FrancophonIA/ELRC3.0 huggingface dataset:
English: Among the 87 patients who were treated with Epclusa + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively.
Croatian: Od 87 bolesnika koji su liječeni lijekom Epclusa + RBV tijekom 12 tjedana, smanjenja hemoglobina na manje od 10 g/dl odnosno 8,5 g/dl tijekom liječenja opaženo je u 23 % odnosno 7 % bolesnika.
English: In the pooled analysis of the Phase 3 studies, 380/1,023 (37%) patients' virus had baseline NS5A RAVs.
Croatian: U objedinjenim analizama ispitivanja faze 3, virus 380/1023 bolesnika (37 %) je imao početne NS5A RAV-ove.
English: Patients who have previously failed therapy with an NS5A-containing regimen Epclusa + ribavirin for 24 weeks may be considered (see section 4.4).
Croatian: Bolesnici u kojih je prethodna terapija režimom koji sadrži NS5A bila neuspješna Mogu se razmotriti Epclusa + ribavirin tijekom 24 tjedna (vidjeti dio 4.4).
English: TN = treatment-naïve patients; TE = treatment-experienced patients (including those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor)
Croatian: TN = engl. treatment-naïve patients = bolesnici koji prethodno nisu liječeni; TE = engl. treatment-experienced patients = prethodno liječeni bolesnici (uključujući one u kojih režim temeljen na peginterferonu alfa + ribavirin sa ili bez inhibitora HCV proteaze nije bio uspješan)
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada su se režimi koji sadrže sofosbuvir koristili u kombinaciji s amiodaronom sa ili bez drugih lijekova koji snižavaju srčanu frekvenciju.
English: d Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184.
Croatian: d. Podaci iz kimeričkih replikona NS5A koji nose aminokiseline NS5A 9-184.
English: 92.9% to 98.0% 82.8% to 96.4% 92.8% to 98.6%
Croatian: 92,9 % do 98,0 % 82,8 % do 96,4 % 92,8 % do 98,6 %
English: Exposure to sofosbuvir in rodent studies could not be detected likely due to high esterase activity and exposure to the major metabolite GS-331007 was instead used to estimate exposure margins.
Croatian: Izloženost sofosubviru u ispitivanjima na glodavcima nije otkrivena, vjerojatno zbog visoke aktivnosti esteraze, pa je umjesto toga za procjenu granica izloženosti upotrijebljen glavni metabolit GS-331007.
English: Reduced susceptibility to sofosbuvir was associated with the primary NS5B substitution S282T in all replicon genotypes examined.
Croatian: Smanjena osjetljivost na sofosbuvir bila je povezana s primarnom supstitucijom S282T u NS5B u svim ispitanim genotipovima replikona.
English: The following pack sizes are available: • outer cartons containing 1 bottle of 28 film-coated tablets
Croatian: Dostupne su sljedeće veličine pakiranja: • kutije koje sadrže 1 bocu s 28 filmom obloženih tableta
English: 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/mL.
Croatian: Vrijednosti HCV RNK u serumu tijekom kliničkih ispitivanja bile su mjerene s pomoću testa COBAS AmpliPrep/COBAS Taqman HCV (inačica 2.0) s donjom granicom kvantifikacije (LLOQ) od 15 IU/ml.
English: 63.9% to 95.5% 6.8% to 93.2% 69.6% to 98.8%
Croatian: 63,9 % do 95,5 % 6,8 % do 93,2 % 69,6 % do 98,8 %
English: Epclusa should be taken with food 4 hours before using a proton pump inhibitor.
Croatian: Lijek Epclusa treba uzeti s hranom 4 sata prije uzimanja inhibitora protonske pumpe.
English: Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk.
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se velpatasvir i metaboliti sofosbuvira izlučuju u mlijeku.
English: In this study, 2 patients treated with Epclusa for 12 or 24 weeks without ribavirin had emergent NS5B S282T at low levels (< 5%) along with L159F.
Croatian: U ovom su ispitivanju dva bolesnika liječena lijekom Epclusa tijekom 12 ili 24 tjedna bez ribavirina imala pojavu NS5B S282T pri niskim razinama (< 5 %) uz L159F.
English: Genotype 1b 89% (16/18) Genotype 3
Croatian: Genotip 1b 89 % (16/18) Genotip 3
English: Film-coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red
Croatian: Film ovojnica: polivinilni alkohol, titanijev dioksid, polietilenglikol, talk, crveni željezov oksid
English: Total (n = 78)
Croatian: Ukupno (n = 78)
English: If you are taking a proton pump inhibitor, take Epclusa with food 4 hours before using a proton pump inhibitor.
Croatian: Ako uzimate inhibitor protonske pumpe, lijek Epclusa uzmite s hranom 4 sata prije uzimanja inhibitora protonske pumpe.
English: When co-administered with Epclusa, careful monitoring for statin adverse reactions should be undertaken and a reduced dose of statins should be considered if required.
Croatian: Kad se primjenjuje s lijekom Epclusa, treba pomno pratiti nuspojave statina te prema potrebi, treba razmotriti smanjenu dozu statina.
English: Epclusa should not be administered concurrently with other medicinal products containing sofosbuvir.
Croatian: Epclusa se ne smije primjenjivati istodobno s drugim lijekovima koji sadrže sofosbuvir.
English: Animal studies do not indicate harmful effects of sofosbuvir or velpatasvir on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke sofosbuvira ili velpatasvira na plodnost.
English: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
Croatian: • rifampicin i rifabutin (antibiotici koji se primjenjuju za liječenje infekcija, uključujući tuberkulozu);
English: Velpatasvir Animal studies have shown a possible link to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su moguću vezu sa štetnim učinkom na reprodukciju (vidjeti dio 5.3)
English: However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.7 fold the human exposure at recommended clinical dose.
Croatian: Međutim, mogući teratogeni učinak indiciran je u kunića pri čemu je povećanje ukupnih visceralnih malformacija primijećeno u izloženim životinjama pri izloženosti AUC do najviše za 0,7 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
English: The pharmacokinetics of sofosbuvir, GS-331007 and velpatasvir in paediatric patients have not been established (see section 4.2).
Croatian: Farmakokinetika sofosbuvira, GS-331007 i velpatasvira u pedijatrijskih bolesnika nije ustanovljena (vidjeti dio 4.2).
English: 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.
Croatian: Put metaboličke aktivacije uključuje sekvencionalnu hidrolizu karboksilnog estera koju kataliziraju ljudski katepsin A (CatA) ili karboksilesteraza 1 (CES1) i cijepanje fosforamidata histidinskim trijadnim proteinom 1 koji veže nukleotide (engl. histidine triad nucleotide-binding protein 1, HINT1) za kojom slijedi fosforilacija putem biosinteze pirimidinskih nukleotida.
English: Demographics and baseline characteristics were balanced between the Epclusa and placebo group.
Croatian: Demografska slika i značajke na početku ispitivanja uravnotežne su između skupine s lijekom Epclusa i skupine s placebom.
English: No human data on the effect of Epclusa on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju lijeka Epclusa na plodnost u ljudi.
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
Croatian: • karbamazepin, fenobarbital i fenitoin (lijekovi koji se primjenjuju za liječenje epilepsije i sprječavanje napadaja).
English: Sofosbuvir was not a carcinogen in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 15 and 9 times, respectively, higher than human exposure.
Croatian: Sofosbuvir nije bio kancerogen u dvogodišnjim ispitivanjima kancerogenosti na miševima i štakorima pri izloženosti GS-331007 do 15 odnosno 9 puta višim od ljudske izloženosti.
English: The safety of Epclusa has been evaluated in a 12-week non-controlled study including 59 subjects with ESRD requiring dialysis (Study 4062).
Croatian: Sigurnost lijeka Epclusa procijenjena je u 12-tjednom nekontroliranom ispitivanju koje je obuhvatilo 59 ispitanika s ESRD-om koji je zahtijevao dijalizu (ispitivanje 4062).
English: Epclusa 400 mg/100 mg film-coated tablets sofosbuvir/velpatasvir
Croatian: Epclusa 400 mg/100 mg filmom obložene tablete sofosbuvir/velpatasvir
English: If ribavirin is used in genotype 3 infected patients with compensated cirrhosis (pre- or post-transplant) the recommended dose of ribavirin is 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg).
Croatian: Ako se ribavirin koristi u bolesnika zaraženih genotipom 3 s kompenziranom cirozom (prije ili poslije transplantacije), preporučena doza ribavirina je 1000/1200 mg (1000 mg za bolesnike težine < 75 kg i 1200 mg za bolesnike težine ≥ 75 kg).
English: Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Epclusa.
Croatian: Ako se istodobna primjena amiodarona smatra neophodnom, preporučuje se da se bolesnike pažljivo prati na početku uzimanja lijeka Epclusa.
English: Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Croatian: Nakon jedne doze od 100 mg [14C]-velpatasvira, većina (> 98 %) radioaktivnosti u plazmi bila je ishodišni lijek.
English: • If you are sick (vomit) more than 3 hours after taking Epclusa, you do not need to take another tablet until your next scheduled tablet.
Croatian: • Ako povratite nakon više od 3 sati nakon uzimanja lijeka Epclusa, ne trebate uzeti drugu tabletu prije sljedeće tablete prema rasporedu.
English: After a single 400 mg oral dose of [14C]-sofosbuvir, GS-331007 accounted for approximately > 90% of total systemic exposure.
Croatian: Nakon jedne peroralne doze od 400 mg [14C]-sofosbuvira, udio GS-331007 u ukupnoj sistemskoj izloženosti iznosio je > 90 %.
English: Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Croatian: Početna doza od 600 mg koja se može titrirati do najviše 1000/1200 mg (1000 mg za bolesnike težine < 75 kg i 1200 mg za bolesnike težine ≥ 75 kg) ako se dobro podnosi.
English: Median peak plasma concentration of GS-331007 was observed 3 hours post-dose.
Croatian: Medijan vršne koncentracije GS-331007 u plazmi bio je opažen 3 sata nakon uzimanja doze.
English: In the ASTRAL-3 study, the Y93H RAV was detected at baseline in 9% of patients treated with Epclusa.
Croatian: U ispitivanju ASTRAL-3, Y93H RAV utvrđen je na početku u 9 % bolesnika liječenih lijekom Epclusa.
English: Velpatasvir was not carcinogenic in the 6-month rasH2 transgenic mouse and 2-year rat carcinogenicity studies at exposures at least 50-times and 5-times higher than human exposure, respectively.
Croatian: Velpatasvir nije bio kancerogen u 6-mjesečnom ispitivanju na rasH2 transgeničnim miševima i 2-godišnjem ispitivanju kancerogenosti na štakorima pri izloženostima najmanje 50 odnosno 5 puta većima od izloženosti u ljudi.
English: Clinically significant medicinal product interactions with Epclusa mediated by P-gp, BCRP, OATP, or CYP450 inhibitors are not expected; Epclusa may be co-administered with P-gp, BCRP, OATP and CYP inhibitors.
Croatian: Ne očekuju se klinički značajne interakcije lijeka s lijekom Epclusa posredovane inhibitorima P-gp-a, BCRP-a, OATP-a ili CYP450; lijek Epclusa može se istodobno primjenjivati s inhibitorima P-gp-a, BCRP-a, OATP-a i CYP-a.
English: Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Croatian: Sofosbuvir i GS-331007 nisu supstrati ili inhibitori enzima UGT1A1 ili CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP2D6.
English: • Do not take any other medicine that contains sofosbuvir, one of the active substances in
Croatian: • Nemojte uzimati nijedan drugi lijek koji sadrži sofosbuvir, što je jedna od djelatnih tvari u lijeku Epclusa.
English: c One patient had on-treatment virologic failure.
Croatian: c. Jedan bolesnik imao je virološki neuspjeh tijekom liječenja.
English: Replicons containing NS5B from clinical isolates
Croatian: Replikoni koji sadrže NS5B iz kliničkih izolata
English: Relative to fasting conditions, the administration of a single dose of Epclusa with a moderate fat (~600 kcal, 30% fat) or high fat (~800 kcal, 50% fat) meal resulted in a 34% and 21% increase in velpatasvir AUC0-inf, respectively, and a 31% and 5% increase in velpatasvir Cmax, respectively.
Croatian: U odnosu na uvjete natašte primjena jedne doze lijeka Epclusa s obrokom s umjerenim udjelom masti (~600 kcal, 30 % masti) ili obrokom s visokim udjelom masti (~800 kcal, 50 % masti) rezultiralo je povećanjem AUC0-inf velpatasvira od 34 % odnosno 21 % i povećanjem Cmax velpatasvira od 31 % odnosno 5 %.
English: Patients receiving tenofovir disoproxil fumarate and Epclusa concomitantly should be monitored for adverse reactions associated with tenofovir disoproxil fumarate.
Croatian: Bolesnike koji istodobno primaju tenofovirdizoproksilfumarat i lijek Epclusa treba pratiti radi štetnih reakcija povezanih s tenofovirdizoproksilfumaratom.
English: Randomisation was stratified by HCV genotype (1, 2, 4, 6, and indeterminate) and the presence or absence of cirrhosis.
Croatian: Randomizacija je stratificirana prema genotipu HCV-a (1, 2, 4, 6 i neutvrđen) i prisutnosti ili odsutnosti ciroze.
English: In clinical studies, headache, fatigue and nausea were the most common (incidence ≥ 10%) treatment emergent adverse events reported in patients treated with 12 weeks of Epclusa.
Croatian: U kliničkim su ispitivanjima glavobolja, umor i mučnina bile najčešći (incidencija ≥ 10 %) štetni događaji nastali tijekom liječenja u bolesnika liječenih lijekom Epclusa tijekom 12 tjedana.
English: Afterwards, close monitoring and potential dose adjustment of ciclosporin may be required.
Croatian: Kasnije može biti potrebno pažljivo praćenje i prilagodba doze ciklosporina.
English: Caution is warranted and therapeutic concentration monitoring of digoxin is recommended when co-administered with Epclusa.
Croatian: Potreban je oprez i preporučuje se praćenje terapijskih koncentracija digoksina kad se primjenjuje istodobno s lijekom Epclusa.
English: Steady-state Cmax for sofosbuvir, GS-331007 and velpatasvir were 566, 868 and 259 ng/mL, respectively.
Croatian: Cmax u stanju dinamičke ravnoteže za sofosbuvir, GS-331007 i velpatasvir iznosio je 566, 868 odnosno 259 ng/ml.
English: Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study.
Croatian: Nije bilo štetnih učinaka sofosbuvira na ponašanje, reprodukciju ili razvoj potomstva u ispitivanjima prenatalnog i postnatalnog razvoja u štakora.
English: Patients who have previously failed therapy with an NS5A-containing regimen There are no clinical data to support the efficacy of sofosbuvir/velpatasvir for the treatment of patients who have failed treatment with a regimen containing another NS5A inhibitor.
Croatian: Bolesnici u kojih je prethodna terapija režimom koji sadrži inhibtor NS5A bila neuspješna Nema kliničkih podataka koji bi poduprli djelotvornost sofosbuvira/velpatasvira za liječenje bolesnika u kojih je liječenje režimom koji sadrži drugi inhibitor NS5A bilo neuspješno.
English: Note: Baseline frequency of ascites was: 20% none, 77% mild/moderate, 3% severe Baseline frequency of encephalopathy was: 38% none, 62% grade 1-2.
Croatian: Napomena: početna učestalost ascitesa bila je: 20 % bez, 77 % blaga/umjerena, 3 % teška početna učestalost encefalopatije bila je 38 % bez, 62 % stadij 1-2.
English: SVR12 was achieved in all 77 patients who had baseline NS5B NI RAVs including N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I, and S282G+V321I.
Croatian: SVR12 je postignut u svih 77 bolesnika koji su na početku imali varijante NS5B povezane s rezistencijom na nukleozidne inhibitore uključujući N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I i S282G+V321I.
English: Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p = 0.018) over treatment with SOF+RBV for 12 weeks (treatment difference +5.2%; 95% confidence interval: +0.2% to +10.3%).
Croatian: Liječenje lijekom Epclusa tijekom 12 tjedana pokazalo je statističku superiornost (p = 0,018) nad liječenjem sa SOF + RBV tijekom 12 tjedana (razlika u liječenju +5,2 %; 95 % interval pouzdanosti: +0,2 % do +10,3 %
English: • shortness of breath;
Croatian: • nedostatak zraka
English: Site-directed mutagenesis of known NS5A 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.
Croatian: Ciljane mutageneze poznatih RAV-ova NS5A pokazale su da su supstitucije koje su dovele do smanjene osjetljivosti velpatasvitra za > 100 puta bile M28G, A92K i Y93H/N/R/W u genotipu 1a, A92K u genotipu 1b, C92T i Y93H/N u genotipu 2b, Y93H u genotipu 3 te L31V iP32A/L/Q/R u genotipu
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Croatian: Sofosbuvir je pan-genotipski inhibitor HCV NS5B RNK-ovisne RNK polimeraze, koja je neophodna za replikaciju virusa.
English: Medicinal products that increase gastric pH are expected to decrease the concentration of velpatasvir.
Croatian: Očekuje se da će lijekovi koji povećavaju želučani pH smanjiti koncentraciju velpatasvira.
English: • If it's 18 hours or more after the time you usually take Epclusa, wait and take the next dose at your usual time.
Croatian: • Ako je prošlo 18 sati ili više od vremena kad obično uzimate lijek Epclusa, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: Omeprazole dosed 4 hours after Epclusad
Croatian: Omeprazol primijenjen 4 sata nakon lijeka Epclusad
English: At clinically relevant plasma concentration, velpatasvir is not an inhibitor of hepatic transporters bile salt export pump (BSEP), sodium taurocholate cotransporter protein (NTCP), OATP2B1, OATP1A2 or organic cation transporter (OCT) 1, renal transporters OCT2, OAT1, OAT3, multidrug resistance-associated protein 2 (MRP2) or multidrug and toxin extrusion protein (MATE) 1, or CYP or uridine glucuronosyltransferase (UGT) 1A1 enzymes.
Croatian: Pri klinički relevantnoj koncentraciji u plazmi, velpatasvir nije inhibitor jetrenih prijenosnika pumpe za izbacivanje žučnih soli (engl. bile salt export pump, BSEP), natrij taurokolat kontransportnog proteina (engl. sodium taurocholate cotransporter protein, NTCP), OATP2B1, OATP1A2 ili prijenosnika organskih kationa (engl. organic cation transporter, OCT) 1, bubrežnih prijenosnika OCT2, OAT1, OAT3, proteina povezanog s rezistencijom na više lijekova 2 (engl. multidrug resistance-associated protein, MRP2) ili proteina ekstruzije više lijekova i toksina (engl. multidrug and toxin extrusion protein, MATE) 1 ili enzima CYP ili uridin glukuronosiltransferaze (UGT) 1A1.
English: Ribavirin was discontinued in 15% of patients treated with Epclusa + RBV for 12 weeks due to adverse events.
Croatian: Liječenje ribavirinom prekinuto je u 15 % bolesnika koji su liječeni lijekom Epclusa + RBV tijekom 12 tjedana zbog štetnih događaja.
English: One additional patient with genotype 3 HCV infection at baseline was reinfected with genotype 1a HCV at virologic failure and was excluded from the virological analysis.
Croatian: Jedan dodatni bolesnik s infekcijom HCV-om genotipa 3 na početku ispitivanja je ponovno zaražen HCV-om genotipa 1a pri virološkom neuspjehu te je isključen iz virološke analize.
English: Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Croatian: Velpatasvir je inhibitor HCV-a usmjeren na NS5A protein HCV-a, koji je neophodan kako za replikaciju RNK, tako i za sklapanje viriona HCV-a.
English: Of the 10 genotype 3 virologic failure patients, Y93H was observed in all 10 patients at failure (6 had Y93H emerge post-treatment and 4 patients had Y93H at baseline and post-treatment).
Croatian: Od 10 bolesnika s genotipom 3 kod kojih je došlo do virološkog neuspjeha, Y93H opažen je u svih 10 bolesnika pri neuspjehu (šest je imalo pojavu Y93H nakon liječenja, a četiri bolesnika je imalo Y93H na početku liječenja i poslije liječenja).
English: If it is considered necessary to co-administer, then Epclusa should be administered with food and taken 4 hours before proton pump inhibitor at max doses comparable to omeprazole 20 mg.
Croatian: Ako se smatra da je istodobna primjena nužna, lijek Epclusa treba primijeniti s hranom i uzeti 4 sata prije inhibitora protonske pumpe pri maksimalnim dozama usporedivim s dozom omeprazola od 20 mg.
English: Table 4: Activity of sofosbuvir and velpatasvir against full-length or chimeric laboratory replicons
Croatian: Tablica 4: Djelovanje sofosbuvira i velpatasvira protiv replikona pune duljine ili kimeričkih laboratorijskih replikona Genotip replikona
English: Otherb a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Croatian: Nazivnik za relaps je broj pacijenata s HCV RNK < LLOQ na njihovom posljednjem pregledu za vrijeme trajanja liječenja.
English: Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p < 0.001) compared to treatment with SOF+RBV for 24 weeks (treatment difference +14.8%; 95% confidence interval: +9.6% to +20.0%).
Croatian: Liječenje lijekom Epclusa tijekom 12 tjedana pokazalo je statističku superiornost (p < 0,001) u usporedbi s liječenjem sa SOF + RBV tijekom 24 tjedna (razlika u liječenju +14,8 %; 95 % interval pouzdanosti: +9,6 % do +20,0 %).
English: However, on the basis of NS5A resistance associated variants (RAVs) typically seen in patients who have failed therapy with other NS5A inhibitor containing regimens, the in vitro pharmacology of velpatasvir, and the outcomes of sofosbuvir/velpatasvir treatment in NS5A-naïve patients with baseline NS5A RAVs enrolled into the ASTRAL-studies, treatment with Epclusa + RBV for 24 weeks can be considered for patients who have failed therapy on an NS5A-containing regimen and who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Croatian: Međutim, na temelju varijanti NS5A povezanih s rezistencijom koje se obično primjećuju u bolesnika u kojih je terapija drugim režimom koji sadrži inhibitor NS5A bila neuspješna, in vitro farmakologije velpatasvira i ishoda liječenja sofosbuvirom/velpatasvirom u bolesnika koji nisu bili liječeni s inhibitorom NS5A s početnim varijantama NS5A povezanima s rezistencijom uključenih u ispitivanja ASTRAL, liječenje lijekom Epclusa + RBV tijekom 24 tjedna može se razmatrati za bolesnike u kojih je terapija režimom koji sadrži inhibitor NS5A bila neuspješna i za koje se smatra da su izloženi velikom riziku od kliničke progresije bolesti te koji nemaju alternativnih opcija liječenja.
English: Ribavirin dose adjustments were performed according to the ribavirin prescribing information.
Croatian: Prilagodbe doze ribavirina provedene su sukladno informacijama o propisivanju ribavirina.