natgillin/translations-raw huggingface dataset:
NS3 variants V36A/M and R155K and NS5B variants M414T and S556G remained detectable at posttreatment Week 48, whereas NS3 variant D168V and all other NS5B variants were not observed at posttreatment Week 48.
Varianti V36A/M in R155K gena NS3 in varianti M414T in S556G gena NS5B so ostale zaznavne 48. teden po zdravljenju, medtem ko variante D168V gena NS3 in vseh drugih variant gena NS5B 48. teden po zdravljenju niso ugotovili.
800 mg once daily (given at the same time)
800 mg enkrat na dan (uporabljen ob istem času)
4-24 mg/16 mg once daily8
4-24 mg/1-6 mg enkrat na dan8
Fatigue *Data set includes all genotype 1-infected subjects in Phase 2 and 3 trials including subjects with cirrhosis.
*Nabor podatkov obsega vse preiskovance, okužene z genotipom 1, vključene v preskušanja 2. in 3. faze, tudi preiskovance s cirozo.
Viekirax is not recommended for administration as monotherapy and must be used in combination with other medicinal products for the treatment of hepatitis C infection (see sections 4.2 and 5.1).
Zdravilo Viekirax ni priporočljivo za uporabo v monoterapiji in ga je treba uporabljati v kombinaciji z drugimi zdravili za zdravljenje okužbe s hepatitisom C (glejte poglavji 4.2 in 5.1).
Results from the pharmacokinetic evaluation of the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg, with dasabuvir 400 mg can be extrapolated to the combination of ombitasvir 25 mg, paritaprevir 200 mg, and ritonavir 100 mg.
Rezultate farmakokinetične ocene kombinacije 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja, s 400 mg dasabuvirja, je mogoče ekstrapolirati na kombinacijo 25 mg ombitasvirja, 200 mg paritaprevirja in 100 mg ritonavirja.
• Swelling of the layers of skin which can affect any part of the body including the face, tongue or throat and may cause difficulty swallowing or breathing (angioedema)
Redki: pojavijo se lahko pri največ 1 od 1000 bolnikov • Otekanje plasti kože, ki lahko prizadane katerikoli del telesa, vključno z obrazom, jezikom ali grlom, in lahko povzroči oteženo požiranje ali dihanje (angioedem).
Co-administration of Viekirax with or without dasabuvir with medicinal products that are substrates of OATP1B1, OATP1B3, OATP2B1 or OCT1 may increase plasma concentrations of these transporter substrates, potentially requiring dose adjustment/clinical monitoring.
Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z zdravili, ki so substrati OATP1B1, OATP1B3, OATP2B1 ali OTC1, lahko poveča koncentracijo teh substratov prenašalcev v plazmi in to lahko zahteva prilagoditev odmerka in klinično spremljanje.
Clinical monitoring and dose adjustment may be required for levothyroxine
Morda bo potrebno klinično spremljanje in prilagoditev odmerka levotiroksina.
Ombitasvir has shown malformations in rabbits at maximal feasible exposures 4-fold higher than the AUC exposure at recommended clinical dose.
Z ombitasvirjem so pri kuncih ugotovili malformacije pri največjih možnih izpostavljenostih, 4-krat večjih od AUC izpostavljenosti ob priporočenih kliničnih odmerkih.
Ethinyloestradiol is contraindicated in combination with Viekirax (see sections 4.3 and 4.4).
Etinilestradiol je kontraindiciran v kombinaciji z zdravilom Viekirax (glejte poglavji 4.3 in 4.4).
- have liver disease other than hepatitis C; -have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.
Pred začetkom jemanja zdravila Viekirax se posvetujte z zdravnikom ali farmacevtom, če: - imate tudi bolezen jeter, ki ni hepatitis C; - imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal;
Paritaprevir was positive in an in vitro human chromosome aberration test. Paritaprevir was negative in a bacterial mutation assay, and in two in vivo genetic toxicology assays (rat bone marrow micronucleus and rat liver Comet tests).
Paritaprevir je bil negativen v preizkusu bakterijskih mutacij ter v dveh genetskih toksikoloških preizkusih in vivo (mikrojedrni preizkus na kostnem mozgu podgan in kometni test na podganjih jetrih).
The safety of Viekirax in children and adolescents aged < 18 years has not yet been established.
Varnost zdravila Viekirax še ni ugotovljena pri otrocih in mladostnikih, starih < 18 let.
If statin treatment is required during the treatment period, a switch to a reduced dose of pravastatin/rosuvastatin is possible (see section 4.5, Table 2).
Če je med obdobjem zdravljenja potrebno zdravljenje s statinom, je treba preiti na zmanjšan odmerek pravastatina/rosuvastatina, če je mogoče (glejte poglavje 4.5,
The activity of paritaprevir was reduced 96-fold by D168V, and 50- to 219-fold by each of the other D168 substitutions.
Substitucija D168V je zmanjšala aktivnost paritaprevirja za 96-krat, vsaka od drugih substitucij D168 pa od 50- do 219-krat.
Viekirax and dasabuvir for 8 weeks n/N (%)
Zdravilo Viekirax in dasabuvir 8 tednov n/N (%)
Appropriate monitoring of serum digoxin levels is recommended.
Priporočljivo je ustrezno kontrolirati koncentracijo digoksina v serumu.
In another open-label phase 3b study evaluating 12 weeks of Viekirax with or without dasabuvir and without RBV in non-cirrhotic, treatment-naive GT1a and GT4 patients with CKD stage 4 or 5 (Ruby II), the SVR12 rate was 94.4% (17/18), with no subjects experiencing on-treatment virologic failure or relapse.
V drugi odprti študiji faze 3b, ki je ocenila zdravilo Viekirax z ali brez dasabuvirja 12 tednov in brez RBV pri še nezdravljenih GT1a in GT4 bolnikih brez ciroze, s CKD stopnje 4 ali 5 (Ruby II), je bila stopnja SVR12 94,4 % (17/18); pri tem se pri nobenem preiskovancu nista pojavila virusna neodzivnost med zdravljenjem ali ponovitev bolezni.
Viekirax administered with or without dasabuvir did not affect the exposures of the CYP2C9 substrate, warfarin.
Zdravilo Viekirax, uporabljeno z dasabuvirjem ali brez njega, ni vplivalo na izpostavljenost substratu CYP2C9, varfarinu.
Viekirax and dasabuvir for 12 or 24 weeks with or without ribavirin ( investigator chosen dose ) for GT1 and GT4 infection
Zdravljenje: Zdravilo Viekirax in dasabuvir 12 ali 24 tednov z ali brez ribavirina (odmerki določeni s strani raziskovalca), za okužbo s GT1 in GT4
For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
1000 mg ribavirina na dan, če so tehtali manj kot 75 kg, oziroma odmerek 1200 mg na dan, če so tehtali 75 kg ali več.
Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Skupno je imelo v kliničnih preskušanjih 2. in 3. faze rezultate HCV RNA za SVR12 in za SVR24 660
However, co-administration of digoxin with Viekirax without dasabuvir may result in increased plasma concentrations (see Table 2).
Vendar pa lahko sočasna uporaba digoksina z zdravilom Viekirax brez dasabuvirja poveča koncentracijo v plazmi (glejte preglednico 2).
Use with statins
Uporaba s statini
Ritonavir dose in Viekirax will provide atazanavir pharmacokinetic enhancement).
Odmerek ritonavirja v zdravilu Viekirax bo povzročilo okrepitev farmakokinetike atazanavirja.
GT1b Viekirax and dasabuvir (12 weeks)
GT1b Viekirax in dasabuvir (12 tednov)
If dose adjustments of concomitant medicinal products are made due to treatment with Viekirax or Viekirax with dasabuvir, doses should be re-adjusted after administration of Viekirax or Viekirax with dasabuvir is completed.
Če se odmerek sočasnih zdravil zaradi zdravljenja z zdravilom Viekirax ali z zdravilom Viekirax in dasabuvirjem prilagodi, je treba odmerek ponovno prilagoditi, ko se zdravljenje z zdravilom Viekirax ali zdravilom Viekirax in dasabuvirjem konča.
Medicinal products that inhibit transport proteins
Zdravila, ki zavrejo prenašalne proteine
Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing ombitasvir, paritaprevir, and dasabuvir with or without ribavirin (for 8, 12, or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
Od 2.510 oseb s HCV genotipa 1, zdravljenih s shemami, ki so vsebovale ombitasvir, paritaprevir in dasabuvir, z ribavirinom ali brez njega (v obdobju 8, 12 ali 24 tednov) v kliničnih preskušanjih faze 2b in 3, je virusno neodzivnost (primarni recidiv po zdravljenju) doživelo skupno 74 (3 %).
Food increased the exposure (AUC) of ombitasvir, paritaprevir and ritonavir by up to 82%, 211% and 49%, respectively relative to the fasting state.
V primerjavi s stanjem na tešče je hrana povečala izpostavljenost (AUC) ombitasvirju do 82 %, paritaprevirju do 211 % in ritonavirju do 49 %.
Co-administration of Viekirax and dasabuvir with medicinal products that are moderate or strong enzyme inducers is expected to decrease ombitasvir, paritaprevir, ritonavir and dasabuvir plasma concentrations and reduce their therapeutic effect.
Pričakovati je, da sočasna uporaba zdravila Viekirax in dasabuvirja z zdravili, ki zmerno ali močno inducirajo encime, zmanjša koncentracijo ombitasvirja, paritaprevirja, ritonavirja in dasabuvirja v plazmi in zmanjša njihov terapevtski učinek.
Theoretically, Viekirax with and without dasabuvir is expected to increase the exposure to pitavastatin and fluvastatin.
Teoretično je treba pričakovati, da zdravilo Viekirax z dasabuvirjem ali brez njega poveča izpostavljenost pitavastatinu in fluvastatinu.
Following dosing of ombitasvir/paritaprevir /ritonavir, mean plasma half-life of ritonavir was approximately 4 hours.
Po uporabi ombitasvirja/paritaprevirja/ritonavirja je bil povprečni plazemski razpolovni čas ritonavirja približno 4 ure.
HIV ANTIVIRALS: PHARMACOKINETIC ENHANCER Cobicistatcontaining regimens
PROTIVIRUSNA ZDRAVILA PROTI HIV: FARMAKOKINETIČNI OJAČEVALEC sheme, ki vsebujejo kobicistat
OATP1B1/3 substrates evaluated in drug interaction studies include pravastatin and rosuvastatin (see Table 2).
Med substrati OATP1B1/3, ocenjenimi v študijah medsebojnega delovanja zdravil, so pravastatin in rosuvastatin (glejte preglednico 2).
Co-administration of Viekirax with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QT-prolongation co ombitasvir paritaprevir
Sočasna uporaba zdravila Viekirax z rilpivirinom enkrat na dan pride v poštev le pri bolnikih brez znanega podaljšanja intervala QT, ki ob tem tudi ne uporabljajo kakšnih drugih zdravil, ki podaljšajo interval
Following administration of a single 200 mg/100 mg oral dose of 14C paritaprevir /ritonavir to humans, the parent drug was the major circulating component, accounting for approximately 90% of the plasma radioactivity.
Po uporabi enkratnega peroralnega odmerka 200 mg/100 mg 14C-paritaprevirja/ritonavirja pri človeku, je bilo matično zdravilo glavna sestavina v obtoku; na njen račun je šlo približno 90 % radioaktivnosti v plazmi.
Treatment duration was 12 weeks for treatment naïve subjects, 12-24 weeks for treatment experienced subjects and 24 weeks for subjects with cirrhosis.
Pri še nezdravljenih bolnikih je zdravljenje trajalo 12 tednov, pri že zdravljenih od 12 do 24 tednov, in pri bolnikih s cirozo 24 tednov.
If tacrolimus with Viekirax and dasabuvir are used concomitantly, tacrolimus should not be administered on the day Viekirax and dasabuvir are initiated.
Če so takrolimus in zdravilo Viekirax in dasabuvir uporabljeni skupaj, se takrolimus ne sme dati na isti dan kot je začetek uporabe zdravila Viekirax in dasabuvirja.
Genotype 4, without cirrhosis or with compensated cirrhosis
Genotip 4, brez ciroze ali s kompenzirano cirozo
Dasabuvir treatment-emergent variants M414T, G554S, S556G, G558R or D559G/N in NS5B were observed in 34 subjects.
Med zdravljenjem z dasabuvirjem nastale variante M414T, G554S, S556G, G558R ali D559G/N gena NS5B so ugotovili pri 34 preiskovancih.
Clinical studies in subjects with genotype 1 hepatitis C infection The efficacy and safety of Viekirax in combination with dasabuvir with and without ribavirin was evaluated in eight Phase 3 clinical trials, including two trials exclusively in subjects with cirrhosis (ChildPugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Učinkovitost in varnost zdravila Viekirax v kombinaciji z dasabuvirjem (z ribavirinom ali brez njega) so preučili v osmih kliničnih preskušanjih 3. faze (vključno z dvema preskušanjema izključno pri bolnikih s cirozo (Child-Pugh A)) pri več kot 2.360 preiskovancih s kronično okužbo s hepatitisom C genotipa 1, kot povzema preglednica 6.
Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).
Zdravilo Viekirax je v kombinaciji z drugimi zdravili indicirano za zdravljenje kroničnega hepatitisa C pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
To be noted, darunavir should be taken without ritonavir, since ritonavir 100 mg once daily is provided as part of Viekirax.
Poudariti velja, da je treba darunavir uporabljati brez ritonavirja, kajti 100 mg ritonavirja enkrat na dan je sestavina zdravila Viekirax.
Sulfamethoxazole, Trimethoprim
sulfametoksa zol, trimetoprim
300 mg once daily (given at the same time)
300 mg enkrat na dan (uporabljen ob istem času)
HIV ANTIVIRALS: NUCLEOSIDE INHIBITORS Abacavir/ lamivudine
PROTIVIRUSNA ZDRAVILA PROTI HIV: NUKLEOZIDNI ZAVIRALCI abakavir/lamivu din
These metabolites are not expected to have antiviral activity or off-target pharmacologic activity.
Za te presnovke ni pričakovati, da bi delovali protivirusno ali da bi imeli farmakološko delovanje drugje kot na svojem tarčnem mestu.
Pooled analyses of clinical trials
Kumulativne analize kliničnih preskušanj
Following a 600 mg dose of 14C -ritonavir oral solution, 86.4% of the radioactivity was recovered in the faeces and 11.3% of the dose was excreted in the urine.
Po uporabi odmerka 600 mg 14C-ritonavirja v peroralni raztopini se je 86,4 % radioaktivnosti pojavilo v blatu in 11,3 % odmerka se je izločilo v urinu.
TURQUOISE-I: treatment-naïve or pegIFN + RBV-experienced with HCV GT1 or GT4/HIV-1 coinfection, without cirrhosis or with compensated cirrhosis
TURQUOISE-I - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s sočasno HCV GT1 ali GT4/HIV-1 okužbo, brez ciroze ali s kompenzirano cirozo
Recommendations for co-administration of Viekirax with and without dasabuvir for a number of medicinal products are provided in Table 2.
Priporočila za sočasno uporabo zdravila Viekirax (z dasabuvirjem ali brez njega) s številnimi zdravili so navedena v preglednici 2.
To be noted, atazanavir should be taken without ritonavir, since ritonavir 100 mg once daily is provided as part of Viekirax.
Poudariti velja, da je treba atazanavir uporabljati brez ritonavirja, kajti 100 mg ritonavirja enkrat na dan je sestavina zdravila Viekirax.
In the genotype 1b replicon, the activity of ombitasvir was reduced by less than 10-fold by variants at amino acid positions 30 and 31.
V replikonu genotipa 1b so variante na aminokislinskih mestih 30 in 31
NA A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Viekirax with or without dasabuvir .
NP Razmisliti je treba o 50 % zmanjšanju odmerka hidrokodona in/ali kliničnem spremljanju pri sočasnem dajanju s kombinacijo Viekirax z ali brez dasabuvirja.
0.75 mg single dose
0,75 mg enkratni odmerek
In the presence of dasabuvir, paritaprevir exposures increased by 50% to 65% while there was no change in ombitasvir exposures.
Vpliv dasabuvirja na paritaprevir/ritonavir in ombitasvir V prisotnosti dasabuvirja se je izpostavljenost paritaprevirju povečala za 50 do 65 %, izpostavljenost ombitasvirju pa se ni spremenila.
↑ voriconazole ↑ dasabuvir ↑ paritaprevir
↑ dasabuvir ↑ paritaprevir
Pink, oblong, biconvex, film-coated tablets of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘AV1'.
Rožnate, podolgovate bikonveksne filmsko obložene tablete velikosti 18,8 mm x 10,0 mm, ki imajo na eni strani vtisnjeno oznako "AV1".
Co-administration of Viekirax and dasabuvir with systemic tacrolimus, sirolimus or everolimus increases the concentrations of the immunosuppressant due to CYP3A inhibition by ritonavir (see section 4.5).
Sočasna uporaba zdravila Viekirax in dasabuvirja s sistemsko delujočimi takrolimusom, sirolimusom ali everolimusom poveča koncentracije imunosupresiva zaradi CYP3A inhibicije z ritonavirjem (glejte poglavje 4.5).
Plasma protein binding is not meaningfully altered in subjects with renal or hepatic impairment.
Vezava na beljakovine v plazmi pri bolnikih z okvaro ledvic ali jeter ni pomembno spremenjena.
Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments.
Za druge substrate CYP2C9 (NSAID (npr. ibuprofen), antidiabetiki (npr. glimepirid,
< 90, n (%)
< 90, n (%) ≥ 90, n (%)
Note: For laboratory abnormalities, refer to Table 4
Opomba: Za laboratorijske nepravilnosti glejte preglednico 4.
Phase 3 global multicentre studies conducted with Viekirax and dasabuvir with or without ribavirin (RBV).
Preglednica 6: Globalne multicentrične študije 3. faze z zdravilom Viekirax in dasabuvirjem, z ribavirinom (RBV) ali brez njega.
Following a 25 mg single dose of 14C-ombitasvir given alone, unchanged parent drug accounted for 8.9% of total radioactivity in human plasma; a total of 13 metabolites were identified in human plasma.
14C-ombitasvirja, uporabljenega samega, je šlo na račun nespremenjenega matičnega zdravila 8,9 % celotne radioaktivnosti v človeški plazmi; skupno so v človeški plazmi ugotovili 13 presnovkov.
Following dosing of ombitasvir/paritaprevir /ritonavir with or without dasabuvir, mean plasma half-life of paritaprevir was approximately 5.5 hours.
Po uporabi ombitasvirja/paritaprevirja/ritonavirja (z dasabuvirjem ali brez njega) je bil povprečni plazemski razpolovni čas paritaprevirja približno 5,5 ure.
Paritaprevir/ritonavir has shown malformations (open eye lids) at a low incidence in mice at exposures 32/8-fold higher than the exposure in humans at the recommended clinical dose.
S paritaprevirjem/ritonavirjem so pri miših ugotovili malformacije (odprte očesne veke) z majhno incidenco ob izpostavljenostih, ki so bile 32-/8-krat večje od izpostavljenosti človeka ob priporočenih kliničnih odmerkih.
Plasma HCV RNA values were measured during the clinical trials using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System (except GARNET which used COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0).
COBAS TaqMan HCV test (verzija 2.0), ki je namenjen za uporabo s sistemom High Pure System.
Medicines you must tell your doctor about before taking Viekirax Medicine or active substance
Zdravila, o katerih morate obvestiti zdravnika, preden vzamete zdravilo Viekirax
Emergent amino acid substitutionsa
Nastale aminokislinske substitucijea
The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as Viekirax + dasabuvir (ritonavir dose in Viekirax will provide darunavir pharmacokinetic enhancement).
Priporočeni odmerek darunavirja je 800 mg enkrat na dan, brez ritonavirja, če se da ob istem času kot zdravilo Viekirax in dasabuvir (odmerek ritonavirja v zdravilu Viekirax zagotavlja okrepitev
Co-administration of Viekirax with or without dasabuvir with medicinal products primarily metabolized by CYP3A may result in increased plasma concentrations of these medicinal products.
Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z zdravili, ki se presnavljajo predvsem s CYP3A, lahko poveča koncentracijo takšnih zdravil v plazmi.
Overall SVR12 Outcome for subjects without SVR12 On-treatment VF Relapse Other * Ombitasvir tablets, paritaprevir tablets and ritonavir capsules administered separately.
Celotni SVR12 Izid pri preiskovancih brez SVR12 VN med zdravljenjem Recidiv Drugo * Tablete ombitasvirja, tablete paritaprevirja in kapsule ritonavirja so bile uporabljene ločeno.
The maximum daily dose of rosuvastatin should be 10 mg (see section 4.4).
Največji dnevni odmerek rosuvastatina sme biti 10 mg (glejte poglavje 4.4).
↑ fluvastatin ↑ pitavastatin
Pričakovano: ↑ fluvastatin ↑ pitavastatin
Genotype 1a, without cirrhosis
Genotip 1a, brez ciroze
ANTI-DIURETIC HORMONE Conivaptan
ANTIDIURETIČNI HORMON
Propylene glycol monolaurate Sorbitan monolaurate Colloidal anhydrous silica (E 551) Sodium stearyl fumarate
Jedro tablete kopovidon tokofersolan propilenglikol monolavrat sorbitan monolavrat koloidni brezvodni silicijev dioksid (E 551) natrijev stearilfumarat
Paritaprevir, ritonavir and dasabuvir are inhibitors of BCRP in vivo.
Paritaprevir, ritonavir in dasabuvir in vivo zavirajo BCRP.
Following a single 25 mg dose of 14C- ombitasvir approximately 90% of the radioactivity was recovered in faeces and 2% in urine.
Po uporabi posameznega odmerka 25 mg 14C-ombitasvirja se je približno 90 % radioaktivnosti pojavilo v blatu in 2 % v urinu.
Increase in paritaprevir exposures may be due to
povečanje izpostavljenosti paritaprevirju je
Pharmacokinetics of the combination of ombitasvir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg, with or without dasabuvir 400 mg were evaluated in subjects with mild (CrCl: 60 to 89 ml/min), moderate (CrCl: 30 to 59 ml/min) and severe (CrCl: 15 to 29 ml/min) renal impairment.
Farmakokinetiko kombinacije 25 mg ombitasvirja, 150 mg paritaprevirja in 100 mg ritonavirja (s 400 mg dasabuvirja ali brez njega) so ocenili pri preiskovancih z blago (očistek kreatinina od 60 do 89 ml/min), zmerno (očistek kreatinina od 30 do 59 ml/min) in hudo (očistek kreatinina od 15 do 29 ml/min) okvaro ledvic.
Tell your doctor or pharmacist before taking Viekirax also if you are using hormonal contraceptives.
Pred začetkom jemanja zdravila Viekirax svojemu zdravniku povejte, če jemljete hormonske kontraceptive.
In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine +/- naloxone (N=19) received 12 weeks of Viekirax and dasabuvir with ribavirin.
V multicentrični, odprti študiji 2. faze z eno samo skupino, je 38 še nezdravljenih bolnikov oz. bolnikov, že zdravljenih s pegIFN/RBV, brez ciroze, in okuženih z genotipom 1, ki so dobivali stabilne odmerke metadona (N = 19) ali buprenorfina, z naloksonom ali brez njega (N = 19), 12 tednov prejemalo zdravilo Viekirax in dasabuvir skupaj z ribavirinom.
randomised, global multicentre, double-blind, placebo-controlled
Oblika preskušanja: randomizirano, globalno, multicentrično, dvojno slepo, s placebom kontrolirano
NARCOTIC ANALGESICS Paracetamol (as given in a fixed-dose hydrocodone/ paracetamol)
Paracetamol (kot fiksni odmerek kombinacije hidrokodon/par acetamol)
In genotype 1b, substitutions L28T, L31F/V, as well as Y93H alone or in combination with L28M, R30Q, L31F/M/V or P58S in HCV NS5A reduced susceptibility to ombitasvir.
Pri genotipu 1b so substitucije L28T, L31F/V, pa tudi Y93H sama ali v kombinaciji z L28M, R30Q, L31F/M/V ali P58S v NS5A HCV zmanjšala občutljivost za ombitasvir.
Following administration of Viekirax, the changes in ombitasvir, paritaprevir, and ritonavir exposures in subjects with mild, moderate and severe renal impairment were similar to those observed when Viekirax was administered with dasabuvir, and are not considered to be clinically significant.
Po uporabi zdravila Viekirax Po uporabi zdravila Viekirax so bile spremembe izpostavljenosti ombitasvirju, paritaprevirju in ritonavirju pri preiskovancih z blago, zmerno in hudo okvaro ledvic podobni, kot če je bilo zdravilo Viekirax uporabljeno z dasabuvirjem, in ne veljajo za klinično pomembne.
Medicinal Product/Poss ible Mechanism of Interaction
Zdravilo/može n mehanizem medsebojnega delovanja
BCRP substrates evaluated in drug interaction studies include rosuvastatin (see Table 2).
Med substrati BCRP, raziskanimi v študijah medsebojnega delovanja zdravil, je rosuvastatin (glejte preglednico 2).