FrancophonIA/ELRC3.0 huggingface dataset:
English: Women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded as recommended in the Summary of Product Characteristics for ribavirin.
Croatian: Žene reproduktivne dobi ili njihovi partneri moraju koristiti učinkoviti oblik kontracepcije tijekom liječenja i u razdoblju nakon završetka liječenja kako je preporučeno u Sažetku opisa svojstava lijeka za ribavirin.
English: The use of Harvoni in children and adolescents has not yet been studied.
Croatian: Primjena lijeka Harvoni u djece i adolescenata nije još ispitana.
English: • statins used to treat high cholesterol.
Croatian: • statine koji se primjenjuju za liječenje visokog kolesterola.
English: Each bottle contains a silica gel desiccant (drying agent) that must be kept in the bottle to help protect your tablets.
Croatian: Jedna boca sadrži silika-gel kao sredstvo za sušenje koje se mora držati u boci kao pomoć u zaštiti tableta.
English: HCV/HBV (hepatitis B virus) co-infection
Croatian: Istovremena infekcija HCV/HBV (virusom hepatitisa B)
English: b. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Croatian: Ostalo uključuje pacijente koji nisu postigli SVR i nisu zadovoljili kriterije virološkog neuspjeha (npr. izgubljeni iz praćenja).
English: The safety and efficacy of Harvoni in children and adolescents aged less than 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Harvoni djece i adolescenata u dobi manjoj od 18 godina nisu još ustanovljene.
English: Table 13 presents relapse rates with the 12-week regimens (with or without ribavirin) for selected subgroups (see also previous section “Effect of baseline HCV resistance-associated variants on treatment outcome”).
Croatian: Tablica 13 prikazuje stope relapsa kod 12-tjednih režima (s ribavirinom ili bez njega) za odabrane podskupine (vidjeti također prethodni dio „Utjecaj početnih varijanti HCV-a povezanih s rezistencijom na ishod liječenja“).
English: NARCOTIC ANALGESICS Methadone
Croatian: OPIOIDNI ANALGETICI Metadon
English: Patients should be instructed that if vomiting occurs within 5 hours of dosing an additional tablet should be taken.
Croatian: Pacijente treba uputiti da uzmu dodatnu tabletu ako povraćanje nastupi u roku od 5 sati nakon primjene.
English: (Inhibition of drug transporters OATP and BCRP)
Croatian: (Inhibicija prijenosnika lijekova OATP i BCRP)
English: 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.
Croatian: Rezultati FibroTesta koji nisu nedostajali bili su mapirani na Metavir-rezultate prema sljedećem: 0-0,31 = F0-F1; 0,32-0,58 = F2; 0,59-1,00 = F3-F4.
English: 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).
Croatian: Iako su se štetni događaji, uključujući ozbiljne štetne događaje, češće javljali u ovom ispitivanju nego u ispitivanjima iz kojih su bili isključeni dekompenzirani pacijenti i/ili pacijenti poslije transplantacije jetre, opaženi štetni događaji bili su očekivani kao kliničke posljedice uznapredovale bolesti jetre i/ili transplantacije ili su bile u skladu s poznatim sigurnosnim profilom ribavirina (vidjeti dio 5.1 za detalje ovog ispitivanja).
English: Further data include a double-blind comparison of the safety of ledipasvir/sofosbuvir (12 weeks) and placebo in 155 cirrhotic patients (see section 5.1).
Croatian: Dodatni podaci uključuju dvostruko slijepu usporedbu sigurnosti ledipasvira/sofosbuvira (12 tjedana) i placeba u 155 pacijenata s cirozom (vidjeti dio 5.1).
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Croatian: Silika-gel kao sredstvo za sušenje nalazi se u posebnoj vrećici ili spremniku i ne smije se progutati.
English: No dose adjustment of Harvoni is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2).
Croatian: Nije potrebna prilagodba doze lijeka Harvoni u pacijenata s blagim, umjerenim ili teškim oštećenjem jetre (Child-Pugh-Turcotte [CPT] stadij A, B ili C) (vidjeti dio 5.2).
English: a. HCV RNA values were determined using the Roche TaqMan Assay; a patient's HCV RNA may vary from visit to visit.
Croatian: Vrijednosti HCV RNK bile su utvrđene pomoću testa Roche TaqMan; HCV RNK pacijenta može se razlikovati od posjeta do posjeta.
English: In patients with decompensated cirrhosis, ribavirin should be administered at a starting dose of 600 mg given in a divided daily dose.
Croatian: U pacijenata s dekompenziranom cirozom, ribavirin treba primijeniti u početnoj dozi od 600 mg koja se daje u raspodijeljenoj dnevnoj dozi.
English: 3 years.
Croatian: 12 tjedana.
English: (≥ 1/10,000 to < 1/1,000) or very rare (< 1/10,000).
Croatian: manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) ili vrlo rijetko (< 1/10 000).
English: No clinically relevant differences in ledipasvir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment.
Croatian: Nisu bile opažene klinički važne razlike u farmakokinetici ledipasvira između zdravih ispitanika i pacijenata s teškim oštećenjem bubrega.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ledipasvir/sofosbuvir in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja ledipasvira/sofosbuvira u jednoj ili više podskupina pedijatrijske populacije u liječenju kroničnog hepatitisa C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Dose modification of ribavirin in patients taking 1,000-1,200 mg daily If Harvoni is used in combination with ribavirin and a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Croatian: Prilagodba doze ribavirina u pacijenata koji uzimaju 1000-1200 mg na dan Ako se Harvoni primjenjuje u kombinaciji s ribavirinom, a pacijent ima ozbiljnu nuspojavu potencijalno povezanu s ribavirinom, dozu ribavirina potrebno je prilagoditi ili prekinuti njegovu primjenu, ako je to primjereno, sve dok se nuspojava ne povuče ili se ne smanji težina nuspojave.
English: • Tell your doctor if you are lactose intolerant or intolerant to other sugars.
Croatian: • Obavijestite svog liječnika ako ne podnosite laktozu ili druge šećere.
English: 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).
Croatian: Ako se početna doza dobro podnosi, tu se dozu može titrirati do najviše 1000-1200 mg na dan (1000 mg za pacijente tjelesne težine < 75 kg i 1200 mg za pacijente tjelesne težine ≥ 75 kg).
English: Haemoglobin in patients with no cardiac disease
Croatian: Hemoglobin u pacijenata bez srčane bolesti
English: If it is after 18 hours then patients should be instructed to wait and take the next dose at the usual time.
Croatian: Ako je proteklo više od 18 sati, onda pacijentima treba savjetovati da pričekaju i uzmu sljedeću dozu u uobičajeno vrijeme.
English: Table 5: Activity of ledipasvir and sofosbuvir against chimeric replicons Genotype replicons
Croatian: Tablica 5: Djelovanje ledipasvira i sofosbuvira protiv kimeričkih replikona
English: F3-F4
Croatian: F0-F1 F2 F3-F4
English: Ledipasvir was not carcinogenic in the 6-month rasH2 transgenic mouse study at exposures up to 26-fold higher than human exposure.
Croatian: Ledipasvir nije bio kancerogen u 6-mjesečnom ispitivanju na rasH2 transgeničnim miševima pri izloženostima do 26 puta većim od izloženosti ljudi.
English: In clinical studies - Genotype 2, 3, 4, 5 and 6
Croatian: U kliničkim ispitivanjima - genotip 2, 3, 4, 5 i 6
English: C]-radioactivity ranged between 0.51 and 0.66.
Croatian: C]-radioaktivnosti u krvi u odnosu na plazmu kretao se u rasponu između 0,51 i 0,66.
English: Post-baseline NS5A and NS5B deep sequencing data (assay cut off of 1%) were available for 37/37 and 36/37 patients, respectively.
Croatian: Podaci detaljnog sekvenciranja za NS5A i NS5B (granična vrijednost testa od 1 %) nakon početka ispitivanja bili su dostupni za 37/37 odnosno 36/37 pacijenata.
English: Harvoni tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
Croatian: Harvoni tablete isporučuju se u bocama od polietilena visoke gustoće (HDPE), s polipropilenskim sigurnosnim zatvaračem za djecu, koje sadrže 28 filmom obloženih tableta sa sredstvom za sušenje od silika-gela i poliesterskom vaticom.
English: Table 3: Interactions between Harvoni and other medicinal products Medicinal product by therapeutic areas
Croatian: Tablica 3: Interakcije između lijeka Harvoni i drugih lijekova
English: NS5A RAVs: No genotype 2 infected patients experienced relapse in the clinical study and therefore there are no data regarding NS5A RAVs at the time of failure.
Croatian: NS5A RAV-ovi: Niti jedan pacijent zaražen genotipom 2 nije imao relaps u kliničkom ispitivanju te stoga nema podataka o NS5A RAV-ovima u vrijeme virološkog neuspjeha.
English: a. TE: number of treatment-experienced patients.
Croatian: TE: broj pacijenata koji su prethodno bili liječeni.
English: Pharmacokinetics in special populations
Croatian: Farmakokinetika u posebnim populacijama Rasa i spol
English: c/ sofosbuvir (400 mg single dose)c, d Famotidine dosed simultaneously with Harvonid
Croatian: c/ sofosbuvir (jedna doza od 400 mg)c, d Famotidin primijenjen istovremeno s lijekom Harvonid
English: Harvoni + ribavirin for 12 weeks or
Croatian: Harvoni s ribavirinom tijekom 12 tjedana ili
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/958/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/958/001
English: In cirrhotic patients relapses occurred with both regimens, and in the absence and presence of baseline NS5A RAVs.
Croatian: Pacijenti s cirozom imali su relaps uz oba režima te i u prisutnosti i odsutnosti početnih NS5A RAV.
English: The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT class B and C).
Croatian: Farmakokinetika sofosbuvira bila je ispitana nakon 7 dana doziranja 400 mg sofosbuvira u pacijenata zaraženih HCV-om s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
English: Use with potent P-gp inducers
Croatian: Primjena s jakim induktorima P-gp-a
English: If you take Harvoni you may get one or more of the side effects below:
Croatian: Ako uzimate Harvoni, možete dobiti jednu ili više sljedećih nuspojava: Vrlo česte nuspojave
English: In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1.
Croatian: In vitro, ledipasvir inhibira crijevne CYP3A4 i UGT1A2.
English: At the time of the interim analysis 40 patients have reached 12 weeks post treatment and SVR12 was 98% (39/40).
Croatian: U vrijeme interim analize, u 40 pacijenata proteklo je 12 tjedana od liječenja, a SVR12 je bio 98 %
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare
Croatian: Učestalost se definira kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10),
English: 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.
Croatian: U pacijenata sa završnim stadijem bolesti bubrega, u odnosu na pacijente s normalnom funkcijom bubrega, AUC0-inf sofosbuvira bila je 28 % viša kad se doza sofosbuvira dala 1 sat prije hemodijalize u usporedbi sa 60 % višim vrijednostima kad se doza sofosbuvira dala 1 sat nakon hemodijalize.
English: 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.
Croatian: Ako ne podnosite laktozu ili su Vam rekli da ne podnosite druge šećere, obratite se svom liječniku prije uzimanja ovog lijeka.
English: • simeprevir (a medicine used to treat hepatitis C infection);
Croatian: • simeprevir (lijek koji se primjenjuje za liječenje infekcije virusom hepatitisa C);
English: SVR rates for selected subgroups Genotype Genotype 1a Genotype 1b Cirrhosis No c c
Croatian: Stope SVR-a u odabranim podskupinama Genotip Genotip 1a Genotip 1b Ciroza Ne c c
English: Patients were randomised in a 1:1:1 ratio to one of the three treatment groups and stratified by HCV genotype (1a versus 1b).
Croatian: Pacijenti su bili randomizirani u omjeru 1:1:1 u jednu od tri terapijske skupine i stratificirani prema genotipu HCV-a (1a naspram 1b).
English: Patients with genotype 3 CHC Patients with compensated cirrhosis and/or prior treatment failure
Croatian: Pacijenti s CHC-om uzrokovanim genotipom 3 Pacijenti s kompenziranom cirozom i/ili prethodno neuspješnim lječenjem
English: In the pooled analysis of the Phase 3 studies, 16% of patients had baseline NS5A RAVs identified by population or deep sequencing irrespective of subtype.
Croatian: U analizi objedinjenih podataka iz ispitivanja faze 3, 16 % pacijenata imalo je početne NS5A RAV utvrđene populacijskim ili detaljnim sekvencioniranjem bez obzira na podtip.
English: Haemoglobin in patients with history of stable cardiac disease
Croatian: Hemoglobin u pacijenata sa stabilnom srčanom bolesti u anamnezi
English: HMG-CoA REDUCTASE INHIBITORS Rosuvastating
Croatian: INHIBITORI HMG-CoA REDUKTAZE Rosuvastating
English: The pharmacokinetics of ledipasvir, sofosbuvir and GS-331007 in paediatric patients have not been established (see section 4.2).
Croatian: Farmakokinetika ledipasvira, sofosbuvira i GS-331007 u pedijatrijskih pacijenata nije ustanovljena (vidjeti dio 4.2).
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Croatian: U odnosu na pacijente s normalnom jetrenom funkcijom, AUC0-24 sofosbuvira bila je 126 % odnosno 143 % viša kod umjerenog i teškog oštećenja funkcije jetre, dok je AUC0-24 GS-331007 bila 18 % odnosno 9 % viša.
English: 264b a. Transient replicons carrying NS5A or NS5B from patient isolates.
Croatian: Prolazni replikoni koji nose NS5A ili NS5B iz izolata pacijenata.
English: Table 16: Response rates (SVR12) with ledipasvir/sofosbuvir for 12 weeks in patients with genotype 2, 4, 5 and 6 HCV infection
Croatian: Tablica 16: Stope odgovora (SVR12) na ledipasvir/sofosbuvir tijekom 12 tjedana u pacijenata s infekcijom genotipom 2, 4, 5 i 6 HCV-a
English: NS5B transient replicons Median (range)
Croatian: NS5B prolazni replikoni Medijan (raspon)
English: Safety and efficacy of ledipasvir/sofosbuvir have been established in patients with decompensated cirrhosis (see section 5.1).
Croatian: Sigurnost i djelotvornost ledipasvira/sofosbuvira ustanovljene su u pacijenata s dekompenziranom cirozom (vidjeti dio 5.1).
English: The final study report shall be submitted by:
Croatian: Završno izvješće o ispitivanju treba dostaviti u drugom tromjesječju:
English: In vitro data indicate that ledipasvir may be a weak inducer of metabolising enzymes such as CYP3A4, CYP2C and UGT1A1.
Croatian: Podaci in vitro pokazuju da ledipasvir može biti slabi induktor metaboličkih enzima kao što su CYP3A4, CYP2C i UGT1A1.
English: However, patients should be advised that fatigue was more common in patients treated with ledipasvir/sofosbuvir compared to placebo.
Croatian: Međutim, pacijente treba upozoriti da je umor bio češći u pacijenata liječenih ledipasvirom/sofosbuvirom nego placebom.
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Croatian: Srčane aritmije Slučajevi teške bradikardije i srčanog bloka uočeni su kada se Harvoni korišten istovremeno s amiodaronom i/ili drugim lijekovima koji snižavaju srčanu frekvenciju (vidjeti dijelove 4.4 i 4.5).
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Croatian: AUC0-24 i Cmax sofosbuvira i GS-331007 bile su slične u zdravih odraslih ispitanika i pacijenata s HCV-infekcijom.
English: If ribavirin is co-administered with Harvoni, the contraindications regarding use of ribavirin during pregnancy and breast-feeding apply (see also the Summary of Product Characteristics for ribavirin).
Croatian: Ako se ribavirin primjenjuje istovremeno s lijekom Harvoni, vrijede kontraindikacije za primjenu ribavirina tijekom trudnoće i dojenja (vidjeti također Sažetak opisa svojstava lijeka za ribavirin).
English: d. Metavir score = 4 or Ishak score ≥ 5 by liver biopsy, or FibroTest score of > 0.75 and (APRI) of > 2.
Croatian: Metavir-rezultat = 4 ili rezultat po Ishaku ≥ 5 na biopsiji jetre ili rezultat FibroTesta > 0,75 i (APRI) > 2.
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.
Croatian: U pacijenata bez dekompenzirane ciroze čijem je terapijskom režimu potrebno dodati ribavirin (vidjeti tablicu 1) dnevna doza ribavirina temelji se na tjelesnoj težini (< 75 kg = 1000 mg i ≥ 75 kg = 1200 mg) i primjenjuje se peroralno, raspodijeljeno u dvije doze, s hranom.
English: f. One patient who achieved a viral load < LLOQ at end of treatment had missing baseline NS5A data and was excluded from the analysis.
Croatian: Za jednog pacijenta u kojeg je virusno opterećenje postiglo < LLOQ na kraju liječenja nedostajali su početni podaci za NS5A i on je bio isključen iz analize.
English: Relative to healthy subjects (n = 191), ledipasvir AUC0-24 and Cmax were 24% lower and 32% lower, respectively, in HCV-infected patients.
Croatian: U odnosu na one u zdravih ispitanika (n = 191), AUC0-24 i Cmax ledipasvira u pacijenata zaraženih HCV-om iznosile su 24 % manje odnosno 32 % manje.
English: • If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine
Croatian: • Ako ste alergični na ledipasvir, sofosbuvir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6 ove upute).
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.
Croatian: Trenutno nema podataka koji podupiru učinkovitost ponovnog liječenja pacijenata u kojih su ledipasvir/sofosbuvir bili neuspješni pomoću režima koji sadrži inhibitor NS5A.
English: Patients were stratified by HCV genotype (1a versus 1b) and prior treatment response (whether HCV RNA < LLOQ had been achieved).
Croatian: Pacijenti su bili stratificirani prema genotipu HCV-a (1a naspram 1b) i prethodnom terapijskom odgovoru (je li bio postignut HCV RNK < LLOQ).
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone with or without other drugs that lower heart rate.
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada se Harvoni koristi istovremeno s amiodaronom i drugim lijekovima koji snižavaju srčanu frekvenciju ili bez njih.
English: For genotype 2, 4, 5 and 6 infection, therapy consisted of ledipasvir/sofosbuvir without ribavirin, given for 12 weeks (Table 16).
Croatian: Za infekciju genotipom 2, 4, 5 i 6, terapija se sastojala od ledipasvira/sofosbuvira bez ribavirina, koja se davala 12 tjedana (tablica 16).
English: Harvoni contains lactose monohydrate.
Croatian: Harvoni sadrži laktozu hidrat.
English: 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.
Croatian: a, Šest pacijenata (1 u terapijskoj skupini liječenoj 12 tjedana, 5 u terapijskoj skupini liječenoj 24 tjedna) s HCV RNK < LLOQ na zadnjem mjerenju prije transplantacije u kojih je transplantacija bila provedena prije SVR12 bilo je isključeno iz analize SVR12 i analize relapsa.
English: Warnings and precautions Your doctor will know if any of the following conditions apply to you.
Croatian: Vaš će liječnik znati imate li neko od sljedećih stanja.
English: • Do not take any of these medicines with Harvoni:
Croatian: • Nemojte uzimati nijedan od sljedećih lijekova s lijekom Harvoni:
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.
Croatian: AUC0-inf GS-331007 u pacijenata sa završnim stadijem bolesti bubrega kod kojih je primijenjen sofosbuvir 1 sat prije odnosno 1 sat nakon hemodijalize bila je najmanje 10 puta odnosno 20 puta viša.
English: Table 2: Ribavirin dose modification guideline for co-administration with Harvoni Laboratory values
Croatian: Tablica 2: Smjernica za prilagodbu doze ribavirina kod istovremene primjene s lijekom Harvoni Laboratorijske vrijednosti
English: Following oral administration of ledipasvir/sofosbuvir to HCV-infected patients, ledipasvir median peak plasma concentration was observed at 4.0 hours post-dose.
Croatian: Nakon peroralne primjene ledipasvira/sofosbuvira u pacijenata zaraženih HCV-om, medijan vršnih koncentracija ledipasvira u plazmi bio je opažen 4,0 sata nakon uzimanja doze.
English: However, the NS5B S282T substitution in combination with NS5A substitutions L31M, Y93H and Q30L were detected in one patient at failure following 8 weeks of treatment with ledipasvir/sofosbuvir from a Phase 2 study (LONESTAR).
Croatian: Međutim, bila je otkrivena supstitucija NS5B S282T u kombinaciji s NS5A supstitucijama L31M, Y93H i Q30L u jednog pacijenta u vrijeme virološkog neuspjeha nakon 8 tjedana liječenja ledipasvirom/sofosbuvirom u jednom ispitivanju faze 2
English: Gender Male Female IL28 genotype CC Non-CC Baseline HCV RNAa
Croatian: Spol muški ženski IL28 genotip CC ne-CC
English: The median age was 56 years (range: 23 to 77); 74% of patients were male; 97% were white; 63% had genotype 1a HCV infection; 94% had non-CC IL28B alleles (CT or TT).
Croatian: 56 godina (raspon: od 23 do 77); 74 % pacijenata bili su muškarci; 97 % bili su bijelci; 63 % imalo je infekciju HCV-om genotipa 1a; 94 % imalo je ne-CC IL28B alele (CT ili TT).
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.
Croatian: 154 pacijenta, njih ukupno 149 iz obje terapijske skupine postiglo je SVR12; 96 % (74/77) pacijenata u skupini liječenoj ledipasvirom/sofosbuvirom s ribavirinom tijekom 12 tjedana i 97 % (75/77) pacijenata u skupini liječenoj ledipasvirom/sofosbuvirom tijekom 24 tjedna.
English: b. 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 terapije.
English: Cirrhosis d
Croatian: Ciroza d