natgillin/translations-raw huggingface dataset:
In order to evaluate the recurrence of hepatocellular carcinoma associated with Harvoni, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Da bi lahko ugotovili ponovitev hepatocelularnega karcinoma, povezanega z zdravilom Harvoni, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate prospektivne študije varnosti s podatki, ugotovljenimi v kohortah natančno določenih skupin bolnikov, dogovorjenih v protokolu.
- Harvoni for 8 weeks may be considered in previously untreated genotype 1-infected patients (see section 5.1, ION-3 study).
- O 8 tednih zdravila Harvoni je možno razmisliti pri predhodno nezdravljenih bolnikih, okuženih z genotipom 1 (glejte poglavje 5.1, študija ION-3).
Although adverse events, including serious adverse events, occurred more frequently in this study compared to studies that excluded decompensated patients and/or patients who were post-liver transplantation, the adverse events observed were those expected as clinical sequelae of advanced liver disease and/or transplantation or were consistent with the known safety profile of ribavirin (see section 5.1 for details of this study).
Čeprav so se neželeni učinki, vključno z resnimi neželenimi učinki, v teh študijah pojavili pogosteje kot v študijah, ki so izključile dekompenzirane bolnike in/ali bolnike po presaditvi jeter, so bili opaženi učinki pričakovani kot klinična posledica napredovale bolezni jeter in/ali presadtive ali pa so bili skladni z znanim profilom varnosti zdravljenja z ribavirinom (za podrobnosti te študije glejte poglavje 5.1).
Harvoni contains lactose monohydrate.
Zdravilo Harvoni vsebuje laktozo monohidrat.
The use of Harvoni in children and adolescents has not yet been studied.
Uporabe zdravila Harvoni pri otrocih in mladostnikih niso preučili.
Women of childbearing potential / contraception in males and females When Harvoni is used in combination with ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Pri uporabi zdravila Harvoni v kombinaciji z ribavirinom je potrebna izjemna previdnost, da se prepreči nosečnost bolnic in partnerk bolnikov.
In clinical studies - Genotype 2, 3, 4, 5 and 6
V kliničnih študijah - genotip 2, 3, 4, 5 in 6
a. Six patients (1 in the 12-week, 5 in the 24-week treatment group) with HCV RNA < LLOQ at last measurement prior to transplant, were transplanted prior to SVR12 and were excluded from SVR12 and relapse analyses.
a. Pri šestih bolnikih (1 v 12-tedenski, 5 v 24-tedenski skupini zdravljenja) z vrednostjo RNA HCV < LLOQ ob zadnjem merjenju pred presaditvijo so opravili presaditev pred SVR12 in so jih izključili iz analiz SVR12 ter relapsa.
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- do 65-odstotna, ni pa odvisna od koncentracije zdravila v razponu od 1 μg/ml do 20 μg/ml.
• tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
• dizoproksiltenofovirat fumarat ali katero koli zdravilo, ki vsebuje dizoproksiltenofovirat fumarat, ki se uporablja za zdravljenje okužbe s HIV,
SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No c c
Stopnje SVR za izbrane podskupine Genotip Genotip 1a Genotip 1b Ciroza Ne
f. One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
f. En bolnik, ki je dosegel virusno obremenitev < LLOQ ob koncu zdravljenja, ni imel izhodiščnih podatkov za NS5A in je bil iz analize izključen.
• kidney problems, since Harvoni has not been fully tested in patients with severe kidney problems;
• težave z ledvicami, saj učinkov zdravila Harvoni pri bolnikih s hudimi težavami z ledvicami niso v celoti preučili;
ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
ANTIKONVULZANTI Karbamazepin Fenobarbital Fenitoin
Clinical efficacy and safety in genotype 2, 3, 4, 5 and 6 (see also section 4.4) Ledipasvir/sofosbuvir has been evaluated for the treatment of non-genotype 1 infection in small Phase 2 studies, as summarised below.
Klinična učinkovitost in varnost pri genotipu 2, 3, 4, 5 in 6 (glejte tudi poglavje 4.4) Ledipasvir/sofosbuvir so ovrednotili za zdravljenje okužb, razen z genotipom 1, v majhnih študijah 2. faze, kot je povzeto spodaj.
The improvement in CPT scores observed was driven largely by improvements in total bilirubin and albumin.
Izboljšanje rezultatov CPT je bilo večinoma posledica izboljšanja skupne ravni bilirubina in albumina.
HCV/HIV co-infected adults - ERADICATE
Odrasli s sočasno okužbo HCV/HIV - ERADICATE
• Obligation to conduct post-authorisation measures
Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
Table 1: Recommended treatment duration for Harvoni and the recommended use of co-administered ribavirin for certain subgroups
Preglednica 1: Priporočeno trajanje zdravljenja za zdravilo Harvoni in priporočena uporaba sočasno dajanega ribavirina za nekatere podskupine Populacija bolnikov*
In patients with decompensated cirrhosis, ribavirin should be administered at a starting dose of 600 mg given in a divided daily dose.
Pri bolnikih z dekompenzirano cirozo je treba ribavirin dajati z začetnim odmerkom 600 mg v razdeljenih dnevnih odmerkih.
• Tell your doctor if you are lactose intolerant or intolerant to other sugars.
• Povejte zdravniku, če ne prenašate laktoze ali katerega drugega sladkorja.
Serum HCV RNA values were measured during the clinical studies using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System.
Vrednosti RNA HCV v serumu so izmerili med kliničnimi študijami s testom COBAS TaqMan za virus HCV (različica 2.0), za uporabo s sistemom
Unchanged ledipasvir excreted in faeces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose.
Nespremenjeni ledipasvir, ki se je izločil v blatu, je predstavljal povprečno 70 % uporabljenega odmerka, oksidativni presnovek M19 pa je predstavljal 2,2 %
It is not known whether ledipasvir or sofosbuvir, the two active substances of Harvoni, pass into human breast milk.
Ni znano, ali ledipasvir ali sofosbuvir, dve zdravilni učinkovini v zdravilu Harvoni, prehajata v materino mleko.
Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side.
Oranžne, filmsko obložene tablete v obliki romba z merami 19 mm x 10 mm, z vtisnjeno oznako »GSI« na eni in »7985« na drugi strani.
Potential for Harvoni to affect other medicinal products Ledipasvir is an in vitro inhibitor of drug transporter P-gp and breast cancer resistance protein (BCRP) and may increase intestinal absorption of co-administered substrates for these transporters.
Možnost vpliva zdravila Harvoni na druga zdravila Ledipasvir je in vitro zaviralec prenašalca P-gp in proteina rezistence pri raku dojke (BCRP-breast cancer resistance protein) in lahko poveča absorpcijo sočasno uporabljenih substratov za te prenašalce v črevesju.
d. Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
d. Rezultat Metavir = 4 ali rezultat Ishak ≥ 5 s pomočjo biopsije jeter ali rezultat FibroTest > 0,75 in (APRI) > 2.
e. 0/4 of these patients had cirrhosis.
e. 0 od teh 4 bolnikov ni imel ciroze.
If the starting dose is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
Če bolnik začetni odmerek dobro prenaša, ga je mogoče povečevati do največ 1.000-1.200 mg na dan (1.000 mg za bolnike s telesno maso < 75 kg in 1.200 mg za bolnike s telesno maso ≥ 75 kg).
If you are lactose intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine.
Če ne prenašate laktoze ali če so vam povedali, da ne prenašate nekaterih sladkorjev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
The EC50 values of ledipasvir and sofosbuvir against full-length or chimeric replicons encoding NS5A and NS5B sequences from clinical isolates are detailed in Table 5.
Vrednosti EC50 za ledipasvir in sofosbuvir proti replikonom polne dolžine ali himeričnim replikonom, ki kodirajo zaporedje NS5A in NS5B iz kliničnih izolatov, so prikazane v preglednici 5.
• The active substances are ledipasvir and sofosbuvir.
• Zdravilni učinkovini sta ledipasvir in sofosbuvir.
Patients with decompensated cirrhosis, irrespective of transplant status
Bolniki z dekompenzirano cirozo ne glede na presaditev
In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart (rat) effects and gastrointestinal reactions (dog).
V študijah toksičnosti pri ponavljajočih odmerkih pri podganah in psih so veliki odmerki diastereomeričnih mešanic v razmerju 1:1 povzročili neželene učinke na jetra (psi) in srce (podgane)
In patients with ESRD, relative to patients with normal renal function, sofosbuvir AUC0-inf was 28% higher when sofosbuvir was dosed 1 hour before haemodialysis compared with 60% higher when sofosbuvir was dosed 1 hour after haemodialysis.
Pri bolnikih z ESRD je bila v primerjavi z bolniki z normalnim delovanjem ledvic vrednost AUC0-inf sofosbuvirja za 28 % višja pri odmerjanju sofosbuvirja 1 uro pred hemodializo v primerjavi s 60 % višjo vrednostjo pri odmerjanju sofosbuvirja 1 uro po hemodializi.
Decreases in haemoglobin to < 10 g/dL and < 8.5 g/dL during treatment were experienced by 39% and 13% of patients treated with ledipasvir/sofosbuvir with ribavirin, respectively.
Zmanjšanje ravni hemoglobina na < 10 g/dl in < 8,5 g/dl med zdravljenjem so opazili pri 39 % oziroma 13 % bolnikov, zdravljenih z ledipasvirjem/sofosbuvirjem z ribavirinom.
b. Non-missing FibroTest results are mapped to Metavir scores according to: 0-0.31 = F0-F1; 0.32-0.58 = F2; 0.59-1.00 = F3-F4.
b. Nemanjkajoči rezultati FibroTest so kartirani v rezultate Metavir glede na: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,591,00 = F3-F4.
Table 5: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Preglednica 5: Aktivnost ledipasvirja in sofosbuvirja proti himeričnim replikonom
a. HCV RNA values were determined using the Roche TaqMan Assay; a patient's HCV RNA may vary from visit to visit.
a. Vrednosti HCV RNA so bile ugotovljene s pomočjo testa Roche TaqMan; vrednost HCV RNA bolnika se lahko med obiski razlikuje.
Patients in the latter treatment arm received placebo (for ledipasvir/sofosbuvir and ribavirin) during the first 12 weeks, followed by active blinded therapy during the subsequent 12 weeks.
Bolniki v slednji skupini zdravljenja so prejemali placebo (za ledipasvir/sofosbuvir in ribavirin) v prvih 12 tednih, potem pa slepo zdravljenje z zdravilno učinkovino v naslednjih 12 tednih.
Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Zaporedja NS5A in NS5B po izhodišču s podatki karakterizacije strukture genoma (deep sequencing) (mejna vrednost testa 1 %) so bila na voljo za 37 od 37 oz. 36 od 37 bolnikov.
This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment.
Ta bolnik se je nato 24 tednov ponovno zdravil z ledipasvirjem/sofosbivirjem + ribavirinom in je po ponovnem zdravljenju dosegel SVR.
↔ GS-331007 (Induction of P-gp)
↔ GS-331007 (indukcija P-gp)
• Do not take any of these medicines with Harvoni:
• Z zdravilom Harvoni ne jemljite nobenega od naslednjih zdravil:
The AUC0-inf of GS-331007 in patients with ESRD administered with sofosbuvir 1 hour before or 1 hour after haemodialysis was at least 10-fold and 20-fold higher, respectively.
Vrednost AUC0-inf GS-331007 pri bolnikih z ESRD pri dajanju sofosbuvirja 1 uro pred hemodializo je bila vsaj 10-krat večja, 1 uro po hemodializi pa vsaj 20-krat večja.
Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and
Zdravilo Harvoni je indicirano za zdravljenje kroničnega hepatitisa C (CHC-chronic hepatitis C) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 and GS-331007 is not an inhibitor of OAT1, OCT2 and MATE1.
Sofosbuvir in GS-331007 nista zaviralca prenašalcev P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 in GS-331007 ni zaviralec OAT1, OCT2 in MATE1.
Among patients with a baseline HCV RNA < 6 million IU/mL, the SVR was 97% (119/123) with 8-week treatment of ledipasvir/sofosbuvir and 96% (126/131) with 12-week treatment of ledipasvir/sofosbuvir.
Med bolniki z ravnijo HCV RNA ob izhodišču < 6 millijonov i.e./ml je bil SVR 97 % (119/123) z 8-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem in 96 % (126/131) z 12-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem.
Use with potent P-gp inducers
Uporaba z močnimi induktorji P-gp
What Harvoni looks like and contents of the pack The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side.
Izgled zdravila Harvoni in vsebina pakiranja Filmsko obložene tablete so oranžne tablete v obliki romba, z vtisnjeno oznako »GSI« na eni in »7985« na drugi strani.
Of the remaining 154 patients, a total of 149 achieved SVR12 across both treatment groups; 96% (74/77) of patients in the ledipasvir/sofosbuvir with ribavirin 12-week group and 97% (75/77) of patients in the ledipasvir/sofosbuvir 24-week group.
Od ostalih 154 bolnikov jih je skupno 149 doseglo SVR12 v obeh skupinah zdravljenja; 96 % (74/77) v skupini bolnikov z 12-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem z ribavirinom in 97 % (75/77) v skupini bolnikov s 24-tedenskim zdravljenjem z ledipasvirjem/sofosbuvirjem.
Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
V primerjavi z zdravimi osebami (n = 191) sta bili vrednosti AUC0-24 in Cmax za ledipasvir pri bolnikih, okuženih s HCV, za 24 % oz. 32 % manjši.
Not interpretable a. One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype.
Razlaga ni mogoča a. En bolnik v skupini 8-tedenskega zdravljenja z LDV/SOF ni imel potrjenega podtipa genotipa 1.
A conservative 24 weeks of therapy is advised in all treatment-experienced genotype 3 patients and those treatment-naïve genotype 3 patients with cirrhosis (see section 4.2).
Konzervativno 24-tedensko zdravljenje je priporočljivo pri vseh predhodno zdravljenih bolnikih z genotipom 3 in pri predhodno nezdravljenih bolnikih z genotipom 3 s cirozo (glejte poglavje 4.2).
All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above).
Pri vseh 5 bolnikih, ki niso dosegli SVR12, je prišlo po odzivu ob koncu zdravljenja do relapsa (glejte zgornje poglavje
Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b.
Zmanjšana dovzetnost za ledipasvir je bila povezana s primarno substitucijo Y93H v polimerazi NS5A v obeh genotipih 1a in 1b.
In patients without decompensated cirrhosis requiring the addition of ribavirin to their treatment regimen (see Table 1), the daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food.
Pri bolnikih brez dekompenzirane ciroze, pri katerih je treba k režimu zdravljenja dodajati ribavirin (glejte preglednico 1), temelji dnevni odmerek ribavirina na telesni masi (< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
• If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine
• če ste alergični na ledipasvir, sofosbuvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
Table 14: Response rates in study ION-4
Preglednica 14: Stopnje odziva v študiji ION-4
Interactions between Harvoni and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined equivalence boundaries).
V preglednici 3 je seznam ugotovljenih ali možnih klinično pomembnih interakcij med zdravili (pri čemer je bil 90-odstotni interval zaupanja [IZ] razmerja geometričnega povprečja najmanjših kvadratov [GLSM-geometric least-squares mean] znotraj "↔", razširjenimi nad "↑" ali razširjenimi pod "↓" vnaprej določenih mej ekvivalentnosti).
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Sofosbuvir je nukleotidno predzdravilo, ki se znotraj celice presnavlja in tvori farmakološko aktivni uridinski analog trifosfat (GS-461203), ki ga polimeraza NS5B lahko vgradi v RNA HCV, in deluje kot terminator verige.
Table 15: Response rates (SVR12) in study SOLAR-1 LDV/SOF+RBV 12 weeks (n = 168)
Preglednica 15: Stopnje odziva (SVR12) v študiji SOLAR-1 LDV/SOF+RBV 12 tednov (n = 168)
Harvoni + ribavirin for 12 weeks (see section 5.1).
Zdravilo Harvoni + ribavirin 12 tednov (glejte poglavje 5.1).
The pharmacokinetics of ledipasvir were studied with a single dose of 90 mg ledipasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault, median [range] CrCl 22 [17-29] mL/min).
Farmakokinetiko ledipasvirja so preučili z enkratnim 90-miligramskim odmerkom ledipasvirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi Cockcroft-Gault, mediana [razpon] CrCl 22 [17-29] ml/min).
Effect of baseline HCV resistance-associated variants on treatment outcome Genotype 1
Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja
Table 17: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Preglednica 17: Stopnje odziva (SVR12) pri bolnikih z okužbo z genotipom 3 (ELECTRON-2) LDV/SOF+RBV 12 tednov
Proton pump inhibitor doses comparable to omeprazole 20 mg can be administered simultaneously with Harvoni.
Odmerke zaviralca protonske črpalke, primerljive z omeprazolom 20 mg, se lahko uporablja sočasno z zdravilom Harvoni.
Ledipasvir was not carcinogenic in the 6-month rasH2 transgenic mouse study at exposures up to 26-fold higher than human exposure.
Ledipasvir v 6-mesečni študiji pri rasH2 transgenih miših pri izpostavljenosti, do 26-krat večji od izpostavljenosti pri človeku, ni bil kancerogen.
When used in combination with ribavirin, refer also to the Summary of Product Characteristics of ribavirin.
Če se uporablja v kombinaciji z ribavirinom, glejte tudi povzetek glavnih značilnosti zdravila za ribavirin.
Only patients who demonstrated SVR12 or relapse were included in relapse analyses.
V analize relapsa so bili vključeni samo bolniki, pri katerih so potrdili SVR12 ali relaps.
f. Staggered administration (12 hours apart) of atazanavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate or darunavir/ritonavir + emtricitabine/tenofovir disoproxil fumarate and Harvoni provided similar results.
f. Uporaba z zamikom (12 ur kasneje) atazanavirja/ritonavirja + emtricitabina/dizoproksiltenofovirata fumarata ali darunavirja/ritonavirja + emtricitabina/dizoproksiltenofovirata fumarata in zdravila Harvoni je pokazala podobne rezultate.
Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Zdravila, ki so močni induktorji P-glikoproteina (P-gp) v črevesju (rifampicin, rifabutin, šentjanževka [Hypericum perforatum], karbamazepin, fenobarbital in fenitoin).
All patients were treatment-naïve to HCV therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Noben bolnik se predhodno ni zdravil zaradi HCV in noben ni imel ciroze, 26 % (13/50) bolnikov se predhodno ni zdravilo s protiretrovirusno terapijo proti HIV in 74 % (37/50) bolnikov je prejemalo sočasno protiretrovirusno terapijo proti HIV.
SVR rates for selected subgroups Patients with cirrhosis Previously treated patients with cirrhosis a. 8 patients with genotype 4 HCV infection were enrolled in the study with 8/8 achieving SVR12.
Stopnje SVR za izbrane podskupine Bolniki s cirozo Predhodno zdravljeni bolniki s cirozo a. 8 bolnikov z okužbo HCV genotipa 4 je bilo vključenih v študijo, pri čemer jih je 8/8 doseglo SVR12.
Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to ledipasvir.
Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza ni imela klinično pomembnega učinka na izpostavljenost ledipasvirju.
Change in MELD score: 53% (72/135) and 21% (28/135) had an improvement or no change of MELD score from baseline to post-treatment week 4, respectively; of the 35 patients whose MELD score was ≥ 15 at baseline, 63% (22/35) had a MELD score < 15 at post-treatment week 12.
Sprememba rezultata MELD: 53 % (72/135) oziroma 21 % (28/135) je imelo izboljšanje ali nobene spremembe rezultata MELD od izhodišča do 4. tedna po zdravljenju; od 35 bolnikov, ki so imeli rezultat MELD ≥ 15 ob izhodišču, jih je imelo 63 % (22/35) rezultat MELD < 15 v 12. tednu po zdravljenju.
• 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).
Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Predhodno zdravljenje HCV PEG-IFN+RBV Zaviralec proteaze HCV + PEG-IFN+RBV
The three Phase 3 studies included one study conducted in non-cirrhotic treatment-naïve patients (ION-3); one study in cirrhotic and non-cirrhotic treatment-naïve patients (ION-1); and one study in cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2).
Tri študije 3. faze so vključevale eno študijo, opravljeno pri predhodno nezdravljenih bolnikih brez ciroze (ION-3), eno študijo, opravljeno pri predhodno nezdravljenih bolnikih s cirozo in brez ciroze (ION-1) in eno študijo, opravljeno pri bolnikih s cirozo in brez ciroze, pri katerih predhodno zdravljenje na podlagi interferona, vključno z režimi, ki so vključevali zaviralec proteaze HCV, ni bilo uspešno (ION-2).
For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 16).
Za okužbo z genotipom 2, 4, 5 in 6 je bilo zdravljenje sestavljeno iz ledipasvirja/sofosbuvirja brez ribavirina in dajano 12 tednov (preglednica 16).
c. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
c. Med drugo so bili vključeni bolniki, ki niso dosegli SVR in niso izpolnjevali kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
• rifapentine (antibiotic used to treat infections, including tuberculosis);
• rifampicin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo),
For genotype 3 infection, ledipasvir/sofosbuvir was given with or without ribavirin, also for 12 weeks (Table 17).
Za okužbo z genotipom 3 so ledipasvir/sofosbuvir dajali z ribavirinom ali brez njega, prav tako 12 tednov (preglednica 17).