natgillin/translations-raw huggingface dataset:
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.
Súbežné podávanie Exviery s ombitasvirom/paritaprevirom/ritonavirom môže viesť k zmene funkcie pečene, odporúča sa pravidelne sledovať hodnoty medzinárodného normalizovaného pomeru
Treatment duration was fixed in each trial and was not guided by subjects'
Dĺžka liečby bola pevne stanovená v každom skúšaní a nebola determinovaná hladinami HCV RNA u subjektov (algoritmus bez ohľadu na odpoveď).
Exviera safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Bezpečnosť a účinnosť Exviery bola stanovená v kombinácii s ombitasvirom/ paritaprevirom
Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Exviera with ombitasvir/paritaprevir/ritonavir with and without ribavirin.
Riziko dekompenzácie pečene a zlyhania pečene u pacientov s cirhózou Dekompenzácia pečene a zlyhanie pečene, vrátane transplantácie pečene alebo fatálnych následkov,
Co-administration of dasabuvir with medicinal products that inhibit CYP2C8 (e.g. teriflunomide, deferasirox) may increase dasabuvir plasma concentrations.
Súbežné podávanie dasabuviru s liekmi, ktoré inhibujú CYP2C8 (napríklad teriflunomid, deferasirox),
Geometric mean Cmax, AUC of multiple doses of Exviera 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
Tabuľka 17. Geometrický priemer Cmax, AUC opakovaných dávok Exviery 250 mg dvakrát denne a ombitasviru/paritapreviru/ritonaviru 25 mg/150 mg/100 mg jedenkrát denne s jedlom u zdravých dobrovoľníkov
Phase 3 global multicentre trials conducted with Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin (RBV).
Tabuľka 6. Globálne multicentrické skúšania fázy 3 zamerané na Exvieru a ombitasvir/paritaprevir/ritonavirs ribavirínom alebo bez neho (RBV).
Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Pacienti randomizovaní do skupiny s placebom dostávali placebo počas 12 týždňov; po tomto období dostávali Exvieru a ombitasvir/paritaprevir/ritonavir v kombinácii s ribavirínom počas 12 týždňov.
SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV
SVR12 pre pacientov infikovaných genotypom 1 s kompenzovanou cirhózou, ktorí boli buď predtým neliečení, alebo boli predtým liečení pegIFN/RBV.
HIV ANTIVIRALS: NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Rilpivirine
HIV: NENUKLEOZIDOVÉ INHIBÍTORY REVERZNEJ TRANSKRIPTÁZY
Co-administration of Exviera with medicinal products that are strong or moderate enzyme inducers is expected to decrease dasabuvir plasma concentrations and reduce its therapeutic effect (see section 4.5.
Predpokladá sa, že súbežné podávanie Exviery s liekmi, ktoré sú silnými alebo stredne silnými induktormi enzýmov by viedlo k zníženiu jeho terapeutického účinku (pozri čať 4.5).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Iné lieky a Exviera Prosím, informujte svojho lekára alebo lekárnika o všetkých liekoch, ktoré užívate, ktoré ste nedávno užívali alebo ktoré by ste mohli užívať.
PEARL-III - genotype 1b, treatment-naïve
PEARL-III - genotyp 1b, predtým neliečení pacienti
The efficacy and safety of Exviera in combination with ombitasvir/paritaprevir/ritonavir with and without ribavirin was evaluated in seven Phase 3 clinical trials, including two trials exclusively in subjects with compensated cirrhosis (Child-Pugh A), in over 2,360 subjects with genotype 1 chronic hepatitis C infection as summarised in Table 6.
Účinnosť a bezpečnosť Exviery v kombinácii s ombitasvirom/paritaprevirom/ritonavirom s ribavirínom alebo bez neho bola hodnotená v siedmich randomizovaných klinických skúšaniach fázy 3, vrátane dvoch štúdií výhradne u pacientov s kompenzovanou cirhózou (trieda
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Ak potrebujete akúkoľvek informáciu o tomto lieku, kontaktujte, prosím, miestneho zástupcu držiteľa rozhodnutia o registrácii: België/Belgique/Belgien AbbVie SA
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.
Ak sa vykonajú úpravy dávok súbežne podávaných liekov z dôvodu liečby Exvierou a ombitasvirom/paritaprevirom/ritonavirom, dávky sa majú znovu upraviť potom, ako sa podávanie
Microcrystalline cellulose (E460(i)) Lactose monohydrate Copovidone
Mikrokryštalická celulóza (E460(i))
The majority of these ALT elevations were transient and assessed as related to Exviera and ombitasvir/paritaprevir/ritonavir.
Väčšina týchto prípadov zvýšenia hladín ALT bola prechodná a bola posúdená ako súvisiaca s Exvierou a ombitasvirom/paritaprevirom/ritonavirom.
Use of ethinylestradiol-containing medicinal products such as those contained in most combined oral contraceptives or contraceptive vaginal rings (see section 4.4 and 4.5).
Používanie liekov obsahujúcich etinylestradiol, aké sú obsiahnuté vo väčšine kombinovaných perorálnych antikoncepčných prípravkov alebo v antikoncepčných vaginálnych krúžkoch (pozri časti
• enzalutamide
• enzalutamid;
Mechanism: CYP2C19 induction by ritonavir
Mechanizmus: indukcia CYP2C19 ritonavirom
Tacrolimus 2 mg was dosed alone and 2 mg was administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Takrolimus 2 mg bol podávaný samostatne a súbežne s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
No dose adjustment of Exviera is required for patients with mild, moderate, or severe renal impairment or end-stage-renal disease on dialysis (see section 5.2).
U pacientov s miernou, stredne ťažkou alebo ťažkou poruchou funkcie obličiek alebo v konečnom štádiu ochorenia obličiek na dialýze nie je potrebná úprava dávky Exviery (pozri časť 5.2).
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.
Súbežné podávanie Exviery a ombitasviru/ paritapreviru/ritonaviru s rilpivirínom jedenkrát denne sa môže zvážiť len u pacientov bez známeho
SVR12 for HIV-1 co-infected Subjects in TURQUOISE-I
Tabuľka 16. SVR12 u pacientov so súbežnou infekciou HIV-1 v štúdii TURQUOISE-I
NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets
Exviera 250 mg filmom obalené tablety
ALT >5-20 × ULN* (Grade 3) >20 × ULN (Grade 4) Haemoglobin <100-80 g/L (grade 2) <80-65 g/L (grade 3) <65 g/L (Grade 4) Total bilirubin >3-10 × ULN (grade 3) >10 × ULN (grade 4) *ULN: Upper Limit of Normal
80 - 65 g/l (Stupeň 3) < 65 g/l (Stupeň 4)
Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects.
V36A/M, R155K alebo D168V, ktoré sa objavili počas liečby paritaprevirom, boli pozorované v NS3
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
enzalutamid na liečbu karcinómu prostaty lieky obsahujúce etinylestradiol, ktorý obsahuje väčšina antikoncepčných tabletiek a antikoncepčné vaginálne krúžky na antikoncepciu gemfibrozil na zníženie hladiny cholesterolu a ďalších tukov v krvi mitotán na niektoré zhubné nádory nadobličiek rifampicín na liečbu bakteriálnych infekcií ľubovník bodkovaný (Hypericum perforatum) rastlinný liek na úzkosť a miernu depresiu, tento liek je dostupný bez lekárskeho predpisu
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of dasabuvir (as sodium monohydrate).
Jedna filmom obalená tableta obsahuje 250 mg dasabuviru (vo forme monohydrátu sodnej soli).
SAPPHIRE-I was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 631 treatment-naïve adults with genotype 1 chronic hepatitis C virus infection without cirrhosis.
SAPPHIRE-I bola randomizovaná, globálna multicentrická, dvojito zaslepená, placebom kontrolovaná štúdia vykonaná na 631 predtým neliečených dospelých pacientoch s chronickou infekciou vírusom hepatitídy
The mean EC50 of dasabuvir against replicons containingNS5B from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.77 nM (range 0.4 to 2.1 nM; n=11) and 0.46 nM (range 0.2 to 2 nM; n=10), respectively.
EC50 dasabuviru proti replikónom obsahujúcim NS5B zo skupiny doteraz neliečených izolátov genotypu 1a respektíve 1b v teste zameranom na replikónové bunkové kultúry HCV bola 0,77 nM (rozsah 0,4 až 2,1 nM, n =
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).
Je potrebné informovať pacientov, že počas liečby Exvierou v kombinácii s ombitasvirom/paritaprevirom/ritonavirom a ribavirínom bola hlásená únava (pozri časť 4.8). 4.8 Nežiaduce účinky
Exviera is not recommended in patients with moderate hepatic impairment (Child-Pugh B).
Exviera sa neodporúča u pacientov so stredne ťažkou poruchou funkcie pečene (trieda
↑ dabigatran etexilate
Očakáva sa: ↑ dabigatránetexilát
D168Y V36A
V36A
Subjects were randomised in a 1:2 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Pacienti boli randomizovaní v pomere 1:2 na podávanie Exviery a ombitasviru/paritapreviru/ritonaviru s ribavirínom alebo bez neho počas 12 týždňov liečby.
Subjects were randomised in a 1:1 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Pacienti boli randomizovaní v pomere 1:1 na podávanie Exviery a ombitasviru/paritapreviru/ritonaviru s ribavirínom alebo bez neho počas 12 týždňov liečby.
Ciclosporin 100 mg dosed alone and 30 mg administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Cyklosporín 100 mg podávaný samostatne a 30 mg podávaný súbežne s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
Exviera and ombitasvir/paritaprevir/ritonavir were given for 12 weeks of treatment in combination with ribavirin.
Exviera a ombitasvir/paritaprevir/ritonavir boli podávané počas 12 týždňov liečby v kombinácii s ribavirínom.
Mechanism: CYP3A4 inhibition by ritonavir
Mechanizmus: inhibícia CYP3A4 ritonavirom
ANTIBIOTICS (SYSTEMIC ADMINISTRATION) Sulfamethoxazole, trimethoprim
Sulfametoxazol, trimetoprim
A reduction of hydrocodone dose by 50% and/or clinical monitoring should be considered when administered with Exviera + ombitasvir/paritaprevir /ritonavir.
NA Pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom sa má zvážiť zníženie dávkovania hydrokodónu o 50 % a/alebo klinické monitorovanie.
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.
Celkový bezpečnostný profil u pacientov infikovaných HCV po transplantácii pečene, ktorým bola podávaná Exviera a ombitasvir/paritaprevir/ritonavir a ribavirín (popri imunosupresívnych liekoch),
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir.
Mechanizmus: inhibícia OATP1B paritaprevirom a inhibícia BCRP dasabuvirom, paritaprevirom a ritonavirom.
Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin were administered for either 12 or 24 weeks of treatment.
Exviera a ombitasvir/paritaprevir/ritonavir v kombinácii s ribavirínom boli podávané počas 12- alebo 24-týždňovej liečby.
OTHER
Ostatné
Other a. These virologic failures appear to have resulted from reinfection based on analyses of baseline and virologic failure samples
Na základe analýzy východiskového stavu a vzoriek virologického zlyhania sa zdá, že tieto virologické zlyhania boli výsledkom reinfekcie.
Contents of the pack and other information
Obsah balenia a ďalšie informácie Čo Exviera obsahuje
While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Aj keď v prípade warfarínu sa neočakáva žiadna zmena vo farmakokinetike,
Dose normalized cyclosporine ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Pomery cyklosporínu normalizované na dávku sú uvedené pre interakciu s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
NAME OF THE MEDICINAL PRODUCT Exviera 250 mg film-coated tablets dasabuvir
Exviera 250 mg filmom obalené tablety dasabuvir
Adverse reactions identified with Exviera in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Tabuľka 3. Nežiaduce reakcie zistené pri Exviere v kombinácii s ombitasvirom/paritaprevirom/ritonavirom alebo s ombitasvirom/paritaprevirom/ritonavirom a ribavirínom
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.
V štúdii TURQUOISE-I boli hodnoty SVR12 u pacientov infikovaných HCV so súbežnou infekciou HIV-1 konzistentné s hodnotami SVR12 zistenými v rámci klinických štúdií fázy 3 zameraných na pacientov s monoinfekciou HCV. 7 zo 7 pacientov s infekciou genotypom 1b a 51 z 56 pacientov s infekciou genotypom 1a dosiahlo SVR12.
PEARL-III was a randomised, global multicentre, double-blind, controlled trial conducted in 419 treatment-naïve adults with genotype 1b chronic hepatitis C virus infection without cirrhosis.
PEARL-III bola randomizovaná, globálna multicentrická, dvojito zaslepená, kontrolovaná štúdia vykonaná na 419 predtým neliečených dospelých pacientoch s chronickou infekciou vírusom hepatitídy
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir
Mechanizmus: inhibícia CYP3A4/P-gp ketokonazolom a dasabuvirom, paritaprevi rom/ritonavirom /ombitasvirom.
↔ carba mazepine
↔ karba mazepín
Tacrolimus 2 mg single dose4
2 mg jednorazová dávka4
In subjects with mild, moderate and severe renal impairment, dasabuvir mean AUC values were 21% higher, 37% higher and 50% higher, respectively.
U pacientov s miernou, stredne ťažkou a ťažkou poruchou funkcie pečene boli hodnoty AUC o 17 %
PEARL-IV was a randomised, global multicentre, double-blind, controlled trial conducted in 305 treatment-naïve adults with genotype 1a chronic hepatitis C virus infection without cirrhosis.
PEARL-IV bola randomizovaná, globálna multicentrická, dvojito zaslepená, kontrolovaná štúdia vykonaná na 305 predtým neliečených dospelých pacientoch s chronickou infekciou vírusom hepatitídy
Biotransformation
Cyklosporín
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.
% malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 15,4 % malo portálnu fibrózu (F2) a 8,7 % malo premosťujúcu fibrózu (F3); 67,7 % malo infekciu HCV genotypu 1a; 32,3 % malo infekciu HCV genotypu 1b.
PEARL-IV- genotype 1a, treatment-naïve
PEARL-IV- genotyp
Age, median (range) years Male gender, n (%) IL28B Non-CC genotype, n (%) Prior HCV Treatment:
Vek, priemer (rozpätie) roky Mužské pohlavie, n (%)
Baseline platelet count, median (× 109/L) < 90, n (%) ≥ 90, n (%) Pooled analyses of clinical trials Durability of response Overall, 660 subjects in Phase 2 and 3 clinical trials had HCV RNA results for both the SVR12 and SVR24 time points.
Dovedna 660 pacientov v klinických skúšaniach fázy 2 a 3 malo výsledky HCV RNA tak v časovom bode SVR12, ako aj SVR24.
Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV
Rameno A: Exviera a ombitasvir/paritaprevir/ritonavir + RBV
No dose adjustment is necessary for emtricitabine/tenofovir and Exviera + ombitasvir/paritaprevir/ ritonavir.
Nie je potrebná úprava dávkovania emtricitabínu/tenofoviru a Exviery + ombitasviru/ paritapreviru/ritonaviru.
ANTICONVULSANTS carbamazepine
ANTIKONVULZÍVA Karbamazepín
Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin was given for 12 weeks of treatment.
Exviera a ombitasvir/paritaprevir/ritonavir v kombinácii s ribavirínom boli podávané počas 12-týždňovej liečby.
Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
63) mali medián veku 51 rokov (rozsah: 31 až 69); 24 % pacientov boli černosi; 81 % pacientov malo genotyp IL28B non-CC;
Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Rameno B: Exviera a ombitasvir/paritaprevir/ritonavir
Resistance to dasabuvir conferred by variants in NS5B selected in cell culture or identified in Phase 2b and 3 clinical trials were phenotypically characterised in the appropriate genotype 1a or 1b replicons.
Mutácie NS5B, identifikované v bunkových kultúrach alebo počas klinických štúdií fázy IIb a III,
In this study, Exviera and ombitasvir/paritaprevir/ritonavir without ribavirin had a similar SVR12 rate (100%) compared to Exviera and ombitasvir/paritaprevir/ritonavir with ribavirin (97.7%).
V tejto štúdii Exviera a ombitasvir/paritaprevir/ritonavir bez ribavirínu mali podobnú mieru SVR12 (100
Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily
200 mg jedenkrát denne/ 300 mg jedenkrát denne
Dose normalized tacrolimus ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Pomery takrolimu normalizované na dávku sú uvedené pre interakciu s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
trimethopri m
trimethoprim
Treated subjects (N=305) had a median age of 54 years (range: 19 to 70); 65.2% were male; 11.8% were Black; 19.7% had a body mass index of at least 30 kg/m2; 20.7% had a history of depression or bipolar disorder; 69.2% had IL28B non-CC genotype; 86.6% had baseline HCV RNA levels of at least 800,000 IU/mL; 18.4% had portal fibrosis (F2) and 17.7% had bridging fibrosis (F3).
% boli černosi; 19,7 % malo index telesnej hmotnosti najmenej 30 kg/m2; 20,7 % malo v anamnéze depresiu alebo bipolárnu poruchu; 69,2 % malo IL28B non-CC genotyp; 86,6 % malo východiskovú hladinu HCV RNA na úrovni najmenej 800 000 IU/ml; 18,4
Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
Koloidný oxid kremičitý (E551)
aprevir/ ritonavi r ombitasvir with dasabuvir and ombitasvir/paritaprevir/r itonavir due to increase in paritaprevir exposures (see Summary of Product Characteristics of ombitasvir/paritaprevir/r itonavir).
Exviera + ombitasvir/ paritaprevir/ ritonavir ketokonazol nevzťahuje a Súbežné používanie je kontraindikované (pozri súhrn charakteristických vlastností lieku pre ombitasvir/paritaprevir /ritonavir).
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- pacienti infikovaní genotypom 1, predtým neliečení alebo predtým liečení peginterferónom + ribavirínom s kompenzovanou cirhózou TURQUOISE-II bola randomizovaná, globálna multicentrická, otvorená (open-label) štúdia vykonaná výlučne na 380 dospelých pacientoch infikovaných genotypom 1 s kompenzovanou cirhózou (trieda
No dose adjustment of Exviera is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 4.2).
U pacientov s miernou, strednou alebo závažnou poruchou funkcie obličiek alebo v konečnom štádiu ochorenia obličiek na dialýze nie je potrebná úprava dávky Exviery (pozri časť
NA No dose adjustment needed for abacavir or lamivudine when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
NA Nie je potrebná úprava dávkovania abakaviru alebo lamivudínu pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
NAME OF THE MARKETING AUTHORISATION HOLDER AbbVie Ltd
DRŽITEĽA ROZHODNUTIA O REGISTRÁCII AbbVie
Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks
Exviera a ombitasvir/paritaprevir /ritonavir 12 týždňov
Exviera and ombitasvir/paritaprevir/ritonavir for 12 weeks With RBV
Exviera a ombitasvir/paritaprevir/ritonavir počas 12 týždňov s RBV
No dose adjustment is necessary for raltegravir or Exviera + ombitasvir/paritaprevir/ ritonavir.
Nie je potrebná úprava dávkovania raltegraviru alebo Exviery + ombitasviru/paritapreviru/ritonaviru.
Mechanism: OATP1B inhibition by paritaprevir.
Mechanizmus: inhibícia OATP1B paritaprevirom pôsobením ritonaviru.
HIV-1 Co-infection
INHIBÍTOR HMG-CoA
Following a 400 mg 14C-dasabuvir dose, approximately 94% of the radioactivity was recovered in faeces with limited radioactivity (approximately 2%) in urine.
Po podaní dávky 400 mg 14C-dasabuviru bolo približne 94 %
Exviera ombitas vir/parit aprevir/ ritonavi r atazanavir
Exviera + ombitasvir/ paritaprevir/ ritonavir atazanavir
SAPPHIRE-I - genotype 1, treatment-naïve
Klinické skúšania u predtým neliečených dospelých SAPPHIRE-I - genotyp 1, predtým neliečení pacienti
Clinical Comments possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Mechanizmus: pravdepodobne dôsledkom inhibície UGT1A1 paritaprevirom, ombitasvirom a dasabuvirom.
NA No dose adjustment is necessary for paracetamol when administered with Exviera + ombitasvir/paritaprevir/ ritonavir.
NA Nie je potrebná úprava dávkovania paracetamolu pri podávaní s Exvierou + ombitasvirom/paritaprevirom/ritonavirom.
(see also Table 2).
(pozri časť 5.3).
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 with or without naloxone (N=19) received 12 weeks of Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
Klinické skúšanie u pacientov, ktorí dostávali dlhodobú opioidnú substitučnú terapiu V multicentrickej, otvorenej štúdii fázy 2 s jedným ramenom 38 predtým neliečených pacientov alebo liečených PegIFN/RBV bez cirhózy s infekciou genotypom 1, ktorí boli na stabilných dávkach metadónu (N =
NA Concomitant use is contraindicated (see the Summary of Product Characteristics for ombitasvir/paritaprevir/ ritonavir).
Podrobnosti pozri v súhrne charakteristických vlastností pre ombitasvir/paritaprevir/ritonavir (pozri aj tabuľku 2).
Treated subjects (N=419) had a median age of 50 years (range: 19 to 70); 45.8% were male; 4.8% were Black; 16.5% had a body mass index of at least 30 kg/m2; 9.3% had a history of depression or bipolar disorder; 79.0% had IL28B non-CC genotype; 73.3% had baseline HCV RNA of at least 800,000 IU/mL; 20.3% had portal fibrosis (F2) and 10.0% had bridging fibrosis (F3).
% boli černosi; 16,5 % malo index telesnej hmotnosti najmenej 30 kg/m2; 9,3 % malo v anamnéze depresiu alebo bipolárnu poruchu; 79,0 % malo IL28B non-CC genotyp; 73,3