FrancophonIA/ELRC3.0 huggingface dataset:
English: Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected patients.
Slovenian: V primerjavi z zdravimi osebami (n = 284) je bila pri bolnikih, okuženih s HCV, vrednost AUC0-24 za sofosbuvir za 57 % višja in vrednost AUC0-24 za GS-331007 za 39 % nižja.
English: Genotype 1 treatment-naïve SOF+RBV 24 weeks (n = 114)
Slovenian: Genotip 1 predhodno nezdravljeni SOF+RBV 24 tednov (n = 114)
English: * The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food.
Slovenian: 1.200 mg/dan * Odmerek ribavirina na dan temelji na telesni masi in se daje peroralno s hrano, razdeljen na dva odmerka.
English: Safety data are limited in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Slovenian: Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) in
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, relative to patients with normal renal function (eGFR >80 mL/min/1.73 m2).
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
English: Table 18 presents the subgroup analysis by genotype for cirrhosis.
Slovenian: V preglednici 18 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo.
English: Otherc a. The efficacy analysis includes 6 patients with recombinant genotype 2/1 HCV infection.
Slovenian: Drugoc a. Analiza učinkovitosti vključuje 6 bolnikov z okužbo s HCV z rekombinantnim genotipom 2/1.
English: Table 16: SVR12 rates for selected subgroups by genotype in study VALENCE
Slovenian: Preglednica 16: Stopnje SVR12 za izbrane podskupine po genotipu v študiji VALENCE Genotip 2
English: Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms
Slovenian: zelo pogosti artralgija, mialgija pogosti artralgija, bolečine v hrbtu, mišični spazmi, mialgija bolečine v hrbtu, mišični spazmi
English: The efficacy of sofosbuvir in HCV-infected patients aged 12 to <18 years was evaluated in a Phase 2, open label clinical trial that enrolled 50 patients with genotype 2 (n = 13) or genotype 3 (n = 37) chronic HCV infection.
Slovenian: Učinkovitost sofosbuvirja pri bolnikih, okuženih s HCV, starih 12 do < 18 let, so ocenili v odprtem kliničnem preskušanju 2. faze, v katero je bilo vključenih 50 bolnikov s kronično okužbo s HCV
English: Co-administration of such medicinal products is not recommended with Sovaldi (see section 4.5).
Slovenian: Sočasna uporaba teh zdravil z zdravilom Sovaldi ni priporočljiva (glejte poglavje 4.5).
English: Very common haemoglobin decreased anaemia, neutropenia, lymphocyte count decreased, platelet count decreased
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti znižana raven hemoglobina anemija, nevtropenija, znižano število limfocitov, znižano število trombocitov pogosti anemija
English: Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection
Slovenian: Zdravljenje brez interferona za okužbo s HCV genotipa 1, 4, 5 in 6
English: Table 14: SVR12 rates for selected subgroups by genotype in study FUSION
Slovenian: Preglednica 14: Stopnje SVR12 za izbrane podskupine po genotipu v študiji FUSION Genotip 2
English: Sofosbuvir in a fixed dose combination with ledipasvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Slovenian: Kombinacijo s fiksnim odmerkom sofosbuvirja in ledipasvirja so v odprti študiji (študija 0154) 12 tednov dajali 18 bolnikom s CHC genotipa 1 in hudo okvaro ledvic.
English: Treatment-experienced (VALENCE)
Slovenian: Predhodno nezdravljeni in predhodno zdravljeni odrasli - VALENCE (študija 133)
English: Treatment-naïve (QUANTUMb and 11-1-0258b) SOF+RBV 24 weeks
Slovenian: Predhodno nezdravljeni (QUANTUMb in 11-1-0258b)
English: 24 weeks (n = 28)
Slovenian: 12 tednov (n = 68)
English: If sofosbuvir is used in combination with peginterferon alfa, and a patient has a serious adverse reaction potentially related to this medicinal product, the peginterferon alfa dose should be reduced or discontinued.
Slovenian: Če se sofosbuvir uporablja v kombinaciji s peginterferonom alfa in ima bolnik resne neželene učinke,
English: HCV/HIV co-infected adult patients - PHOTON-1 (study 123) Sofosbuvir was studied in an open-label clinical study evaluating the safety and efficacy of 12 or 24 weeks of treatment with sofosbuvir and ribavirin in patients with genotype 1, 2 or 3 chronic hepatitis C co-infected with HIV-1.
Slovenian: Klinična učinkovitost in varnost pri posebnih populacijah Odrasli bolniki s sočasno okužbo z virusoma HCV in HIV - PHOTON-1 (študija 123) Sofosbuvir so preučili v odprti klinični študiji, v kateri so ocenjevali varnost in učinkovitost 12- ali 24-tedenskega zdravljenja s sofosbuvirjem in ribavirinom pri bolnikih s kroničnim hepatitisom C
English: Sofosbuvir ↓ Cmax 0.95c (0.68, 1.33) ↑ AUC 1.30c (1.00, 1.69) Cmin (NA)
Slovenian: ↓ Cmax 0,95c (0,68; 1,33) ↑ AUC 1,30c (1,00; 1,69)
English: • shortness of breath when exercising
Slovenian: • zasoplost pri telesni vadbi
English: The dose of ribavirin, when used in combination with Sovaldi is weight-based (<75 kg = 1,000 mg and ≥75 kg = 1,200 mg) and administered orally in two divided doses with food.
Slovenian: (< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
English: Cirrhotic
Slovenian: Ciklosporin
English: Sovaldi is contraindicated with carbamazepine (see section 4.3).
Slovenian: Zdravilo Sovaldi je kontraindicirano v kombinaciji s karbamazepinom (glejte poglavje 4.3).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Sovaldi Vsebina pakiranja in dodatne informacije
English: Sovaldi is contraindicated with rifampicin (see section 4.3).
Slovenian: Zdravilo Sovaldi je kontraindicirano v kombinaciji z rifampicinom (glejte poglavje 4.3).
English: Co-administration with such medicinal products is not recommended with Sovaldi (see section 4.4).
Slovenian: Sočasna uporaba teh zdravil z zdravilom Sovaldi ni priporočljiva (glejte poglavje 4.4).
English: Sovaldi [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Sovaldi [samo zunanja ovojnina]
English: The sofosbuvir-associated resistance substitution S282T was not detected in any of these patients by deep sequencing or population sequencing.
Slovenian: Substitucije S282T, povezane z odpornostjo na sofosbuvir, s karakterizacijo strukture genoma ali karakterizacijo nukleotidnih sledi genoma niso odkrili pri nobenem od teh bolnikov.
English: The safety profile of sofosbuvir and ribavirin in HCV infected adult patients prior to liver transplantation was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Slovenian: Profil varnosti sofosbuvirja in ribavirina pri odraslih bolnikih, okuženih z virusom HCV, pred presaditvijo jeter, je bil podoben tistemu, ki so ga opazili pri bolnikih, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
English: Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection.
Slovenian: Drugoc a. Analiza učinkovitosti vključuje 3 bolnike z okužbo s HCV z rekombinantnim genotipom 2/1.
English: Sovaldi is not recommended for administration as monotherapy and should be prescribed in combination with other medicinal products for the treatment of hepatitis C infection.
Slovenian: Zdravilo Sovaldi je indicirano v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C
English: Treatment-naïve and previously treated adults - VALENCE (study 133) VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve patients or patients who did not achieve SVR with prior interferon-based treatment, including patients with compensated cirrhosis.
Slovenian: VALENCE je bila študija 3. faze, v kateri so ocenili sofosbuvir v kombinaciji z ribavirinom na podlagi telesne mase za zdravljenje okužbe s HCV genotipa 2 ali 3 pri predhodno nezdravljenih bolnikih ali pri bolnikih, ki niso dosegli SVR s predhodnim zdravljenjem na podlagi interferona, vključno z bolniki s kompenzirano cirozo.
English: Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors.
Slovenian: Replikoni HCV z izraženo substitucijo S282T, povezano z odpornostjo na sofosbuvir, so bili v celoti dovzetni za druge razrede učinkovin proti HCV. Sofosbuvir je ohranil aktivnost proti substitucijama NS5B L159F in L320F, povezanima z odpornostjo na druge nukleozidne zaviralce.
English: No dose adjustment of sofosbuvir is recommended for patients with mild, moderate and severe hepatic impairment (see section 4.2).
Slovenian: Pri bolnikih z blago, zmerno in hudo jetrno okvaro prilagajanje odmerka sofosbuvirja ni potrebno (glejte poglavje 4.2).
English: Clinical studies in patients with genotype 2 and 3 chronic hepatitis C Treatment-naïve adults - FISSION (study 1231)
Slovenian: Klinične študije pri bolnikih s kroničnim hepatitisom C genotipa 2 in 3
English: Table 11: Response rates in study POSITRON
Slovenian: Preglednica 11: Stopnje odziva v študiji POSITRON SOF+RBV
English: No dose adjustment of sofosbuvir or emtricitabine is required when sofosbuvir and emtricitabine are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in emtricitabina odmerka sofosbuvirja ali emtricitabina ni treba prilagajati.
English: Sofosbuvir ↓ Cmax 0.97 (0.65, 1.43) ↑ AUC 1.13 (0.81, 1.57) Cmin (NA)
Slovenian: ↓ Cmax 0,97 (0,65; 1,43) ↑ AUC 1,13 (0,81; 1,57) Cmin (n/n)
English: The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Slovenian: Klinični podatki, ki bi podprli uporabo zdravila Sovaldi pri bolnikih z okužbo s HCV genotipa 5 in 6,
English: Clinical studies in patients with genotype 1, 4, 5 and 6 chronic hepatitis C Treatment-naïve adult patients - NEUTRINO (study 110) NEUTRINO was an open-label, single-arm study that evaluated 12 weeks of treatment with sofosbuvir in combination with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 1, 4, 5 or 6 HCV infection.
Slovenian: Odrasli bolniki, ki se predhodno še niso zdravili - NEUTRINO (študija 110) Študija NEUTRINO je bila odprta študija z enim krakom, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem v kombinaciji s peginterferonom alfa 2a in ribavirinom pri zdravljenju bolnikov z okužbo s HCV genotipa 1, 4, 5 ali 6, ki se predhodno še niso zdravili.
English: Metabolism and nutrition disorders: Very common decreased appetite
Slovenian: zelo pogosti zmanjšan apetit pogosti zmanjšanje telesne mase
English: The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant).
Slovenian: Primarni opazovani dogodek študije je bil virološki odziv po presaditvi (pTVR-post-transplant virologic response;
English: Table 23: Outcomes by therapeutic regimen and treatment duration, a comparison across studies in genotype 4, 5 and 6 HCV infection
Slovenian: Preglednica 23: Izidi glede na režim zdravljenja in trajanje zdravljenja, primerjava med študijami pri okužbi s HCV genotipov 4, 5 in 6
English: Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C.
Slovenian: Zdravilo Sovaldi vedno jemljite v kombinaciji z drugimi zdravili proti hepatitisu C. Težave z ledvicami
English: Impact of DAA therapy on drugs metabolized by the liver
Slovenian: Vpliv zdravil z direktnim delovanjem na viruse (DAA - direct-acting antivirals) na zdravila, ki se presnavljajo v jetrih
English: • Decide what other medicines you should take with Sovaldi and for how long;
Slovenian: • odloči, katera druga zdravila morate jemati z zdravilom Sovaldi in kako dolgo • potrdi, da je bilo pri vas zdravljenje učinkovito in da ste brez virusa hepatitisa C
English: Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection
Slovenian: Predhodno zdravljeni bolniki z okužbo s HCV genotipa 1, 4, 5 in 6
English: b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Slovenian: b. Razmisliti je treba o možnem podaljšanju trajanja zdravljenja na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (npr. napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28B, predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom).
English: S-methadone ↔ Cmax 0.95 (0.79, 1.13) ↔ AUC 0.95 (0.77, 1.17) ↔ Cmin 0.95 (0.74, 1.22)
Slovenian: ↔ Cmax 0,95 (0,79; 1,13) ↔ AUC 0,95 (0,77; 1,17) ↔ Cmin 0,95 (0,74; 1,22)
English: Darunavir ↔ Cmax 0.97 (0.94, 1.01) ↔ AUC 0.97 (0.94, 1.00) ↔ Cmin 0.86 (0.78, 0.96)
Slovenian: ↔ Cmax 0,97 (0,94; 1,01) ↔ AUC 0,97 (0,94; 1,00) ↔ Cmin 0,86 (0,78; 0,96)
English: SOF+RBV 24 weeks (n = 250)
Slovenian: SOF+RBV 24 tednov (n = 250)
English: SOF+PEG+RBV 12 weeks
Slovenian: SOF+PEG+RBV 12 tednov
English: The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106).
Slovenian: Povprečje ± SD EC50 za sofosbuvir proti himeričnim replikonom, ki kodirajo zaporedje NS5B iz kliničnih izolatov, je bilo 0,068 ± 0,024 μM za genotip 1a (n = 67),
English: SVR12 to SVR24 concordance
Slovenian: Ujemanje med SVR12 in SVR24
English: PEG+RBV 24 weeks (n = 176)
Slovenian: PEG+RBV 24 tednov (n = 176)
English: No dose adjustment of sofosbuvir or methadone is required when sofosbuvir and methadone are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in metadona odmerka sofosbuvirja ali metadona ni treba prilagajati.
English: The safety profile of sofosbuvir and ribavirin in HCV/HIV co-infected adult patients was similar to that observed in mono-infected HCV patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1).
Slovenian: Profil varnosti sofosbuvirja in ribavirina pri odraslih bolnikih, sočasno okuženih z virusoma HCV in HIV, je bil podoben tistemu, ki so ga opazili pri bolnikih, okuženih samo z virusom HCV, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
English: SOF+RBV 16 weeks
Slovenian: SOF+RBV 16 tednov
English: Dose modification in adults Dose reduction of Sovaldi is not recommended.
Slovenian: Zmanjšanje odmerka zdravila Sovaldi se ne priporoča.
English: GS 331007 ↔ Cmax 1.04 (0.97, 1.11) ↔ AUC 0.99 (0.94, 1.04) Cmin (NA)
Slovenian: GS 331007 ↔ Cmax 1,04 (0,97; 1,11) ↔ AUC 0,99 (0,94; 1,04) Cmin (n/n) (indukcija P-gp)
English: SOF+RBV 24 weeks
Slovenian: SOF+RBV 24 tednov
English: The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 6).
Slovenian: Pri uporabi sofosbuvirja v kombinaciji z ribavirinom ali v kombinaciji s peginterferonom alfa in ribavirinom so ugotovili naslednje neželene učinke zdravila (preglednica 6).
English: Sofosbuvir ↑ Cmax 1.45 (1.10, 1.92) ↑ AUC 1.34 (1.12, 1.59) Cmin (NA)
Slovenian: ↑ AUC 1,34 (1,12; 1,59) Cmin (n/n)
English: Not applicable.
Slovenian: Niso voljni
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 3350 (E1521) Talc (E553b) Yellow iron oxide (E172)
Slovenian: smukec (E553b) rumeni železov oksid (E172)
English: Norgestrel ↔ Cmax 1.18 (0.99, 1.41)
Slovenian: ↔ Cmax 1,18 (0,99; 1,41)
English: Co-administration of Sovaldi with rifapentine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Slovenian: Sovaldi z rifapentinom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
English: Renal impairment No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment.
Slovenian: Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro odmerka zdravila Sovaldi ni treba prilagajati.
English: No dose adjustment of sofosbuvir or rilpivirine is required when sofosbuvir and rilpivirine are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in rilpivirina odmerka sofosbuvirja ali rilpivirina ni treba prilagajati.
English: Consideration should be given to treating these patients, and potentially extending the duration of therapy with sofosbuvir, peginterferon alfa and ribavirin beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon-based therapies (advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype).
Slovenian: Razmisliti je treba o zdravljenju teh bolnikov in morebitnem podaljšanju trajanja zdravljenja s sofosbuvirjem, peginterferonom alfa in ribavirinom na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28b).
English: Ethinyl estradiol ↔ Cmax 1.14 (0.96, 1.36)
Slovenian: ↔ Cmax 1,14 (0,96; 1,36)
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.
Slovenian: Pri uporabi režimov zdravljenja, ki vključujejo sofosbuvir v kombinaciji z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
English: PEG+RBV 24 weeks (n = 243)
Slovenian: PEG+RBV 24 tednov (n = 243)
English: Sofosbuvir is a nucleotide prodrug that is extensively metabolised.
Slovenian: 5.2 Farmakokinetične lastnosti Sofosbuvir je nukleotidno predzdravilo, ki se obsežno presnavlja.
English: GS-331007 ↓ Cmax 0.77 (0.70, 0.84) ↔ AUC 0.84 (0.76, 0.92) Cmin (NA)
Slovenian: ↓ Cmax 0,77 (0,70; 0,84) ↔ AUC 0,84 (0,76; 0,92) Cmin (n/n)
English: SOF+RBV 16 weeks (n = 98)a
Slovenian: SOF+RBV 16 tednov (n = 98)a
English: Co-administration of Sovaldi with modafinil is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of Sovaldi.
Slovenian: Sovaldi z modafinilom zmanjšalo koncentracije sofosbuvirja, kar bo povzročilo zmanjšan terapevtski učinek zdravila Sovaldi.
English: No dose adjustment of sofosbuvir or raltegravir is required when sofosbuvir and raltegravir are used concomitantly.
Slovenian: Pri sočasni uporabi sofosbuvirja in raltegravirja odmerka sofosbuvirja ali raltegravirja ni treba prilagajati.
English: Table 9: Response rates in study FISSION
Slovenian: Preglednica 9: Stopnje odziva v študiji FISSION SOF+RBV
English: The efficacy of sofosbuvir was evaluated in five Phase 3 studies in a total of 1,568 adult patients with genotypes 1 to 6 chronic hepatitis C. One study was conducted in treatment-naïve patients with genotype 1, 4, 5 or 6 chronic hepatitis C in combination with peginterferon alfa 2a and ribavirin and the other four studies were conducted in patients with genotype 2 or 3 chronic hepatitis C in combination with ribavirin including one in treatment-naïve patients, one in interferon intolerant, ineligible or unwilling patients, one in patients previously treated with an interferon-based regimen, and one in all patients irrespective of prior treatment history or ability to receive treatment with interferon.
Slovenian: Druge štiri študije pa so opravili pri bolnikih s kroničnim hepatitisom C genotipa 2 ali 3 v kombinaciji z ribavirinom, in sicer eno študijo z bolniki, ki se predhodno še niso zdravili, eno študijo z bolniki, ki niso prenašali interferona ali za zdravljenje z njim niso bile primerni ali voljni, eno študijo z bolniki, ki so bili predhodno zdravljeni z režimom na podlagi interferona, in eno študijo z vsemi bolniki, ne glede na predhodno anamnezo zdravljenja ali zmožnost zdravljenja z interferonom.
English: Until liver transplantationc
Slovenian: Do presaditve jeterc
English: FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve patients with genotype 2 or 3 HCV infection.
Slovenian: Odrasli, ki se predhodno še niso zdravili - FISSION (študija 1231) Študija FISSION je bila randomizirana, odprta, z aktivno učinkovino kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom v primerjavi s 24-tedenskim zdravljenjem s peginterferonom alfa 2a in ribavirinom za zdravljenje bolnikov, ki se predhodno še niso zdravili, z okužbo s HCV genotipa 2 ali 3.
English: No dose adjustment of Sovaldi is required when concomitantly used with rifabutin.
Slovenian: Pri sočasni uporabi z rifabutinom odmerka zdravila Sovaldi ni treba prilagajati.
English: No dose adjustment of sofosbuvir or ciclosporin is required at initiation of co-administration.
Slovenian: Odmerka sofosbuvirja ali ciklosporina ob uvedbi sočasnega dajanja ni treba prilagajati.
English: Co-administration with other direct-acting antivirals against HCV
Slovenian: Sočasno dajanje z drugimi zdravili proti HCV z direktnim delovanjem na viruse
English: SOF+RBV 12 weeks (n = 183)
Slovenian: SOF+RBV 12 tednov (n = 183)
English: No dose adjustment of sofosbuvir or tacrolimus is required at initiation of co-administration.
Slovenian: Odmerka sofosbuvirja ali takrolimusa ob uvedbi sočasnega dajanja ni treba prilagajati.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf (400 mg twice daily)
Slovenian: Raltegravirf (400 mg dvakrat na dan)
English: a. See Table 4 for weight based ribavirin dosing recommendations b. Consideration should be given to potentially extending the duration of therapy beyond 12 weeks and up to 24 weeks; especially for those subgroups who have one or more factors historically associated with lower response rates to interferon based therapies (e.g. advanced fibrosis/cirrhosis, high baseline viral concentrations, black race, IL28B non CC genotype, prior null response to peginterferon alfa and ribavirin therapy).
Slovenian: a. Glejte preglednico 4 za priporočila o odmerjanju ribavirina na podlagi telesne mase b. Razmisliti je treba o možnem podaljšanju trajanja zdravljenja na več kot 12 tednov, vse do 24 tednov; zlasti za tiste podskupine, ki imajo enega ali več dejavnikov, v preteklosti povezanih z nižjo stopnjo odziva na zdravljenja na podlagi interferona (npr. napredovala fibroza/ciroza, visoke koncentracije virusov ob izhodišču, črna rasa, genotip ne-CC IL28B, predhodni ničelni odziv na zdravljenje s peginterferonom alfa in ribavirinom).
English: PEG+RBV 24 weeks (n = 67)
Slovenian: PEG+RBV 24 tednov (n = 67)
English: Sofosbuvir was administered at a dose of 400 mg once daily.
Slovenian: Sofosbuvir so dajali v odmerku 400 mg enkrat na dan. Odmerek ribavirina je bil določen na podlagi telesne mase in je znašal