FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have had a liver transplant.
Slovenian: • če ste imeli presaditev jeter.
English: The SVR12 was 98% among those with two or fewer factors and 81% among those with three or four factors.
Slovenian: SVR12 je bil 98 % med tistimi, ki so imeli dva ali manj dejavnikov, in 81 % med tistimi s tremi ali štirimi dejavniki.
English: e. Bioequivalence/Equivalence boundary 80-125%.
Slovenian: e. Meja bioekvivalence/ekvivalence 80-125 %.
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Slovenian: Stopnje odziva, ki so jih opazili pri bolnikih, starih ≥ 65 let, so bile podobne kot pri bolnikih, starih < 65 let, v vseh skupinah zdravljenja.
English: Recommended dose The recommended dose is one tablet once a day for 8 or 12 weeks.
Slovenian: Priporočeni odmerek je ena tableta enkrat na dan 8 ali 12 tednov.
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Slovenian: Bolezni kože Neznana pogostnost: Stevens-Johnsonov sindrom
English: • Your doctor can confirm that your treatment has worked and you are free of the hepatitis C virus.
Slovenian: • da lahko potrdi, da je bilo pri vas zdravljenje učinkovito in da ste brez virusa hepatitisa C.
English: If this applies to you, do not take Vosevi and tell your doctor immediately.
Slovenian: Če to velja za vas, ne jemljite zdravila Vosevi in se takoj posvetujte z zdravnikom.
English: Contact your doctor or nearest emergency department immediately for advice.
Slovenian: Takoj se posvetujte z zdravnikom ali pojdite na najbližji oddelek nujne pomoči.
English: Cross resistance in cell culture
Slovenian: Navzkrižna odpornost v celični kulturi
English: f. Data obtained from transiently transfected replicons.
Slovenian: f. Podatki, pridobljeni iz replikonov, ki se prehodno transfekcirajo.
English: NA: Not available a. Mean value from multiple experiments of same laboratory replicon.
Slovenian: NA = podatkov ni na voljo a. Povprečna vrednost v več poskusih istega laboratorijskega replikona.
English: Treatment of overdose with Vosevi consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerka z zdravilom Vosevi je sestavljeno iz splošnih podpornih ukrepov, ki vključujejo spremljanje vitalnih znakov in opazovanje kliničnega stanja bolnika.
English: Demographics and baseline characteristics for all studies are detailed in Table 9.
Slovenian: Demografske in izhodiščne značilnosti za vse študije so podrobno opisane v preglednici 9.
English: Otherc a. The majority (85%) of patients previously failed a regimen containing sofosbuvir.
Slovenian: Drugoc a. Pri večini (85 %) bolnikov je bilo prejšnje zdravljenje z režimom, ki vsebuje sofosbuvir, neuspešno.
English: If you do miss a dose, work out how long it is since you last took your Vosevi:
Slovenian: Če pozabite vzeti odmerek, določite, koliko časa je minilo od takrat, ko ste zdravilo Vosevi nazadnje vzeli:
English: Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Slovenian: Zdravnik bo morda moral povečati pogostnost krvnih preiskav, s katerimi bo preverjal, kako dobro se vam strjuje kri.
English: Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); or uncommon (≥ 1/1000 to < 1/100).
Slovenian: Pogostnosti so opredeljene kot sledi: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10) ter občasni (≥1/1.000 do
English: Additional study details
Slovenian: Dodatni podatki o študiji
English: Swallow the tablet whole with food.
Slovenian: Tableto pogoltnite celo s hrano.
English: Patients should be instructed not to take a double dose of Vosevi.
Slovenian: Bolniku je treba naročiti, naj ne vzame dvojnega odmerka zdravila Vosevi.
English: AUC Cmin
Slovenian: Cmax AUC Cmin
English: Study arms and duration (Number of patients treated)
Slovenian: Skupine v študiji in trajanje študije (število zdravljenih bolnikov)
English: For both velpatasvir and voxilaprevir, combinations of RAVs often showed greater reductions in susceptibility than individual RAVs alone.
Slovenian: Tako za velpatasvir kot za voksilaprevir so kombinacije RAV pogosto pokazale večja zmanjšanja dovzetnosti kot posamezne RAV.
English: The active substances in this medicine work together by blocking three different proteins that the hepatitis C virus needs to grow and reproduce itself, causing the infection to be eliminated from the body.
Slovenian: Učinkovine v zdravilu delujejo skupaj tako, da zavirajo tri različne beljakovine, ki jih virus hepatitisa C potrebuje za svojo rast in razmnoževanje, kar povzroči, da se okužba odstrani iz telesa.
English: Tell your doctor if you have kidney problems or if you are on kidney dialysis, since Vosevi has not been fully tested in patients with severe kidney problems.
Slovenian: Povejte zdravniku, če imate težave z ledvicami ali ste na ledvični dializi, saj zdravila Vosevi niso v celoti testirali pri bolnikih s hudimi težavami z ledvicami.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Vosevi, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Slovenian: Za ocenitev ponovitve hepatoceličnega karcinoma, povezanega z zdravilom Vosevi, bo imetnik dovoljenja za promet z zdravilom izvedel in predložil rezultate prospektivne študije varnosti s podatki, izpeljanimi iz kohorte dobro opredeljene skupine bolnikov na podlagi dogovorjenega protokola.
English: Medicinal products that are sensitive substrates of these transporters and for which elevated plasma levels are associated with serious events are contraindicated (see Table 2).
Slovenian: Zdravila, ki so občutljivi substrati teh prenašalcev in za katere so zvišane ravni v plazmi povezane z resnimi neželenimi učinki, so kontraindicirana (glejte preglednico 2).
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.
Slovenian: Če imate intoleranco za laktozo ali so vam povedali, da imate intoleranco za druge sladkorje, se pred jemanjem tega zdravila posvetujte z zdravnikom.
English: • ciclosporin, used to suppress the immune system.
Slovenian: • ciklosporin, ki se uporablja za zaviranje imunskega sistema.
English: In the 13 patients aged 75 to 84 years with available pharmacokinetic data, mean exposure to voxilaprevir was 93% higher than the mean exposure observed in patients aged 18 to 64 years.
Slovenian: Pri 13 bolnikih, starih od 75 do 84 let, z razpoložljivimi farmakokinetičnimi podatki, je bila povprečna izpostavljenost voksilaprevirju 93 % večja kot povprečna izpostavljenost, ki so jo opazili pri bolnikih, starih od 18 do 64 let.
English: Co-administration of Vosevi with digoxin may increase the concentration of digoxin.
Slovenian: Vosevi z digoksinom lahko poveča koncentracijo digoksina.
English: As liver function may change during treatment with Vosevi, close monitoring of International Normalised Ratio (INR) values is recommended.
Slovenian: Ker se delovanje jeter v času zdravljenja z zdravilom Vosevi lahko spremeni, se priporoča natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR- International Normalised Ratio).
English: Each film-coated tablet contains 117 mg of lactose (as lactose monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 117 mg laktoze (v obliki laktoze monohidrata).
English: Co-administration of Vosevi with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products.
Slovenian: Sočasna uporaba zdravila Vosevi z zdravili, ki so substrati teh prenašalcev, lahko poveča izpostavljenost takšnim zdravilom.
English: The effects of Vosevi during pregnancy are not known.
Slovenian: Učinki zdravila Vosevi med nosečnostjo niso znani.
English: • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Slovenian: • če imate hepatitis B ali ste kdaj bili okuženi z virusom hepatitisa B, saj vas bo morda zdravnik spremljal bolj skrbno;
English: What Vosevi is and what it is used for
Slovenian: Kaj je zdravilo Vosevi in za kaj ga uporabljamo
English: The recommended durations of treatment applicable to all HCV genotypes are shown in Table 1.
Slovenian: Priporočena trajanja zdravljenj, ki veljajo za vse genotipe HCV, so prikazana v preglednici 1.
English: • rosuvastatin (a medicine used to treat high blood cholesterol or decrease the risk of certain cardiovascular events);
Slovenian: • rosuvastatin (zdravilo, ki se uporablja za zdravljenje visokih ravni holesterola v krvi ali zmanjševanje tveganja nekaterih srčnožilnih dogodkov);
English: These medicines can decrease the amount of Vosevi in your blood.
Slovenian: Ta zdravila lahko zmanjšajo količino zdravila Vosevi v krvi.
English: The safety and efficacy of Vosevi in children and adolescents aged less than 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Vosevi pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
English: 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.8-fold↑ GS-331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 18-fold↑
Slovenian: 1,6-krat↑ 2,1-krat↑ 2,7-krat↑ 1,3-krat↑ 1,6- krat↑ ~2- krat↑ 1,8- krat↑ GS-331007 1,6-krat↑ 1,9-krat↑ 5,5-krat↑ ≥10-krat↑ ≥20-krat↑ ~7- krat↑ 18- krat↑ Velpatasvir
English: If you are pregnant, think you may be pregnant, are breast-feeding your baby, or are planning to have a baby ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči, dojite, menite, da bi lahko bili noseči, dojite otroka ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: • abnormality in a laboratory test of liver function (total bilirubin)
Slovenian: • nenormalne vrednosti laboratorijskih preiskav delovanja jeter (celokupni bilirubin)
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Vosevi.
Slovenian: Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z zdravilom Vosevi.
English: If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Vosevi.
Slovenian: Če jemljete antacid, ga vzemite vsaj 4 ure pred zdravilom Vosevi ali najmanj 4 ure po tem.
English: If you forget to take Vosevi
Slovenian: Če ste pozabili vzeti zdravilo Vosevi
English: • ethinylestradiol containing medicines, including many contraceptives.
Slovenian: • zdravila, ki vsebujejo etinilestradiol, vključno s številnimi kontraceptivi.
English: Caution is warranted and therapeutic concentration monitoring of digoxin is recommended.
Slovenian: Potrebna je previdnost, priporoča se tudi spremljanje terapevtske koncentracije digoksina.
English: No patients in the placebo group achieved SVR4.
Slovenian: V skupini, ki je prejemala placebo, noben bolnik ni dosegel SVR4.
English: The difference in SVR12 was driven by a lower response rate in patients with genotype 1a infection and/or cirrhosis.
Slovenian: Razlika v SVR12 je bila posledica nizke stopnje odziva pri bolnikih z okužbo genotipa 1a in/ali s cirozo.
English: Clinical studies of Vosevi included 189 patients aged 65 and over (17% of total number of patients in the Phase 2 and 3 clinical studies).
Slovenian: V klinične študije zdravila Vosevi je bilo vključenih 189 bolnikov, starih 65 let ali več (17 % skupnega števila bolnikov v kliničnih študijah 2. in 3. faze).
English: If vomiting occurs more than 4 hours after dosing, no further dose of Vosevi is needed (see section 5.1).
Slovenian: Če se bruhanje pojavi več kot 4 ure po odmerjanju, dodaten odmerek zdravila Vosevi ni potreben (glejte poglavje 5.1).
English: In healthy volunteer studies with sofosbuvir and velpatasvir, there were no untoward effects observed at these dose levels, and adverse events were similar in frequency and severity to those reported in the placebo groups.
Slovenian: V študijah z zdravimi prostovoljci s sofosbuvirjem in velpatasvirjem ob teh ravneh odmerkov niso opazili neugodnih učinkov, neželeni učinki pa so bili po pogostnosti in resnosti podobni tistim, o katerih so poročali v skupinah, ki so prejemale placebo.
English: Animal studies have shown a possible link to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale možno povezavo z reproduktivno toksičnostjo (glejte poglavje 5.3).
English: • you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).
Slovenian: • jemljete ali ste v zadnjih nekaj mesecih jemali amiodaron za zdravljenje nerednega srčnega utripa (če jemljete ali ste jemali to zdravilo, bo zdravnik morda razmislil o drugih možnostih zdravljenja).
English: Carcinogenicity studies for voxilaprevir have not been conducted.
Slovenian: Študij kancerogenosti voksilaprevirja niso izvedli.
English: The use of Vosevi in children and adolescents has not yet been studied.
Slovenian: Uporabe zdravila Vosevi pri otrocih in mladostnikih niso preučevali.
English: HCV/HBV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Slovenian: Pri bolnikih s sočasno okužbo s HCV in HBV obstaja tveganje za reaktivacijo HBV, zato jih je treba spremljati in nadzirati v skladu s trenutnimi kliničnimi smernicami.
English: Active
Slovenian: Aktiven
English: Some of the active substances of Vosevi may pass into human breast milk.
Slovenian: Nekatere od učinkovin v zdravilu Vosevi morda prehajajo v materino mleko.
English: Voxilaprevir is approximately > 99% bound to human plasma proteins.
Slovenian: Voksilaprevir se približno > 99-odstotno veže na humane beljakovine v plazmi.
English: The recommended dose of Vosevi is one tablet, taken orally, once daily with food (see section 5.2).
Slovenian: Priporočeni odmerek zdravila Vosevi je ena tableta peroralno enkrat na dan s hrano (glejte poglavje 5.2).
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP56
Slovenian: Farmakoterapevtska skupina: zdravila z neposrednim delovanjem na viruse, oznaka ATC: J05AP56 Mehanizem delovanja
English: This may make Vosevi work less well.
Slovenian: Zaradi tega bo morda zdravilo Vosevi slabše delovalo.
English: Vosevi is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo Vosevi je indicirano za zdravljenje kronične okužbe z virusom hepatitisa C (HCV) pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
English: Table 8: Studies conducted with Vosevi
Slovenian: Preglednica 8: Študije, ki so jih izvedli z zdravilom Vosevi Študija
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Vosevi compared to subjects with normal renal function, as described in the text below, are provided in Table 15.
Slovenian: Ledvična okvara Povzetek učinka različnih stopenj ledvične okvare na izpostavljenost sestavinam zdravila Vosevi v primerjavi z osebami z normalnim delovanjem ledvic, kot je opisano spodaj, so na voljo v preglednici 15.
English: The safety of sofosbuvir in a fixed dose combination with either ledipasvir or velpatasvir has been studied in 154 patients with ESRD requiring dialysis (Study 4062 and Study 4063).
Slovenian: Varnost kombinacije s fiksnim odmerkom sofosbuvirja in bodisi ledipasvirja ali velpatasvirja so preučili pri 154 bolnikih z ESRD, ki so potrebovali dializo (študija 4062 in študija 4063).
English: Should direct Xa inhibitor use be deemed necessary, apixaban or rivaroxaban may be considered.
Slovenian: Če se oceni, da je potrebna uporaba neposrednega zaviralca Xa, se lahko razmisli o uporabi apiksabana ali rivaroksabana.
English: c. Pharmacokinetic data for the 1 patient with on-treatment virologic failure was consistent with non-adherence.
Slovenian: c. Farmakokinetični podatki za enega bolnika z virološkim neuspehom med zdravljenjem so bili v skladu z neupoštevanjem zdravljenja.
English: Total bilirubin levels decreased after completing Vosevi treatment.
Slovenian: Ravni celokupnega bilirubina so se po končanem zdravljenju z zdravilom Vosevi zmanjšale.
English: For sofosbuvir, the NS5B substitution S282T was selected in genotype 1-6 replicons and was associated with 2- to 18-fold reduced susceptibility to sofosbuvir.
Slovenian: Za sofosbuvir je bila substitucija S282T v NS5B selekcionirana v replikonih genotipov 1-6 in je bila povezana z 2- do 18-kratno zmanjšano dovzetnostjo za sofosbuvir.
English: 1.4-fold↑
Slovenian: 1,4- krat↑
English: Table 2 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
Slovenian: V preglednici 2 je seznam ugotovljenih ali možnih klinično pomembnih interakcij med zdravili (pri čemer je bil 90-odstotni interval zaupanja [IZ] povprečnega razmerja (geometrično povprečje po metodi najmanjših kvadratov [GLSM, geometric least-squares mean]) znotraj „↔“, razširjen nad „↑“ ali razširjen pod „↓“ vnaprej določene meje interakcij).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with sofosbuvir/velpatasvir/voxilaprevir 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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s sofosbuvirjem/velpatasvirjem/voksilaprevirjem za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Table 1: Recommended treatment durations for Vosevi for all HCV genotypes
Slovenian: Preglednica 1: Priporočeno trajanje zdravljenja za zdravilo Vosevi za vse genotipe HCV Populacija bolnikov
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Slovenian: Posledično bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze tega zdravila ne smejo jemati.
English: Patients should be instructed to swallow the tablet whole with food (see section 5.2).
Slovenian: Bolnikom je treba naročiti, naj pogoltnejo celo tableto s hrano (glejte poglavje 5.2).
English: Patients treated with ethinylestradiol-containing medicinal products
Slovenian: Bolniki, ki prejemajo zdravila, ki vsebujejo etinilestradiol
English: The hydrolysed and dehydrogenated voxilaprevir were the major metabolites identified in human plasma.
Slovenian: Hidrolizirani in dehidrogenirani voksilaprevir sta bila glavna presnovka, ugotovljena v plazmi pri človeku.
English: The safety and efficacy of Vosevi in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
Slovenian: Varnost in učinkovitost zdravila Vosevi pri zdravljenju bolnikov z okužbo s HCV po presaditvi jeter nista bili ocenjeni.
English: 8 weeks may be considered in genotype 3 infected patients (see section 5.1)
Slovenian: 12 tednov za bolnike, okužene z genotipom 3, je možno razmisliti o 8 tednih (glejte poglavje 5.1)
English: * 29% of patients enrolled into POLARIS-3 had received prior treatment with an interferon-based regimen.
Slovenian: * 29 % bolnikov, ki so bili vključeni v študijo POLARIS-3, je prejelo predhodno zdravljenje z režimom na osnovi interferona.
English: * 23% of patients enrolled into POLARIS-2 had received prior treatment with an interferon-based regimen.
Slovenian: * 23 % bolnikov, ki so bili vključeni v študijo POLARIS-2, je prejelo predhodno zdravljenje z režimom na osnovi interferona.
English: Do not stop taking Vosevi
Slovenian: Ne prenehajte jemati zdravila Vosevi
English: • atorvastatin, pravastatin, or other statins, used to treat high cholesterol;
Slovenian: • atorvastatin, pravastatin ali druge statine, ki se uporabljajo za zdravljenje visokih ravni holesterola;
English: As a precautionary measure, Vosevi use is not recommended during pregnancy.
Slovenian: Kot previdnostni ukrep uporaba zdravila Vosevi ni priporočljiva med nosečnostjo.
English: GS-461203 is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Slovenian: GS-461203 ni niti zaviralec polimeraz DNK in RNK pri človeku niti ne zavira mitohondrijske polimeraze RNK.
English: All patients receiving Vosevi in combination with amiodarone with or without other medicinal products that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Slovenian: Vse bolnike, ki prejemajo zdravilo Vosevi v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško pomoč.
English: Sofosbuvir, velpatasvir, and voxilaprevir were fully active against substitutions associated with resistance to other classes of DAAs with different mechanisms of actions, e.g. voxilaprevir was fully active against NS5A and NS5B NI RAVs.
Slovenian: Sofosbuvir, velpatasvir in voksilaprevir so bili v celoti aktivni proti substitucijam, povezanim z odpornostjo na DAA drugih razredov z različnimi mehanizmi delovanja, npr. voksilaprevir je bil v celoti aktiven proti RAV NI NS5A in NS5B.
English: Should concomitant use of amiodarone be considered necessary, it is recommended that patients are closely monitored when initiating Vosevi.
Slovenian: Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom Vosevi priporoča skrbno spremljanje bolnikov.
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Slovenian: Sušilno sredstvo iz silikagela je v posebni vrečki ali plastenki in ga ne smete pogoltniti.
English: Co-administration of Vosevi with atazanavir is expected to increase the concentration of voxilaprevir.
Slovenian: Pri uporabi zdravila Vosevi z atazanavirjem se pričakuje, da se bo povečala koncentracija voksilaprevirja.
English: Voxilaprevir (studied under fed conditions) AUC increases in a greater than doseproportional manner over the dose range of 100 to 900 mg.
Slovenian: Vrednost AUC za voksilaprevir (pri preiskavah po jedi) se poviša več kot sorazmerno z odmerkom v razponu odmerka 100-900 mg.
English: Vosevi treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Slovenian: Zdravljenje z zdravilom Vosevi mora uvesti in nadzirati zdravnik z izkušnjami v obravnavi bolnikov z okužbo s HCV.
English: DAA: direct-acting antiviral; GT: genotype; SOF: sofosbuvir; VEL: velpatasvir; VOX: voxilaprevir
Slovenian: DAA: zdravilo z neposrednim delovanjem na viruse; GT: genotip; SOF: sofosbuvir; VEL: velpatasvir; VOKS: voksilaprevir
English: Observed: Raltegravir
Slovenian: Raltegravir
English: Sofosbuvir and GS-331007 are not inhibitors or inducers of CYP or uridine glucuronosyltransferase (UGT) 1A1 enzymes.
Slovenian: Sofosbuvir in GS-331007 nista zaviralca ali induktorja encimov CYP ali uridin glukuroniltransferaze (UGT) 1A1.