natgillin/translations-raw huggingface dataset:
Following a single 400 mg dose of sofosbuvir, a 4-hour haemodialysis removed 18% of administered dose.
Po enkratnem 400-miligramskem odmerku sofosbuvirja se je s 4-urno hemodializo izločilo približno 18 % uporabljenega odmerka.
The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Pot presnovne aktivacije vključuje sekvenčno hidrolizo karboksil-esternega dela, ki jo katalizira humani katepsin A (CatA) ali karboksilesteraza 1 (CES1), in cepitev fosforamidata z nukleotid-vezajočo beljakovino s histidinsko triado 1 (HINT1, histidine triad nucleotide-binding protein 1), čemur sledi fosforilacija po biosintezni poti pirimidinskih nukleotidov.
Additionally, velpatasvir is active in vitro against most of the NS5A RAVs that confer resistance to ledipasvir and daclatasvir.
Poleg tega velpatasvir deluje in vitro proti večini RAV NS5A, ki doprinesejo k odpornosti na ledipasvir in daklatasvir.
The EC50 values of sofosbuvir, velpatasvir and voxilaprevir against clinical isolates are presented in Table 5.
Vrednosti EC50 za sofosbuvir, velpatasvir in voksilaprevir proti kliničnim izolatom so prikazane v preglednici 5.
Iron oxide black (E172) Iron oxide red (E172) Iron oxide yellow (E172)
Filmska obloga črni železov oksid (E172) rdeči železov oksid (E172) rumeni železov oksid (E172)
Pack size: outer carton containing 1 bottle of 28 film-coated tablets.
Velikosti pakiranja: škatla, ki vsebuje 1 plastenko z 28 filmsko obloženimi tabletami.
• muscle pain (myalgia)
• bruhanje • bolečine v mišicah (mialgija)
Concomitant use with ethinylestradiol-containing medicinal products such as combined oral contraceptives or contraceptive vaginal rings (see section 4.5).
Sočasna uporaba z zdravili, ki vsebujejo etinilestradiol, kot so kombinirani peroralni kontraceptivi ali kontracepcijski vaginalni obročki (glejte poglavje 4.5).
Following oral administration of Vosevi, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 2 hours post-dose.
Po peroralni uporabi zdravila Vosevi se je sofosbuvir hitro absorbiral in dosegel najvišje koncentracije v plazmi 2 uri po odmerku.
H2-receptor antagonists may be administered simultaneously with or staggered from Vosevi at a dose that does not exceed doses comparable with famotidine 40 mg twice daily.
Antagoniste receptorjev H2 se lahko uporablja sočasno z zdravilom Vosevi ali s časovnim zamikom, v odmerku, ki ne presega odmerkov, primerljivih s famotidinom 40 mg dvakrat na dan.
There are no data on the use of Vosevi in patients with HCV/hepatitis B virus (HBV) co-infection.
Podatkov o uporabi zdravila Vosevi pri bolnikih s sočasno okužbo s HCV in virusom hepatitisa B (HBV) ni.
Table 2: Interactions between Vosevi and other medicinal products
Preglednica 2: Interakcije med zdravilom Vosevi in drugimi zdravili
Vosevi should not be used if you have moderate or severe liver problems.
Zdravilo Vosevi se ne sme uporabljati pri bolnikih z zmernimi ali hudimi težavami z jetri.
Animal studies do not indicate harmful effects of sofosbuvir, velpatasvir or voxilaprevir on fertility.
Študije na živalih ne kažejo škodljivih učinkov sofosbuvirja, velpatasvirja ali voksilaprevirja na plodnost.
Sofosbuvir was not carcinogenic in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 17 and 10-times higher, respectively than human exposure.
Sofosbuvir ni bil kancerogen v 2-letnih študijah kancerogenosti pri miših in podganah ob izpostavljenostih GS-331007, ki so bile do 17-krat oz. 10-krat večje od izpostavljenosti pri človeku.
Vosevi has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Pokazalo se je, da zdravilo Vosevi poveča izpostavljenost tenofovirju, če se uporablja skupaj z režimom proti HIV, ki vsebuje dizoproksiltenofovirijev fumarat in farmakokinetični ojačevalec (ritonavir ali kobicistat).
It is given to adults of 18 years and older to treat a chronic (long-term) viral infection of the liver called hepatitis C.
Daje se odraslim, starim 18 let in več, za zdravljenje kronične (dolgotrajne) okužbe jeter,
These are shown in Table 7.
Analize so prikazane v preglednici 7.
The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir but reduced the anti-HCV activity of velpatasvir and voxilaprevir by 13- and 6.8-fold, respectively, against genotype 1a HCV replicons.
NA = podatkov ni na voljo Prisotnost 40-odstotnega humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV, je pa aktivnost velpatasvirja in voksilaprevirja proti HCV zmanjšala za 13-krat oz. 6,8-krat proti replikonom HCV genotipa 1a.
No individual RAV tested in genotypes 2a, 4a or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Nobene posamezne RAV, testirane v genotipih 2a, 4a ali 5a, niso doprinesle k > 100kratnemu zmanjšanju dovzetnosti za velpatasvir.
In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a, and 4a.
Na biokemičnem testu je GS-461203 zaviral aktivnost polimeraze rekombinantne NS5B virusa HCV genotipov 1b, 2a, 3a in 4a.
• dabigatran (a medicine used to prevent blood clots);
• dabigatran (zdravilo, ki se uporablja za preprečevanje strjevanja krvi);
• If you are sick (vomit) more than 4 hours after taking Vosevi, you do not need to take another tablet until your next scheduled tablet.
• Če bruhate več kot 4 ure po uporabi zdravila Vosevi, ne vzemite še ene tablete do naslednje načrtovane tablete.
Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Vosevi.
Zdravnik bo morda moral skrbno spremljati druga zdravila, ki jih jemljete, in po uvedbi zdravila Vosevi prilagoditi njihov odmerek.
• Placebo 12 weeks (N=152)
• Placebo 12 tednov (N = 152)
Serum HCV RNA values were measured during the clinical studies using the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU per mL.
Med kliničnimi študijami so izmerili vrednosti RNK HCV v serumu s testom COBAS AmpliPrep/COBAS Taqman za virus HCV (različica 2.0), s spodnjo mejo kvantifikacije (LLOQ, lower limit of quantification) 15 i.e. na ml.
When Vosevi or its components taken together were administered with food, sofosbuvir AUC0-inf and Cmax were 64% to 144% and 9% to 76% higher, respectively; velpatasvir AUC0-inf and Cmax were 40% to 166% and 37% to 187% higher, respectively; and voxilaprevir AUC0-inf and Cmax were 112% to 435% and 147% to 680% higher, respectively.
Pri jemanju zdravila Vosevi ali njegovih učinkovin skupaj s hrano sta bili vrednosti AUC0-24 in Cmax za sofosbuvir za 64 % do 144 % oz. 9 % do 76 % višji; vrednosti AUC0-24 in Cmax za velpatasvir sta bili za 40 % do 166 % oz. 37 % do 187 % višji; in vrednosti AUC0-24 in Cmax za voksilaprevir sta bili za 112 % do 435 % oz. 147 % do 680 % višji.
Paediatric population The pharmacokinetics of Vosevi in paediatric patients have not been established (see section 4.2).
Pediatrična populacija Farmakokinetike zdravila Vosevi pri pediatričnih bolnikih niso ugotavljali (glejte poglavje 4.2).
• If you are sick (vomit) less than 4 hours after taking Vosevi, take another tablet.
• Če bruhate manj kot 4 ure po uporabi zdravila Vosevi, vzemite še eno tableto.
HMG-CoA REDUCTASE INHIBITORS Atorvastatin
ZAVIRALCI REDUKTAZE HMG-CoA
d. Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184. e. Stable cell lines expressing Renilla luciferase-encoding replicons.
d. Podatki iz himeričnega replikona NS5A, ki prenaša aminokisline NS5A 9-184. e. Stabilne celične linije, ki izražajo replikone, ki kodirajo Renilla luciferazo.
Effect on atazanavir and ritonavir exposure not studied.
Učinka na izpostavljenost atazanavirju in ritonavirju niso preučevali.
The safety of tenofovir disoproxil fumarate in the setting of Vosevi and a pharmacokinetic enhancer has not been established.
Varnost dizoproksiltenofovirijevega fumarata z zdravilom Vosevi in farmakokinetičnim ojačevalcem ni bila dokazana.
There was an increase in tenofovir exposure (AUC and Cmax) of around 40% during co-treatment with Vosevi and darunavir + ritonavir + tenofovir disoproxil fumarate/emtricitabine.
Zvečanje izpostavljenosti tenofovirju (AUC in Cmax) je bilo med sočasnim zdravljenjem z zdravilom Vosevi in darunavirjem + ritonavirjem + dizoproksiltenofovirijevim fumaratom/emtricitabinom približno 40 %.
Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 85 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Populacijska farmakokinetična analiza pri bolnikih, okuženih s HCV, je pokazala, da znotraj analiziranega starostnega razpona (18-85 let) starost ni imela klinično pomembnega učinka na izpostavljenost sofosbuvirju, GS-331007, velpatasvirju ali voksilaprevirju.
The unbound fraction of voxilaprevir was approximately 2-fold higher in severe hepatic impairment compared with moderate hepatic impairment or normal hepatic function.
Nevezani del voksilaprevirja je bil približno 2-krat večji pri bolnikih s hudo jetrno okvaro kot pri bolnikih z zmerno jetrno okvaro ali z normalnim delovanjem jeter.
Velpatasvir is > 99% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 μg/mL to 1.8 μg/mL.
Velpatasvir se > 99-odstotno veže na humane beljakovine v plazmi, kar ni odvisno od koncentracije zdravila v razponu 0,09-1,8 μg/ml.
Table 3: Adverse drug reactions identified with Vosevi Frequency
Preglednica 3: Neželeni učinki, ki so jih zabeležili pri zdravilu Vosevi Pogostnost
Co-administration of Vosevi with edoxaban is not recommended.
Vosevi z edoksabanom ni priporočljiva.
These are shown in Table 6.
Analize so prikazane v preglednici 6.
• digoxin, used to treat heart conditions;
• digoksin, ki se uporablja za zdravljenje bolezni srca;
Vosevi has been shown to increase tenofovir exposure (P-gp inhibition).
Pokazalo se je, da zdravilo Vosevi poveča izpostavljenost tenofovirju (zaviranje P-gp).
• rifapentine (an antibiotic used to treat infections, including tuberculosis);
• rifapentin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo);
Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Vezava sofosbuvirja na humane beljakovine v plazmi je približno 61-65 %, ni pa odvisna od koncentracije zdravila v razponu 1-20 μg/ml.
Some medicines must not be taken with Vosevi.
Nekaterih zdravil ne smete uporabljati sočasno z zdravilom Vosevi.
If a dose of Vosevi is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Če bolnik izpusti odmerek zdravila Vosevi in je preteklo manj kot 18 ur od običajnega časa za jemanje zdravila, bolniku naročite, naj tableto vzame takoj, ko je mogoče, nato pa naj naslednji odmerek vzame ob običajnem času.
Colloidal anhydrous silica, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
brezvodni koloidni silicijev dioksid, kopovidon, premrežen natrijev karmelozat, laktoza monohidrat, magnezijev stearat, mikrokristalna celuloza.
Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Zdravilo Vosevi se sme pri teh bolnikih uporabljati brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
Vosevi 400 mg/100 mg/100 mg film-coated tablets
Vosevi 400 mg/100 mg/100 mg filmsko obložene tablete
Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Sofosbuvir, velpatasvir in voksilaprevir so substrati prenašalcev P-gp in BCRP, GS-331007 pa ni.
The patient with genotype 1a and virologic breakthrough developed the NS5A RAVs L31M and Y93H.
Bolnik z genotipom 1a in virološkim prebojem je razvil RAV NS5A L31M in Y93H.
• amiodarone, used to treat irregular heartbeats;
• amiodaron, ki se uporablja za zdravljenje nerednega srčnega utripa;
Vosevi is not recommended during pregnancy.
Zdravilo Vosevi se med nosečnostjo ne priporoča.
No individual RAV tested in genotypes 2b, 5a or 6a conferred a > 100-fold reduction in voxilaprevir susceptibility.
Nobene posamezne RAV, testirane v genotipih 2b, 5a ali 6a, niso doprinesle k > 100-kratnemu zmanjšanju dovzetnosti za voksilaprevir.
Vosevi has not been studied in patients with ESRD requiring dialysis.
Zdravila Vosevi niso preučevali pri bolnikih z ESRD, zaradi katere je potrebna dializa.
and <50 mL/min/1.73 m2)
in < 50 ml/min/1,73 m2)
Table 14: SVR12 and virologic outcome in study POLARIS-3 (HCV genotype 3 with compensated cirrhosis)*
Preglednica 14: SVR12 in virološki odziv v študiji POLARIS-3 (HCV genotipa 3 s kompenzirano cirozo)*
Of these 21 patients, 1 patient had virus with emergent NS5A RAVs Q30R and L31M at failure.
Od teh 21 bolnikov je imel 1 bolnik virus, pri katerem je prišlo do RAV NS5A Q30R in L31M ob neuspehu.
SOF/VEL/VOX 8 weeks
SOF/VEL/VOKS 8 tednov
Potential for other medicinal products to affect Vosevi
Možnost vpliva drugih zdravil na zdravilo Vosevi
Patients should be instructed that if vomiting occurs within 4 hours of dosing an additional tablet of Vosevi should be taken.
Bolnikom je treba naročiti, naj vzamejo dodatno tableto zdravila Vosevi, če v 4 urah po odmerjanju bruhajo.
Velpatasvir had no adverse effects on mating and fertility.
Velpatasvir ni imel neželenih učinkov na parjenje in plodnost.
Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Zdravilo Vosevi se sme pri teh bolnikih uporabljati brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.8, 5.1 in 5.2).
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, multidrug resistanceassociated protein 2 (MRP2), bile salt export pump (BSEP), OATP1B1, OATP1B3 and organic cation transporter (OCT) 1 and GS-331007 is not an inhibitor of OAT1, OAT3, OCT2, and multidrug and toxin extrusion protein (MATE) 1.
Sofosbuvir in GS-331007 nista zaviralca prenašalcev P-gp in BCRP, beljakovine, povezane z odpornostjo proti več zdravilom 2 (MRP2, multidrug resistance-associated protein 2), izlivne črpalke žolčnih soli (BSEP, bile salt export pump), OATP1B1, OATP1B3 in prenašalcev organskih kationov (OCT, organic cation transporter) 1; GS-331007 ni zaviralec prenašalcev OAT1, OAT3, OCT2 in beljakovine za ekstruzijo več zdravil in toksinov (MATE, multidrug and toxin extrusion protein) 1.
Your doctor may need to give you a different medicine or adjust the dose of medicine you are taking.
Zdravnik vam bo morda moral predpisati drugo zdravilo ali prilagoditi odmerek zdravila, ki ga uporabljate.
The efficacy of Vosevi (sofosbuvir [SOF]/velpatasvir [VEL]/voxilaprevir [VOX]) was evaluated in four Phase 3 studies, two studies in DAA-experienced patients and two studies in DAA-naïve patients with, genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis, as summarised in Table 8.
Učinkovitost zdravila Vosevi (sofosbuvir [SOF]/velpatasvir [VEL]/voksilaprevir [VOKS]) so ocenili v štirih študijah 3. faze, dveh študijah pri bolnikih, ki so bili predhodno že zdravljeni z DAA, in dveh študijah pri bolnikih, ki predhodno še niso bili zdravljeni z DAA, z okužbo s HCV genotipa od 1 do 6 brez ciroze ali s kompenzirano, kot je povzeto v preglednici 8.
Treatment with Vosevi for 8 weeks in POLARIS-2 did not demonstrate noninferiority to treatment with sofosbuvir/velpatasvir for 12 weeks with a prespecified margin of -5%.
V študiji POLARIS-2 8-tedensko zdravljenje z zdravilom Vosevi ni pokazalo neinferiornosti v primerjavi z 12-tedenskim zdravljenjem s sofosbuvirjem/velpatasvirjem z vnaprej določeno mejo5 %.
Site directed mutagenesis of NS5A resistance associated variants (RAVs) showed that substitutions conferring a > 100-fold reduction in velpatasvir susceptibility are M28G, A92K and Y93H/N/R/W in genotype 1a, A92K in genotype 1b, C92T and Y93H/N in genotype 2b, Y93H in genotype 3, and L31V and P32A/L/Q/R in genotype 6.
Usmerjena mutageneza z odpornostjo povezanih različic NS5A (RAV, resistance-associated variant) je pokazala, da so substitucije, ki doprinesejo k > 100-kratnemu zmanjšanju dovzetnosti za velpatasvir, M28G, A92K in Y93H/N/R/W v genotipu 1a, A92K v genotipu 1b, C92T in Y93H/N v genotipu 2b, Y93H v genotipu 3 ter L31V in P32A/L/Q/R v genotipu 6.
Voxilaprevir metabolites also identified in faeces included des[methylcyclopropylsulphonamide]-voxilaprevir (22.1%), which is formed intestinally, dehydrovoxilaprevir (7.5%), and two des-[methylcyclopropylsulphonamide]-oxy-voxilaprevir metabolites (5.4% and 3.9%).
Med presnovki voksilaprevirja, ki so jih prav tako zabeležili v blatu, so bili des-[metilciklopropilsulfonamid]-voksilaprevir (22,1 %), ki se tvori v črevesju, dehidro-voksilaprevir (7,5 %) in dva presnovka des-[metilciklopropilsulfonamid]-oki voksilaprevir (5,4 % in 3,9 %).
If it is after 18 hours then patients should be instructed to wait and take the next dose of Vosevi at the usual time.
Če je preteklo več kot 18 ur, bolniku naročite, naj počaka in vzame naslednji odmerek zdravila Vosevi ob običajnem času.
The median terminal half-life of voxilaprevir following administration of Vosevi was approximately 33 hours.
Mediani končni razpolovni čas za voksilaprevirja po uporabi zdravila Vosevi je bil približno 33 ur.
The median terminal half-lives of sofosbuvir and GS-331007 following administration of Vosevi were 0.5 and 29 hours, respectively.
Mediani končni razpolovni čas za sofosbuvir in GS-331007 po uporabi zdravila Vosevi je bil 0,5 ure oz. 29 ur.
Among subjects with genotype 1a in POLARIS-2, SVR12 was 87% (53/61) for those with Q80K/L/R RAVs and 94% (99/105) for those without Q80K/L/R RAVs.
V študiji POLARIS-2 je od preiskovancev z genotipom 1a SVR12 doseglo 87 % (53/61) bolnikov z RAV Q80K/L/R in 94 % (99/105) bolnikov brez RAV Q80K/L/R.
Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm, debossed with “GSI” on one side and “3” on the other side.
Bež filmsko obložene tablete v obliki kapsule z merami 10 mm × 20 mm, z vtisnjeno oznako „GSI“ na eni in „3“ na drugi strani.
SVR12 was achieved in 18 of 19 (95%) patients who had baseline NS5B NI RAVs in POLARIS-1, including 2 patients who had virus with the S282T NS5B NI RAV in addition to NS5A RAVs at baseline.
V študiji POLARIS-1 je SVR12 doseglo 18 od 19 (95 %) bolnikov z izhodiščnimi RAV NI NS5B, vključno z 2 bolnikoma, ki sta imela poleg RAV NS5A v izhodišču virus z RAV NI NS5B S282T.
Taking Vosevi with any of these may stop your medicines from working properly, or make any side effects worse.
Jemanje zdravila Vosevi s katerim koli od teh zdravil lahko povzroči, da vaša zdravila morda ne bodo pravilno delovala ali pa se bodo neželeni učinki okrepili.
(Induction of CYPs)
(indukcija CYP)
GT = genotype * The most common prior NS5A inhibitors were ledipasvir (LDV) (51%), daclatasvir (27%), and ombitasvir (11%).
GT = genotip * Najpogostejši predhodno uporabljeni zaviralci NS5A so bili ledipasvir (LDV) (51 %), daklatasvir (27 %) in ombitasvir a. SVR12 je dosegel en bolnik z nedoločenim genotipom.
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.
Usmerjena mutageneza znanih z odpornostjo povezanih različic (RAV) NS3 je pokazala, da so substitucije, ki doprinesejo k > 100-kratnemu zmanjšanju dovzetnosti za voksilaprevir, A156V, A156T ali A156L v genotipu 1a, 1b, 2a, 3a in 4.
What you need to know before you take Vosevi Do not take Vosevi
Kaj morate vedeti, preden boste vzeli zdravilo Vosevi Ne jemljite zdravila Vosevi:
b. Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
b. Za preskušanje so bili uporabljeni stabilni himerični replikoni 1b, ki vsebujejo gene NS5B genotipa 2b, 5a ali 6a.
Table 5: Activity of sofosbuvir, velpatasvir and voxilaprevir against transient replicons containing NS5A, NS5B or NS3 protease from clinical isolates
Preglednica 5: Aktivnost sofosbuvirja, velpatasvirja in voksilaprevirja proti prehodnim replikonom, ki vsebujejo NS5A, NS5B ali proteazo NS3 iz kliničnih izolatov Genotip replikona
Velpatasvir plasma exposure (AUCinf) was similar in patients with moderate hepatic impairment, severe hepatic impairment, and control subjects with normal hepatic function.
Skupna izpostavljenost velpatasvirju v plazmi (AUCinf) je bila pri bolnikih z zmerno jetrno okvaro, pri bolnikih s hudo jetrno okvaro ter pri kontrolnih preiskovancih z normalnim delovanjem jeter podobna.
Relative to healthy subjects (n = 63), voxilaprevir AUC0-24 and Cmax were both 260% higher in HCV-infected patients.
primerjavi z zdravimi osebami (n = 63) sta bili obe vrednosti AUC0-24 in Cmax za voksilaprevir pri bolnikih, okuženih s HCV, za 260 % višji.
HBV screening should be performed in all patients before initiation of treatment.
Pred začetkom zdravljenja je treba pri vseh bolnikih opraviti presejalno testiranje za virus HBV.
Totalb (n = 150)
Skupajb (n = 150)
Therefore, Vosevi should not be used during breast-feeding.
Zato se zdravila Vosevi med dojenjem ne sme uporabljati.
Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP.
Sofosbuvir, velpatasvir in voksilaprevir so substrati prenašalcev P-gp in BCRP.
Total bilirubin
Pogosti povišan celokupni bilirubin
Placebo-controlled study in which patients with GT1 infection were randomised in a 1:1 ratio to SOF/VEL/VOX or placebo for 12 weeks.
S placebom nadzorovana študija, v kateri so bili bolniki z okužbo GT 1 randomizirani v razmerju 1 : 1 za 12tedensko zdravljenje s SOF/VEL/VOKS ali s placebom.
• carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
• karbamazepin, fenobarbital in fenitoin (zdravila, ki se uporabljajo za zdravljenje epilepsije in preprečevanje epileptičnih napadov);
In POLARIS-4, a total of 14 patients had virus with NS5B NI RAVs at baseline and all achieved SVR12.
V študiji POLARIS-4 je imelo skupno 14 bolnikov virus z RAV NI NS5B v izhodišču in vsi so dosegli SVR12.
Overall SVR12a Genotype 1b
Skupni SVR12a Genotip 1b
Concomitant use with rosuvastatin or dabigatran etexilate (see section 4.5).
Sočasna uporaba z rosuvastatinom ali dabigatran eteksilatom (glejte poglavje 4.5).
Although exposures of the fixed-dose combination sofosbuvir, GS-331007, velpatasvir, and voxilaprevir were not directly evaluated in HCV-infected patients with ESRD requiring dialysis after administration of Vosevi, the exposures of sofosbuvir, GS-331007, and velpatasvir are expected to be similar to those observed after administration of sofosbuvir/velpatasvir 400/100 mg in HCV-infected patients with ESRD requiring dialysis.
Čeprav izpostavljenosti kombinacije s fiksnim odmerkom sofosbuvirja, GS-331007, velpatasvirja in voksilaprevirja niso neposredno ocenili pri bolnikih, okuženih s HCV, z ESRD, zaradi katere je potrebna dializa, se pričakuje, da bodo po dajanju zdravila Vosevi izpostavljenosti sofosbuvirju, GS-331007 in velpatasvirju podobne tistim, ki so jih opazili po dajanju sofosbuvirja/velpatasvirja
Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease.
Voksilaprevir je pangenotipski zaviralec proteaze HCV NS3/4A.
Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) (see section 5.2).
Zdravilo Vosevi ni priporočljivo pri bolnikih z zmerno ali hudo jetrno okvaro (stopnje B ali C po CPT) (glejte poglavje 5.2).