FrancophonIA/ELRC3.0 huggingface dataset:
English: This patient was subsequently retreated with ledipasvir/sofosbuvir + ribavirin for 24 weeks and achieved SVR following retreatment.
Slovenian: Ta bolnik se je nato 24 tednov ponovno zdravil z ledipasvirjem/sofosbivirjem + ribavirinom in je po ponovnem zdravljenju dosegel SVR.
English: ↔ GS-331007 (Induction of P-gp)
Slovenian: ↔ GS-331007 (indukcija P-gp)
English: • Do not take any of these medicines with Harvoni:
Slovenian: • Z zdravilom Harvoni ne jemljite nobenega od naslednjih zdravil:
English: 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.
Slovenian: 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.
English: Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and
Slovenian: Zdravilo Harvoni je indicirano za zdravljenje kroničnega hepatitisa C (CHC-chronic hepatitis C) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
English: 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.
Slovenian: Sofosbuvir in GS-331007 nista zaviralca prenašalcev P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 in GS-331007 ni zaviralec OAT1, OCT2 in MATE1.
English: 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.
Slovenian: 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.
English: Use with potent P-gp inducers
Slovenian: Uporaba z močnimi induktorji P-gp
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
Slovenian: 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.
English: Not interpretable a. One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype.
Slovenian: Razlaga ni mogoča a. En bolnik v skupini 8-tedenskega zdravljenja z LDV/SOF ni imel potrjenega podtipa genotipa 1.
English: 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).
Slovenian: 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).
English: All 5 patients who did not achieve SVR12 relapsed after having end-of-treatment response (see section “Resistance” - “In clinical studies” above).
Slovenian: Pri vseh 5 bolnikih, ki niso dosegli SVR12, je prišlo po odzivu ob koncu zdravljenja do relapsa (glejte zgornje poglavje
English: Reduced susceptibility to ledipasvir was associated with the primary NS5A substitution Y93H in both genotype 1a and 1b.
Slovenian: Zmanjšana dovzetnost za ledipasvir je bila povezana s primarno substitucijo Y93H v polimerazi NS5A v obeh genotipih 1a in 1b.
English: 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.
Slovenian: 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.
English: • If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine
Slovenian: • če ste alergični na ledipasvir, sofosbuvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
English: Table 14: Response rates in study ION-4
Slovenian: Preglednica 14: Stopnje odziva v študiji ION-4
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Table 15: Response rates (SVR12) in study SOLAR-1 LDV/SOF+RBV 12 weeks (n = 168)
Slovenian: Preglednica 15: Stopnje odziva (SVR12) v študiji SOLAR-1 LDV/SOF+RBV 12 tednov (n = 168)
English: Harvoni + ribavirin for 12 weeks (see section 5.1).
Slovenian: Zdravilo Harvoni + ribavirin 12 tednov (glejte poglavje 5.1).
English: 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).
Slovenian: 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).
English: Effect of baseline HCV resistance-associated variants on treatment outcome Genotype 1
Slovenian: Učinki izhodiščnih različic HCV, povezanih z odpornostjo, na izid zdravljenja
English: Table 17: Response rates (SVR12) in patients with genotype 3 infection (ELECTRON-2) LDV/SOF+RBV 12 weeks
Slovenian: Preglednica 17: Stopnje odziva (SVR12) pri bolnikih z okužbo z genotipom 3 (ELECTRON-2) LDV/SOF+RBV 12 tednov
English: Proton pump inhibitor doses comparable to omeprazole 20 mg can be administered simultaneously with Harvoni.
Slovenian: Odmerke zaviralca protonske črpalke, primerljive z omeprazolom 20 mg, se lahko uporablja sočasno z zdravilom Harvoni.
English: Ledipasvir was not carcinogenic in the 6-month rasH2 transgenic mouse study at exposures up to 26-fold higher than human exposure.
Slovenian: Ledipasvir v 6-mesečni študiji pri rasH2 transgenih miših pri izpostavljenosti, do 26-krat večji od izpostavljenosti pri človeku, ni bil kancerogen.
English: When used in combination with ribavirin, refer also to the Summary of Product Characteristics of ribavirin.
Slovenian: Če se uporablja v kombinaciji z ribavirinom, glejte tudi povzetek glavnih značilnosti zdravila za ribavirin.
English: Only patients who demonstrated SVR12 or relapse were included in relapse analyses.
Slovenian: V analize relapsa so bili vključeni samo bolniki, pri katerih so potrdili SVR12 ali relaps.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: Zdravila, ki so močni induktorji P-glikoproteina (P-gp) v črevesju (rifampicin, rifabutin, šentjanževka [Hypericum perforatum], karbamazepin, fenobarbital in fenitoin).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to ledipasvir.
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza ni imela klinično pomembnega učinka na izpostavljenost ledipasvirju.
English: 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.
Slovenian: 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.
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
Slovenian: • karbamazepin, fenobarbital in fenitoin (zdravila, ki se uporabljajo za zdravljenje epilepsije in preprečevanje epileptičnih napadov).
English: Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Slovenian: Predhodno zdravljenje HCV PEG-IFN+RBV Zaviralec proteaze HCV + PEG-IFN+RBV
English: Genotype 1b
Slovenian: Genotip 1b
English: 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).
Slovenian: 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).
English: For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 16).
Slovenian: Za okužbo z genotipom 2, 4, 5 in 6 je bilo zdravljenje sestavljeno iz ledipasvirja/sofosbuvirja brez ribavirina in dajano 12 tednov (preglednica 16).
English: c. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Slovenian: c. Med drugo so bili vključeni bolniki, ki niso dosegli SVR in niso izpolnjevali kriterijev za virološki neuspeh (npr. izgubljeni za spremljanje).
English: • rifapentine (antibiotic used to treat infections, including tuberculosis);
Slovenian: • rifampicin (antibiotik, ki se uporablja za zdravljenje okužb, vključno s tuberkulozo),
English: For genotype 3 infection, ledipasvir/sofosbuvir was given with or without ribavirin, also for 12 weeks (Table 17).
Slovenian: Za okužbo z genotipom 3 so ledipasvir/sofosbuvir dajali z ribavirinom ali brez njega, prav tako 12 tednov (preglednica 17).
English: Breast-feeding It is unknown whether ledipasvir or sofosbuvir and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se ledipasvir ali sofosbuvir in njegovi presnovki izločajo v materino mleko.
English: Table 16: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection
Slovenian: Preglednica 16: Stopnje odziva (SVR12) z 12-tedenskim dajanjem ledipasvirja/sofosbuvirja bolnikom z okužbo s HCV z genotipom 2, 4, 5 in 6
English: Table 3: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Slovenian: Preglednica 3: Interakcije med zdravilom Harvoniin drugimi zdravili Zdravila po terapevtskih področjih
English: Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, sunset yellow FCF aluminium lake (E110)
Slovenian: Filmska obloga: polivinilalkohol, titanov dioksid, makrogol 3350, smukec, sončno rumeno FCF (E110).
English: The clinical data to support the use of Harvoni in patients infected with HCV genotype 2 and 6 are limited (see section 5.1).
Slovenian: Klinični podatki, ki bi podprli uporabo zdravila Harvoni pri bolnikih z okužbo s HCV genotipov 2 in 6, so omejeni (glejte poglavje 5.1).
English: Of 169 patients with decompensated cirrhosis (pre- or post-transplant CPT B or C), those patients who achieved SVR12 and had post-treatment week 12 laboratory data available (e.g. excluding patients who died, were transplanted, or had missing data at this time-point) were assessed for changes in their MELD and CPT scores.
Slovenian: Od 169 bolnikov z dekompenzirano cirozo (CPT B ali C pred presaditvijo ali po njej) so spremembe rezultatov MELD in CPT ocenili pri bolnikih, ki so dosegli SVR12 in pri katerih so bili na voljo laboratorijski podatki v 12. tednu po zdravljenju (npr. izključili so bolnike, ki so umrli, pri katerih so opravili presaditev ali ni bilo podatkov na tej časovni točki).
English: Of the 8 genotype 1b patients who qualified for resistance testing, 7/8 (88%) harboured one or more NS5A RAVs at positions L31 and Y93 at failure, while 1/8 patients had no NS5A RAVs at failure.
Slovenian: Od 8 bolnikov z genotipom 1b, ki so bili primerni za testiranje odpornosti, jih je bilo 7 od 8 (88 %) nosilcev enega ali več RAV NS5A na položajih L31 in Y93 ob neuspehu, medtem ko 1 od 8 bolnikov ob neuspehu ni imelo nobene RAV NS5A.
English: Co-administration of Harvoni with rosuvastatin may significantly increase the concentration of rosuvastatin (several fold-increase in AUC) which is associated with increased risk of myopathy, including rhabdomyolysis.
Slovenian: Sočasno dajanje zdravila Harvoni z rosuvastatinom lahko značilno poveča koncentracijo rosuvastatina (večkrtano povečanje AUC), kar je povezano z večjim tveganjem za miopatijo, vključno z rabdomiolizo.
English: Harvoni contains the azo colouring agent sunset yellow FCF aluminium lake (E110), which may cause allergic reactions.
Slovenian: Zdravilo Harvonivsebuje azobarvilo sončno rumeno FCF (E110), ki lahko povzroči alergijske reakcije.
English: Co-administration of Harvoni and HMG-CoA reductase inhibitors (statins) can significantly increase the concentration of the statin, which increases the risk of myopathy and rhabdomyolysis (see section 4.5).
Slovenian: Sočasno dajanje zdravila Harvoniin zaviralcev reduktaze HMG-CoA (statinov) lahko značilno poveča koncentracijo statina, kar poveča tveganje za miopatijo in rabdomiolizo (glejte poglavje 4.5).
English: Patients with genotype 3 CHC Patients with compensated cirrhosis and/or prior treatment failure
Slovenian: Bolniki s kompenzirano cirozo in/ali predhodno neuspešnim zdravljenjem
English: Relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Slovenian: V primerjavi z bolniki z normalnim delovanjem ledvic (eGFR > 80 ml/min/1,73 m2) je bila vrednost AUC0-inf za sofosbuvir za 61 % višja pri bolnikih z blago, za 107 % pri bolnikih z zmerno in za 171 % s hudo ledvično okvaro, medtem ko je bila vrednost AUC0-inf za GS-331007 višja za 55 %, 88 % oz. za 451 %.
English: Median peak plasma concentration of GS-331007 was observed at 4 hours post-dose.
Slovenian: Mediano najvišje koncentracije GS-331007 v plazmi so opazili 4 ure po odmerku.
English: The clinical data to support the use of Harvoni in patients infected with HCV genotype 3 are limited (see section 5.1).
Slovenian: Klinični podatki, ki bi podprli uporabo zdravila Harvoni pri bolnikih z okužbo s HCV genotipa 3, so omejeni (glejte poglavje 5.1).
English: The medicinal product interactions described are based on studies conducted with either ledipasvir/sofosbuvir or ledipasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with ledipasvir/sofosbuvir.
Slovenian: izvedenih z bodisi ledipasvirjem/sofosbuvirjem ali ledipasvirjem in sofosbuvirjem kot posameznimi učinkovinami ali so predvidene interakcije med zdravili, ki se lahko pojavijo z ledipasvirjem/sofosbuvirjem.
English: - Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options (see section 4.4).
Slovenian: - O 12 tednih zdravila Harvoni + ribavirina ali 24 tednih zdravila Harvoni (brez ribavirina) je treba razmisliti pri predhodno zdravljenih bolnikih z negotovo možnostjo za naknadno ponovno zdravljenje (glejte poglavje 4.4).
English: NS5B transient replicons Median (range)
Slovenian: Stabilni replikoni prehodni replikoni NS5B mediana (razpon)
English: NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets
Slovenian: IME ZDRAVILA Harvoni 90 mg/400 mg filmsko obložene tablete
English: When ledipasvir/sofosbuvir was studied with ribavirin, the most frequent adverse drug reactions to ledipasvir/sofosbuvir + ribavirin combination therapy were consistent with the known safety profile of ribavirin, without increasing the frequency or severity of the expected adverse drug reactions.
Slovenian: Ko so ledipasvir/sofosbuvir preučevali z ribavirinom, so bili najpogostejši neželeni učinki kombinirane terapije ledipasvirja/sofosbuvirja + ribavirina skladni z znanim profilom varnosti zdravljenja z ribavirinom,
English: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Slovenian: Pokazalo se je, da zdravilo Harvoni poveča izpostavljenost tenofovirju, zlasti, če se uporablja skupaj z režimom proti HIV, ki vsebuje dizoproksiltenofovirat fumarat in farmakokinetični ojačevalec
English: In a pooled analysis of patients who received ledipasvir/sofosbuvir in Phase 3 studies (ION-3, ION-1 and ION-2), 37 patients (29 with genotype 1a and 8 with genotype 1b) qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA > 1,000 IU/mL.
Slovenian: V združeni analizi bolnikov, ki so prejeli ledipasvir/sofosbuvir v študijah 3. faze (ION-3, ION-1 in ION-2), je bilo 37 bolnikov (29 z genotipom 1a in 8 z genotipom 1b) primernih za analizo odpornosti zaradi virološkega neuspeha ali predčasne prekinitve uporabe preiskovanega zdravila in zaradi
English: Otherb
Slovenian: Drugoc
English: • Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110”
Slovenian: • Povejte zdravniku, če ste alergični na barvilo sončno rumeno FCF (E110) preden uporabite to zdravilo.
English: Taking Harvoni with any of these may make Harvoni work less well or make any side effects of the medicines worse.
Slovenian: Jemanje zdravila Harvoni s katerim koli od teh zdravil lahko povzroči, da bo morda zdravilo Harvoni slabše delovalo ali pa se bodo kateri od neželenih učinkov zdravila okrepili.
English: Concentrations of ledipasvir, sofosbuvir and simeprevir are increased when simeprevir is co-administered with Harvoni.
Slovenian: Koncentracije ledipasvirja, sofosbuvirja in simeprevirja se povečajo pri sočasnem dajanju simeprevirja z zdravilom Harvoni.
English: 24% (4/17)e a. These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Slovenian: Da e a. Ti 4 bolniki brez ciroze z relapsom so imeli izhodiščne z odpornostjo povezane polimorfizme NS5A.
English: There are presently no data to support the effectiveness of retreatment of patients who have failed ledipasvir/sofosbuvir with a subsequent regimen that contains an NS5A inhibitor.
Slovenian: Trenutno ni na voljo podatkov, ki bi podprli učinkovitost ponovnega zdravljenja z naknadnim režimom, ki vključuje zaviralca NS5A, pri bolnikih,
English: Genotype Genotype 1a Genotype 1b a. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Slovenian: Genotip Genotip 1a Genotip 1b a. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
English: The pharmacokinetics of sofosbuvir were studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
Slovenian: Farmakokinetiko sofosbuvirja so preučili pri bolnikih, negativnih za HCV, z blago (eGFR ≥ 50 in < 80 ml/min/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ter pri bolnikih z ESRD, zaradi katere bolnik potrebuje hemodializo, po enkratnem 400-miligramskem odmerku sofosbuvirja.
English: No dose adjustment of Harvoni or abacavir/ lamivudine is required.
Slovenian: Odmerka zdravila Harvoni ali abakavirja/ lamivudina ni treba prilagajati.
English: Similarly, there are presently no data to support the effectiveness of NS3/4A protease inhibitors in patients who previously failed prior therapy that included an NS3/4A protease inhibitor.
Slovenian: Podobno trenutno ni na voljo podatkov, ki bi podprli učinkovitost zaviralcev proteaze NS3/4A pri bolnikih, pri katerih zdravljenje,