natgillin/translations-raw huggingface dataset:
Viekirax + dasabuvir ciclosporin
Viekirax + dasabuvir ciklosporin
− Notice yellowing of your skin or eyes
− žuta boja kože ili očiju − tamnija boja mokraće nego inače
Following a 600 mg dose of 14C -ritonavir oral solution, 86.4% of the radioactivity was recovered in the faeces and 11.3% of the dose was excreted in the urine.
86,4% radioaktivnosti pronađeno je u fecesu, a 11,3% doze izlučeno je kroz mokraću.
Mechanism: CYP3A4/Pgp inhibition by clarithromyci n and ritonavir.
CYP3A4/Pgp inhibicija klaritromici nom i ritonavirom.
Adverse drug reactions identified with Viekirax in combination with dasabuvir with and without ribavirin
Tablica 3. Nuspojave na lijek utvrđene kod primjene lijeka Viekirax u kombinaciji s dasabuvirom, s ribavirinom ili bez njega
Smephenytoin
Smefenitoin
HCV Genotype 1b Viekirax and dasabuvir
HCV genotipa 1b Viekirax i dasabuvir
HIV ANTIVIRALS: INTEGRASE STRAND TRANSFER INHIBITOR Dolutegravir
ANTIVIROTICI ZA LIJEČENJE HIV-a: INHIBITORI PRIJENOSA LANCA INTEGRAZE
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
Tablica 12. SVR12 za ispitanike prethodno liječene peginterferonom i ribavirinom s infekcijom genotipom 1b u ispitivanju PEARL II
Ritonavir is predominantly metabolised by CYP3A and to a lesser extent, by CYP2D6.
Ritonavir se najvećim dijelom metabolizira posredstvom CYP3A, a u manjoj mjeri posredstvom
D168Y V36Ac, V36Mc, F43Lc, D168H, E357Kc NS5A M28T M28Ve Q30Re 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.
↔ ombitasvir/paritaprevir (based on the cross-study comparison)
↔ ombitasvir/paritaprevir/ (na temelju usporedbe podataka iz različitih ispitivanja)
The efficacy of Viekirax has not been established in patients with HCV genotypes 2, 3, 5 and 6; therefore Viekirax should not be used to treat patients infected with these genotypes.
Za preporučeno doziranje kod različitih genotipova HCV-a vidjeti dio 4.2. Za virološku i kliničku aktivnost protiv pojedinih genotipova vidjeti dio 5.1. Djelotvornost lijeka Viekirax nije ustanovljena u bolesnika s HCV-om genotipova 2, 3, 5 i 6 te se stoga Viekirax ne smije koristiti u liječenju bolesnika s infekcijom ovim genotipovima.
CYP3A4 inhibition by ritonavir
CYP3A4 inhibicija ritonavirom
Viekirax and dasabuvir with weight-based ribavirin for 12 or 24 weeks
Viekirax i dasabuvir tijekom 12 ili 24 tjedna s ribavirinom čija je doza temeljena na težini
Mechanism: CYP2C19 induction by ritonavir
Mehanizam: indukcija CYP2C19 ritonavirom
NA No dose adjustment required for cyclobenzaprine; increase dose if clinically indicated.
NP Nije potrebno prilagođavati dozu za ciklobenzaprin; primijeniti veću dozu ako je to klinički indicirano.
The EC50 of paritaprevir against genotype 1a-H77 and 1b-Con1 strains in the HCV replicon cell culture assay was 1.0 and 0.21 nM, respectively.
U testu replikona HCV-a u staničnoj kulturi, EC50 paritaprevira protiv sojeva genotipa 1a-H77 iznosio je 1,0 nM, a protiv sojeva genotipa 1b-Con1 0,21 nM.
Prior pegIFN/RBV null responder Prior pegIFN/RBV partial responder Prior pegIFN/RBV relapser Outcome for subjects without SVR12 On-treatment VF
Djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV Relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV Ishodi za ispitanike bez SVR12 Virološki neuspjeh tijekom liječenja
Package leaflet: Information for the patient Viekirax 12.5 mg/75 mg/50 mg film-coated tablets ombitasvir/paritaprevir/ritonavir This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Viekirax 12,5 mg/75 mg/50 mg filmom obložene tablete ombitasvir/paritaprevir/ritonavir
Viekirax with ribavirin & without dasabuvir was evaluated for 12 weeks in genotype 1 treatment naive and treatment experienced non-cirrhotic subjects in a phase 2 study M11-652 (AVIATOR).
Liječenje lijekom Viekirax s ribavirinom i bez dasabuvira ispitivalo se tijekom 12 tjedana u prethodno liječenih te prethodno neliječenih ispitanika s infekcijom genotipom 1 bez ciroze u ispitivanju faze II
250 mg single dose
karisoprodol 250 mg pojedinačna doza
Pitavastatin Mechanism: OATP1B inhibition by paritaprevir
Mehanizam : OATP1B inhibicija paritaprevir om
Baseline platelet count, median (× 109/L)
Početne razine albumina, medijan g/L
Buprenorphine / naloxone
buprenorfin / nalokson
The EC50 of ombitasvir against genotype 1a-H77 and 1b-Con1 strains in HCV replicon cell culture assays was 14.1 and 5 pM, respectively.
U testovima replikona HCV-a u staničnoj kulturi, EC50 ombitasvira protiv sojeva genotipa 1a-H77 iznosio je 14,1 pM, a protiv sojeva genotipa 1b-Con1 5 pM.
CALCIUM CHANNEL BLOCKERS Amlodipine
BLOKATORI KALCIJEVIH KANALA amlodipin pojedinačna doza od 5 mg
PEARL-II - genotype 1b, pegIFN+RBV-experienced, without cirrhosis
PEARL-II - ispitanici prethodno liječeni pegIFN i RBV s infekcijom genotipom 1b, bez ciroze Dizajn:
Co-administration with other direct-acting antivirals against HCV
ANTIVIROTICI ZA LIJEČENJE HCV-a
Mechanism: CYP2C19 induction by ritonavir.
Mehanizam : CYP2C19 indukcija ritonavirom.
Mechanism: CYP3A4 inhibition by
Mehanizam : CYP3A4 inhibicija kobicistato m
↑ ticagrelor
↑ tikagrelor
CYP3A4 inhibition by ritonavir.
CYP3A4 inhibicija ritonavirom.
TURQUOISE-III: treatment-naïve or pegIFN + RBV-experienced with compensated cirrhosis Design:
TURQUOISE-III: ispitanici s kompenziranom cirozom, prethodno neliječeni ili prethodno liječeni pegIFN i RBV Dizajn:
In genotype 4a, resistance to paritaprevir or ombitasvir by variants in NS3 or NS5A, respectively, selected in cell culture were phenotypically characterised.
NS3 te rezistencija na ombitasvir uzrokovana varijantama u NS5A, koje su izdvojene u staničnim kulturama.
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).
Ako je potrebno liječenje lijekom Viekirax s dasabuvirom ili bez njega, kod bolesnika koji imaju urednu funkciju bubrega ili jetre preporučuje se smanjenje doze kolhicina ili prekid liječenja s kolhicinom (vidjeti dio 4.5).
NA No dose adjustment necessary for paracetamol when administered with Viekirax with or without dasabuvir.
NP Nije potrebno prilagođavati dozu za paracetamol kada se primjenjuje s lijekom Viekirax s dasabuvirom ili bez njega.
SVR12 for HCV Genotype 4-Infected Subjects with Compensated Cirrhosis Ombitasvir + Paritaprevir + Ritonavir with RBV 12 Weeks
Ombitasvir + paritaprevir + ritonavir s RBV 12 tjedana
Ethinyloestradiolcontaining oral contraceptives are contraindicated (see section 4.3).
Oralni kontraceptivi koji sadrže etinilestradiol su kontraindicirani (vidjeti dio
NA No dose adjustment needed for abacavir or lamivudine when coadministered with Viekirax with or without dasabuvir.
NP Nije potrebno prilagođavati dozu abakavira ili lamivudina kada se primjenjuju s lijekom Viekirax s dasabuvirom ili bez njega.
Upon completion of Viekirax and dasabuvir treatment, the appropriate dose and dosing frequency of tacrolimus should be guided by assessment of tacrolimus blood concentrations.
odgovarajuću dozu i učestalost primjene takrolimusa treba odrediti na temelju koncentracija takrolimusa u krvi.
Clinical monitoring and dose adjustment may be needed for other CYP1A2 substrates (e.g. ciprofloxacin, cyclobenzaprine, theophylline and caffeine).
Klinički nadzor i prilagodba doze mogu biti potrebni za ostale supstrate za CYP1A2 (npr.
Treatment duration 12 weeks
Skupina liječena 12
Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported postmarketing in patients treated with Viekirax with and without dasabuvir and with and without ribavirin.
Nakon stavljanja lijeka u promet, u bolesnika liječenih lijekom Viekirax u kombinaciji s dasabuvirom ili bez njega 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.
Viekirax and dasabuvir with RBV 12-week arm
Viekirax i dasabuvir s RBV-om
If statin treatment is required during the treatment period, a switch to dose reduced pravastatin or rosuvastatin is possible.
moguće je prebacivanje na smanjene doze pravastatina ili rosuvastatina.
↓ esomeprazole, lansoprazole
Kliničke napomene esomeprazo l lanzoprazol
Dabigatran etexilate Mechanism: Intestinal Pgp inhibition by paritaprevir and ritonavir.
Mehanizam : inhibicija crijevnog Pgp paritaprevir om i ritonavirom.
Mechanism: OATP1B inhibition by paritaprevir and BCRP inhibition by paritaprevir, ritonavir or dasabuvir.
Mehanizam paritaprevir inhibira OATP1B, a paritaprevir, ritonavir ili dasabuvir inhibiraju BCRP.
Skin and subcutaneous tissue disorders Very common
Poremećaji kože i potkožnog tkiva vrlo često pruritus često pruritus rijetko angioedem angioedem
Viekirax with or without dasabuvir ethinyloestra diol
Viekirax s dasabuvirom ili bez njega etinilestradiol
Mechanism: CYP3A4 induction by phenytoin.
Mehanizam : Indukcija CYP3A4 fenitoinom
Expected: ↑ sildenafil
Očekuje se: ↑ enkorafenib
No dose adjustment is necessary for norethindrone or Viekirax with or without dasabuvir.
Nije potrebna prilagodba doze noretindrona niti lijeka Viekirax s dasabuvirom ili bez njega.
Viekirax and dasabuvir with weight-based ribavirin for 12 weeks
Viekirax i dasabuvir tijekom 12 tjedana s ribavirinom čija je doza temeljena na težini
25 mg once daily administered in the
25 mg jedanput na dan, ujutro s hranom
Viekirax with or without dasabuvir coadminstered with or without weight-based ribavirin for 12 or 24 weeks
Viekirax s dasabuvirom ili bez njega tijekom 12 ili 24 tjedna, u kombinaciji s ribavirinom čija je doza temeljena na težini ili bez njega
paritaprevir ombitasvir
paritaprevir ombitasvir dabigatranet eksilat
Arm B: Viekirax and dasabuvir + RBV (24 weeks)
skupina A: Viekirax i dasabuvir + RBV (12 tjedana) skupina B: Viekirax i dasabuvir + RBV (24 tjedna)
Overall SVR12 Outcome for subjects without SVR12 On-treatment VF Relapse Other * Ombitasvir tablets, paritaprevir tablets and ritonavir capsules administered separately.
Ostalo * Tablete ombitasvira, tablete paritaprevira i kapsule ritonavira primjenjivale su se odvojeno.
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.
Concomitant use with fluvastatin and pitavastatin is not recommended (see section 4.4).
Ne preporuča se istodobna primjena s fluvastatinom i pitavastatinom. (vidjeti dio
Viekirax without dasabuvir omeprazole
Viekirax bez dasabuvira vorikonazol
No dose adjustment needed for Viekirax with or without dasabuvir.
Nije potrebno prilagođavati dozu lijeka Viekirax s ili bez dasabuvira.
↑ fexofenadine
↑ feksofenadin
NA No dose adjustment needed for sofosbuvir when administered with Viekirax with or without dasabuvir.
NP Nije potrebno prilagođavati dozu sofosbuvira kada se primjenjuje s lijekom Viekirax s dasabuvirom ili bez njega.
Clinical trials in treatment-naïve adults
Klinička ispitivanja u ispitanika s kompenziranom cirozom
Following administration of Viekirax
Nakon primjene lijeka Viekirax
Note: Doses used for Viekirax and dasabuvir were: ombitasvir 25 mg, paritaprevir 150 mg, ritonavir 100 mg, once daily and dasabuvir 400 mg twice daily or 250 mg twice daily.
150 mg, ritonavir 100 mg jedanput na dan i dasabuvir 400 mg dvaput na dan ili 250 mg dvaput na dan.
Mechanism: UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
UGT1A1 inhibicija paritaprevir om, ombitasviro m i dasabuviro m.
Table 2 provides the Least Squares Means Ratio (90% Confidence Interval) effect on concentration of Viekirax with or without dasabuvir and concomitant medicinal products.
(90% interval pouzdanosti) na koncentraciju lijeka Viekirax, s dasabuvirom ili bez njega, te istodobno primijenjenih lijekova.
Viekirax and dasabuvir for 12 weeks With RBV
Viekirax i dasabuvir tijekom 12 tjedana bez ribavirina
CYP3A4 induction by phenobarbital.
Mehanizam : Indukcija CYP3A4 fenobarbital om.
No dose adjustment is necessary for emtricitabine/tenofovir and Viekirax with or without dasabuvir.
Nije potrebno prilagođavati dozu za emtricitabin/tenofovir niti
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.
Ako je istodobno liječenje rosuvastatinom neophodno, maksimalna dnevna doza rosuvastatina smije biti 5 mg (vidjeti dio 4.5, Tablica 2).
Viekirax without dasabuvir
Viekirax bez dasabuvira
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).
Medijan dobi ispitanika (N=135) iznosio je 51 godinu (raspon: 19 do 70); 63,7% bili su prethodno neliječeni, 17,0% nisu odgovarali na prethodno liječenje pegIFN/RBV, 6,7% su djelomično odgovarali na prethodno liječenje pegIFN/RBV, 12,6% je imalo relaps nakon prethodnog liječenja pegIFN/RBV;
NA Concomitant use of Viekirax with dasabuvir is contraindicated (see section 4.3).
NP Istodobna primjena lijeka Viekirax s dasabuvirom je kontraindicirana (vidjeti dio
400 mg twice daily
raltegravir 400 mg dvaput na dan
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
Mechanism: CYP3A4 inhibition by ritonavir
Mehanizam: CYP3A4 inhibicija ritonavirom
Expected: lomitapide
Očekuje se: ↑ lomitapid
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).
kontracepcija samo progestinom ili nehormonske metode) prije započinjanja liječenja lijekom Viekirax s dasabuvirom ili bez njega (vidjeti dijelove 4.3 i 4.5).
Disopyramide
dezmetilcitalopram
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).
povećava koncentracije tih lijekova u plazmi; preporuča se rutinsko kliničko praćenje za lijekove s uskim terapijskim indeksom (tj. levotiroksin).
Target
Ciljno mjesto
CONTRACEPTIVES
Lijek/
↑ salmeterol
Očekuje se: ↑ salmeterol
The SVR12 rates in HCV/HIV-1 co-infected subjects were thus consistent with SVR12 rates in the phase 3 trials of HCV mono-infected subjects.
om tipa 1 odgovarala je stopi SVR12 u ispitivanjima faze III u ispitanika s infekcijom samo HCV-om.
Expected: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
Očekuje se: ↓ombitasvir ↓ paritaprevir ↓ dasabuvir
Medicinal products transported by BCRP
Lijekovi koji se prenose putem P-gp-a u crijevima
A
U
ANTITPLATELET AGENTS Ticagrelor
ANTITROMBOTICI tikagrelor
Tacrolimus
Metformin
The activity of paritaprevir in genotype 1a was not significantly affected (less than or equal to 3-fold) by single substitutions V36A/M, V55I, Y56H, Q80K or E357K.
Pojedinačne supstitucije V36A/M, V55I, Y56H, Q80K i E357K nisu značajno utjecale na aktivnost paritaprevira protiv genotipa 1a (trostruko ili manje).
DIURETICS Furosemide
↑ dabigatraneteksilat
Mechanism: CYP3A4 inhibition by ritonavir.
Mehanizam: CYP3A4 inhibicija ritonavirom.
Mechanism: CYP3A4 induction by carbamazepine
Mehanizam : Indukcija CYP3A4 karbamazep inom.
Viekirax without dasabuvir ciclosporin ombitasvir
Viekirax bez dasabuvira ciklosporin ombitasvir
Viekirax and dasabuvir in combination with ribavirin is recommended for 24 weeks in liver transplant recipients with genotype 1 HCV infection.
Kod bolesnika s transplantiranom jetrom s infekcijom HCV-om genotipa 1 preporučuje se kombinacija lijeka Viekirax i dasabuvira s ribavirinom tijekom 24 tjedna.
Esomeprazole Lansoprazole Mechanism: CYP2C19 induction by ritonavir.
Mehanizam : Indukcija CYP2C19 ritonavirom.
Viekirax without dasabuvir duloxetine
Viekirax bez dasabuvira duloksetin
CYP3A4 inhibition by ritonavir and increase in paritaprevir exposures may be due to OATP/BCRP/ P-gp inhibition by ciclosporin.
Kliničke napomene inhibicije OATPa/BCRPa/P-gp-a uzrokovane primjenom ciklosporina
Clinical Comments raltegravir exposures may be due to UGT1A1 inhibition by paritaprevir, ombitasvir.
: Povećanje izloženosti raltegraviru moglo bi biti posljedica inhibicije UGT1A1 koju uzrokuju paritaprevir, ombitasvir i dasabuvir.
NA If clinically indicated higher doses of omeprazole should be used.
NP Primijeniti veće doze omeprazola, ako je to klinički indicirano.
CYP3A4/Pgp inhibition.
Mehanizam : Inhibicija CYP3A4 /P-gp.
No dose adjustment is necessary for methadone and Viekirax with or without dasabuvir.
Nije potrebno prilagođavati dozu metadona niti lijeka Viekirax u kombinaciji s dasabuvirom ili bez njega.
↑ norbu
↑ kinidin
Viekirax + dasabuvir dolutegravir
Viekirax + dasabuvir buprenorfin
CYP3A4 induction by St. John's Wort
Mehanizam: CYP3A4 indukcija gospinom travom
Viekirax and dasabuvir for 8 weeks
GT1b Viekirax i dasabuvir (8 tjedana)
No dose adjustment needed for dolutegravir when coadministered with Viekirax with or without dasabuvir.
Nije potrebno prilagođavati dozu dolutegravira kada se primjenjuje s lijekom Viekirax s dasabuvirom ili bez njega.
Similarly, paritaprevir/ritonavir was not carcinogenic in a 2-year rat study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 8-fold higher than those in humans at 150 mg.
godišnjem istraživanju na štakorima ni pri najvišoj ispitivanoj dozi (300 mg/30 mg/kg/dan), koja je dovela do približno 8 puta veće izloženosti paritapreviru (određene na temelju AUC-a) od izloženosti koja se postiže u ljudi nakon primjene doze od 150 mg.
Mechanism: CYP3A inhibition by ritonavir
CYP3A inhibicija ritonavirom
↔ lopinavir The magnitude of interaction was similar to that observed with Viekirax + dasabuvir.
Jačina interakcije bila je slična onoj primijećenoj kod kombinacije Viekirax +
Mechanism: CYP2C19 induction and CYP3A4 inhibition by ritonavir
Mehanizam ritonavir inducira CYP2C19 i inhibira CYP3A4
Durability of response
Trajanje liječenja
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).
Viekirax i dasabuvir tijekom 12 tjedana bez ribavirina ili s ribavirinom čija je doza temeljena na težini 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
↑ digoxin
↑ pimozid
Caution should be used when Viekirax with or without dasabuvir is coadministered with fexofenadine.
Potreban je oprez kod istodobne primjene lijeka Viekirax s dasabuvirom ili bez njega i feksofenadina.
The mean EC50 of ombitasvir against replicons containing NS5A from a panel of treatment-naïve genotype 1a and 1b isolates in the HCV replicon cell culture assay was 0.66 pM (range 0.35 to 0.88 pM; n=11) and 1.0 pM (range 0.74 to 1.5 pM; n=11), respectively.
U testu replikona HCV-a u staničnoj kulturi, srednja vrijednost EC50 ombitasvira protiv replikona koji sadrže NS5A iz palete izolata genotipa 1a odnosno 1b prikupljenih u prethodno neliječenih ispitanika iznosila je 0,66 pM (raspon:
↑ encorafenib
↑ kvetiapin
Clinical Comments inhibition of OATP1B1/B3 and CYP3A by atazanavir and CYP3A by the additional dose of ritonavir.
CYP3A koju uzrokuje atazanavir i CYP3A uzrokuje dodatna doza ritonavira.
Duration
Dojenje
ANTIFUNGALS Ketoconazole 400 mg once daily
KONTRACEPTIVI etinilestradiol/ norgestimat mg jedanput na dan
Apalutamide
pitavastatin
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.
Medijan dobi liječenih ispitanika (N=394) iznosio je 54 godine (raspon: 19 do 71); 49,0% nije ostvarilo odgovor na prethodno liječenje kombinacijom pegIFN/RBV, 21,8% ostvarilo je djelomičan odgovor na prethodno liječenje kombinacijom pegIFN/RBV, a 29,2% doživjelo je relaps nakon prethodnog liječenja kombinacijom pegIFN/RBV; 57,6% ispitanika bili su muškarci; 8,1% bili su crnci; 20,6% imalo je depresiju ili bipolarni poremećaj u anamnezi; 87,1% imalo je početnu razinu
General disorders and administration and administration site conditions Very common
Opći poremećaji i reakcije na mjestu primjene vrlo često astenija umor
Treated subjects (N=166) had a median age of 53 years (range: 22 to 82); 56.6% were female; 3.0% were Asian; 0.6% were Black; 7.2% had baseline HCV RNA levels of at least 6,000,000 IU per mL; 9% had advanced fibrosis (F3) and 98.2% had HCV genotype 1b infection (one subject each had genotype 1a, 1d, and 6 infection).
HCV RNK od najmanje 6 000 000 IU po ml; 9% imalo je uznapredovalu fibrozu (F3), a 98,2% imalo je infekciju HCV-om genotipa 1b (po jedan ispitanik imao je infekciju HCV-om genotipa 1a, 1d i 6).
No dose adjustment needed for Viekirax with dasabuvir ombitasvir paritaprevir
Nije potrebna prilagodba doze lijeka Viekirax u ombitasvir dasabuvir
Mechanism of action
Mehanizam
OPIOIDS Methadone
NARKOTIČKI ANALGETICI
Mechanism: CYP3A4/Pgp inhibition by ketoconazole and paritaprevir/ ritonavir/ ombitasvir paritaprevir
Mehanizam ketokonazol i paritaprevir/ ritonavir/o mbitasvir inhibiraju CYP3A4/Pgp.
ANTICANCER AGENTS Encorafenib
ANTITUMORSKI LIJEKOVI enkorafenib
Mechanism: CYP3A4 induction by rifampicin.
CYP3A4 indukcija rifampicino m.
Trazodone Mechanism: CYP3A4 inhibition by ritonavir.
Mehanizam : CYP3A4 inhibicija ritonavirom.
Mechanism: CYP3A4 inhibition by ritonavir ombitasvir
Mehanizam : Inhibicija CYP3A4 ritonavirom
No dose adjustment is necessary for buprenorphine/naloxone and Viekirax with or without dasabuvir.
Nije potrebno prilagođavati dozu buprenorfina/ naloksona niti lijeka Viekirax u kombinaciji s dasabuvirom ili bez njega.
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.
28% nisu odgovarali na prethodno liječenje pegIFN/RBV, 10% su djelomično odgovarali na prethodno liječenje pegIFN/RBV, 13% je imalo relaps nakon prethodnog liječenja pegIFN/RBV; 70% bili su muškarci; 17% bili su crnci; 73% imalo je početnu razinu HCV RNK od najmanje 800 000