natgillin/translations-raw huggingface dataset:
Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks. 
V preglednici 13 so predstavljene stopnje odziva za skupine, zdravljene s sofosbuvirjem + ribavirinom za 12 tednov in 16 tednov.
The ribavirin doses used in the sofosbuvir + ribavirin and peginterferon alfa 2a + ribavirin arms were weight-based 1,000-1,200 mg/day and 800 mg/day regardless of weight, respectively. 
Odmerki ribavirina, ki so jih uporabili v kraku sofosbuvir + ribavirin, so temeljili na telesni masi in so bili 1.000-1.200 mg/dan, v kraku peginterferon alfa 2a + ribavirin pa 800 mg/dan, neodvisno od telesne mase.
Table 15: Response rates in study VALENCE 
Preglednica 15: Stopnje odziva v študiji VALENCE Genotip 2
The SVR rates for the 8, 12, and 24 week ledipasvir/sofosbuvir treatment groups were 93% (42/45), 100% (31/31), and 79% (15/19), respectively. 
za skupine, zdravljene 8, 12 in 24 tednov z ledipasvirjem/sofosbuvirjem, so bile 93 % (42/45), 100 %
Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and adolescents from the age of 12 years up to the age of 18 years. 
Kaj je zdravilo Sovaldi in za kaj ga uporabljamo Zdravilo Sovaldi vsebuje učinkovino sofosbuvir, ki se daje za zdravljenje okužbe z virusom hepatitisa C pri odraslih in mladostnikih, starih 12 do 18 let.
Non-Black 
Črna rasa Ne-črna rasa
No liver or heart findings were observed in chronic toxicity studies at exposures 9 times (rat) and 27 times (dog) higher than the clinical exposure. 
V študijah kronične toksičnosti pri izpostavljenostih, ki so bile 9-krat (podgana) oz. 27-krat večje od klinične izpostavljenosti, ni bilo izsledkov na jetrih ali srcu.
Table 15 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks. 
V preglednici 15 so predstavljene stopnje odziva za skupine, zdravljene s sofosbuvirjem + ribavirinom za 12 tednov in 24 tednov.
Patients with genotype 3 CHC 
Bolniki z genotipom 3 CHC
Patients with genotype 1, 4, 5 or 6 CHC 
Bolniki s CHC genotipa 1, 4, 5 ali 6
Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected patients in the Phase 3 clinical studies. 
V kliničnih študijah 3. faze so odkrili dve substituciji NS5B, L159F in V321A, v vzorcih relapsa po zdravljenju več bolnikov, okuženih z virusom HCV genotipa 3.
Expected: ↓ Sofosbuvir ↔ GS-331007 
↓ sofosbuvir ↔ GS-331007
There are no data to support the co-administration of Sovaldi and telaprevir or boceprevir. 
Podatkov, ki bi podprli sočasno uporabo zdravila Sovaldi s telaprevirjem ali boceprevirjem, ni.
• changes in your liver (as shown by increased amounts of a substance called bilirubin in the blood) 
• spremembe na jetrih (kar kaže povečanje snovi, imenovane bilirubin, v krvi) Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
Medicinal products that are strong P-glycoprotein (P-gp) inducers in the intestine (carbamazepine, phenobarbital, phenytoin, rifampicin and St. John's wort). 
Zdravila, ki so močni induktorji P-glikoproteina (P-gp) v črevesju (karbamazepin, fenobarbital,
If the starting dose of ribavirin is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing <75 kg and 1,200 mg for patients weighing ≥75 kg). 
Če bolnik začetni odmerek ribavirina dobro prenaša, se lahko odmerek titrira na največ 1.000 do 1.200 mg na dan (1.000 mg za bolnike s telesno maso < 75 kg in 1.200 mg za bolnike s telesno maso ≥ 75 kg).
An interim analysis was conducted on 61 patients who received sofosbuvir and ribavirin; the majority of patients had HCV genotype 1, 44 patients were CPT class A and 17 patients were CPT class B. Of these 61 patients, 44 patients underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation. 
Vmesno analizo so opravili pri 61 bolnikih, ki so prejeli sofosbuvir in ribavirin; večina bolnikov je imela HCV genotipa 1, 44 bolnikov je imelo stopnjo A po CPT in 17 bolnikov je imelo stopnjo B po CPT.
Cases are potentially life threatening, therefore amiodarone should only be used in patients on Sovaldi when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated. 
Primeri so lahko smrtno nevarni, zato se lahko amiodaron pri bolnikih, ki prejemajo zdravilo Sovaldi, uporablja samo,
Mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate. 
• Druge sestavine zdravila so Jedro tablete: manitol, mikrokristalna celuloza, premrežen natrijev karmelozat, brezvodni koloidni silicijev dioksid, magnezijev stearat.
Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo. 
preglednici 11 so predstavljene stopnje odziva za skupine, zdravljenje s sofosbuvirjem + ribavirinom in za placebo.
• low red blood cell count (anaemia); the signs may include feeling tired, headaches, shortness of breath when exercising 
Krvne preiskave lahko pokažejo tudi: • nizko število rdečih krvnih celic (anemija); znaki lahko vključujejo občutek utrujenosti,
Table 12 presents the subgroup analysis by genotype for cirrhosis and interferon classification. 
V preglednici 12 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in razvrstitev glede na interferon.
HCV ANITIVIRAL AGENTS: HCV PROTEASE INHIBITORS Boceprevir (BOC) 
PROTIVIRUSNE UČINKOVINE PROTI HCV: ZAVIRALCI PROTEAZNE HCV
Study 4063 was an open-label study that evaluated a fixed dose combination of sofosbuvir and ledipasvir in 95 patients with HCV-infection and ESRD requiring dialysis. 
Študija 4063 je bila odprta študija, v kateri so ocenili kombinacijo s fiksim odmerkom sofosbuvirja in ledipasvirja pri 95 bolnikih z okužbo s HCV in ESRD, zaradi katere je potrebna dializa.
Table 3: Recommended treatment regimen and durations for adolescents aged 12 to < 18 years treated with Sovaldi 
Preglednica 3: Priporočeni režim in trajanje zdravljenja z zdravilom Sovaldi za mladostnike, stare od 12 do < 18 let
HCV infected patients, regardless of genotype, with hepatocellular carcinoma (HCC) meeting the MILAN criteria received 400 mg sofosbuvir and 1,000-1,200 mg ribavirin daily for a maximum of 24 weeks, subsequently amended to 48 weeks, or until the time of liver transplantation, whichever occurred first. 
Bolniki, okuženi s HCV, neodvisno od genotipa, s hepatoceličnim karcinomom (HCC-hepatocellular carcinoma), ki so izpolnjevali kriterije po lestvici MILAN, so prejemali 400 mg sofosbuvirja in 1.000-1.200 mg ribavirina na dan za največ 24 tednov,
Otherb a. The denominator for relapse is the number of patients with HCV RNA <LLOQ at their last on-treatment assessment. 
Drugob a. Denominator za relaps je število bolnikov z RNA HCV < LLOQ ob zadnji oceni med zdravljenjem.
In HCV replicon assays, the effective concentration (EC50) values of sofosbuvir against full-length replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05, 0.05 and 0.04 μM, respectively, and EC50 values of sofosbuvir against chimeric 1b replicons encoding NS5B from genotype 2b, 5a or 6a were 0.014 to 0.015 μM. 
V replikonskem sistemu HCV so bile vrednosti učinkovite koncentracije (EC50) sofosbuvirja proti replikonom polne dolžine genotipa 1a, 1b, 2a, 3a in 4a kot sledi: 0,04, 0,11, 0,05, 0,05 oz. 0,04 μM;
Adolescents (12 to 18 years of age) The recommended dose of Sovaldi is one tablet once daily with food (see section 5.2). 
Priporočeni odmerek zdravila Sovaldi je ena tableta enkrat na dan s hrano (glejte poglavje 5.2).
Table 7 presents the response rates for the treatment group of sofosbuvir + peginterferon alfa + ribavirin. 
V preglednici 7 so predstavljene stopnje odziva za skupino, zdravljeno s sofosbuvirjem + peginterferonom alfa + ribavirinom.
↔ GS-331007 (Induction of P-gp) 
↓ Sofosbuvir ↔ GS-331007 (indukcija P-gp)
Refer to the ribavirin prescribing information for guidance on dose modification or discontinuation. 
Za smernice glede prilagajanja odmerka ali ukinitev glejte navodila za predpisovanje ribavirina.
Sovaldi + ribavirin Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4) 
Uporablja se samo za bolnike, ki za zdravljenje peginterferonom alfa niso primerni ali ga ne prenašajo (glejte poglavje 4.4)
Mean ratio (90% confidence interval) for 
Povprečno razmerje (90odstotni interval zaupanja) za AUC, Cmax,
Table 18: SVR12 rates for selected subgroups by genotype in study PHOTON-1 
Preglednica 18: Stopnje SVR12 za izbrane podskupine po genotipu v študiji PHOTON-1
No dose adjustment of Sovaldi is required for patients with mild, moderate or severe hepatic impairment (Child-Pugh-Turcotte [CPT] class A, B or C) (see section 5.2). 
Pri bolnikih z blago, zmerno ali hudo jetrno okvaro (stopnja A, B ali C po Child-Pugh-Turcotteu [CPT]) odmerka zdravila Sovaldi ni treba prilagajati (glejte poglavje 5.2).
Sovaldi 400 mg film-coated tablets 
IME ZDRAVILA Sovaldi 400 mg filmsko obložene tablete
Tenofovir disoproxilf (245 mg once daily)d 
Dizoproksiltenofoviratf (245 mg enkrat na dan)d
You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Sovaldi. 
Po začetku jemanja zdravila Sovaldi morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
(n = 327) 
12 tednov (n = 327)
Table 2: Ribavirin dose modification guideline for co-administration with Sovaldi in adults 
Preglednica 2: Smernice za prilagajanje odmerka ribavirina pri sočasnem dajanju z zdravilom Sovaldi pri odraslih
How to store Sovaldi 
Shranjevanje zdravila Sovaldi
Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro. 
Defosforilacija povzroči nastanek nukleozidnega presnovka GS-331007, ki ga ni mogoče učinkovito ponovno refosforilati in ki in vitro ni aktiven proti HCV. Sofosbuvir in GS-331007 nista substrata ali zaviralca
Sofosbuvir is not a substrate for hepatic uptake transporters, organic anion-transporting polypeptide (OATP) 1B1 or 1B3, and organic cation transporter (OCT) 1. 
(OATP-organic anion-transporting polypeptide) 1B1 ali 1B3 in prenašalca organskih kationov (OCT
Study 4062 was an open-label study that evaluated a fixed dose combination of sofosbuvir and velpatasvir in 59 HCV-infected patients with ESRD requiring dialysis. 
Študija 4062 je bila odprta študija, v kateri so ocenili kombinacijo s fiksim odmerkom sofosbuvirja in ledipasvirja pri 59 bolnikih z okužbo s HCV in ESRD, zaradi katere je potrebna dializa.
Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Sovaldi. 
Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Sovaldi,
Such co-administration is not recommended (see also section 4.5). 
Taka sočasna uporaba ni priporočljiva (glejte poglavje 4.5).
The concomitant use of amiodarone was limited through the clinical development of sofosbuvir . 
Med kliničnim razvojem sofosbuvirja je bila sočasna uporaba amiodarona omejena.
No effects on foetal development have been observed in rats and rabbits at the highest doses tested. 
Pri najvišjih testiranih odmerkih pri podganah in kuncih niso opazili učinkov na razvoj ploda.
Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in patients who are interferon intolerant, ineligible or unwilling. 
Odrasli, ki niso prenašali interferona, niso bili primerni ali voljni - POSITRON (študija 107) Študija POSITRON je bila randomizirana, dvojno slepa, s placebom kontrolirana študija, v kateri so ocenili 12-tedensko zdravljenje s sofosbuvirjem in ribavirinom (n = 207) v primerjavi s placebom
Sovaldi in combination with ribavirin is recommended for 24 weeks in liver transplant recipients. 
Pri prejemnikih presajenih jeter se priporoča 24-tedenska uporaba zdravila Sovaldi v kombinaciji z ribavirinom.
• diarrhoea, feeling sick (nausea), being sick (vomiting) 
• driska, siljenje na bruhanje (navzea), bruhanje
Sovaldi + ribavirina for 12 weeks b 
Sovaldi + ribavirina 12 tednovb
No dose adjustment of norgestimate/ethinyl estradiol is required when sofosbuvir and norgestimate/ethinyl estradiol are used concomitantly. 
Pri sočasni uporabi sofosbuvirja in norgestimata/etinilestradiola odmerka norgestimata/etinilestradiola ni treba prilagajati.
Refer to the peginterferon alfa Summary of Product Characteristics for additional information about how to reduce and/or discontinue the peginterferon alfa dose. 
Za dodatne informacije o zmanjšanju in/ali ukinitvi odmerka peginterferona alfa glejte povzetek glavnih značilnosti zdravila za peginterferon alfa.
Hepatic impairment 
Predhodno nezdravljeni
After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively. 
Po enkratnem 400-miligramskem peroralnem odmerku [14C]-sofosbuvirja je sofosbuvir prispeval približno 4 % sistemske izpostavljenosti z zdravilom povezanega materiala (vsota vrednosti AUC
Table 16 presents the subgroup analysis by genotype for cirrhosis and exposure to prior HCV treatment. 
V preglednici 16 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in izpostavljenost predhodnemu zdravljenju HCV.
≥2 g/dL decrease in haemoglobin during any 4 week treatment period 
Hemoglobin pri bolnikih s stabilno boleznijo srca v anamnezi zmanjšanje hemoglobina za ≥ 2 g/dl v 4-tedenskem obdobju zdravljenja
↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC) 
↑ Sofosbuvir (TPV) ↔ Sofosbuvir (BOC) ↔ GS-331007 (TPV ali
• fever, chills, flu-like symptoms 
• povečana telesna temperatura, mrzlica, gripi podobni simptomi
The safety profile of sofosbuvir and ribavirin in liver transplant adult recipients with chronic hepatitis C was similar to that observed in patients treated with sofosbuvir and ribavirin in Phase 3 clinical studies (see section 5.1). 
Profil varnosti sofosbuvirja in ribavirina pri odraslih prejemnikih presajenih jeter s kroničnim hepatitisom C je bil podoben tistemu, ki so ga opazili pri bolnikih, zdravljenih s sofosbuvirjem in ribavirinom v kliničnih študijah 3. faze (glejte poglavje 5.1).
What Sovaldi is and what it is used for What you need to know before you take Sovaldi How to take Sovaldi 
Kaj morate vedeti, preden boste vzeli zdravilo Sovaldi Kako jemati zdravilo Sovaldi
Sovaldi is contraindicated with phenobarbital and phenytoin (see section 4.3). 
Zdravilo Sovaldi je kontraindicirano v kombinaciji s fenobarbitalom in fenitoinom (glejte poglavje 4.3).
In addition, S282R and L320F substitutions were detected on treatment by deep sequencing in a pre-transplant subject with a partial treatment response. 
S podatki karakterizacije strukture genoma med zdravljenjem so pri osebah pred presaditvijo z delnim odzivom na zdravljenje odkrili tudi substituciji S282R in L320F.
Table 14 presents the subgroup analysis by genotype for cirrhosis and response to prior HCV treatment. 
V preglednici 14 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo in odziv na predhodno zdravljenje HCV.
IMMUNOSUPPRESSANTS Ciclosporine (600 mg single dose) 
Ciklosporine (600 mg enkratni odmerek)
Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected patients. 
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.
Genotype 1 treatment-naïve SOF+RBV 24 weeks (n = 114) 
Genotip 1 predhodno nezdravljeni SOF+RBV 24 tednov (n = 114)
* The daily dosage of ribavirin is weight-based and is administered orally in two divided doses with food. 
1.200 mg/dan * Odmerek ribavirina na dan temelji na telesni masi in se daje peroralno s hrano, razdeljen na dva odmerka.
Safety data are limited in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and ESRD requiring haemodialysis. 
Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) in
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). 
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
Table 18 presents the subgroup analysis by genotype for cirrhosis. 
V preglednici 18 je predstavljena analiza za podskupine, razmejene po genotipu, glede na cirozo.
Otherc a. The efficacy analysis includes 6 patients with recombinant genotype 2/1 HCV infection. 
Drugoc a. Analiza učinkovitosti vključuje 6 bolnikov z okužbo s HCV z rekombinantnim genotipom 2/1.
Table 16: SVR12 rates for selected subgroups by genotype in study VALENCE 
Preglednica 16: Stopnje SVR12 za izbrane podskupine po genotipu v študiji VALENCE Genotip 2
Common arthralgia, back pain, muscle spasms, myalgia back pain, muscle spasms 
zelo pogosti artralgija, mialgija pogosti artralgija, bolečine v hrbtu, mišični spazmi, mialgija bolečine v hrbtu, mišični spazmi
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. 
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
Co-administration of such medicinal products is not recommended with Sovaldi (see section 4.5). 
Sočasna uporaba teh zdravil z zdravilom Sovaldi ni priporočljiva (glejte poglavje 4.5).
Very common haemoglobin decreased anaemia, neutropenia, lymphocyte count decreased, platelet count decreased 
Bolezni krvi in limfatičnega sistema zelo pogosti znižana raven hemoglobina anemija, nevtropenija, znižano število limfocitov, znižano število trombocitov pogosti anemija
Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection 
Zdravljenje brez interferona za okužbo s HCV genotipa 1, 4, 5 in 6
Table 14: SVR12 rates for selected subgroups by genotype in study FUSION 
Preglednica 14: Stopnje SVR12 za izbrane podskupine po genotipu v študiji FUSION Genotip 2
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). 
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.
Treatment-experienced (VALENCE) 
Predhodno nezdravljeni in predhodno zdravljeni odrasli - VALENCE (študija 133)
Treatment-naïve (QUANTUMb and 11-1-0258b) SOF+RBV 24 weeks 
Predhodno nezdravljeni (QUANTUMb in 11-1-0258b)
24 weeks (n = 28) 
12 tednov (n = 68)
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. 
Če se sofosbuvir uporablja v kombinaciji s peginterferonom alfa in ima bolnik resne neželene učinke,
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. 
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
• shortness of breath when exercising 
• zasoplost pri telesni vadbi
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. 
(< 75 kg = 1.000 mg in ≥ 75 kg = 1.200 mg) in se daje peroralno v dveh razdeljenih odmerkih s hrano.
Sovaldi is contraindicated with carbamazepine (see section 4.3). 
Zdravilo Sovaldi je kontraindicirano v kombinaciji s karbamazepinom (glejte poglavje 4.3).
Contents of the pack and other information 
Shranjevanje zdravila Sovaldi Vsebina pakiranja in dodatne informacije
Sovaldi is contraindicated with rifampicin (see section 4.3). 
Zdravilo Sovaldi je kontraindicirano v kombinaciji z rifampicinom (glejte poglavje 4.3).
Co-administration with such medicinal products is not recommended with Sovaldi (see section 4.4). 
Sočasna uporaba teh zdravil z zdravilom Sovaldi ni priporočljiva (glejte poglavje 4.4).
Sovaldi [Outer packaging only] 
PODATKI V BRAILLOVI PISAVI Sovaldi [samo zunanja ovojnina]
The sofosbuvir-associated resistance substitution S282T was not detected in any of these patients by deep sequencing or population sequencing. 
Substitucije S282T, povezane z odpornostjo na sofosbuvir, s karakterizacijo strukture genoma ali karakterizacijo nukleotidnih sledi genoma niso odkrili pri nobenem od teh bolnikov.
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). 
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).
Otherc a. The efficacy analysis includes 3 patients with recombinant genotype 2/1 HCV infection. 
Drugoc a. Analiza učinkovitosti vključuje 3 bolnike z okužbo s HCV z rekombinantnim genotipom 2/1.
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. 
Zdravilo Sovaldi je indicirano v kombinaciji z drugimi zdravili za zdravljenje kroničnega hepatitisa C
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. 
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.
Sofosbuvir retained activity against the NS5B substitutions L159F and L320F associated with resistance to other nucleoside inhibitors. 
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.
No dose adjustment of sofosbuvir is recommended for patients with mild, moderate and severe hepatic impairment (see section 4.2). 
Pri bolnikih z blago, zmerno in hudo jetrno okvaro prilagajanje odmerka sofosbuvirja ni potrebno (glejte poglavje 4.2).