natgillin/translations-raw huggingface dataset:
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). 
Medijan dobi liječenih ispitanika (N=419) iznosio je 50 godina (raspon: 19 do 70); 45,8% bili su muškarci; 4,8% bili su crnci; 9,3% imalo je depresiju ili bipolarni poremećaj u anamnezi; 73,3% imalo je početnu razinu HCV RNK od najmanje 800 000 IU/ml; 20,3% imalo je portalnu fibrozu (F2), a
Atazanavir/ ritonavir 300/100 mg once daily 
Etinilestradiol/ norgestimat mg jedanput na dan
Croscarmellose sodium Colloidal anhydrous silica (E 551) Magnesium stearate (E 470b) 
celuloza, mikrokristalična (E 460(i)) laktoza hidrat kopovidon karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni (E 551) magnezijev stearat (E 470b)
400 mg twice daily 
400 mg dvaput na dan
Dose normalized cyclosporine ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir. 
Omjeri normalizirani za dozu ciklosporina prikazani su za interakciju s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4). 
Ne preporučuje se istodobna primjena s fluvastatinom i pitavastatinom (vidjeti dio
Genotype 1a, with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin* 
Bolesnici s genotipom 1a, s kompenziranom cirozom dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
HCV Genotype 1b dasabuvir and ombitasvir/paritaprevir/ritonavir 
HCV genotipa 1b dasabuvir i ombitasvir/paritaprevir/ritonavir
GT1b dasabuvir and ombitasvir/paritaprevir/ritonavir (8 weeks) 
GT1b dasabuvir i ombitasvir/paritaprevir/ritonavir (8 tjedana)
Drug interaction studies 
Ispitivanja interakcija između lijekova
Genotype 1a, without cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin* 
Bolesnici s genotipom 1a, bez ciroze dasabuvir + ombitasvir/paritaprevir/ritonavir + ribavirin*
Concomitant use of tacrolimus with dasabuvir and ombitasvir/paritaprevir/ ritonavir is not recommended unless the benefits outweigh dasabuvir ombitasvir 
Istodobna primjena takrolimusa s dasabuvirom i ombitasvirom/paritaprevir om/ritonavirom se ne preporučuje osim ako
Other CYP2C9 substrates (NSAIDs (e.g. ibuprofen), antidiabetics (e.g. glimepiride, glipizide) are not expected to require dose adjustments. 
Za ostale supstrate za CYP2C9 (NSAIL-i (npr. ibuprofen), antidijabetici (npr.
Tel: +385 (0)1 5625 501 
AbbVie d.o.o. Tel: +385 (0)1 5625 501
Apalutamide, enzalutamide for prostate cancer ethinyloestradiol 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 
gemfibrozil za snižavanje razine kolesterola i drugih masnoća u krvi mitotan za liječenje nekih tumora nadbubrežnih žlijezda rifampicin za liječenje bakterijskih infekcija gospina trava (Hypericum perforatum)
In Part 2, subjects with HCV GT1 received dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 weeks. 
U drugom su dijelu ispitanici s infekcijom HCV-om genotipa 1 primali dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna.
THYROID HORMONES Levothyroxin e 
TIROIDNI HORMONI Levotiroksi n
Serum ALT elevations 
Povišene razine ALT-a u serumu
Τηλ: +357 22 34 74 40 
Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40
Very common 
Od ukupno
Genotype 1b, without cirrhosis or with compensated cirrhosis dasabuvir + ombitasvir/paritaprevir/ritonavir 
Bolesnici s genotipom 1b, bez ciroze ili s kompenziranom cirozom dasabuvir + ombitasvir/paritaprevir/ritonavir
Refer to the Summary of Product Characteristics of ombitasvir/paritaprevir/ritonavir for its pharmacological properties. 
Za informacije o farmakološkim svojstvima lijekova koji sadrže ombitasvir/paritaprevir/ritonavir pročitati njihov sažetak upute o svojstvima lijeka.
Overall SVR12 HCV genotype 1a Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers HCV genotype 1b Treatment naïve Prior pegIFN/RBV null responders Prior pegIFN/RBV partial responders Prior pegIFN/RBV Prior relapsers Outcome for subjects without SVR12 On-treatment VF Relapse Other a. 97.5% confidence intervals are used for the primary efficacy endpoints (overall SVR12 rate); 95% confidence intervals are used for additional efficacy endpoints (SVR12 rates in HCV genotype 1a and 1b-infected subjects). 
Za primarnu mjeru ishoda za djelotvornost (ukupna stopa SVR12) koriste se intervali pouzdanosti od 97,5%; za dodatne mjere ishoda za djelotvornost (stope SVR12 u ispitanika s infekcijom HCV-om genotipa 1a i 1b) koriste se intervali pouzdanosti od 95%.
Arm A: dasabuvir and ombitasvir/paritaprevir/ritonavir + RBV Arm B: dasabuvir and ombitasvir/paritaprevir/ritonavir 
GT1a skupina A: dasabuvir i ombitasvir/paritaprevir/ritonavir + RBV skupina B: dasabuvir i ombitasvir/paritaprevir/ritonavir
CYP2D6 substrates (e.g. desipramine, metoprolol and dextromethorphan) are not expected to require dose adjustments. 
metoprolol i dekstrometorfan) ne očekuje se potreba prilagodbe doze.
increase in HCV RNA from nadir, or HCV RNA persistently ≥ 25 IU/mL with at least 6 weeks of treatment. 
Potvrđena razina HCV-a od ≥ 25 IU/ml nakon što je HCV RNK tijekom liječenja bio < 25 IU/ml, potvrđeno povećanje HCV RNK od 1 log10 IU/ml u odnosu na najnižu zabilježenu vrijednosti (nadir) ili postojana razina HCV RNK od ≥ 25 IU/ml uz najmanje 6 tjedana liječenja.
Outcome for subjects without SVR12 On-treatment VF 
Ishodi za ispitanike bez SVR12 Virološki neuspjeh tijekom liječenja
Everolimus cannot be used due to lack of suitable dose strengths for dose adjustments. 
čija se doza ne može pravilno prilagoditi s dostupnim jačinama lijeka.
buprenorphin e/ naloxone 4-24 mg/16 mg once daily8 
4-24 mg/1-6 mg jedanput na dan8
Y93H H58D, H58P, Y93N NS5B A553T S556G C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a. Observed in at least 2 subjects of the same subtype. 
C316Y, M414T, G554S, S556R, G558R, D559G, D559N, Y561H a.
The pharmacokinetic properties of the combination of dasabuvir with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 18 shows mean Cmax and AUC of dasabuvir 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers. 
U Tablici 18 navode se srednje vrijednosti Cmax i AUC-a dasabuvira u dozi od 250 mg dvaput na dan u kombinaciji s ombitasvirom/paritaprevirom/ritonavirom u dozi od 25 mg/150 mg/100 mg jedanput na dan nakon višekratnih doza primijenjenih s hranom u zdravih dobrovoljaca.
NA No dose adjustment for cyclobenzaprine required; increase dose if clinically indicated. 
NP Nije potrebno prilagođavati dozu za ciklobenzaprin; primijeniti veću dozu ako je to klinički indicirano.
Subjects with liver transplant and GT4 infection were dosed with ombitasvir/paritaprevir/ritonavir with RBV (noncirrhotic for 12 weeks [n=2] and cirrhotic for 24 weeks [n=1]. 
Ispitanici s jetrenim transplantatom i infekcijom genotipom 4 primali su ombitasvir/paritaprevir/ritonavir u kombinaciji s RBV-om (bolesnici bez ciroze tijekom 12 tjedana
dasabuvir and ombitasvir/paritaprevir /ritonavir + ribavirin 
dasabuvir i ombitasvir/paritaprevir /ritonavir + ribavirin
Sirolimus 2 mg was dosed alone, 0.5 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir. 
Sirolimus se u dozi od 2 mg primjenjivao sam, a u dozi od 0,5 mg s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
• Monitoring should be performed for clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic encephalopathy, variceal haemorrhage). 
• Potreban je nadzor zbog moguće pojave kliničkih znakova i simptoma dekompenzacije jetre
CYP3A/efflu x transporters by lopinavir and higher dose of ritonavir. 
povećanje izloženosti paritaprevir u moglo bi biti posljedica inhibicije CYP3A/eflu ksnih prijenosnika koju uzrokuju lopinavir i viša doza ritonavira.
Frequency dasabuvir and ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2,044 
Učestalost dasabuvir i ombitasvir/paritaprevir/ritonavir + ribavirin* N = 2044
TURQUOISE II (open-label) 
ribavirin, s kompenziranom cirozom TURQUOISE II (otvoreno ispitivanje)
The activity of dasabuvir was reduced by 5- and 11-fold by C316N and S556G, respectively; 46-fold by M414T or Y448H; and 1569-fold by the C316Y substitutions in the genotype 1b replicon. 
U replikonu genotipa 1b, supstitucija C316N smanjila je aktivnost dasabuvira 5 puta, supstitucija S556G 11 puta, supstitucije M414T i Y448H 46 puta, a supstitucija C316Y 1569 puta.
Dabigatran etexilate Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir. 
Mehanizam: crijevna Pgp inhibicija paritaprevir om i ritonavirom.
Treated subjects (N=380) had a median age of 58 years (range: 21 to 71); 42.1% were treatment-naïve, 36.1% were prior pegIFN/RBV null responders; 8.2% were prior pegIFN/RBV partial responders, 13.7% were prior pegIFN/RBV relapsers; 70.3% were male; 3.2% were Black; 14.7% had platelet counts of less than 90 x 109/L; 49.7% had albumin less than 40 g/L; 86.1% had baseline HCV RNA levels of at least 800,000 IU/mL; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection. 
Medijan dobi liječenih ispitanika (N=380) iznosio je 58 godina (raspon: 21 do 71); 42,1% prethodno nije bilo liječeno; 36,1% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 8,2% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 13,7% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 70,3% ispitanika bili su muškarci; 3,2% bili su crnci; 14,7% imalo je broj trombocita manji od 90 x 109/l, 49,7% imalo je razinu albumina manju od 40 g/l; 86,1% imalo je početne razine HCV RNK od najmanje 800 000
The adverse reactions are listed below by system organ class and frequency. 
Nuspojave u nastavku razvrstane su prema organskim sustavima i učestalosti.
0.75 mg single dose 
Everolimus 0,75 mg pojedinačna doza Mehanizam:
global multicentre, open-label 
globalno, multicentrično, otvoreno ispitivanje
Dose normalized tacrolimus ratios are shown for interaction with dasabuvir + ombitasvir/paritaprevir/ritonavir. 
Omjeri normalizirani za dozu takrolimusa prikazani su za interakciju s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis 
TURQUOISE-III: ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni kombinacijom pegIFN + RBV
Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% were Black; 19% had compensated cirrhosis; 67% were treatment-naïve; 33% had failed prior treatment with pegIFN/RBV; 89% had HCV genotype 1a infection. 
(raspon: 31 do 69); 24% bili su crnci; 19% imalo je kompenziranu cirozu; 67% prethodno nije bilo liječeno; 33% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV; 89% imalo je infekciju HCV-om genotipa 1a.
PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis Design: 
PEARL-II - ispitanici s infekcijom genotipom 1b prethodno liječeni kombinacijom pegIFN+RBV, bez ciroze
Ciclosporin 100 mg dosed alone and 30 mg administered with dasabuvir + ombitasvir/paritaprevir/ritonavir. 
Samostalna doza od 100 mg ciklosporina ili doza od 30 mg ciklosporina primijenjena s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
DIURETICS Furosemide 20 mg single dose 
20 mg pojedinačna doza
Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser Outcome for subjects without SVR12 On-treatment VF 
Relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV Ishodi za ispitanike bez SVR12
The highest documented single dose of dasabuvir administered to healthy volunteers was 2 g. No study drug-related adverse reactions or clinically significant laboratory abnormalities were observed. 
2 g. Nisu zabilježene nuspojave povezane s primjenom ispitivanoga lijeka ni klinički značajna odstupanja u laboratorijskim vrijednostima..
Mechanism: possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir. 
Mehanizam: mogao bi biti posljedica inhbicije UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
Methadone 
Metformin
Genotype-specific activity 
Aktivnost protiv pojedinih genotipova
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by dasabuvir paritaprevir, and ritonavir. 
Mehanizam: paritaprevir inhibira OATP1B, a dasabuvir, paritaprevir, ritonavir inhibiraju BCRP.
Resistance-associated variants at amino acid positions R155 and D168 in NS3 were rarely observed (less than 1%) at baseline. 
Varijante na aminokiselinskim položajima R155 i D168 u NS3,
dasabuvir and ombitasvir/paritaprevir/ritonavir without ribavirin for 12 weeks 
dasabuvir i ombitasvir/paritaprevir/ritonavir tijekom 12 tjedana, bez ribavirina
randomised, global multicentre, open-label, regimen-controlled 
randomizirano, globalno, multicentrično, otvoreno ispitivanje kontrolirano terapijskim režimom
Mechanism: possibly due to UGT inhibition by paritaprevir, ombitasvir and dasabuvir. 
Mehanizam: mogao bi biti posljedica inhibicije UGT-a koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
AbbVie d.o.o. 
AbbVie B.V.
800/160 mg twice daily dasabu vir + 
800/160 mg dvaput na dan
ANTIMYCOBACTERIALS Rifampicin 
ANTIKONVULZIVI karbamazepin
Tacrolimus 2 mg was dosed alone and 2 mg was administered with dasabuvir + ombitasvir/paritaprevir/ritonavir. 
Samostalna doza od 2 mg takrolimusa i doza od 2 mg primijenjena s dasabuvirom + ombitasvir/paritaprevir/ritonavir.
Paritaprevir treatment-emergent variants V36A/M, R155K or D168V were observed in NS3 in 47 subjects. 
R155K ili D168V u NS3 nastale tijekom primjene paritaprevira primijećene su u 47 ispitanika.
Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir. 
Mehanizam: ritonavir inhibira CYP3A4 a paritaprevir, ombitasvir i dasabuvir inhibiraju UGT.
↑ fluvastatin ↑ pitavastatin ↔ dasabuvir ↔ ombitasvir ↔ paritaprevir 
↑ darunavir ↓ dasabuvir ombitasvir
HCV Genotype 1a dasabuvir and ombitasvir/paritaprevir/ritonavir with RBV 
HCV genotipa 1a dasabuvir i ombitasvir/paritaprevir/ritonavir
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir aprevir/ ritonavi r ombitasvir 
Mehanizam: CYP3A4 inhibicija ritonavirom ombitasvir/p aritaprevir/ri tonavir
Poly(vinyl alcohol) (E 1203) Titanium dioxide (E 171) Macrogol (3350) Talc (E 553b) 
poli(vinilni alkohol) (E 1203) titanijev dioksid (E 171) makrogol (3350) talk (E 553b) željezov oksid, žuti (E 172) željezov oksid, crveni (E 172) željezov oksid, crni (E 172)
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). 
Medijan dobi liječenih ispitanika (N=179) iznosio je 57 godina (raspon: 26 do 70); 35,2% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 28,5% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 36,3% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 54,2% ispitanika bili su muškarci; 3,9% bili su crnci; 12,8% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,7% imalo je početne razine
Pravastatin 10 mg once daily 
10 mg jedanput na dan
Tell your doctor or pharmacist if you notice any of the following side effects: Side effects when taking Exviera with ombitasvir/paritaprevir/ritonavir: 
Recite svom liječniku ako imate sljedeće simptome tijekom uzimanja lijeka Exviera i ombitasvira/paritaprevira/ritonavira jer oni mogu biti znakovi pogoršanja jetrenih tegoba:
TURQUOISE-II - treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis 
TURQUOISE-II - ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni kombinacijom pegIFN + RBV
Overall SVR12 HCV genotype 1a HCV genotype 1b Outcome for subjects without SVR12 On-treatment VFa Relapse Otherb a. Confirmed HCV ≥ 25 IU/mL after HCV RNA < 25 IU/mL during treatment, confirmed 1 log10 IU/mL 
Ukupan SVR12 HCV genotipa 1a HCV genotipa 1b Ishodi za ispitanike bez SVR12
randomised, global multicentre, open-label 
randomizirano, globalno, multicentrično, otvoreno ispitivanje
250 mg single dose 
karisoprodo l 250 mg pojedinačna doza
ombitasvir/paritaprevir/ritonavir with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks 
ombitasvir/paritaprevir/ritonavir s dasabuvirom ili bez njega tijekom 12 ili 24 tjedna, u kombinaciji s ribavirinom doziranim prema tjelesnoj težini ili bez njega
Phenobarbita l 
Fenobarbita l
Film-coating 
Film ovojnica:
Caution should be used when sulfasalazine is co-administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir. 
Sulfasalazin se mora primjenjivati s oprezom istodobno s dasabuvirom + ombitasvir/paritaprevir/rito navir.
Without cirrhosis 
Bez ciroze
Purpose of the medicine carbamazepine, phenytoin, phenobarbital for epilepsy efavirenz, etravirine, nevirapine for HIV infection 
Namjena lijeka karbamazepin, fenitoin, fenobarbital za liječenje epilepsije efavirenz, etravirin, nevirapin za liječenje HIV infekcije apalutamid, enzalutamid za rak prostate lijekovi koji sadrže etinilestradiol, poput većine lijekova za sprječavanje začeća i vaginalni kontracepcijski prstenovi.
SAPPHIRE-I - genotype 1, treatment-naïve, without cirrhosis 
SAPPHIRE-I - prethodno neliječeni ispitanici s infekcijom genotipom 1, bez ciroze Dizajn:
Dasabuvir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (2 g/kg/day), resulting in dasabuvir AUC exposures approximately 19-fold higher than those in humans at the recommended dose of 500 mg (250 mg twice daily). 
6-mjesečnom istraživanju na transgeničnim miševima, dasabuvir nije bio kancerogen ni pri najvišoj ispitivanoj dozi (2 g/kg/dan), koja je dovela do približno 19 puta veće izloženosti dasabuviru
Hepatic impairment 
Dabigatrane teksilat
Refer to the tacrolimus or sirolimus Summary of Product Characteristics for additional dosing and monitoring instructions. 
Za dodatne upute o doziranju i praćenju, pročitajte sažetak opisa svojstava lijeka za takrolimus ili sirolimus.
dasabuvir and ombitasvir/paritaprevir /ritonavir 
dasabuvir i ombitasvir/paritaprevir/ritonavir
Mechanism: CYP3A4 induction by phenytoin. 
Mehanizam: indukcija CYP3A4 fenobarbital om.
Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported post-marketing in patients treated with dasabuvir with ombitasvir/paritaprevir/ritonavir with and without ribavirin. 
Nakon stavljanja lijeka u promet, u bolesnika liječenih dasabuvirom u kombinaciji s ombitasvirom/ paritaprevirom /ritonavirom te u kombinaciji s ribavirinom ili bez njega prijavljeni su dekompenzacija jetre i zatajenje jetre, uključujući slučajeve koji su završili transplantacijom jetre ili smrtnim ishodom.
SVR12 for genotype 1b-infected treatment-naïve subjects in PEARL III 
SVR12 za prethodno neliječene ispitanike s infekcijom genotipom 1b u ispitivanju
Prior pegIFN/RBV relapser 
Djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV
No dose adjustment is necessary for methadone and dasabuvir + ombitasvir/paritaprevir/ ritonavir. 
Nije potrebno prilagođavati dozu za metadon i dasabuvir + ombitasvir/paritaprevir/rito
↑ hydrocod one 
↑ hidrokodon 1,27
CYP3A4 inhibition by ritonavir. 
učinak na takrolimus posljedica je inhibicije CYP3A4 ritonavirom.
Medicinal products transported by Pgp in the intestine While dasabuvir is an in vitro inhibitor of P-gp, no significant change was observed in the exposure of the P-gp substrate, digoxin, when administered with dasabuvir with ombitasvir/paritaprevir/ritonavir. 
Iako je dasabuvir in vitro inhibitor P-gp-a, nije primijećena značajna promjena izloženosti digoksinu,
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). 
paritaprevir om/ritonavirom zbog povišenja izloženosti paritapreviru (vidjeti sažetak opisa svojstava lijeka ombitasvir/paritaprevir/rito navir ).
Endpoint dasabuvir and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 or 24 Weeks N = 200a 
Mjera ishoda dasabuvir i ombitasvir/paritaprevir/ritonavir u kombinaciji s ribavirinom ili bez njega tijekom 12 ili 24 tjedna N = 200a
NA No dose adjustment needed for abacavir or lamivudine when administered with dasabuvir + ombitasvir/paritaprevir/ ritonavir. 
NP Nije potrebno prilagođavati dozu abakavira ili lamivudina kada se primjenjuju s dasabuvirom + ombitasvir/paritaprevir/rito navir.
Exviera contains lactose. 
Exviera sadrži laktozu.
Mechanism: increase in dasabuvir possibly due to CYP2C8 inhibition by trimethoprim ombitasvir 
povećanje izloženosti dasabuviru kao moguća posljedica inhibicije CYP2C8 trimetoprim om dasabuvir ombitasvir/p aritaprevir/ri tonavir
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. 
Postojanost odgovora Ukupno je 660 ispitanika u kliničkim ispitivanjima faze 2 i 3 postiglo željene razine HCV RNK i u trenutku određivanja SVR12 i u trenutku određivanja SVR24.
No dose adjustment is necessary for emtricitabine/tenofovir and dasabuvir + ombitasvir/paritaprevir/ ritonavir. 
Nije potrebno prilagođavati dozu za emtricitabin/tenofovir i dasabuvir +
Apalutamide 
lamivudin
Dasabuvir and ombitasvir/paritaprevir/ritonavir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients. 
U bolesnika s transplantiranom jetrom preporuča se primjena dasabuvira i ombitasvira/paritaprevira/ritonavira u kombinaciji s ribavirinom tijekom 24 tjedna.
Mechanism: Unknown dasabu vir + ombitas vir/parit aprevir/ ritonavi r 
Mehanizam: nepoznat dasabuvir ombitasvir/ paritaprevir /ritonavir
PEARL-IV - genotype 1a, treatment-naïve, without cirrhosis 
PEARL-IV - prethodno neliječeni ispitanici s infekcijom genotipom 1a, bez ciroze Dizajn:
Metabolism and nutrition disorders Uncommon Dehydration Psychiatric disorders Very common Insomnia Gastrointestinal disorders Very common Nausea, Diarrhoea Common 
Poremećaji jetre i žuči nepoznata učestalost dekompenzacija jetre i zatajenje jetre dekompenzacija jetre i zatajenje jetre
↓ dasabuvir ↓ paritaprevir ↓ ombitasvir 
↓ dasabuvir ↓ ombitasvir
Mechanism: BCRP and Pgp inhibition by paritaprevir, ritonavir and dasabuvir dasabu vir + 
Mehanizam: BCRP i Pgp inhibicija paritaprevir om, ritonavirom i dasabuviro m dasabuvir ombitasvir/ paritaprevir /ritonavir