natgillin/translations-raw huggingface dataset:
The recommended dose of darunavir is 800 mg once daily, without ritonavir, when administered at the same time as ombitasvir/paritaprevir/ ritonavir + dasabuvir (ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide darunavir pharmacokinetic enhancement).
Preporučena doza darunavira je 800 mg jedanput na dan bez ritonavira kada se primjenjuje u isto vrijeme s ombitasvir/paritaprevir/ri tonavir + dasabuvir (doza ritonavira u ombitasvir/paritaprevir/ri tonavir će djelovati kao farmakokinetički pojačivač darunaviru).
In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
U in vivo ispitivanjima interakcije lijekova ocjenjivo se neto učinak kombiniranog liječenja,
Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo and is not expected to inhibit organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations; therefore, Exviera does not affect medicinal product transport by these proteins.
Dasabuvir ne inhibira prijenosnik organskih aniona (OAT1) in vivo te se ne očekuje da će inhibirati prijenosnike organskih kationa (OCT2), prijenosnik organskih aniona (OAT3) niti proteine za ekstruziju više lijekova i toksina (MATE1 i MATE2K) pri klinički značajnim koncentracijama; stoga
Exviera 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 section 4.2 and 5.1).
Exviera se ne preporučuje za primjenu u monoterapiji nego se mora primjenjivati u kombinaciji s drugim lijekovima za liječenje infekcije hepatitisom C (vidjeti dio 4.2 i 5.1).
The overall safety profile in HCV-infected transplant recipients who were administered Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin (in addition to their immunosuppressant medicinal products) was similar to subjects treated with Exviera and ombitasvir/paritaprevir/ritonavir and ribavirin in phase 3 clinical trials, although some adverse reactions were increased in frequency.
Ukupan sigurnosni profil u ispitanika s transplantiranom jetrom s infekcijom HCV-om koji su liječeni lijekom Exviera i ombitasvirom/paritaprevirom/ritonavirom i ribavirinom (uz imunosupresivne lijekove) bio je sličan onome u ispitanika liječenih lijekom Exviera i ombitasvirom/paritaprevirom/ritonavirom i ribavirinom u fazi III kliničkih ispitivanja iako su neke nuspojave imale veću učestalost.
The recommended co-administered medicinal product(s) and treatment duration for Exviera combination therapy are provided in table 1.
Preporučeni lijek(ovi) za istodobnu primjenu s lijekom Exviera te trajanje kombinirang liječenja navedeni su u Tablici 1.
Subjects were on a stable HIV-1 antiretroviral therapy (ART) regimen that included ritonavir-boosted atazanavir or raltegravir, co-administered with a backbone of tenofovir plus emtricitabine or lamivudine.
Ispitanici su bili na stalnom režimu liječenja antiretroviroticima koji uključuje atazanavir ili raltegravir, čiju koncentraciju povećava ritonavir, uz istodobnu primjenu nosača tenofovira plus emtricitabin ili lamivudin.
Table 16 shows the SVR12 rates for subjects with HCV genotype 1 infection and HIV-1 co-infection in TURQUOISE-I.
Tablica 16 prikazuje stope SVR12 kod ispitanika s infekcijom virusom hepatitisa C genotipa 1 i istodobnu infekciju virusom HIV-1 u TURQUOISE-I.
Three interrupted Exviera and ombitasvir/paritaprevir/ritonavir for one to seven days, including one on ethinylestradiol.
Tri su bolesnika prekinula uzimati lijek Exviera s ombitasvirom/paritaprevirom/ritonavirom na jedan do sedam dana, uključujući jednog na etinilestradiolu.
The safety profile of Exviera and ombitasvir/paritaprevir/ritonavir was similar in patients without cirrhosis, and with compensated cirrhosis, with exception of increased rates of transient hyperbilirubinemia when ribavirin was part of the regimen.
Sigurnosni profil lijekova Exviera i ombitasvir/paritaprevir/ritonavir bio je sličan u bolesnika bez ciroze i u bolesnika s kompenziranom cirozom uz izuzetak povećane učestalosti pojave prolazne hiperbilirubinemije kada je ribavirin bio dio liječenja.
− Tablet film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), iron oxide yellow (E172), iron oxide red (E172) and iron oxide black (E172).
Film ovojnica tablete: polivinilni alkohol (E1203), titanijev dioksid (E171), polietilenglikol 3350, talk (E553b), žuti željezov oksid (E172), crveni željezov oksid (E172) i crni željezov oksid (E172).
Cyclobenzap rine 5 mg single dose
Klinička napomena ciklobenzap rin 5 mg pojedinačna doza
Patients should be informed that fatigue has been reported during treatment with Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin (see section 4.8).
Bolesnike je potrebno upozoriti da je tijekom liječenja lijekom Exviera u kombinaciji s ombitasvirom/paritaprevirom/ritonavirom i ribavirinom prijavljen umor (vidjeti dio 4.8).
Recommendations for co-administration of Exviera with ombitasvir/paritaprevir/ritonavir for a number of medicinal products are provided in Table 2.
Preporuke za istodobnu primjenu lijeka Exviera s ombitasvirom/paritaprevirom/ritonavirom s nizom drugih lijekova nalaze se u Tablici 2.
For the use of HIV protease inhibitors other than atazanavir and darunavir refer to the Summary of Product Characteristics of ombitasvir/ paritaprevir /ritonavir.
Za korištenje inhibitora proteaze HIV-a osim atazanavira i darunavira pogledajte Sažetak opisa svojstava lijeka za ombitasvir /paritaprevir /ritonavir.
The effect on rilpivirine exposures was similar to that observed when rilpivirine was administered in the morning with food with Exviera + ombitasvir/paritaprevir/ritonavir.
Učinak na izloženosti rilpivirinu bio je sličan kao i kada se rilpivirin primjenjivao ujutro, s hranom, s lijekovima Exviera i ombitasvir/paritaprevir/ritonavir.
Following a 400 mg 14C-dasabuvir dose in humans, unchanged dasabuvir was the major component (approximately
Nakon primjene doze od 400 mg 14C-dasabuvira u ljudi, neizmijenjeni dasabuvir bio je glavna komponenta (približno 60%) radioaktivnosti povezane s lijekom u plazmi.
Recommended co-administered medicinal product(s) and treatment duration for Exviera by patient population
Preporučeni lijek(ovi) za istodobnu primjenu s lijekom Exviera te trajanje liječenja prema skupinama bolesnika
Medicinal products renally excreted via transport proteins Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo as shown by the lack of interaction with tenofovir (OAT1 substrate).
Dasabuvir ne inhibira prijenosnik organskih aniona (OAT1) in vivo što je pokazao izostanak interakcije s tenofovirom (supstrat za OAT1).
Exviera should be used in combination with other medicinal products for the treatment of HCV (see section 5.1).
Exviera se mora uzimati u kombinaciji s drugim lijekovima za liječenje virusa hepatitisa C (HCV) (vidjeti dio 5.1).
Not Studied.
Nije ispitivano.
Exviera is recommended in combination with paritaprevir/ombitasvir/ritonavir, and ritonavir may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy.
Exviera se preporuča u kombinaciji s paritaprevirom/ombitasvirom/ritonavirom, a ritonavir može izazvati rezistentnost na inhibitore proteaze (PI) kod bolesnika s istodobnom infekcijom HIV-om ako istodobno ne uzimaju antiretrovirusne lijekove.
Patients receiving ribavirin should also refer to the Summary of Product Characteristics of ribavirin.
Bolesnici koji primaju ribavirin moraju pročitati i Sažetak opisa svojstava lijeka za ribavirin.
If ribavirin is co-administered with Exviera and ombitasvir/paritaprevir/ritonavir, the contraindications regarding use of ribavirin during pregnancy apply (see also the Summary of Product Characteristics of ribavirin).
Ako se ribavirin primjenjuje istodobno s lijekovima Exviera i ombitasvir/paritaprevir/ritonavir, vrijede kontraindikacije koje se odnose na primjenu ribavirina tijekom trudnoće (vidjeti i Sažetak opisa svojstava lijeka za ribavirin).
Dabigatran etexilate
Dabigatran eteksilat
Co-administration of Exviera and ombitasvir/paritaprevir/ ritonavir with rilpivirine once daily should only be considered in patients without known QTprolongation, and without other QTprolongation coadministered medicinal products.
Istodobna primjena lijekova Exviera i ombitasvir/paritaprevir/ri tonavir s rilpivirinom jedanput na dan smije se uzeti u obzir jedino u bolesnika bez poznatog produljenja QT intervala te bez produljenja QT intervala zbog istodobno primijenjenih lijekova.
Taking into account the protein binding and in vitro activity of M1 against HCV genotype 1, its contribution to efficacy is expected to be similar to that of dasabuvir.
Uzimajući u obzir vezanje na proteine i in vitro aktivnost M1 protiv genotipa 1 HCV-a,
Refer to the Summary of Product Characteristics of the medicinal products that are used in combination with Exviera.
Pročitajte Sažetak opisa svojstava lijeka za lijekove koji se primjenjuju u kombinaciji s lijekom Exviera.
The safety of Exviera in children and adolescents aged < 18 years has not yet been established.
Sigurnost primjene lijeka Exviera u djece i adolescenata mlađih od 18 godina nije još ustanovljena.
Note: Doses used for Exviera + ombitasvir/paritaprevir/ritonavir were: ombitasvir 25 mg paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
Napomena: primijenjene doze lijekova Exviera + ombitasvir/paritaprevir/ritonavir bile su: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg, jedanput na dan, te dasabuvir 400 mg dvaput na dan ili 250 mg dvaput na dan.
Potential for Exviera to affect the pharmacokinetics of other medicinal products
Farmakokinetičke interakcije Mogući utjecaj lijeka Exviera na farmakokinetiku drugih lijekova
Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection enzalutamide for prostate cancer ethinylestradiol containing medicines such as those contained in most contraceptive pills and vaginal rings used for contraception for contraception gemfibrozil to lower cholesterol and other fats in the blood mitotane for some tumours of the adrenal glands rifampicin for bacterial infections
Namjena lijeka karbamazepin, fenitoin, fenobarbital za liječenje epilepsije efavirenz, etravirin, nevirapin za liječenje HIV infekcije enzalutamid za rak prostate lijekovi koji sadrže etinilestradiol, poput većine lijekova za sprječavanje začeća i vaginalni kontracepcijski prstenovi.
In subjects with all three favourable baseline laboratory values (AFP < 20 ng/mL, platelets ≥ 90 x 109/L, and albumin ≥ 35 g/L), relapse rates were similar in subjects treated for 12 or 24 weeks.
U ispitanika koji su prije početka liječenja ispunjavali kriterije za vrijednosti po sva tri parametra (AFP < 20 ng/ml, broj trombicita ≥ 90 x 109/l i albumin ≥ 35 g/l), stope relapsa bile su slične kod ispitanika iz skupine koja je liječena 12 tjedana kao i kod ispitanika iz skupine koja je liječena 24
See sections 4.8 and 5.1 for additional information.
Za dodatne informacije vidjeti dijelove 4.8 i 5.1. Bolesnici s transplantiranom jetrom
Polyvinyl alcohol (E1203) Titanium dioxide (E171) Polyethylene glycol 3350 Talc (E553b) Iron oxide yellow (E172) Iron oxide red (E172) Iron oxide black (E172)
Film ovojnica: poli(vinilni alkohol) (E1203) titanijev dioksid (E171) polietilenglikol 3350 talk (E553b) željezov oksid, žuti (E172) željezov oksid, crveni (E172) željezov oksid, crni (E172)
In subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin, adverse events typically associated to ribavirin (e.g. nausea, insomnia, anaemia) were less frequent and no subjects (0/588) permanently discontinued treatment due to adverse reactions.
nuspojave najčešće povezane s ribavirinom (npr. mučnina, nesanica, anemija) bile su manje učestale te nijedan ispitanik (0/588) nije trajno obustavio liječenje zbog nuspojava.
A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
NP Mora se razmotriti smanjenje doze hidrokodona za 50% i/ili kliničko praćenje kada se primjenujuje s lijekovima Exviera + ombitasvir/paritaprevir/ri tonavir.
Two patients discontinued Exviera and ombitasvir/paritaprevir/ritonavir due to elevated ALT, including one on ethinylestradiol.
Dva su bolesnika prestala uzimati lijek Exviera u kombinaciji s ombitasvirom/paritaprevirom/ritonavirom zbog povišenih razina ALT-a uključujući jednog na etinilestradiolu.
Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral agents with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Istodobna primjena dasabuvira s ombitasvirom/paritaprevirom/ritonavirom uključuje tri antivirotika koji djeluju izravno na HCV u različitim fazama životnog ciklusa virusa, s različitim mehanizmima djelovanja i profilima rezistencije koji se ne preklapaju.
If dose adjustments of concomitant medicinal products are made due to treatment with Exviera and ombitasvir/paritaprevir/ritonavir, doses should be re-adjusted after administration of Exviera and ombitasvir/paritaprevir/ritonavir is completed.
Ako se zbog liječenja lijekovima Exviera i ombitasvir/paritaprevir/ritonavir prilagode doze istodobno primijenjenih lijekova, te se doze moraju ponovno prilagoditi nakon što liječenje lijekovima Exviera i ombitasvir/paritaprevir/ritonavir završi.
In TURQUOISE-I, the SVR12 rates in HCV/HIV-1 co-infected subjects were consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
U kliničkom ispitivanju TURQUISE-I, stopa SVR12 kod ispitanika koji imaju istodobnu infekciju HCV-om i virusom HIV-1 bila je ista kao i stopa SVR12 zabilježena u fazi 3 ovog ispitivanja kod ispitanika koji imaju monoinfekciju HCV-om.
NS3 V55I
NS3 V55Ic Y56Hc
Methadone ↔ ombitasvir/paritaprevir and dasabuvir (based on the cross-study comparison)
metadon ↔ ombitasvir/paritaprevir i dasabuvir (na temelju usporedbe podataka iz različitih ispitivanja)
Genotype 1a, with compensated cirrhosis
Bolesnici s genotipom 1a, s kompenziranom cirozom
Talk to your doctor or pharmacist before taking Exviera if you: -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.
- imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pobliže pratiti.
Exviera should not be used in patients with severe hepatic impairment (ChildPugh C) (see section 5.2).
Exviera se ne smije koristiti u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) (vidjeti dio 5.2).
Wort (hypericum perforatum)
Gospina trava (hypericum perforatum)
Genotype 1a, without cirrhosis
C genotipa 1a bez ciroze.
In all seven trials, the Exviera dose was 250 mg twice daily and the ombitasvir/paritaprevir/ritonavir dose was 25 mg/150 mg/100 mg once daily.
U svih je sedam ispitivanja doza lijeka Exviera iznosila 250 mg dvaput na dan, a doza lijeka ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg jedanput na dan.
In the CORAL-1 study, the safety and efficacy of Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin for 24 weeks was studied in 34 HCV genotype 1-infected liver transplant recipients who were at least 12 months post-transplant at study enrolment.
U CORAL-1 ispitivanju, ocjenjivala se sigurnost i djelotvornost lijekova Exviera i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribivarinom, tijekom 24 tjedana liječenja, kod 34 bolesnika s transplantiranom jetrom koji imaju infekciju HCV-om genotipa 1 i kojima je u trenutku uključivanja u ispitivanje prošlo više od 12 mjeseci od transplantacije.
As liver function may change during treatment with Exviera administered with ombitasvir/paritaprevir/ritonavir, a close monitoring of International Normalised Ratio (INR) values is recommended.
Budući da prilikom liječenja lijekom Exviera, s ombitasvirom/paritaprevirom/ritonavirom, može doći do promjene funkcije jetre, preporučuje se odgovarajući nadzor internacionalnog normaliziranog omjera (INR).
HIV ANTIVIRALS: INTEGRASE STRAND TRANSFER INHIBITOR Dolutegravir
ANTIVIROTICI ZA LIJEČENJE HIV-a: INIHIBITOR PRIJENOSA LANCA INTEGRAZE Dolutegravir
It may not be excluded that the systemic exposure of dabigatran etexilate is increased by dasabuvir due to inhibition of P-gp in the intestine.
Ne može se isključiti da dasabuvir povećava sistemsku izloženost dabigatran eteksilatu zbog inhibicije
Dasabuvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
5.3 Neklinički podaci o sigurnosti primjene Dasabuvir nije bio genotoksičan u nizu in vitro ili in vivo testova, uključujući test mutagenosti na bakterijama, test kromosomskih aberacija na limfocitima iz ljudske periferne krvi te in vivo mikronukleusni test na štakorima.
The long-term clinical impact of the emergence or persistence of virus containing Exviera and ombitasvir/paritaprevir/ritonavir -resistanceassociated substitutions on future treatment is unknown.
Nije poznat dugoročan klinički utjecaj pojave ili postojanosti virusa koji sadrži supstitucije povezane s rezistencijom na lijekove Exviera i ombitasvir/paritaprevir/ritonavir.
c, V36M
Varijante V36A/M,
Exviera should not be used in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.8 and 5.2).
Exviera se ne smije koristiti u bolesnika s teškim oštećenjem funkcije jetre (ChildPugh stadij C) (vidjeti dijelove 4.2, 4.8 i 5.2).
Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B) (see sections 4.4 and 4.8).
Ne preporučuje se primjena lijeka Exviera u bolesnika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B) (vidjeti dijelove 4.4 i 4.8).
Marketing Authorisation Holder AbbVie Ltd
ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET AbbVie Ltd
Note: The following variants were selected in cell culture but were not treatment-emergent: NS3 variants A156T in genotype 1a, and R155Q and D168H in genotype 1b; NS5A variants Y93C/H in genotype 1a, and L31F/V or Y93H in combination with L28M, L31F/V or P58S in genotype 1b; and NS5B variants Y448H in genotype 1a, and M414T and Y448H in genotype 1b.
varijante A1567T u genotipu 1a te R155Q i D168H u genotipu 1b; NS5A varijante Y93C/H u genotipu 1a te L31F/V ili Y93H u kombinaciji s L28M, L31F/V ili P58S u genotipu 1b; NS5B varijante Y448H u genotipu 1a te M414T i Y448H u genotipu 1b.
Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
laktoza hidrat kopovidon karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni (E551) magnezijev stearat (E470b)
Ethinylestradiol containing oral contraceptives are contraindicated (see section 4.3).
Primjena oralnih kontraceptiva koji sadrže etinilestradiol je kontraindicirana (vidjeti dio 4.3)
TURQUOISE-II: relapse rates by baseline laboratory values after 12 and 24 weeks of treatment in subjects with genotype 1a infection and compensated cirrhosis
Stope relapsa u odnosu na početne laboratorijske vrijednosti u ispitanika s infekcijom genotipom 1a i kompenziranom cirozom nakon 12 i 24 tjedna liječenja
When starting coadministration with Exviera and ombitasvir/paritaprevir/ ritonavir, give one fifth of the total daily dose of ciclosporin once daily with ombitasvir/ paritaprevir /ritonavir.
Kada se započinje istodobna primjena s lijekovima Exviera i ombitasvir/paritaprevir/ri tonavir, primijeniti jednu petinu ukupne dnevne doze ciklosporina jedanput na dan s ombitasvirom/ pariteprivirom/ritonaviro m.
MEDICINAL PRODUCTS USED IN MULTIPLE SCLEROSIS Teriflunomid e
LIJEKOVI ZA LIJEČENJE MULTIPLE SKLEROZE
Other a. These virologic failures appear to have resulted from reinfection based on analyses of baseline and virologic failure samples
Virološki neuspjeh je, vjerojatno, rezultat ponovne infekcije obzirom na rezultate analize uzoraka uzetih prije liječenja i nakon virološkog neuspjeha.
HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine
ANTIVIROTICI ZA LIJEČENJE HIV-a: NENUKLEOZIDNI INHIBITORI REVERZNE TRANSKRIPTAZE Rilpivirin2
NA ↔ ombitasvir /paritaprevir and dasabuvir (based on the cross-study comparison)
NP ↔ ombitasvir/paritaprevir i dasabuvir (na temelju usporedbe podataka iz različitih ispitivanja)
OPIOIDS Methadone Exviera
OPIOIDI Metadon
No dose adjustment of Exviera is required in patients with mild hepatic impairment (Child-Pugh A).
Nije potrebno prilagođavati dozu lijeka Exviera u bolesnika s blagim oštećenjem funkcije jetre (ChildPugh stadij A).
In the 67 genotype 1a infected subjects, NS3 variants were observed in 50 subjects, NS5A variants were observed in 46 subjects, NS5B variants were observed in 37 subjects, and treatment emergent variants were seen in all 3 drug targets in 30 subjects.
Varijante nastale tijekom liječenja i njihova prevalencija u tim populacijama s virološkim neuspjehom prikazane su u Tablici 5. Među 67 ispitanika s infekcijom genotipom 1a, varijante NS3 primijećene su u 50 ispitanika, varijante NS5A u 46 ispitanika, varijante NS5B u 37 ispitanika, a varijante nastale tijekom liječenja na ciljnim mjestima svih triju lijekova primijećene su u 30 ispitanika.
Rilpivirine was also administered with food in the evening and 4 hours after dinner with Exviera + ombitasvir/paritaprevir/ritonavir in the study.
U ispitivanju rilpivirin se uzimao i s hranom navečer te 4 sata nakon večere, s lijekovima Exviera i ombitasvir/paritaprevir/ritonavir.
Peg-IFN + RBV, n (%) Baseline albumin, median g/L
Peg-IFN + RBV, n (%)
Ritonavir dose in ombitasvir/paritaprevir/ ritonavir will provide atazanavir pharmacokinetic enhancement.
Doza ritonavira u ombitasvir/paritaprevir/ri tonavir će djelovati kao farmakokinetički pojačivač atazanaviru.
Mechanism: CYP3A4 induction by enzalutamide or mitotane.
Mehanizam: CYP3A4 indukcija enzalutamid om ili mitotanom.
TURQUOISE-III is a Phase 3b, open-label, single-arm, multicentre study evaluating the efficacy and safety of Exviera and ombitasvir/paritaprevir/ritonavir (without ribavirin) administered for 12 weeks in HCV GT1b-infected, treatment-naïve and pegIFN/RBV treatment-experienced adults with compensated cirrhosis.
TURQUOISE-III je bilo otvoreno, multicentrično ispitivanje faze 3b s jednom skupinom u kojem su se ocjenjivale djelotvornost i sigurnost lijeka Exviera i ombitasvira/paritaprevira/ritonavira (bez ribavirina) primjenjivanih tijekom 12 tjedana u odraslih ispitanika s infekcijom HCV-om genotipa 1b i kompenziranom cirozom koji prethodno nisu bili liječeni ili su primali pegIFN/RBV.
Mechanism: CYP3A4 induction by carbamazepi ne.
Mehanizam: indukcija CYP3A4 karbamazepi nom.
TURQUOISE-II was a randomised, global multicentre, open-label trial conducted exclusively in 380 genotype 1-infected subjects with compensated cirrhosis (Child-Pugh A) who were either treatmentnaïve or did not achieve SVR with prior treatment with pegIFN/RBV.
TURQUOISE-II bilo je randomizirano, globalno, multicentrično, otvoreno ispitivanje provedeno isključivo u 380 ispitanika s infekcijom genotipom 1 i kompenziranom cirozom (Child-Pugh stadij A) koji prethodno nisu bili liječeni ili nisu postigli SVR uz prethodno liječenje kombinacijom pegIFN/RBV.
A majority (86.8%) had baseline HCV RNA levels of at least 800,000 IU/mL and a majority (84.2%) had genotype 1a infection; 68.4% had IL28B non-CC genotype; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment.
800,000 IU/ml a većina (84.2%) je imala infekciju HCV-om genotipa 1a, 68,4% je imalo IL28B nonCC genotip, 15,8% je imalo portalnu fibrozu (F2) a 5,3% premoštavajuću („bridging“) fibrozu (F3)
The recommended dose of atazanavir is 300 mg, without ritonavir, in combination with Exviera + ombitasvir/paritaprevir/ ritonavir.
Preporučena doza atazanavira je 300 mg bez primjene ritonavira s lijekom Exviera + ombitasvir/paritaprevir/ri tonavir.