FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of elbasvir/grazoprevir (co-administered as a fixed-dose combination; EBR/GZR) or elbasvir + grazoprevir (co-administered as single agents; EBR + GZR) were evaluated in 8 clinical studies in approximately 2,000 subjects (see Table 8).
Latvian: EBR + GZR) drošumu un efektivitāti vērtēja 8 klīniskos pētījumos aptuveni 2000 pētāmām personām (skatīt 8. tabulu).
English: ↔ Montelukast AUC 1.11 (1.01, 1.20) Cmax 0.92 (0.81, 1.06) C24 1.39 (1.25, 1.56)
Latvian: ↔ Montelukasts AUC 1,11 (1,01, 1,20) Cmax 0,92 (0,81, 1,06) C24 1,39 (1,25, 1,56)
English: ↔ Elbasvir AUC 1.22 (1.06, 1.40) Cmax 1.41 (1.18, 1.68) C24 1.31 (1.12, 1.53)
Latvian: ↔ Elbasvīrs AUC 1,22 (1,06, 1,40) Cmax 1,41 (1,18, 1,68) C24 1,31 (1,12, 1,53)
English: ↔ Mycophenolic acid AUC 0.95 (0.87, 1.03) Cmax 0.85 (0.67, 1.07)
Latvian: ↔ Mikofenolskābe AUC 0,95 (0,87, 1,03) Cmax 0.85 (0,67, 1,07)
English: Both relapsers had baseline HCV RNA >800,000 IU/mL Both subjects who failed to achieve SVR for reasons other than virologic failure had baseline HCV RNA <=800,000 IU/mL.
Latvian: Abām pētāmajām personām, kuras nesasniedza SVR citu iemeslu dēļ nekā virusoloģiska neveiksme, sākotnējais CHV RNS bija <= 800 000 SV/ml.
English: ↔ S-Methadone AUC 1.09 (0.94, 1.26) Cmax 1.09 (0.95, 1.25) C24 1.20 (0.98, 1.47)
Latvian: ↔ S-metadons AUC 1,09 (0,94, 1,26) Cmax 1,09 (0,95, 1,25) C24 1,20 (0,98, 1,47
English: ↔ Tenofovir AUC 1.27 (1.20, 1.35) Cmax 1.14 (0.95, 1.36) C24 1.23 (1.09, 1.40)
Latvian: ↔ Tenofovīrs AUC 1,27 (1,20, 1,35) Cmax 1,14 (0,95, 1,36) C24 1,23 (1,09, 1,40)
English: ↔ R-Methadone AUC 1.03 (0.92, 1.15) Cmax 1.07 (0.95, 1.20) C24 1.10 (0.96, 1.26)
Latvian: ↔ R-metadons AUC 1,03 (0,92, 1,15) Cmax 1,07 (0,95, 1,20) C24 1,10 (0,96, 1,26)
English: Table 9: SVR in genotype 1b †-infected subjects Baseline Characteristics
Latvian: SVR ar 1.b genotipa † vīrusu inficētām pētāmām personām
English: Placebo-controlled study in which subjects were randomised in a 3:1 ratio to: EBR/GZR for 12 weeks (immediate treatment group [ITG]) or placebo for 12 weeks followed by open-label treatment with EBR/GZR for 12 weeks (deferred treatment group (DTG)).
Latvian: EBR/GZR 12 nedēļas (tūlītējas ārstēšanas grupa [TĀG]) vai placebo 12 nedēļas, pēc tam 12 nedēļas nemaskēti lietojot EBR/GZR (atliktās ārstēšanas grupa (AĀG))
English: Among genotype 1a-infected subjects, the median age was 54 years (range: 19 to 76); 71 % were male; 71 % were White; 22 % were Black or African American; 9% were Hispanic or Latino; 74% were treatment-naïve subjects; 26% were treatment-experienced subjects; mean body mass index was 27 kg/m2; 75 % had baseline HCV RNA levels greater than 800,000 IU/mL; 23 % had cirrhosis; 72% had non-C/C IL28B alleles (CT or TT); 30 % had HCV/HIV-1 co-infection.
Latvian: Pētāmo personu, kuras bija inficētas ar 1.a genotipa vīrusu, vecuma mediāna bija 54 gadi (diapazonā no 19 līdz 76); 71% bija vīrieši, 71% bija baltās rases pārstāvji; 22% bija melnās rases pārstāvji vai afroamerikāņi; 9% bija spāņu izcelsmes vai latīņamerikāņi; 74% personu bija iepriekš neārstētas; 26% personu bija iepriekš ārstētas; vidējais ķermeņa masas indekss bija 27 kg/m2; 75% sākotnējais CHV
English: Grazoprevir has been shown to cross the placenta in rats and rabbits.
Latvian: Pierādīts, ka žurku un trušu organismā grazoprevīrs šķērso placentāro barjeru.
English: Reference
Latvian: Atsauce
English: Table 8: Studies conducted with ZEPATIER
Latvian: Ar ZEPATIER veiktie pētījumi
English: ↔ Efavirenz AUC 0.82 (0.78, 0.86) Cmax 0.74 (0.67, 0.82) C24 0.91 (0.87, 0.96)
Latvian: ↔ Efavirenzs AUC 0,82 (0,78, 0,86) Cmax 0,74 (0,67, 0,82) C24 0,91 (0,87, 0,96)
English: ↔ Dolutegravir AUC 1.16 (1.00, 1.34) Cmax 1.22 (1.05, 1.40) C24 1.14 (0.95, 1.36)
Latvian: ↔ Dolutegravīrs AUC 1,16 (1,00, 1,34) Cmax 1,22 (1,05, 1,40) C24 1,14 (0,95, 1,36)
English: ↔ Grazoprevir AUC 1.10 (0.95, 1.28) Cmax 0.89 (0.71, 1.11) C24 1.12 (0.97, 1.30)
Latvian: ↔ Grazoprevīrs AUC 1,10 (0,95, 1,28) Cmax 0,89 (0,71, 1,11) C24 1,12 (0,97, 1,30)
English: Subjects without baseline NS3 polymorphisms, % (n/N)
Latvian: Pētāmās personas bez sākotnēja NS3 polimorfisma, % (n/N)
English: Montelukast (10 mg single dose)/ grazoprevir (200 mg single dose)
Latvian: Montelukasts (10 mg vienreizēja deva)/ grazoprevīrs (200 mg vienreizēja deva)
English: In genotype 4 replicons, single NS5A substitutions L30S, M31V, and Y93H reduced elbasvir antiviral activity by 3to 23-fold.
Latvian: 4. genotipa replikoniem atsevišķas NS5A substitūcijas L30S, M31V un Y93H elbasvīra pretvīrusu iedarbību pavājināja 3 - 23 reizes.
English: ↔ Grazoprevir AUC 1.16 (0.94, 1.44) Cmax 1.13 (0.77, 1.65) C24 0.93 (0.84, 1.03)
Latvian: ↔ Grazoprevīrs AUC 1,16 (0,94, 1,44) Cmax 1,13 (0,77, 1,65) C24 0,93 (0,84, 1,03)
English: Co-administration of ZEPATIER with strong CYP3A inhibitors increases elbasvir and grazoprevir plasma concentrations, and co-administration is not recommended (see Table 2 and section 4.4).
Latvian: Lietojot ZEPATIER vienlaicīgi ar spēcīgiem CYP3A4 inhibitoriem, paaugstinās elbasvīra un grazoprevīra koncentrācija plazmā, tāpēc tos nav ieteicams lietot vienlaicīgi (skatīt 2. tabulu un 4.4. apakšpunktu).
English: • EBR* + GZR* for 12 weeks (N=14)
Latvian: + GZR* 12 nedēļas (N=14)
English: ↔ Elbasvir AUC 1.17 (1.11, 1.24) Cmax 1.25 (1.16, 1.35) C24 1.04 (0.97, 1.12)
Latvian: ↔ Elbasvīrs AUC 1,17 (1,11, 1,24) Cmax 1,25 (1,16, 1,35) C24 1,04 (0,97, 1,12)
English: (400 mg PO once daily)/ grazoprevir (100 mg single dose)
Latvian: (400 mg p/o vienreiz dienā)/ grazoprevīrs (100 mg vienreizēja deva)
English: • EBR* + GZR* for 12 weeks (N=122)
Latvian: + GZR* 12 nedēļas (N=122)
English: ↔ Emtricitabine AUC 1.07 (1.03, 1.10) Cmax 0.96 (0.90, 1.02) C24 1.19 (1.13, 1.25)
Latvian: ↔ Emtricitabīns AUC 1,07 (1,03, 1,10) Cmax 0,96 (0,90, 1,02) C24 1,19 (1,13, 1,25)
English: Among genotype 1a-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 31% (4/13) of subjects.
Latvian: Starp pētāmajām personām, kuras inficētas ar 1.a genotipa vīrusu, ar NS3 rezistenci saistītas substitūcijas 24. novērošanas nedēļā nosakāmā līmenī saglabājās 31% personu (4/13).
English: ↔ Rilpivirine AUC 1.13 (1.07, 1.20) Cmax 1.07 (0.97, 1.17) C24 1.16 (1.09, 1.23)
Latvian: ↔ Rilpivirīns AUC 1,13 (1,07, 1,20) Cmax 1,07 (0,97, 1,17) C24 1,16 (1,09, 1,23)
English: Expected: ↓ Elbasvir ↓ Grazoprevir
Latvian: Paredzams: ↓ Elbasvīrs ↓ Grazoprevīrs
English: ↔ Grazoprevir AUC 0.81 (0.67, 0.97) Cmax 0.64 (0.44, 0.93) C24 0.86 (0.79, 0.93)
Latvian: ↔ Grazoprevīrs AUC 0,81 (0,67, 0,97) Cmax 0,64 (0,44, 0,93) C24 0,86 (0,79, 0,93)
English: Among genotype 4-infected subjects, the median age was 51 years (range: 28 to 75); 66 % were male; 88 % were White; 8 % were Black or African American; 11% were Hispanic or Latino; 77% were treatment-naïve subjects; 23% were treatment-experienced subjects; mean body mass index was 25 kg/m2; 56 % had baseline HCV RNA levels greater than 800,000 IU/mL; 22 % had cirrhosis; 73% had non-C/C IL28B alleles (CT or TT); 40 % had HCV/HIV-1 co-infection.
Latvian: Pētāmo personu, kuras bija inficētas ar 4. genotipa vīrusu, vecuma mediāna bija 51 gads (diapazonā no 28 līdz 75); 66% bija vīrieši, 88% bija baltās rases pārstāvji; 8% bija melnās rases pārstāvji vai afroamerikāņi; 11% bija spāņu izcelsmes vai latīņamerikāņi; 77% personu bija iepriekš neārstētas; 23% personu bija iepriekš ārstētas; vidējais ķermeņa masas indekss bija 25 kg/m2; 56% sākotnējais
English: ↔ Elbasvir AUC 1.22 (0.98, 1.52) Cmax 1.13 (0.87, 1.46) C24 1.22 (0.99, 1.51)
Latvian: ↔ Elbasvīrs AUC 1,22 (0,98, 1,52) Cmax 1,13 (0,87, 1,46) C24 1,22 (0,99, 1,51)
English: ↔ Lopinavir AUC 1.02 (0.93, 1.13) Cmax 1.02 (0.92, 1.13) C12 1.07 (0.97, 1.18)
Latvian: ↔ Lopinavīrs AUC 1,02 (0,93, 1,13) Cmax 1,02 (0,92, 1,13) C12 1,07 (0,97, 1,18)
English: ↔ Lopinavir AUC 1.03 (0.96, 1.16) Cmax 0.97 (0.88, 1.08) C12 0.97 (0.81, 1.15)
Latvian: ↔ Lopinavīrs AUC 1,03 (0,96, 1,16) Cmax 0,97 (0,88, 1,08) C12 0,97 (0,81, 1,15)
English: TN = Treatment-Naïve
Latvian: TN = iepriekš neārstēti pacienti
English: Digoxin (0.25 mg single dose)/ elbasvir (50 mg once daily)
Latvian: Digoksīns (0,25 mg vienreizēja deva)/ elbasvīrs (50 mg vienreiz dienā)
English: The dose of atorvastatin should not exceed a daily dose of 20 mg when co-administered with ZEPATIER.
Latvian: Lietojot vienlaicīgi ar ZEPATIER, atorvastatīna dienas deva nedrīkst pārsniegt 20 mg.
English: Therefore, no dose adjustment of elbasvir/grazoprevir is recommended based on weight/BMI (see section 4.4).
Latvian: Tādēļ, ņemot vērā ķermeņa masu/ĶMI, elbasvīra/grazoprevīra deva nav jāpielāgo (skatīt 4.4. apakšpunktu).
English: ↔ Grazoprevir AUC 0.80 (0.53, 1.22) Cmax 0.76 (0.40, 1.44) C24 0.69 (0.54, 0.88)
Latvian: ↔ Grazoprevīrs AUC 0,80 (0,53, 1,22) Cmax 0,76 (0,40, 1,44) C24 0,69 (0,54, 0,88)
English: GT1a NS5A polymorphisms: M28T/A, Q30E/H/R/G/K/D, L31M/V/F, H58D, and Y93C/H/N.
Latvian: Q30E/H/R/G/K/D, L31M/V/F, H58D un Y93C/H/N.
English: ↔ Elbasvir AUC 1.09 (0.98, 1.21) Cmax 1.11 (0.99, 1.26) C24 0.96 (0.86, 1.08)
Latvian: ↔ Elbasvīrs AUC 1,09 (0,98, 1,21) Cmax 1,11 (0,99, 1,26) C24 0,96 (0,86, 1,08)
English: Rilpivirine (25 mg once daily)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Latvian: Rilpivirīns (25 mg vienreiz dienā)/ / elbasvīrs (50 mg vienreiz dienā / grazoprevīrs (200 mg vienreiz dienā)
English: (8-24 mg/2-6 mg once daily)/ grazoprevir (200 mg once daily)
Latvian: (8-24 mg/2-6 mg vienreizēja deva)/ grazoprevīrs 200 mg vienreizēja deva)
English: ↔ Buprenorphine AUC 0.98 (0.89, 1.08) Cmax 0.94 (0.82, 1.08) C24 0.98 (0.88, 1.09)
Latvian: ↔ Buprenorfīns AUC 0,98 (0,89, 1,08) Cmax 0,94 (0,82, 1,08) C24 0,98 (0,88, 1,09)
English: (600 mg IV single dose)/ grazoprevir (200 mg single dose)
Latvian: (600 mg iekšķīgi vienreizēja deva)/ grazoprevīrs (200 mg vienreizēja deva)
English: ↔ Grazoprevir AUC 0.86 (0.55, 1.12) Cmax 0.78 (0.51, 1.18) C24 0.89 (0.78, 1.01)
Latvian: ↔ Grazoprevīrs AUC 0,86 (0,55,1,12) Cmax 0,78 (0,51, 1,18) C24 0,89 (0,78, 1,01)
English: ↔ Grazoprevir AUC 1.09 (0.95, 1.25) Cmax 1.34 (1.10, 1.62) C24 0.93 (0.87, 1.00)
Latvian: ↔ Grazoprevīrs AUC 1,09 (0,95, 1,25) Cmax 1,34 (1,10, 1,62) C24 0,93 (0,87, 1,00)
English: No dose adjustment of ZEPATIER is required in patients with mild hepatic impairment (Child-Pugh A).
Latvian: Pacientiem ar viegliem aknu darbības traucējumiem (A pakāpe pēc Child-Pugh klasifikācijas) ZEPATIER deva nav jāpielāgo.
English: Buprenorphine/naloxone (8 mg/2 mg single dose)/ elbasvir (50 mg single dose)
Latvian: Buprenorfīns/naloksons (8 mg/2 mg vienreiz dienā)/ elbasvīrs (50 mg vienreiz dienā)
English: ↔ Darunavir AUC 1.11 (0.99, 1.24) Cmax 1.10 (0.96, 1.25) C12 1.00 (0.85, 1.18)
Latvian: ↔ Darunavīrs AUC 1,11 (0,99, 1,24) Cmax 1,10 (0,96, 1,25) C12 1,00 (0,85, 1,18)
English: Treatment outcomes in genotype 1b-infected subjects treated with elbasvir/grazoprevir for 12 weeks are presented in Table 9.
Latvian: 9. tabulā parādīti ārstēšanas iznākumi ar 1.b genotipa vīrusu inficētām personām, kas saņēmušas 12 nedēļas ilgu terapiju ar elbasvīru/grazoprevīru.
English: ↔ Grazoprevir AUC 0.89 (0.72, 1.09) Cmax 0.85 (0.62, 1.16) C24 0.90 (0.82, 0.99)
Latvian: ↔ Grazoprevīrs AUC 0,89 (0,72, 1,09) Cmax 0,85 (0,62, 1,16) C24 0,90 (0,82, 0,99)
English: ↔ Elbasvir AUC 1.13 (0.94, 1.37) Cmax 1.07 (0.88, 1.29) C24 1.22 (1.02, 1.45)
Latvian: ↔ Elbasvīrs AUC 1,13 (0,94, 1,37) Cmax 1,07 (0,88, 1,29) C24 1,22 (1,02, 1,45)
English: ↔ Grazoprevir AUC 0.81 (0.70, 0.95) Cmax 0.72 (0.57, 0.92) C24 0.91 (0.82, 1.01)
Latvian: ↔ Grazoprevīrs AUC 0,81 (0,70, 0,95) Cmax 0,72 (0,57, 0,92) C24 0,91 (0,82, 1,01)
English: ↔ Grazoprevir AUC 0.98 (0.89, 1.07) Cmax 0.97 (0.83, 1.14) C24 1.00 (0.93, 1.07)
Latvian: ↔ Grazoprevīrs AUC 0,98 (0,89, 1,07) Cmax 0,97 (0,83, 1,14) C24 1,00 (0,93, 1,07)
English: Lopinavir/ritonavir (400 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Latvian: Lopinavīrs/ritonavīrs (400 mg divreiz dienā)/ ritonavīrs (100 mg divreiz dienā/ elbasvīrs 50 mg vienreiz dienā)
English: ↔ Elbasvir AUC 1.05 (0.92, 1.18) Cmax 1.11 (0.98, 1.26) C24 1.03 (0.91, 1.17)
Latvian: ↔ Elbasvīrs AUC 1,05 (0,92, 1,18) Cmax 1,11 (0,98, 1,26) C24 1,03 (0,91, 1,17)
English: Film-coating Lactose monohydrate Hypromellose Titanium dioxide Triacetin
Latvian: Laktozes monohidrāts Hipromeloze
English: ↔ Ciclosporin AUC 0.96 (0.90, 1.02) Cmax 0.90 (0.85, 0.97) C12 1.00 (0.92, 1.08)
Latvian: ↔ Ciklosporīns AUC 0,96 (0,90, 1,02) Cmax 0,90 (0,85, 0,97) C12 1,00 (0,92, 1,08)
English: ↔ Grazoprevir AUC 0.74 (0.60, 0.92) Cmax 0.58 (0.42, 0.82) C24 0.97 (0.89, 1.06)
Latvian: ↔ Grazoprevīrs AUC 0,74 (0,60, 0,92) Cmax 0,58 (0,42, 0,82) C24 0,97 (0,89, 1,06)
English: ↔ Grazoprevir AUC 0.93 (0.75, 1.17) Cmax 1.16 (0.82, 1.65) C24 0.10 (0.07, 0.13)
Latvian: ↔ Grazoprevīrs AUC 0,93 (0,75, 1,17) Cmax 1,16 (0,82, 1,65) C24 0,10 (0,07, 0,13)
English: GT 1, 3 TN with or without cirrhosis TE Null Responder with or without cirrhosis TN HCV/HIV1 co-infection without cirrhosis
Latvian: 1., 3. GT Iepriekš neārstēti pacienti ar cirozi vai bez tās Iepriekš ārstēti pacienti bez atbildes reakcijas un ar cirozi vai bez tās Iepriekš neārstēti pacienti ar CHV/HIV-1 koinfekciju bez cirozes
English: ↔ Grazoprevir AUC 0.79 (0.68, 0.91) Cmax 0.57 (0.40, 0.83) C24 0.77 (0.61, 0.99)
Latvian: ↔ Grazoprevīrs AUC 0,79 (0,68, 0,91) Cmax 0,57 (0,40, 0,83) C24 0,77 (0,61, 0,99)
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin had serious adverse reactions (abdominal pain, transient ischaemic attack and anaemia).
Latvian: Būtiskas blakusparādības (sāpes vēderā, pārejošas išēmiskas lēkmes un anēmija) bija mazāk kā 1% pētāmo personu, kurām lietoja ZEPATIER kopā ar ribavirīnu vai bez tā.
English: (300 mg once daily)/ ritonavir (100 mg once daily/ elbasvir (50 mg once daily)
Latvian: (300 mg vienreiz dienā)/ ritonavīrs (100 mg vienreiz dienā/ elbasvīrs (50 mg vienreiz dienā)
English: Atorvastatin (20 mg single dose)/ grazoprevir (200 mg once daily)
Latvian: Atorvastatīns (20 mg vienreizēja deva)/ grazoprevīrs (200 mg vienreiz dienā)
English: ↔ Elbasvir AUC 1.05 (0.93, 1.18) Cmax 1.02 (0.92, 1.14) C24 1.03 (0.92, 1.17)
Latvian: ↔ Elbasvīrs AUC 1,05 (0,93, 1,18) Cmax 1,02 (0,92, 1,14) C24 1,03 (0,92, 1,17)
English: ↔ Grazoprevir AUC 1.12 (0.96, 1.30) Cmax 1.10 (0.89, 1.37) C24 1.17 (1.02, 1.34)
Latvian: ↔ Grazoprevīrs AUC 1,12 (0,96, 1,30) Cmax 1,10 (0,89, 1,37) C24 1,17 (1,02, 1,34)
English: ↔ Elbasvir AUC 1.17 (0.98, 1.39) Cmax 1.29 (1.06, 1.58) C24 1.21 (1.03, 1.43)
Latvian: ↔ Elbasvīrs AUC 1,17 (0,98, 1,39) Cmax 1,29 (1,06, 1,58) C24 1,21 (1,03, 1,43)
English: Among genotype 1b-infected subjects, NS3 resistance-associated substitutions persisted at detectable levels at follow-up week 24 in 50% (1/2) of subjects.
Latvian: Starp pētāmajām personām, kuras inficētas ar 1.b genotipa vīrusu, ar NS3 rezistenci saistītas substitūcijas 24. novērošanas nedēļā nosakāmā līmenī saglabājās 50% personu (1/2).
English: ↔ Naloxone AUC 0.88 (0.76, 1.02) Cmax 0.85 (0.66, 1.09)
Latvian: ↔ Naloksons AUC 0,88 (0,76, 1,02) Cmax 0.85 (0,66, 1,09)
English: (300 mg once daily)/elbasvir (50 mg once daily)/grazoprevir (100 mg once daily)
Latvian: (300 mg vienreiz dienā)/elbasvīrs (50 mg vienreiz dienā)/grazoprevīrs (100 mg vienreiz dienā)
English: ↔ Elbasvir AUC 0.93 (0.82, 1.05) Cmax 0.88 (0.77, 1.00) C24 0.92 (0.18, 1.05)
Latvian: ↔ Elbasvīrs AUC 0,93 (0,82, 1,05) Cmax 0,88 (0,77, 1,00) C24 0,92 (0,18, 1,05)
English: ↔ Grazoprevir AUC 1.01 (0.79, 1.28) Cmax 0.97 (0.63, 1.50) C24 0.95 (0.87, 1.04)
Latvian: ↔ Grazoprevīrs AUC 1,01 (0,79, 1,28) Cmax 0,97 (0,63, 1,50) C24 0,95 (0,87, 1,04)
English: Emergent Amino Acid Substitutions
Latvian: Konstatētās aminoskābju substitūcijas
English: Rosuvastatin (10 mg single dose)/ grazoprevir (200 mg once daily)
Latvian: Rosuvastatīns (10 mg vienreizēja deva)/ grazoprevīrs (200 mg vienreiz dienā)
English: Subjects without baseline NS5A polymorphisms, % (n/N)
Latvian: Pētāmās personas bez sākotnēja NS5A polimorfisma, % (n/N)
English: ↔ Grazoprevir AUC 1.12 (0.97, 1.30) Cmax 1.07 (0.83, 1.37) C24 0.94 (0.87, 1.02)
Latvian: ↔ Grazoprevīrs AUC 1,12 (0,97, 1,30) Cmax 1,07 (0,83, 1,37) C24 0,94 (0,87, 1,02)
English: ↔ Elbasvir AUC 0.97 (0.90, 1.06) Cmax 0.99 (0.88, 1.10) C24 0.92 (0.83, 1.02)
Latvian: ↔ Elbasvīrs AUC 0,97 (0,90, 1,06) Cmax 0,99 (0,88, 1,10) C24 0,92 (0,83, 1,02)
English: ↔ Elbasvir AUC 0.81 (0.57, 1.17) Cmax 0.89 (0.61, 1.29) C24 0.80 (0.55, 1.16)
Latvian: ↔ Elbasvīrs AUC 0,81 (0,57, 1,17) Cmax 0,89 (0,61, 1,29) C24 0,80 (0,55, 1,16)
English: Elbasvir has been shown to cross the placenta in rats and rabbits.
Latvian: Pierādīts, ka žurku un trušu organismā elbasvīrs šķērso placentāro barjeru.
English: ASTHMA AGENTS
Latvian: LĪDZEKĻI ASTMAS ĀRSTĒŠANAI
English: (combination of OATP1B and CYP3A inhibition)
Latvian: (OATP1B un CYP3A inhibīcijas apvienojums)
English: Darunavir/ritonavir (600 mg twice daily)/ ritonavir (100 mg twice daily/ elbasvir (50 mg once daily)
Latvian: Darunavīrs/ritonavīrs (600 mg divreiz dienā)/ ritonavīrs (100 mg divreiz dienā/ elbasvīrs (50 mg vienreiz dienā)
English: Sevelamer carbonate (2,400 mg single dose)/ elbasvir (50 mg single dose)/ grazoprevir (100 mg single dose)
Latvian: Sevelamēra karbonāts (2400 mg vienreizēja deva)/ elbasvīrs (50 mg vienreizēja deva)/ grazoprevīrs (100 mg vienreizēja deva)
English: † (Grade 3) >10.0 × ULN (Grade 4) Total Bilirubin (mg/dL) 2.6-5.0 × ULN (Grade 3) >5.0 × ULN (Grade 4)
Latvian: (3 pakāpe) > 10,0 x NAR (4 pakāpe)
English: GT 1 TN or TE with or without cirrhosis Chronic Kidney Disease
Latvian: 1. GT Iepriekš neārstēti vai iepriekš ārstēti pacienti ar cirozi vai bez tās Hroniska nieru slimība
English: ↔ Elbasvir AUC 0.92 (0.75, 1.14) Cmax 0.86 (0.71, 1.04) C24 0.87 (0.70, 1.09)
Latvian: ↔ Elbasvīrs AUC 0,92 (0,75, 1,14) Cmax 0,86 (0,71, 1,04) C24 0,87 (0,70, 1,09)
English: ↔ Elbasvir AUC 1.07 (1.00, 1.15) Cmax 1.07 (0.99, 1.16) C24 1.04 (0.98, 1.11)
Latvian: ↔ Elbasvīrs AUC 1,07 (1,00, 1,15) Cmax 1,07 (0,99, 1,16) C24 1,04 (0,98, 1,11)
English: Sofosbuvir (400 mg single dose sofosbuvir)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Latvian: Sofosbuvīrs (400 mg sofosbuvīra vienreizēja deva)/ elbasvīrs (50 mg vienreiz dienā)/ grazoprevīrs (200 mg vienreiz dienā)
English: (300 mg once daily)/ ritonavir (100 mg once daily/ grazoprevir (200 mg once daily)
Latvian: (300 mg vienreiz dienā)/ ritonavīrs (100 mg vienreiz dienā/ grazoprevīrs (200 mg vienreiz dienā)
English: ↔ Grazoprevir AUC 0.82 (0.68, 0.99) Cmax 0.53 (0.37, 0.76) C24 0.84 (0.71, 0.99)
Latvian: ↔ Grazoprevīrs AUC 0,82 (0,68, 0,99) Cmax 0,53 (0,37, 0,76) C24 0,84 (0,71, 0,99)
English: (due in part to OATP1B and CYP3A inhibition)
Latvian: (daļēji OATP1B un CYP3A inhibīcijas dēļ)
English: Mycophenolate mofetil (1,000 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Latvian: Mikofenolāta mofetils (1000 mg vienreizēja deva)/ elbasvīrs (50 mg vienreiz dienā / grazoprevīrs (200 mg vienreiz dienā)
English: Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine.
Latvian: Transportlīdzekļu vadīšana un mehānismu apkalpošana Nav zināms, vai ZEPATIER ietekmēs Jūsu spēju vadīt transportlīdzekļus, lietot instrumentus vai apkalpot mehānismus.
English: HCV ANTIVIRAL AGENTS
Latvian: PRETVĪRUSU LĪDZEKĻI PRET CHV
English: ↔ Elbasvir AUC 1.07 (1.00, 1.14) Cmax 1.07 (0.98, 1.16) C24 1.05 (0.97, 1.14)
Latvian: ↔ Elbasvīrs AUC 1,07 (1,00, 1,14) Cmax 1,07 (0,98, 1,16) C24 1,05 (0,97, 1,14)
English: GT 1, 4, 6 TN with or without cirrhosis HCV/HIV-1 co-infection
Latvian: 1., 4., 6. GT Iepriekš neārstēti pacienti ar cirozi vai bez tās CHV/HIV-1 koinfekcija
English: ↔ Atazanavir AUC 1.07 (0.98, 1.17) Cmax 1.02 (0.96, 1.08) C24 1.15 (1.02, 1.29)
Latvian: ↔ Atazanavīrs AUC 1,07 (0,98, 1,17) Cmax 1,02 (0,96, 1,08 C24 1,15 (1,02, 1,29)
English: Table 11: SVR in genotype 4-infected subjects Baseline Characteristics
Latvian: SVR ar 4. genotipa vīrusu inficētām pētāmām personām
English: (300 mg once daily)/ grazoprevir (200 mg once daily)
Latvian: (300 mg vienreiz dienā)/ grazoprevīrs (200 mg vienreiz dienā)
English: Subjects with baseline NS5A polymorphisms, % (n/N)
Latvian: Pētāmās personas ar sākotnēju NS5A polimorfismu, % (n/N)
English: TE = Treatment-Experienced (failed prior treatment with interferon [IFN] or peginterferon alfa [peg-IFN] with or without ribavirin (RBV) or were intolerant to prior therapy) *EBR = elbasvir 50 mg; GZR = grazoprevir 100 mg; EBR/GZR = co-administered as a fixed-dose combination; EBR + GZR = co-administered as separate single agents
Latvian: TE = iepriekš ārstēti pacienti (iepriekš bijusi neveiksmīga ārstēšana ar interferonu [IFN] vai alfa peginterferonu [peg-IFN] kopā ar ribavirīnu (RBV) vai bez tā vai arī bijusi iepriekš veiktās ārstēšanas nepanesamība) *
English: Raltegravir (400 mg single dose)/ elbasvir (50 mg single dose)
Latvian: Raltegravīrs (400 mg vienreizēja deva)/ elbasvīrs 50 mg vienreiz dienā)
English: (10 mg single dose)/ elbasvir (50 mg once daily) / grazoprevir (200 mg once daily)
Latvian: (10 mg vienreizēja deva)/ elbasvīrs (50 mg vienreiz dienā)/ grazoprevīrs (200 mg vienreiz dienā)
English: ↔ Elbasvir AUC 0.98 (0.93, 1.02) Cmax 0.97 (0.89, 1.05) C24 0.97 (0.92, 1.02)
Latvian: ↔ Elbasvīrs AUC 0,98 (0,93, 1,02) Cmax 0,97 (0,89, 1,05) C24 0,97 (0,92, 1,02)
English: (400 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Latvian: (400 mg divreiz dienā)/ ritonavīrs (100 mg divreiz dienā/ grazoprevīrs (200 mg vienreiz dienā)
English: Pitavastatin (1 mg single dose)/ grazoprevir (200 mg once daily)
Latvian: Pitavastatīns (1 mg vienreizēja deva)/ grazoprevīrs (200 mg vienreiz dienā)
English: Table 10: SVR in genotype 1a-infected subjects Baseline Characteristics
Latvian: SVR ar 1.a genotipa vīrusu inficētām pētāmām personām
English: ANTIARRHYTHMICS
Latvian: ANTIARITMISKIE LĪDZEKĻI
English: EBR with GZR
Latvian: + GZR*
English: • itching
Latvian: • vemšana.
English: ↔ Elbasvir AUC 0.98 (0.93, 1.04) Cmax 0.97 (0.89, 1.05) C24 0.98 (0.93, 1.03)
Latvian: ↔ Elbasvīrs AUC 0,98 (0,93, 1,04) Cmax 0,97 (0,89, 1,05) C24 0,98 (0,93, 1,03)
English: Cirrhotic
Latvian: Triacetīns
English: (600 mg twice daily)/ ritonavir (100 mg twice daily/ grazoprevir (200 mg once daily)
Latvian: (600 mg divreiz dienā)/ ritonavīrs (100 mg divreiz dienā/ grazoprevīrs 200 mg vienreiz dienā)
English: (600 mg once daily)/ grazoprevir (200 mg once daily)
Latvian: (600 mg vienreiz dienā)/ grazoprevīrs (200 mg vienreiz dienā)
English: Midazolam (2 mg single dose)/ grazoprevir (200 mg once daily)
Latvian: Midazolāms (2 mg vienreizēja deva)/ grazoprevīrs (200 mg vienreiz dienā)
English: (600 mg PO single dose)/ elbasvir (50 mg single dose)
Latvian: (600 mg iekšķīgi vienreizēja deva)/elbasvīrs (50 mg vienreiz dienā)
English: ↔ Cobicistat AUC 1.49 (1.42, 1.57) Cmax 1.39 (1.29, 1.50)
Latvian: AUC 1,49 (1,42, 1,57)
English: EBR with GZR + RBV
Latvian: SVR EBR kopā ar GZR EBR kopā ar GZR + RBV 12 nedēļas
English: Prednisone (40 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily
Latvian: Prednizons (40 mg vienreizēja deva/ elbasvīrs (50 mg vienreiz dienā) / grazoprevīrs (200 mg vienreiz dienā)
English: General disorders and administration site conditions: Very common fatigue
Latvian: Vispārēji traucējumi un reakcijas ievadīšanas vietā: Ļoti bieži nespēks
English: ↑ Elbasvir
Latvian: ↑ Elbasvīrs
English: Ciclosporin (400 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Latvian: Ciklosporīns (400 mg vienreizēja deva)/ elbasvīrs (50 mg vienreiz dienā) / grazoprevīrs (200 mg vienreiz dienā)/
English: Tacrolimus (2 mg single dose)/ elbasvir (50 mg once daily)/ grazoprevir (200 mg once daily)
Latvian: Takrolims (2 mg vienreizēja deva)/ elbasvīrs (50 mg vienreiz dienā) / grazoprevīrs (200 mg vienreiz dienā)/
English: (400 mg twice daily)/ grazoprevir (200 mg once daily)
Latvian: (400 mg divreiz dienā)/ grazoprevīrs (200 mg vienreizēja deva)
English: The highest dose of grazoprevir was 1,000 mg once daily for 10 days, and a single dose of 1,600 mg.
Latvian: Lielākā grazoprevīra deva bija 1000 mg vienu reizi dienā 10 dienas, bet vienreizējas devas gadījumā 1600 mg. Šajos pētījumos ar veseliem brīvprātīgajiem blakusparādību biežums un smagums bija līdzīgs placebo grupās novērotajam.