyethylene glycol Talc
Filmska obloga polivinilalkohol titanov dioksid polietilenglikol smukec rdeči železov oksid
Following a single 100 mg oral dose of [14C]-velpatasvir, mean total recovery of the [14C]-radioactivity was 95%, consisting of approximately 94% and 0.4% recovered from the faeces and urine, respectively.
Po enkratnem 100-miligramskem peroralnem odmerku [14C]-velpatasvirja je bil povprečni skupni delež [14C]-radioaktivnosti, ki so jo izolirali, višji kot 95 %, pri čemer je bilo 94 % izolirane v blatu in 0,4 % v urinu.
Velpatasvir AUC increases in a nearly dose proportional manner over the dose range of 25 mg to 150 mg. Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1,200 mg.
Vrednosti AUC za sofosbuvir in GS-331007 sta skoraj sorazmerni z odmerkom v razponu odmerka 200-1.200 mg.