natgillin/translations-raw huggingface dataset:
The type and severity of adverse reactions in subjects with cirrhosis were overall comparable to those seen in subjects without cirrhosis.
Vrsta in izrazitost neželenih učinkov sta bili pri bolnikih s cirozo v splošnem podobni kot pri bolnikih brez ciroze.
Asymptomatic serum ALT elevations (>5x ULN) were observed in 1 out of 70 healthy subjects following multiple doses of glecaprevir (700 mg or 800 mg) once daily for ≥ 7 days.
(na > 5-kratno ULN) so opazili pri 1 od 70 zdravih prostovoljcev po uporabi več odmerkov glekaprevirja (700 ali 800 mg) enkrat na dan ≥ 7 dni.
The EC50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from laboratory strains are presented in Table 5.
Vrednosti EC50 za glekaprevir in pibrentasvir proti replikonom polne dolžine ali himernim replikonom za kodiranje NS3 ali NS5A laboratorijskih sevov so prikazane v preglednici 5.
Co-administration with atazanavir is contraindicated due to the risk of ALT elevations (see section 4.3).
Sočasna uporaba z atazanavirjem je kontraindicirana zaradi tveganja za zvišanje ALT (glejte poglavje
Among subjects with compensated cirrhosis, the overall SVR12 rate for GT3b infected subjects was 87.5% (7/8) [85.7% (6/7) for TN subjects and 100% (1/1) for TE-PRS subjects] and 100% (6/6) for GT3a infected subjects.
Med preiskovanci s kompenzirano cirozo je bila skupna stopnja SVR12 pri preiskovancih, okuženih z GT3b, 87,5 % (7/8) [85,7 % (6/7) pri TN preiskovancih in 100 % (1/1) pri TE-PRS preiskovancih] in 100 % (6/6) pri preiskovancih okuženih z GT3a.
Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral treatment.
Pri sladkornih bolnikih se lahko po začetku zdravljenja okužbe s HCV z zdravilom neposredno delujočim protivirusnim zdravilom izboljša nadzor nad sladkorjem, kar ima lahko za posledico simptomatsko hipoglikemijo.
Maviret for 8 weeks (n=58)
Zdravilo Maviret 8 tednov (n = 58)
Contents of the pack and other information
Shranjevanje zdravila Maviret Vsebina pakiranja in dodatne informacije
Otherd
Drugod
GT1, 2, 4, 5, 6 EXPEDITION-8 Maviret for 8 weeks (n=280) (TN only) Subjects with CKD stage 3b, 4 and 5 with or without cirrhosis GT1-6
GT1, 2, 4, 5, 6 EXPEDITION-8 Zdravilo Maviret 8 tednov (n = 280) (samo TN) Preiskovanci s KLB 3b, 4. in 5. stopnje, s cirozo ali brez nje GT1-6
Ten of 113 subjects treated with Maviret in the MAGELLAN-1 study for 12 or 16 weeks experienced virologic failure.
Virusna neodzivnost se je pojavila pri 10 od 113 preiskovancev, ki so v študiji MAGELLAN 1 prejemali zdravilo Maviret 12 ali 16 tednov.
Adverse reactions in subjects with severe renal impairment including subjects on dialysis The safety of Maviret in subjects with chronic kidney disease (including subjects on dialysis) and genotypes 1, 2, 3, 4, 5 or 6 chronic HCV infection with compensated liver disease (with or without cirrhosis) was assessed in EXPEDITION-4 (n=104) and EXPEDITION-5 (n=101).
Neželeni učinki pri preiskovancih s hudo okvaro ledvic, vključno s preiskovanci na dializi Varnost zdravila Maviret pri bolnikih s kronično boleznijo ledvic (vključno z bolniki na dializi) in kronično okužbo s HCV genotipov 1, 2, 3, 4, 5 ali 6 ter kompenzirano boleznijo jeter (s cirozo ali brez nje) so ocenili v študiji EXPEDITION-4 (n=104) in v študiji EXPEDITION-5 (n=101).
The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2.
Priporočena trajanja zdravljenja z zdravilom Maviret pri bolnikih, okuženih s HCV genotipa 1, 2, 3, 4, 5 ali 6 in s kompenzirano boleznijo jeter (s cirozo ali brez nje), je prikazano v preglednici 1 in preglednici 2.
10 mg once daily
10 mg enkrat na dan
Less than 0.1% of subjects treated with Maviret had serious adverse reactions (transient ischaemic attack).
Resne neželene učinke (prehodni ishemični napad) je imelo manj kot 0,1 % bolnikov, zdravljenih z zdravilom Maviret.
Treatment-experienced with or without cirrhosis
Že zdravljeni s cirozo ali brez nje
Table 1: Recommended Maviret treatment duration for patients without prior HCV therapy Genotype
Preglednica 1: Priporočeno trajanje zdravljenja z zdravilom Maviret za bolnike, ki še niso bili zdravljeni za HCV
Effect on medicinal product levels
Vpliv na koncentracijo zdravila
Baseline polymorphisms in NS3 were detected in 1.1% (9/845), 0.8% (3/398), 1.6% (10/613), 1.2% (2/164), 41.9% (13/31), and 2.9% (1/34) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Izhodiščne polimorfizme NS3 so odkrili pri 1,1 % (9/845), 0,8 % (3/398), 1,6 % (10/613), 1,2 % (2/164), 41,9 % (13/31) in 2,9 % (1/34) preiskovancev, okuženih z genotipom HCV 1, 2, 3, 4, 5 in 6, v tem zaporedju.
Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Med ali po zdravljenju z neposredno delujočimi protivirusnimi zdravili so poročali o primerih reaktivacije virusa hepatitisa B (HBV), med njimi nekaterih s smrtnim izidom.
Significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K are not expected.
UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 ali MATE2K ni pričakovati.
Studies in subjects with or without compensated cirrhosis who were treatment-experienced to NS3/4A protease and/or NS5A inhibitors
Študije pri preiskovancih s kompenzirano cirozo ali brez nje, ki so predhodno prejemali zaviralce proteaze NS3/4A in/ali NS5A
Use with strong P-gp/CYP3A inducers
Uporaba z močnimi induktorji P-gp/CYP3A
(Inhibition of OATP1B1/3)
(zavrtje OATP1B1/3)
Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) (see section 4.5).
Sočasna uporaba z zdravili, ki vsebujejo atazanavir, atorvastatin, simvastatin, dabigatraneteksilat, z zdravili, ki vsebujejo etinilestradiol, močne P-gp in CYP3A induktorje (rifampicin, karbamazepin, šentjanževka (Hypericum perforatum), fenobarbital, fentoin in primidon) (glejte poglavje 4.5).
(P-gp, BCRP, and OATP inhibition by cobicistat, OATP inhibition by elvitegravir)
(zavrtje P-gp, BCRP in OATP s kobicistatom, zavrtje OATP z elvitegravirjem)
ENDURANCE-3 was a partially-randomized, open-label, active-controlled study in treatment-naïve subjects.
Študija ENDURANCE-3 je bila delno randomizirana, z zdravilno učinkovino kontrolirana študija z odprtim načrtom zdravljenja pri predhodno še nezdravljenih preiskovancih.
HCV subtype
Podtip HCV
ANTICONVULSANTS Carbamazepine 200 mg twice daily
ANTIEPILEPTIKI karbamazepin 200 mg dvakrat na dan
None of the GT5 subjects were TE-PRS, and 3 GT6 subjects were TE-PRS.
Nobeden od preiskovancev z GT5 še ni prejemal zdravljenja PRS, 3 od GT6 pa so že prejemali zdravljenje PRS.
Subjects with Genotype 1, 2, 4, 5, or 6 Infection with Cirrhosis who received 8 weeks of Maviret The safety and efficacy of Maviret given for 8 weeks in GT 1, 2, 4, 5 or 6 treatment naïve subjects with compensated cirrhosis was evaluated in a single-arm, open-label study (EXPEDITION-8).
Preiskovanci, okuženi z genotipom 1, 2, 4, 5 ali 6, s cirozo, ki so zdravilo Maviret prejemali 8 tednov Varnost in učinkovitost zdravila Maviret pri uporabi 8 tednov pri predhodno še nezdravljenih preiskovancih, okuženih z genotipom 1, 2, 4, 5 ali 6, s kompenzirano cirozo, je bila ocenjena v študiji brez primerjalne skupine z odprtim načrtom zdravljenja (EXPEDITION-8).
− Tablet core: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.
− Jedro tablete: kopovidon (tip K 28), polietilenglikolsukcinat vitamina E (tokoferola), koloidni brezvodni silicijev dioksid, propilenglikol monokaprilat (tip II), premreženi natrijev karmelozat, natrijev stearilfumarat.
Package leaflet: Information for the user Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir This medicine is subject to additional monitoring.
Navodilo za uporabo Maviret 100 mg/40 mg filmsko obložene tablete glekaprevir/pibrentasvir Za to zdravilo se izvaja dodatno spremljanje varnosti.
If vomiting occurs more than 3 hours after dosing, an additional dose of Maviret is not needed.
Če bruha več kot 3 ure po zaužitju zdravila, dodaten odmerek zdravila Maviret ni potreben.
Maviret for 12 weeks (GT1, 2, 4, 5, and 6 and GT3 TN) (n=157) or
Zdravilo Maviret 12 tednov (GT1, 2, 4, 5, in 6; GT3 TN) (n=157) ali
Maviret 16 weeks (N=69)
Zdravilo Maviret 16 tednov (N = 69)
Adverse Reactions in Subjects with Liver or Kidney Transplant The safety of Maviret was assessed in 100 post-liver or -kidney transplant recipients with genotypes 1, 2, 3, 4, or 6 chronic HCV infection without cirrhosis (MAGELLAN-2).
Varnost zdravila Maviret so ocenili pri 100 prejemnikih po presaditvi jeter ali ledvic s kronično okužbo s HCV genotipov 1, 2, 3, 4 ali 6 brez ciroze (MAGELLAN-2).
Treatment-emergent NS5A substitutions M28G, A30G/K, L31F, P58T, or Y93H were observed in 16 subjects, and 13 subjects had A30K (n=9) or Y93H (n=5) at baseline and posttreatment.
Med zdravljenjem nastale substitucije M28G, A30G/K, L31F, P58T ali Y93H v NS5A so ugotovili pri 16 preiskovancih in 13 preiskovancev je imelo izhodiščno in po zdravljenju A30K (n = 9) ali Y93H (n = 5).
Table 9: SVR12 in treatment-naïve, genotype 3-infected subjects without cirrhosis (ENDURANCE-3)
Preglednica 9: SVR12 pri še nezdravljenih preiskovancih brez ciroze, okuženih z genotipom 3 (študija ENDURANCE-3)
The overall SVR12 rate was 97.9% (274/280).
Skupna stopnja SVR12 pri preiskovancih je bila 97,9 % (274/280).
• diabetes.
• imate sladkorno bolezen.
Clinical Study in Renally Impaired Subjects
Klinične študije pri preiskovancih z okvaro ledvic
Among the 18 genotype 3-infected subjects treated with Maviret for 8, 12, or 16 weeks who experienced virologic failure, treatment-emergent NS3 substitutions Y56H/N, Q80K/R, A156G, or Q168L/R were observed in 11 subjects.
Pri 18 preiskovancih, okuženih z genotipom 3 in zdravljenih z zdravilom Maviret 8, 12 ali 16 tednov, pri katerih se je pojavila virusna neodzivnost, so med zdravljenjem nastale substitucije Y56H/N, Q80K/R, A156G ali Q168L/R v NS3 ugotovili pri 11 preiskovancih.
GT3b is a subtype reported in a relatively small number of HCV infected patients in China and a few countries in South and Southeast Asia, but rarely outside of this region.
Kitajskem in v nekaterih državah v južni in jugovzhodni Aziji, a le redko izven te regije.
Subjects with genotype 3 infection
Preiskovanci, okuženi z genotipom 3
Talk to your doctor before taking Maviret if you are breast-feeding.
Posvetujte se z zdravnikom, preden vzamete zdravilo Maviret, če dojite.
Pibrentasvir bioavailability when coadministered with glecaprevir is 3-fold of pibrentasvir alone.
Biološka uporabnost pibrentasvirja je med sočasno uporabo z glekaprevirjem 3-krat večja od biološke uporabnosti pibrentasvirja samega.
• carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy)
• karbamazepin, fenobarbital, fentoin, primidon (običajno se uporabljajo za zdravljenje epilepsije); • dabigatraneteksilat (za preprečevanje krvnih strdkov);
Maviret for 12 weeks (n=66) or 16 weeks (n=47) HCV/HIV-1 Co-Infected Subjects with or without Cirrhosis GT1-6
Zdravilo Maviret 12 tednov (n = 66) ali 16 tednov (n = 47) Preiskovanci, sočasno okuženi s HCV / HIV-1, s cirozo ali brez nje GT1-6
In patients with chronic hepatitis C infection without cirrhosis, following 3 days of monotherapy with either glecaprevir 300 mg per day (N=6) or pibrentasvir 120 mg per day (N=8) alone, geometric mean AUC24 values were 13600 ng∙h/mL for glecaprevir and 459 ng∙h/mL for pibrentasvir.
Pri bolnikih s kronično okužbo s hepatitisom C brez ciroze je bila po 3 dneh monoterapije s 300 mg glekaprevirja na dan (N = 6) ali 120 mg pibrentasvirja na dan (N = 8) geometrična sredina AUC24
Maviret 12 weeks (N=40)
Zdravilo Maviret 12 tednov (N = 40)
(Induction of Pgp/CYP3A)
(indukcija Pgp/CYP3A)
The SVR12 rate was 95.7% (22/23) for GT5-infected subjects and 98.4% (60/61) for GT6-infected subjects.
Stopnja SVR12 pri preiskovancih, okuženih z GT5, je bila 95,7 % (22/23) in pri preiskovancih, okuženih z GT6, 98,4 % (60/61).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON
PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA
Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.
Pri občutljivih substratih CYP3A (midazolam, felodipin) ali UGT1A1 (raltegravir), danih sočasno z zdravilom Maviret, niso opazili klinično pomembnih povečanj izpostavljenosti.
Relative to healthy subjects (N=230), population estimates of AUC24, ss were similar (10% difference) for glecaprevir and 34% lower for pibrentasvir in HCV-infected patients without cirrhosis.
Bolniki, okuženi s HCV in brez ciroze, so imeli v primerjavi z zdravimi preiskovanci (N = 230) populacijsko oceno AUC24, ss podobno (10-odstotna razlika) za glekaprevir in 34 % nižjo za pibrentasvir.
Clinical Study in Liver or Kidney Transplant Recipients MAGELLAN-2 was a single-arm, open-label study in 100 post-liver or -kidney transplant HCV GT1-6 infected subjects without cirrhosis who received Maviret for 12 weeks.
Klinične študije pri prejemnikih presajenih jeter ali ledvic MAGELLAN-2 je bila študija brez primerjalne skupine z odprtim načrtom zdravljenja, izvedena na 100 preiskovancih po presaditvi jeter ali ledvic z HCV GT1-6 okužbo brez ciroze, ki so prejemali
Outcome for subjects without SVR12 On-treatment VF
Izid pri preiskovancih brez SVR12 VN med zdravljenjem Recidivc
ENDURANCE-3 Maviret for 8 weeks (n=157) or 12 weeks (n=233) Sofosbuvir + daclatasvir for 12 weeks (n=115) SURVEYOR-2 Maviret for 8 weeks (TN only, n=29) or 12 weeks (n=76) or 16 weeks (TE only, n=22)
ENDURANCE-3 Zdravilo Maviret 8 tednov (n = 157) ali 12 tednov (n = 233) Sofosbuvir + daklatasvir 12 tednov (n = 115) SURVEYOR-2 Zdravilo Maviret 8 tednov (samo TN, n = 29) ali 12 tednov (n = 76) ali 16 tednov (samo TE, n = 22)
Co-administration is not recommended.
Sočasna uporaba ni priporočljiva.
Expected: ↓ glecaprevir and ↓ pibrentasvir
Pričakovano: ↓ glekaprevir in ↓ pibrentasvir
Maviret contains lactose.
Zdravilo Maviret vsebuje laktozo.
substitutions at these positions showed reductions in susceptibility to pibrentasvir.
Nekatere kombinacije substitucij v NS5A na teh položajih so bile povezane z manjšo občutljivostjo za pibrentasvir.
15 IU/mL (except for SURVEYOR-1 and SURVEYOR-2 which used the Roche COBAS TaqMan real-time reverse transcriptase-PCR (RT-PCR) assay v. 2.0 with an LLOQ of 25 IU/mL).
AmpliPrep/COBAS Taqman HCV (različica 2.0) s spodnjo mejo kvantifikacije (LLOQ - lower limit of quantification) 15 i.e./ml (razen v študijah SURVEYOR-1 in SURVEYOR-2, v katerih so uporabljali preizkus Roche COBAS TaqMan s PCR z reverzno transkriptazo v realnem času (RT
No dose adjustment of Maviret is required in patients with any degree of renal impairment including patients on dialysis (see sections 5.1 and 5.2).
Prilagoditev odmerka zdravila Maviret pri bolnikih z okvaro ledvic, vključno z bolniki na dializi, ni potrebna, ne glede na stopnjo okvare ledvic (glejte poglavji 5.1 in 5.2).
It contains the active substances glecaprevir and pibrentasvir.
Vsebuje učinkovini glekaprevir in pibrentasvir.
ANNEX II A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Maviret is a fixed-dose combination of two pan-genotypic, direct-acting antiviral agents, glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor), targeting multiple steps in the HCV viral lifecycle.
Zdravilo Maviret je kombinacija fiksnih odmerkov dveh pangenotipskih zdravil z neposrednim delovanjem na viruse: glekaprevirja (zaviralec proteaze NS3/4A) in pibrentasvirja (zaviralec NS5A),
In vitro data indicate that the majority of the resistance-associated substitutions in NS5A at amino acid positions 24, 28, 30, 31, 58, 92, or 93 that confer resistance to ombitasvir, daclatasvir, ledipasvir, elbasvir, or velpatasvir remained susceptible to pibrentasvir.
Po podatkih in vitro večina z odpornostjo povezanih substitucij v NS5A na aminokislinskih položajih 24, 28, 30, 31, 58, 92 ali 93, ki dajejo odpornost proti ombitasvirju, daklatasvirju,
ENDURANCE-4 Maviret for 12 weeks (n=121) ENDURANCE-5,6 Maviret for 8 weeks (n=75) SURVEYOR-1 Maviret for 12 weeks (n=32) SURVEYOR-2c
ENDURANCE-4 Zdravilo Maviret 12 tednov (n = 121) ENDURANCE-5,6 Zdravilo Maviret 8 tednov (n=75) SURVEYOR-1 Zdravilo Maviret 12 tednov (n = 32) SURVEYOR-2c
Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.
Zdravila, ki zavirajo OATP1B1/3 (npr. elvitegravir, ciklosporin, darunavir,
EXPEDITION-5 Maviret for 8 weeks (n=84) or 12 weeks (n=13) or 16 weeks (n=4) NS5A inhibitor and/or PI-experienced subjects with or without cirrhosis GT1, 4
EXPEDITION-5 Zdravilo Maviret 8 tednov (n = 84) ali 12 tednov (n=13) ali 16 tednov (n=4) Preiskovanci, že zdravljeni z zaviralcem NS5A in/ali zaviralcem proteaz, s cirozo ali brez nje GT1, 4
(Induction of Pgp/BCRP/CYP3A)
(indukcija Pgp/BCRP/CYP3A)
One GT3b TN subject experienced relapse.
Pri enem TN preiskovancu z GT3b se je pojavil recidiv.
DAA=direct acting antiviral a. Effect of rifampicin on glecaprevir and pibrentasvir 24 hours after final rifampicin dose.
a. Vpliv rifampicina na glekaprevir in pibrentasvir 24 ur po zadnjem odmerku rifampicina.
SVR Outcome for subjects without SVR12 On-treatment VF Relapsea Otherb SVR by cirrhosis status No Cirrhosis
SVR Izid pri preiskovancih brez SVR12 VN med zdravljenjem Recidiva Drugob SVR po stanju ciroze Brez ciroze
− Tablet film-coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172).
− Filmska obloga tablete: hipromeloza (E464), laktoza monohidrat, titanov dioksid, makrogol
Maviret tablets are packed into foil blisters, each containing 3 tablets.
En pretisni omot vsebuje 3 tablete.
Maviret 100 mg/40 mg film-coated tablets glecaprevir/pibrentasvir
Maviret 100 mg/40 mg filmsko obložene tablete glekaprevir/pibrentasvir
• feeling sick (nausea)
• siljenje na bruhanje (navzea)
The overall SVR12 rate was 97.6% (82/84).
Skupna stopnja SVR12 pri preiskovancih je bila 97,6 % (82/84).
If vomiting occurs within 3 hours of dosing, an additional dose of Maviret should be taken.
Če bolnik bruha v 3 urah po zaužitju odmerka, mora vzeti dodaten odmerek zdravila Maviret.
Follow the dosing recommendations in Tables 1 and 2.
Bolniki, sočasno okuženi s HIV-1 Sledite priporočilom o odmerjanju v preglednicah 1 in 2.
Of the genotype 1-, 2-, 4-, 5-, or 6-infected subjects with end stage renal disease enrolled in EXPEDITION-4, 97.8% (91/93) achieved SVR12 with no virologic failures.
Med preiskovanci, okuženimi z genotipom 1, 2, 4, 5 ali 6, ki so imeli končno odpoved ledvic in so bili vključeni v študijo EXPEDITION-4, jih je SVR12 doseglo 97,8 % (91/93).
The most common adverse reactions in subjects with severe renal impairment were pruritus (17%) and fatigue (12%) in EXPEDITION-4 and pruritus (14.9%) in EXPEDITION-5.
Najpogostejša neželena učinka pri bolnikih s hudo okvaro ledvic sta bila srbenje (17 %) in utrujenost (12 %) v študiji
Baseline polymorphisms in NS5A were detected in 26.8% (225/841), 79.8% (331/415), 22.1% (136/615), 49.7% (80/161), 12.9% (4/31), and 54.1% (20/37) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
26,8 % (225/841), 79,8 % (331/415), 22,1 % (136/615), 49,7 % (80/161), 12,9 % (4/31) in 54,1 % (20/37) preiskovancev, okuženih z genotipom HCV 1, 2, 3, 4, 5 in 6, v tem zaporedju.
Substrate of transporter
Substrat prenašalca
Raltegravir 400 mg twice daily
↑ pibrentasvir raltegravir 400 mg dvakrat na dan
Liver or kidney transplant patients
Bolniki s presajenimi jetri ali ledvicami
In TN subjects without cirrhosis who received the recommended duration of 8 weeks, 97.5% (749/768) achieved SVR12, while 0.1% (1/768) experienced on-treatment virologic failure and 0.7% (5/755) experienced post-treatment relapse.
Med preiskovanci brez ciroze, ki predhodno še niso bili zdravljeni in kateri so prejeli zdravljenje v priporočenem trajanju 8 tednov, jih je 97,5 % (749/768) doseglo SVR12; pri 0,1 % (1/768) je med zdravljenjem prišlo do virusne neodzivnosti, pri 0,7 % (5/755) pa se je pojavil recidiv po zdravljenju.
Table 2: Recommended Maviret treatment duration for patients who failed prior therapy with peg-IFN + ribavirin +/- sofosbuvir, or sofosbuvir + ribavirin Genotype Recommended treatment duration No cirrhosis
Preglednica 2: Priporočeno trajanje zdravljenja z zdravilom Maviret za bolnike, pri katerih predhodno zdravljenje s peg-IFN + ribavirin z ali brez sofosbuvirja ali s sofosbuvirjem in ribavirinom ni bilo uspešno
Maviret for 8 weeks (GT1, 2, 4, 5, and 6 and GT3 TN) (n=356) or 16
Zdravilo Maviret 8 tednov (GT1, 2, 4, 5, in 6; GT3 TN) (n=356) ali 16 tednov (samo GT3 TE) (n=6)
Glecaprevir is affected to a lower extent by coadministration with pibrentasvir.
Sočasna uporaba pibrentasvirja vpliva na glekaprevir v manjšem obsegu.
TN and PRS-TE subjects with cirrhosis GT1, 2, 4, 5, 6 EXPEDITION-1 Maviret for 12 weeks (n=146) GT3
GT1, 2, 4, 5, 6 EXPEDITION-1 Zdravilo Maviret 12 tednov (n = 146) GT3
The SVR12 rate in TN or TE-PRS HCV/HIV-1 co-infected subjects treated for 8 or 12 weeks (without cirrhosis and with compensated cirrhosis, respectively) was 98.2% (165/168) from ENDURANCE-1 and EXPEDITION-2.
Delež SVR12, dosežen pri preiskovancih, sočasno okuženih s HCV/HIV-1, ki so bili še ne zdravljeni ali pa so bili predhodno zdravljeni s kombinacijo interferona, peginterferona, ribavirina in/ali sofosbuvirja in so bili zdravljeni 8 tednov (brez ciroze) ali 12 tednov (s kompenzirano cirozo), je v študiji ENDURANCE-1 in EXPEDITION-2 znašal 98,2 % (165/168).
EXPEDITION-2 Maviret for 8 weeks (n=137) or 12 weeks (n=16) Liver or Kidney Transplant Recipients GT1-6
EXPEDITION-2 Zdravilo Maviret 8 tednov (n = 137) ali 12 tednov (n = 16) Prejemniki presajenih jeter ali ledvic
Additional drug-drug interaction studies were performed with the following medical products and showed no clinically significant interactions with Maviret: abacavir, amlodipine, buprenorphine, caffeine, dextromethorphan, dolutegravir, emtricitabine, felodipine, lamivudine, lamotrigine, methadone, midazolam, naloxone, norethindrone or other progestin-only contraceptives, rilpivirine, tenofovir alafenamide and tolbutamide.
buprenorfinom, kofeinom, dekstrometorfanom, dolutegravirjem, emtricitabinom, felodipinom, lamivudinom, lamotriginom, metadonom, midazolamom, naloksonom, noretindronom ali drugimi kontraceptivi, ki vsebujejo samo progestin, rilpivirinom, tenofoviralafenamidom in tolbutamidom.
Method of administration
Mehanizem delovanja
The physician in charge of the diabetic care of the patient should be informed when direct acting antiviral therapy is initiated.
O začetku zdravljenja z zdravilom neposredno delujočim protivirusnim zdravilom je treba obvestiti zdravnika, odgovornega za zdravljenje sladkorne bolezni pri zadevnem bolniku.
ENDURANCE-1a Maviret for 8 weeks (n=351) or 12 weeks (n=352) SURVEYOR-1 Maviret for 8 weeks (n=34)
Zdravilo Maviret 8 tednov (n = 351) ali 12 tednov (n = 352) SURVEYOR-1 Zdravilo Maviret 8 tednov (n = 34)
Glecaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
kodiranega poliproteina (v zrele oblike proteinov NS3, NS4A, NS4B, NS5A in NS5B), ki je ključna za replikacijo virusa.