natgillin/translations-raw huggingface dataset:
In subjects with severe hepatic impairment, paritaprevir mean Cmax and AUC values increased by 3.2-to 9.5-fold; ritonavir mean Cmax values were 35% lower and AUC values were 13% higher and ombitasvir mean Cmax and AUC values decreased by 68% and 54%, respectively, compared to subjects with normal hepatic function, therefore, Viekirax must not be used in patients with severe hepatic impairment (see sections 4.2 and 4.4). 
Pri preiskovancih s hudo okvaro jeter so bile v primerjavi s preiskovanci z normalnim delovanjem jeter vrednosti naslednje: povprečni Cmax in AUC paritaprevirja sta bili za 3,2- do 9,5-krat večji, povprečna Cmax ritonavirja je bila za 35 % manjša in njegova povprečna AUC za 13 % večja, povprečna Cmax ombitasvirja je bila za 68 % manjša in njegova povprečna AUC za 54 % manjša.
In the genotype 1a replicon, the activity of paritaprevir was reduced 20-, 37-, and 17-fold by the F43L, R155K and A156T substitutions, respectively. 
V replikonu genotipa 1a so substitucije F43L, R155K oziroma A156T zmanjšale aktivnost paritaprevirja za 20-, 37- in 17-krat.
NA ↔ ombitasvir/paritaprevir/dasabuvir (based on the crossstudy comparison) 
NP ↔ ombitasvir/paritaprevir/dasabuvir (na podlagi primerjave med študijami)
Mechanism: CYP3A4/Pgp inhibition by erythromycin, paritaprevir, ritonavir and dasabuvir. 
CYP3A4/P-gp z eritromicinom, paritaprevirjem, ritonavirjem in dasabuvirjem.
Ombitasvir has EC50 values of 12, 4.3, 19, 1.7, 3.2, and 366 pM against replicon cell lines constructed with NS5A from single isolates representing genotypes 2a, 2b, 3a, 4a, 5a, and 6a, respectively. 
ki so predstavljali genotipe 2a, 2b, 3a, 4a, 5a in 6a, je bila EC50 ombitasvirja 12, 4,3, 19, 1,7, 3,2 in 366 pM.
HCV Genotype 1b Viekirax and dasabuvir 
HCV Genotip 1b Viekirax in dasabuvir
These metabolites are not expected to have antiviral activity. 
Ni pričakovati, da bi ti presnovki delovali protivirusno.
General disorders and administration and administration site conditions Very common 
Splošne težave in spremembe na mestu aplikacije Zelo pogosti astenija utrujenost
PEARL- I- genotype 4, treatment-naïve or pegIFN + RBV experienced without cirrhosis 
PEARL- I- genotip 4, še nezdravljeni ali že zdravljeni s kombinacijo pegIFN + RBV, brez ciroze
AGATE-1 -treatment-naïve or pegIFN +RBV experienced patients with compensated cirrhosis 
AGATE-1 - še nezdravljeni ali že zdravljeni s kombinacijo pegIFN + RBV, s kompenzirano cirozo
GT1b Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir 
GT1b Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir
SVR12 for genotype 4-infected, subjects who were treatment-naïve or previously treated with pegIFN/RBV in PEARL I 
Preglednica 18: SVR12 pri še nezdravljenih preiskovancih ali takih, ki so bili predhodno zdravljeni s pegIFN/RBV, okuženih z genotipom 4, v preskušanju PEARL I
↑ fusidic acid 
fusidna kislina
• Each tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir. 
• Ena tableta vsebuje 12,5 mg ombitasvirja, 75 mg paritaprevirja in 50 mg ritonavirja.
Mechanism: possible CYP3A4 induction by efavirenz. 
Mehanizem: morda indukcija CYP3A4 z efavirenzom.
Co-administration of Viekirax with or without dasabuvir with medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir plasma concentrations and must not be co-administered with Viekirax (see section 4.5). 
Sočasno z zdravilom Viekirax z ali brez dasabuvirja se ne sme uporabljati zdravil, ki so močni zaviralci CYP3A4, za katere se pričakuje da povečajo plazemske koncentracije peritaprevirja (glejte poglavje 4.5).
GT1a Arm A: Viekirax and dasabuvir + RBV Arm B: Viekirax and dasabuvir 
GT1a Skupina A: Viekirax in dasabuvir+ RBV Skupina B: Viekirax in dasabuvir
Following administration of Viekirax 
Po uporabi zdravila Viekirax
Patients who are taking ethinyloestradiol-containing medicinal products (i.e. most combined oral contraceptives or contraceptive vaginal rings) must switch to an alternative method of contraception (e.g., progestin only contraception or non-hormonal methods) prior to initiating Viekirax with or without dasabuvir therapy (see sections 4.3 and 4.5). 
Bolnice, ki uporabljajo zdravila z etinilestradiolom (takšna je večina kombiniranih peroralnih kontraceptivov ali kontracepcijskih vaginalnih obročkov), jih morajo prenehati uporabljati ali preiti na drugačen način kontracepcije (npr. na samo progestinsko kontracepcijo ali na nehormonske načine),
Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate mg once daily 
efavirenz/emtri citabin/dizopro ksiltenofovirat fumarat
↑ pimozide ↑ quetiapine ↑ lurasidone 
↑ kvetiapin ↑ lurasidon
Caution should be used when sulfasalazine is coadministered with Viekirax with or without dasabuvir. 
Previdnost je priporočljiva pri sočasni uporabi feksofenadina z zdravilom Viekirax z dasabuvirjem ali brez njega.
No dose adjustment needed for Viekirax with dasabuvir. 
Odmerka zdravila Viekirax z dasabuvirjem ni treba prilagoditi.
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks Treated subjects (N=419) had a median age of 50 years (range: 19 to 70), 45.8% were male; 4.8% were Black; 9.3% had a history of depression or bipolar disorder; 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). 
Zdravljenje: Viekirax in dasabuvir brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov Zdravljeni preiskovanci (N = 419) so bili mediano stari 50 let (razpon: od 19 do 70), 45,8 % je bilo moških; 4,8 % je bilo črncev; 9,3 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 73,3 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 20,3 % jih je imelo portalno fibrozo (F2) in 10,0 % jih je imelo fibrozo z mostiči (F3).
Clinical efficacy and safety 
Zdravilo ali učinkovina
Mechanism: CYP2C19 induction by ritonavir 
Mehanizem: Indukcija CYP2C19 z ritonavirjem
• fusidic acid 
• fusidna kislina
A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Viekirax with or without dasabuvir is required (see section 4.5). 
Če je potrebno zdravljenje z zdravilom Viekirax z dasabuvirjem ali brez njega, je pri bolnikih z normalnim delovanjem ledvic ali jeter priporočljivo zmanjšati odmerek kolhicina ali zdravljenje s kolhicinom prekiniti (glejte poglavje 4.5).
Co-administration of Viekirax with or without dasabuvir with medicinal products that are primarily metabolized by UGT1A1 result in increased plasma concentrations of such medicinal products; routine clinical monitoring is recommended for narrow therapeutic index medicinal products (i.e. levothyroxine). 
Sočasna uporaba zdravila Viekirax z dasabuvirjem ali brez njega skupaj z zdravili, ki se presnavljajo predvsem z UGT1A1, lahko poveča koncentracijo takšnih zdravil v plazmi; med uporabo zdravil z ozkim terapevtskim indeksom (npr.
Mechanism: CYP3A4 induction by carbamazepine 
Mehanizem: Indukcija CYP3A4 s karbamazepino m.
No subjects with HCV genotype 1b infection experienced on-treatment virologic failure and 2 subjects with HCV genotype 1b infection experienced relapse. 
Virusna neodzivnost med zdravljenjem se ni pojavila pri nobenem preiskovancu, okuženem s HCV genotipa 1b, recidiv pa se je pojavil pri 2 takšnih preiskovancih.
SEDATIVES / HYPNOTICS Zolpidem 
SEDATIVI / HIPNOTIKI zolpidem enkraten odmerek 5 mg
Baseline platelet count, median (× 109/L) 
≥ 35, n (%) Izhodiščno število trombocitov, mediano (× 109/L) 132.0
Subjects had a median age of 56 years (range: 32 to 81); 50% were treatment-naïve, 28% were prior pegIFN/RBV null responders; 10% were prior pegIFN/RBV partial responders, 13% were prior pegIFN/RBV relapsers; 70% were male; 17% were Black; 73% had baseline HCV RNA levels of at least 800,000 IU per mL; 17% had platelet counts of less than 90 x 109 per L; and 4% had albumin less than 3.5 mg per dL. 
Preiskovanci so bili mediano stari 56 let (razpon: 32 do 81); 50 % jih še ni bilo zdravljenih, 28 % se jih predhodno ni odzvalo na pegIFN/RBV; 10 % se jih je predhodno delno odzvalo na pegIFN/RBV, 13 % se je predhodno pojavil recidiv s pegIFN/RBV; 70 % je bilo moških; 17 % je bilo črncev; 73 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i.e./ml; 17 % jih je imelo število trombocitov manj kot 90 x 109/l; in 4 % jih je imelo albumin manj kot 3,5 mg/dl.
The pharmacokinetic properties of the combination of Viekirax with dasabuvir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 20 shows mean Cmax and AUC of Viekirax 25 mg/150 mg/100 mg once daily with dasabuvir 250 mg twice daily following multiple doses with food in healthy volunteers. 
Farmakokinetične lastnosti kombinacije zdravila Viekirax in dasabuvirja so ocenili pri zdravih odraslih in pri bolnikih s kroničnim hepatitisom C. Preglednica 20 prikazuje povprečni Cmax in AUC za zdravilo
Treatment with darunavir + Viekirax without dasabuvir is not recommended-(↑ paritaprevir). 
Zdravljenje z darunavirjem in zdravilom Viekirax brez dasabuvirja ni priporočljivo -(↑
↔ darunavir ombitasvir 
↔ atazanavir ↔ ombitasvir
Viekirax with weight-based ribavirin for 12 or 16 weeks 
Zdravljenje: zdravilo Viekirax z ribavirinom, odvisnim od telesne mase, 12 do 16 tednov
Mechanism: P-gp inhibition by paritaprevir, ritonavir and dasabuvir. 
Zavrtje P-gp s paritaprevirjem, ritonavirjem in dasabuvirjem.
Indinavir Saquinavir Tipranavir 
Klinične opombe indinavir sakvinavir tipranavir
CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments. 
metoprolol in dekstrometorfan) ni pričakovati, da bi bila potrebna prilagoditev odmerka.
Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir. 
CYP3A4/P-gp s klaritromicinom in ritonavirjem.
Co-administration of Viekirax with or without dasabuvir can decrease exposures of medicinal products that are metabolized by CYP2C19 (e.g. lansoprazole, esomeprazole, s-mephenytoin), which may require dose adjustment/clinical monitoring. 
ki se presnavljajo s CYP2C19 (npr. lansoprazol, esomeprazol, s-mefenitoin), zaradi česar bo morda potrebna prilagoditev odmerka in klinično spremljanje.
Treated subjects (N=394) had a median age of 54 years (range: 19 to 71); 49.0% were prior pegIFN/RBV null responders; 21.8/% were prior pegIFN/RBV partial responders, and 29.2% were prior pegIFN/RBV relapsers; 57.6% were male; 8.1% were Black; 20.6% had a history of depression or bipolar disorder; 87.1% had baseline HCV RNA levels of at least 800,000 IU per mL; 17.8% had portal fibrosis (F2) and 14.5% had bridging fibrosis (F3); 58.4% had HCV genotype 1a infection; 41.4% had HCV genotype 1b infection. 
Zdravljeni preiskovanci (N = 394) so bili mediano stari 54 let (razpon: od 19 do 71); 49,0 % jih predhodno ni imelo odziva na pegIFN/RBV; 21,8 % jih je predhodno imelo delen odziv na pegIFN/RBV in 29,2 % jih je predhodno imelo recidiv ob pegIFN/RBV; 57,6 % je bilo moških; 8,1 % je bilo črncev; 20,6 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 87,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800,000 i.e./ml; 17,8 % jih je imelo portalno fibrozo (F2) in 14,5 % jih je imelo fibrozo z mostiči (F3); 58,4 % jih je imelo okužbo s HCV genotipa 1a; 41,4 % jih je imelo okužbo s HCV genotipa 1b.
Subjects (N=135) had a median age of 51 years (range: 19 to 70); 63,7% were treatment-naïve, 17.0% were prior pegIFN/RBV null responders, 6.7% were prior pegIFN/RBV partial responders, 12.6% were prior pegIFN/RBV relapsers; 65.2%were male; 8.9% were Black, 69.6% had baseline HCV RNA levels at least 800,000 IU/mL; 6.7% had bridging fibrosis (F3). 
Preiskovanci (N = 135) so bili mediano stari 51 let (razpon: od 19 do 70); 63,7 % jih še ni bilo zdravljenih, 17,0 % se jih predhodno ni odzvalo na pegIFN/RBV, 6,7 % se jih je predhodno delno odzvalo na pegIFN/RBV, 12,6 % se je predhodno pojavil recidiv s pegIFN/RBV; 65,2 % je bilo moških; 8,9 % je bilo črncev; 69,6 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i.e./ml; 6,7 % jih je imelo fibrozo z mostiči (F3).
This medicine is available without a prescription ticagrelor stops blood from clotting 
To zdravilo je na voljo brez recepta.
CYP3A4 inhibitors: 
Zaviralci CYP3A4:
In the presence of ombitasvir, paritaprevir exposures were minimally affected (5% to 27% change) while dasabuvir exposures increase by approximately 30%. 
Vpliv ombitasvirja na paritaprevir/ritonavir in dasabuvir Prisotnost ombitasvirja je minimalno vplivala na izpostavljenost paritaprevirju (sprememba za 5 do 27 %),
↑ ombitasvir ↑ paritaprevir ↑ dasabuvir 
Pričakovano: ↑ konivaptan ↑ paritaprevir ↑ dasabuvir
Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir 
Mehanizem: Indukcija CYP2C19 in indukcija CYP3A4 z ritonavirjem.
Viekirax and dasabuvir without ribavirin or with weight-based ribavirin for 12 weeks 
Zdravljenje: Viekirax in dasabuvir brez ribavirina ali z ribavirinom, odvisnim od telesne mase, 12 tednov
Viekirax and dasabuvir with RBV 12 weeks 
Viekirax in dasabuvir z RBV 12 tednov
Adverse drug reactions identified with Viekirax in combination with dasabuvir with and without ribavirin 
Preglednica 3: Neželeni učinki zdravila ugotovljeni z zdravilom Viekirax v kombinaciji z dasabuvirjem ter z ribavirinom ali brez njega
500 mg single dose 
Posamezni odmerek 500 mg
Drug interactions were evaluated for the Viekirax and dasabuvir regimen, but not for the Viekirax without dasabuvir, with carbamazepine, furosemide, zolpidem, darunavir twice daily, darunavir (evening administration), atazanavir (evening administration), rilpivirine, abacavir/lamivudine, dolutegravir, metformin, sulfamethoxazole/trimethoprim, cyclobenzaprine, carisoprodol, hydrocodone/ 
(uporaba zvečer), rilpivirinom, abakavir/lamivudinom, dolutegravirjem, metforminom, sulfametoksazol/trimetoprimom, ciklobenzaprinom, karisoprodolom, hidrokodon/paracetamolom ali diazepamom.
Expected in CYP2C19 Extensive Metabolisers: 
Pričakovano pri učinkovinah, ki se v veliki meri presnavljajo preko CYP2C19:
ANTICONVULSANTS Carbamazepine 
ANTIEPILEPTIKI karbamazepin
Potential for other medicinal products to affect the pharmacokinetics of ombitasvir, paritaprevir, and dasabuvir 
Možnost vpliva drugih zdravil na farmakokinetiko ombitasvirja, paritaprevirja in dasabuvirja Zdravila, ki zavrejo CYP3A4
400/100 mg twice daily1 
lopinavir / ritonavir 400/100 mg dvakrat na dan1 Mehanizem:
If rosuvastatin treatment is required during the treatment period, the maximum daily dose of rosuvastatin should be 5 mg (see section 4.5, Table 2).The increase in rosuvastatin when combined with Viekirax without dasabuvir is less pronounced. 
Če je med obdobjem zdravljenja potrebno zdravljenje z rosuvastatinom, sme biti največji dnevni odmerek rosuvastatina 5 mg (glejte poglavje 4.5, preglednico 2).
Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious events must not be co-administered with Viekirax (see section 4.5). 
Sočasno z zdravilom Viekirax se ne sme uporabljati zdravil, ki so zelo odvisna od očistka s CYP3A in katerih povečana koncentracija v plazmi je povezana z resnimi učinki (glejte poglavje 4.5).
CYP3A substrates evaluated in drug interaction studies which may require dose adjustment and/or clinical monitoring include (see Table 2) ciclosporin, sirolimus, tacrolimus, amlodipine, rilpivirine and alprazolam. 
Med substrati CYP3A, ki so bili ocenjeni v študijah medsebojnega delovanja zdravil in pri katerih je lahko potrebna prilagoditev odmerka, klinično spremljanje ali oboje (glejte preglednico 2) so ciklosporin,
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; 15.8% had portal fibrosis (F2) and 5.3% had bridging fibrosis (F3); and 94.7% were naïve to prior HCV treatment. 
1a; 15,8 % jih je imelo portalno fibrozo (F2) in 5,3 % jih je imelo fibrozo z mostiči (F3); 94,7 % jih predhodno še ni bilo zdravljenih za HCV.
For patients coadministered ribavirin refer to the Summary of Product Characteristics of ribavirin. 
Pri bolnicah, ki sočasno prejemajo ribavirin, je treba upoštevati tudi povzetek glavnih značilnosti ribavirina.
In genotype 4a, resistance to paritaprevir or ombitasvir by variants in NS3 or NS5A, respectively, selected in cell culture were phenotypically characterised. 
Genotip 4 Pri genotipu 4a so fenotipsko opredelili odpornost proti paritaprevirju ali ombitasvirju zaradi variant NS3
Treated subjects (N=179) had a median age of 57 years (range: 26 to 70); 35.2% were prior pegIFN/RBV null responders; 28.5% were prior pegIFN/RBV partial responders, and 36.3% were prior pegIFN/RBV relapsers; 54.2% were male; 3.9% were Black; 12.8% had a history of depression or bipolar disorder; 87.7% had baseline HCV RNA levels of at least 800,000 IU/mL; 17.9% had portal fibrosis (F2) and 14.0% had bridging fibrosis (F3). 
Zdravljeni preiskovanci (N = 179) so bili mediano stari 57 let (razpon: od 26 do 70); 35,2 % jih predhodno ni imelo odziva na pegIFN/RBV; 28,5 % jih je predhodno imelo delen odziv na pegIFN/RBV in 36,3 % jih je predhodno imelo recidiv ob pegIFN/RBV; 54,2 % je bilo moških; 3,9 % je bilo črncev; 12,8 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 87,7 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 17,9 % jih je imelo portalno fibrozo (F2) in 14,0 % jih je imelo fibrozo z mostiči (F3).
The maximum daily dose of rosuvastatin should be 5 mg (see section 4.4). 
Največji dnevni odmerek rosuvastatina sme biti 5 mg (glejte poglavje
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis Design: 
TURQUOISE-II - še nezdravljeni ali že zdravljeni s pegIFN + RBV, s kompenzirano cirozo
Expected: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir 
Pričakovano: ↓ ombitasvir ↓ paritaprevir ↓ dasabuvir
ANTICANCER AGENTS Encorafenib 
ZDRAVILA PROTI RAKU enkorafenib
Each film-coated tablet contains 12.5 mg of ombitasvir, 75 mg of paritaprevir and 50 mg of ritonavir. 
Ena filmsko obložena tableta vsebuje 12,5 mg ombitasvirja, 75 mg paritaprevirja in 50 mg ritonavirja.
A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with Viekirax with or without dasabuvir is required. 
Pri bolnikih z normalnim delovanjem jeter ali ledvic, ki potrebujejo zdravljenje z zdravilom Viekirax z dasabuvirjem ali brez njega, je priporočljivo zmanjšanje odmerka kolhicina ali prekinitev zdravljenja s kolhicinom.
Double variants including combinations of V36LM, F43L, Y56H, Q80K or E357K with R155K or with a D168 substitution reduced the activity of paritaprevir by an additional 2 to 3-fold relative to the single R155K or D168 substitution. 
R155K ali s substitucijo D168, so zmanjšale aktivnost paritaprevirja za dodatno 2- do 3-krat glede na eno samo substitucijo R155K ali D168.
Viekirax and dasabuvir for 12 weeks With RBV 
Viekirax in dasabuvir 12 tednov Z RBV
Genotype 4 
Tarčni gen
↑ naloxone 
↑ digoksin
Following administration of Viekirax and dasabuvir 
Po uporabi zdravila Viekirax in dasabuvirja
A temporary suspension of fluvastatin and pitavastatin is recommended for the duration of treatment with Viekirax. 
Med zdravljenjem z zdravilom Viekirax je priporočljivo začasno opustiti fluvastatin in pitavastatin.
How to store Viekirax 
Shranjevanje zdravila Viekirax
No dose adjustment of Viekirax is required for patients with mild, moderate, or severe renal impairment, or end-stage-renal disease on dialysis (see section 5.2). 
Bolnikom z blago, zmerno ali hudo okvaro ledvic ali bolnikom s končno ledvično odpovedjo, ki so na dializi, odmerka zdravila Viekirax ni treba prilagoditi (glejte poglavje 5.2).
The safety summary is based on pooled data from phase 2 and 3 clinical trials in subjects who received Viekirax and dasabuvir with or without ribavirin. 
Povzetek o varnosti temelji na kumulativnih podatkih kliničnih preskušanj 2. in 3. faze pri preiskovancih,
400 mg twice daily 
raltegravir 400 mg dvakrat na dan
Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks 
Zdravljenje: zdravilo Viekirax in dasabuvir z ribavirinom, odvisnim od telesne mase, 12 ali 24 tednov
Increase in paritaprevir exposures may be due to inhibition of OATP1B1/B3 and CYP3A by atazanavir. 
OATP1B1/B3 in CYP3A z atazanavirjem.
Viekirax and dasabuvir with RBV 24-week arm 
Viekirax in dasabuvir z RBV 24-tedenska skupina
No dose adjustment is necessary for norethindrone or Viekirax with or without dasabuvir. 
Prilagoditev odmerka noretindrona ali zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
Treatment-naïve pegIFN + RBV experienced Prior relapse Prior partial response Prior null response 100% (32/32) Other pegIFN/RBV failures TOTAL +Other types of pegIFN/RBV failure include less well documented non-response, relapse/breakthrough or other pegIFN failure. 
+Druge vrste neuspehov s pegIFN/RBV vključuje slabše dokumentirane neodzive, recidive/preboje ali druge neuspehe s pegIFN.
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Viekirax is taken in combination with ribavirin. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Če je zdravilo Viekirax uporabljeno v kombinaciji z ribavirinom, je potrebna skrajna previdnost, da bi preprečili nosečnost bolnic in partnerk bolnikov.
PEARL-III - genotype 1b, treatment-naïve, without cirrhosis Design: 
PEARL-III - genotip 1b, še nezdravljeni, brez ciroze
All clinical trials with ombitasvir, paritaprevir and ritonavir have been conducted following administration with food. 
paritaprevirjem in ritonavirjem in dasabuvirjem so bila izvedena po uporabi s hrano.
↑ trazodone 
konivaptan
Mechanism: CYP3A4 inhibition by protease inhibitors. 
Mehanizem: Zavrtje CYP3A4 z zaviralci proteaz.
NA 
SERIJ
Nausea, Diarrhoea 
Bolezni prebavil Zelo pogosti navzea, diareja
SVR12 for Genotype 1b-infected treatment-naïve subjects without cirrhosis 
Preglednica 10: SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1b, brez ciroze
Transient elevations in total bilirubin >3 x ULN (mostly indirect) occurred in 17 (27.0%) subjects; 15 of these subjects were receiving atazanavir. 
Bolniki, sočasno okuženi s HIV in HCV Celotne varnostne značilnosti pri preiskovancih sočasno okuženih s HCV in HIV-1 so bile podobne, kot so jih opažali pri preiskovancih, okuženih samo s HCV. Prehodna zvišanja celokupnega bilirubina (v glavnem indirektnega) na > 3-kratno ZNM so se pojavila pri 17 (27,0 %) preiskovancih; 15 teh preiskovancev je prejemalo atazanavir.
The magnitude of interaction was similar to that observed with Viekirax + dasabuvir. 
Izrazitost interakcije je bila podobna kot s kombinacijo Viekirax + dasabuvir.
No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir. 
Prilagoditev odmerka metadona in zdravila Viekirax z dasabuvirjem ali brez njega ni potrebna.
Viekirax dasabuvir 
Viekirax brez dasabuvirja
↑ tacrolimus ombitasvir 
karbamazepin epoksid ombitasvir
Viekirax with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks 
Zdravljenje: Zdravilo Viekirax z ali brez dasabuvirja z ali brez ribavirina, odmerjenega glede na telesno maso, 12 ali 24 tednov
NA No dose adjustment needed for abacavir or lamivudine when coadministered with Viekirax with or without dasabuvir. 
NP Prilagoditev odmerka abakavirja ali lamivudina ni potrebna, kadar se sočasno daje s kombinacijo Viekirax z ali brez dasabuvirja.
Paritaprevir had an EC50 value of 5.3 nM against the 2a-JFH-1 replicon cell line, and EC50 values of 19, 0.09, and 0.68 nM against replicon cell lines containing NS3 from a single isolate each of genotype 3a, 4a, and 6a, respectively 
19, 0,09 oziroma 0,68 nM proti replikonskim celičnim linijam, ki so vsebovale NS3 iz posamičnih izolatov genotipov 3a, 4a oziroma 6a.
25 mg once daily administered in the 
25 mg enkrat na dan, zjutraj s hrano
Do not pass it on to others. 
njega ni treba prilagoditi.