natgillin/translations-raw huggingface dataset:
Other includes patients with detectable HCV RNA at their actual end of treatment but who did not have viral breakthrough, and patients with a missing HCV RNA assessment during planned follow-up.
Ostalo vključuje preiskovance z zaznavno HCV RNK ob načrtovanem koncu zdravljenja, ki pa niso imeli virusnega preboja, in bolnike, pri katerih manjka ocena HCV RNK pri načrtovanem spremljanju.
Treatment-naive patients and prior relapsers who did not achieve eRVR, prior partial responders, prior null responders, and all cirrhotic patients received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 36 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 48 weeks).
Nezdravljeni bolniki in bolniki brez ciroze, pri katerih se je bolezen ponovila in, ki niso dosegli eRVR, bolniki s predhodno delnim odzivom in bolniki, ki se na zdravljenje niso odzvali ter vsi bolniki s cirozo, so prejeli 12-tedensko zdravljenje z zdravilom INCIVO, skupaj s peginterferonom alfa-2a in ribavirinom, sledilo mu je 36-tedensko zdravljenje s peginterferonom alfa-2a in ribavirinom (skupno trajanje zdravljenja 48 tednov).
BOTTLE LABEL (4-bottle pack)
NALEPKA NA PLASTENKI (4 plastenke)
The control regimen (Pbo/PR) had a fixed treatment duration of 48 weeks, with telaprevir-matching placebo for the first 12 weeks and peginterferon alfa-2a and ribavirin for 48 weeks.
Za kontrolno shemo (Pbo/PR) je bilo določeno trajanje zdravljenja 48 tednov, enako za telaprevir kot za placebo v prvih 12. tednih, in z jemanjem peginterferona alfa-2a in ribavirina v
Please consult sections 4.4 and 5.1 regarding the selection of peginterferon alfa-2a or -2b.
Za navodila o izbiri peginterferona alfa-2a ali -2b glejte poglavji 4.4 in 5.1.
Pregnancy and breast-feeding If you are pregnant, you must not take INCIVO.
Če ste noseči, ne smete jemati zdravila INCIVO.
Table 1: Guidelines for discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin treatment
Preglednica 1: smernice za ukinitev zdravljenja z zdravilom INCIVO, peginterferonom alfa in ribavirinom
Study HPC3006 was an open-label, Phase 3b study in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected patients who were first time liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A. No patients had cirrhosis of the liver graft.
HPC3006 je bila odprta študija faze IIIb pri še nezdravljenih in že zdravljenih kroničnih s HCV-1 okuženih bolnikih, ki so jim prvič presadili jetra in so prejemali stabilen odmerek imunosupresiva (takrolimus ali ciklosporin A).
In the C211 Phase 3 clinical trial, there was no difference in the type of emerging variants between patients receiving telaprevir 1,125 mg twice daily (b.i.d.)
V kliničnem preskušanju faze III (C211) ni bilo razlik v pojavu za telaprevir rezistentnih variant med bolniki, ki so prejemali 1.125 mg telaprevirja dvakrat na dan in bolniki, ki so prejemali 750 mg telaprevirja na 8 ur.
Study HPC3008 was an open-label, Phase 3b study conducted in patients with chronic genotype 1 HCV/HIV-1 co-infection who were treatment-naïve for hepatitis C or who did not achieve SVR with prior treatment with peginterferon alfa (2a or 2b) and ribavirin (including prior relapsers, prior partial responders and prior null responders).
Odprta študija, faze 3b pri bolnikih s kroničnim HCV genotipa 1, sočasno okuženih s HIV, ki še niso prejemali zdravil proti hepatitisu C ali s predhodnim zdravljenjem s peginterferonom alfa (2a ali 2b) in ribavirinom (vključno z bolniki s ponovitvijo bolezni, z delnim odzivom ali bolniki, ki se na predhodno zdravljenje niso odzvali).
OUTER CARTON (4-bottle pack)
ŠKATLA (4 plastenke)
T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4
T12(DS)/PR % (n/N) zmanjšanje koncentracije HCV RNK za < 1 log10 v zmanjšanje koncentracije HCV RNK za ≥ 1 log10 v 4. tednu vključuje samo podatke o bolnikih, pri katerih je na razpolago podatek o koncentraciji HCV RNK 4. tednu
Co-administration of domperidone with INCIVO should be avoided (see section 4.4).
Sočasni uporabi domperidona z zdravilom INCIVO se je torej treba izogibati (glejte poglavje 4.4).
Table 13 shows the SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction in HCV RNA) for prior partial responders and for prior null responders in the T12(DS)/PR group.
Preglednica 13 kaže stopnje SVR glede na odziv v 4. tednu pri bolnikih v skupini T12(DS)/PR, ki so se na predhodno zdravljenje delno odzvali ali se niso odzvali (zmanjšanje koncentracije HCV RNK za < 1 log10 ali ≥ 1 log10)
No adjustment of the buprenorphine dose is required when co-administered with telaprevir.
Pri sočasni uporabi s telaprevirjem ni potrebno prilagajati odmerka buprenorfina.
In placebo-controlled Phase 2 and 3 trials, the overall incidence and severity of rash increased when INCIVO was co-administered with peginterferon alfa and ribavirin.
V s placebom nadzorovanih preskušanjih faze II in III sta se skupna pogostnost in jakost izpuščaja povečali, ko so bolniki jemali zdravilo INCIVO sočasno s peginterferonom alfa in ribavirinom.
Similar proportions of patients in both treatment groups had telaprevir-resistant variants at the time of failure.
V času virološkega neuspeha je bil delež za telaprevir rezistentnih variant pri obeh skupinah bolnikov podoben.
Haemoglobin values gradually improve after completion of INCIVO dosing.
Po prenehanju jemanja zdravila INCIVO se koncentracije hemoglobina postopoma zvečujejo.
OUTER CARTON (1-bottle pack)
ŠKATLA (1 plastenka)
Close monitoring of immunosuppressant blood levels, renal function and immunosuppressant related side effects are recommended when co-administered with telaprevir.
Pri sočasni uporabi imunosupresiva s telaprevirjem je priporočljivo skrbno spremljanje koncentracij imunosupresiva v krvi, delovanja ledvic ter neželenih učinkov imunosupresiva.
Among prior relapsers in the T12/PR24 treatment group who had undetectable HCV RNA (target not detected) at week 4 and 12 of treatment, the SVR rate was 100%
Med tistimi bolniki iz terapevtske skupine T12/PR24, ki se jim je bolezen ponovila in so imeli v 4. in 12. tednu zdravljenja nemerljive koncentracije HCV RNK (nezaznaven analit), je bila stopnja trajnega virološkega odziva 100% (24/24).
)/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks
)/PR: INCIVO 1.125 mg dvakrat na dan 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov T12(q8h)/PR: INCIVO 750 mg na 8 ur 12 tednov s peginterferonom alfa-2a in ribavirinom 24 ali 48 tednov
No clinical data are available regarding the treatment of pre- or peri-liver or other transplant patients with INCIVO in combination with peginterferon alfa and ribavirin.
Klinični podatki o zdravljenju bolnikov z zdravilom INCIVO v kombinaciji s peginterferonom alfa in ribavirinom pred ali ob presaditvi jeter ali drugih organov niso na voljo.
The appropriate dose of INCIVO in hepatitis C-infected patients with moderate hepatic impairment has not been determined.
Ustrezen odmerek zdravila INCIVO pri bolnikih s hepatitisom C in zmerno okvaro jeter ni bil določen, zato uporaba zdravila INCIVO pri teh bolnikih ni priporočena
Table 16: Treatment outcome in adult patients with genotype 1 HCV infection and HIV-1 co-infection in Study HPC3008)
Preglednica 16: Izidi zdravljenja pri odraslih bolnikih s HCV genotipa 1, sočasno okuženih
Discontinuation of INCIVO combination treatment is not
Priporočene začetne vrednosti za uvedbo kombiniranega zdravljenja z zdravilom INCIVO so
In the Pbo/PR arm, 2 (9%) patients had baseline bridging fibrosis and no patients had baseline cirrhosis.
V kraku Pbo/PR pa na začetku zdravljenja ciroze ni imel noben bolnik, mostno fibrozo pa sta
- itching around or near the anus, bleeding around or near the anus or rectum, a small tear in the skin that lines the anus that may cause pain and/or bleeding during bowel movements; - red, cracked, dry, scaly skin (eczema), rash with red, cracked, dry, scaly skin (exfoliative rash); - swelling of the face, swelling of the arms and/or legs (oedema);
- srbenje okoli ali v bližini zadnjika, krvavitve okoli ali zraven zadnjika (anusa) ali danke (rektuma), majhna raztrganina v koži, ki oblaga zadnjik - ta lahko povzroča bolečine in/ali
The active substance is telaprevir.
Zdravilna učinkovina je telaprevir.
QT interval prolongation and Torsade de Pointes have been reported with methadone (see section 4.4).
Pri sočasnem jemanju metadona so poročali o podaljšanju intervala QT in o pojavu torsade de pointes (glejte poglavje 4.4).
T12/PR: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks P < 0.0001; T12/PR compared to Pbo/PR48.
T12/PR: INCIVO 12 tednov in peginterferon alfa-2a in ribavirin 24 ali 48 tednov; Pbo/PR: placebo 12 tednov in peginterferon alfa-2a in ribavirin 48 tednov P < 0,0001; za skupino T12/PR v primerjavi s Pbo/PR48.
No relevant effect of gender was identified.
Pomembnega učinka spola na
HCV RNA< 25 IU/ml in the week 12 follow-up window
HCV RNK< 25 i.e./ml v 12 - tedenskem nadaljevanju zdravljenja
↑ midazolam (intravenous) AUC 3.40 (3.04-3.79) Cmax 1.02 (0.80-1.31)
AUC 3,40 (3,04-3,79) Cmax 1,02 (0,80-1,31)
In Phase 2 and 3 clinical trials of telaprevir, treatment-naïve and prior treatment-failure patients with predominant telaprevir-resistant variants at baseline (pre-treatment) were rare (V36M, T54A and R155K < 1% and T54S 2.7%).
še pred zdravljenjem), redki (V36M, T54A in R155K < 1% in T54S 2,7%).
Table 7 shows the response rates for the recommended T12/PR and the Pbo/PR48 groups.
Preglednica 7 kaže stopnje odziva za priporočene skupine T12/PR in
Do not remove this desiccant from the bottle.
Sušilnega sredstva ne smete vzeti iz plastenke.
All patients received 12 weeks of INCIVO in combination with the peginterferon alfa/ribavirin standard therapy.
Vsi bolniki so 12 tednov prejemali zdravilo INCIVO v kombinaciji z običajno terapijo s peginterferonom alfa in ribavirinom.
Always take this medicine exactly as your doctor or pharmacist has told you.
Pri jemanju tega zdravila INCIVO natančno upoštevajte navodila zdravnika ali farmacevta.
to treat inflammatory arthritis (anti-gout agents) to treat certain infections (antimycobacterials) to help you sleep and/or relieve anxiety (benzodiazepines) to help you sleep and/or relieve anxiety (non-benzodiazepine sedatives)
alprazolam, midazolam dan z injekcijo za lažje spanje in/ali za lajšanje tesnobe (benzodiazepini) za lažje spanje in/ali za lajšanje tesnobe (nebenzodiazepinski sedativi)
Relapse was defined as having detectable plasma HCV RNA from planned end of treatment onwards after previous HCV RNA < 25 IU/ml at planned end of HCV treatment, and not achieving SVR12.
Ponovitev bolezni je bila določena kot zaznavna koncentracija HCV med spremljanjem, po koncentraciji HCV RNK < 25 i.e./ml ob načrtovanem zaključku zdravljenja okužbe s HCV, brez doseženega SVR12.
Contraindications of concomitant use (see section 4.3) INCIVO must not be administered concurrently with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as cardiac arrhythmia (i.e., amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine), or peripheral vasospasm or ischemia (i.e., dihydroergotamine, ergonovine, ergotamine, methylergonovine), or myopathy, including rhabdomyolysis (i.e., lovastatin, simvastatin, atorvastatin), or prolonged or increased sedation or respiratory depression (i.e., quetiapine, orally administered midazolam or triazolam), or hypotension or cardiac arrhythmia (i.e., alfuzosin and sildenafil for pulmonary arterial hypertension).
Kontraindicije pri sočasni uporabi zdravil (glejte poglavje 4.3) Zdravila INCIVO ne smete uporabljati sočasno z učinkovinami, ki se v veliki meri presnavljajo preko CYP3A in pri katerih je zvišanje plazemskih koncentracij povezano s hudimi in/ali življenje ogrožujočimi dogodki, kot so srčne aritmije (npr. pri amiodaronu, astemizolu, bepridilu, cisapridu, pimozidu, kinidinu, terfenadinu) ali periferni vazospazem ali ishemija (t.j.
abacavir
↑ telaprevirja
amiodarone, bepridil, quinidine, other Class Ia or III antiarrhythmics to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
amiodaron, bepridil, kinidin, drugi antiaritmiki razreda Ia ali III
Telaprevir exposure is comparable during co-administration with either peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Stopnja izpostavljenosti telaprevirju pri njegovi sočasni uporabi s peginterferonom alfa-2a in ribavirinom je podobna kot pri njegovi sočasni uporabi s peginterferonom alfa-2b in ribavirinom.
All patients includes the 322 patients with undetectable HCV RNA (target not detected) at weeks 4 and 12 and the 218 other patients treated in the study (118 who did not have undetectable HCV RNA (target not detected) at week 4 and 12 and 100 who discontinued the study before week 20, when randomisation occurred).
T12/PR48: Jemanje zdravila INCIVO 12 tednov s peginterferonom alfa-2a in ribavirinom v času 48 tednov Vsi bolniki zajemajo 322 bolnikov z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu ter 218 drugih bolnikov, ki so bili zdravljeni v okviru študije (118 takih, ki niso imeli nemerljive HCV RNK (nezaznaven analit) v 4. in 12. tednu, in 100 takih, ki so izstopili iz študije pred 20. tednom, ko je bila opravljena randomizacija).
Carbamazepine, phenytoin and phenobarbital
šentjanževka (Hypericum perforatum)
In addition, the limit of quantification of 25 IU/ml was used to determine SVR.
Za določanje SVR so uporabili tudi mejo kvantifikacije
Pbo/PR48: placebo for 16 weeks in combination with peginterferon alfa-2a and ribavirin for 48 weeks
Pbo/PR48: Jemanje placeba 16 tednov v kombinaciji s peginterferonom alfa-2a in ribavirinom v času 48 tednov.
regimen results in the same daily dose with similar drug exposures of telaprevir, the relative drug interactions are expected to be similar.
Glede na to, da je pri odmerjanju 1.125 mg dvakrat na dan dnevni odmerek enak in je izpostavljenost telaprevirju primerljiva, je pričakovati, da bodo podobna tudi zadevna medsebojna delovanja.
INCIVO must be used in combination with peginterferon alfa and ribavirin.
Zdravilo INCIVO je treba uporabljati v kombinaciji s peginterferonom alfa in ribavirinom.
In patients with HCV RNA between 100 IU/ml and 1,000 IU/ml at week 12,
Med bolniki s koncentracijami HCV RNK med 100 i.e./ml in 1.000 i.e./ml v 12 tednu, sta 2/8 (25%) dosegla SVR.
Increased systemic exposures are expected if telaprevir is combined with drugs highly metabolised by this enzyme.
Če telaprevir uporabljamo istočasno z učinkovinami, ki se pretežno presnavljajo s tem encimom, je pričakovano zvečanje sistemske izpostavljenosti tem učinkovinam.
Hepatic impairment
- Jetrne bolezni
), in case a dose of INCIVO is missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVO with food as soon as possible.
Jemanje zdravila dvakrat na dan: v primeru, da bolnik pozabi vzeti odmerek zdravila INCIVO do 6 ur po času, ko ga običajno jemlje, mu naročite, naj čimprej vzame predpisani odmerek zdravila INCIVO s hrano.
All treatment regimens had a 48-week duration of peginterferon alfa-2a and ribavirin treatment.
Vse terapevtske sheme so vključevale tudi 48-tedensko zdravljenje s peginterferonom alfa-2a in
Relapse was defined as having HCV RNA ≥ 25 IU/ml during the follow-up period after previous HCV RNA < 25 IU/ml at planned end of treatment and not achieving SVR12.
Ponovitev bolezni je bila določena kot koncentracija HCV RNK ≥ 25 i.e./ml med spremljanjem, po koncentraciji HCV RNK pod 25 i.e./ml ob načrtovanem zaključku zdravljenja, brez doseženega SVR12.
Patients with undetectable HCV RNA ( target not detected) at weeks 4 and 12 were randomised at week 20 to receive either 24 weeks or 48 weeks of peginterferon alfa-2a and ribavirin treatment.
Bolniki z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu so bili v 20. tednu randomizirani v skupini zdravljenja s peginterferonom alfa-2a in ribavirinom bodisi za 24 tednov ali pa za 48 tednov.
Prior Non-responders N = 69 % (n/N)
Bolniki, ki se na zdravljenje niso odzvali N = 69 % (n/N)
INCIVO can be used for patients with chronic hepatitis C infection who have never been treated before or can be used in patients with chronic hepatitis C infection who have been treated previously with an interferon-based regimen.
Zdravilo INCIVO se uporablja pri bolnikih, okuženih z virusom hepatitisa C, ki še niso bili zdravljeni ali pri bolnikih, ki so
ADRs to INCIVO are presented in table 3.
Neželeni učinki zdravila INCIVO so navedeni v preglednici 3.
Your doctor may stop your treatment.
Lahko bo prekinil zdravljenje z zdravilom INCIVO.
Following the end of the INCIVO treatment, please see the ribavirin package leaflet regarding continued contraception
Za navodila o prepreprečevanju nosečnosti po koncu zdravljenja z zdravilom INCIVO glejte navodilo za uporabo ribavirina.
Caution is warranted and clinical monitoring is recommended.
Potrebna je previdnost in klinično spremljanje.
Table 10 shows SVR rates by extent of liver fibrosis at baseline.
V preglednici 10 so prikazane stopnje trajnega virološkega odziva po obsegu jetrne fibroze na začetku študije.
an herbal product to relieve anxiety to lower cholesterol levels (HMG CoA reductase inhibitors)
zeliščni pripravek za lajšanje tesnobe atorvastatin, lovastatin, simvastatin za zniževanje koncentracije holesterola (zaviralci HMG CoA reduktaze) za zdravljenje psihiatričnih bolezni (nevroleptiki)
Duration of treatment - Previously treated adults with prior partial or prior null response Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks, followed by peginterferon alfa and ribavirin therapy alone (without INCIVO) for a total treatment duration of 48 weeks (see figure 2).
Zdravljenje z zdravilom INCIVO je treba uvesti v kombinaciji s peginterferonom alfa in ribavirinom ter ga izvajati 12 tednov, temu naj sledi zdravljenje samo s peginterferonom alfa in ribavirinom (brez zdravila INCIVO) v skupnem trajanju zdravljenja 48 tednov (glejte sliko 2).
There may be itching with the rash.
Ob izpuščaju je lahko prisotno tudi srbenje.
The primary objective was to demonstrate the noninferiority of T12(b.i.d.
Primarni cilj je bil dokazati primerljivost režimov T12(q8h)/PR in T12(b.i.d.)/PR.
Animal studies are insufficient with respect to human reproductive toxicity (see section 5.3).
Študije na živalih ne zadostujejo za oceno vpliva na nosečnost /in-ali/ razvoj zarodka/plodu /in-ali/ porod/ in-ali/ postnatalni razvoj pri človeku (glejte poglavje 5.3).
Therefore this combination should be used with caution or alternatives should be considered.
Sočasna uporaba lahko vodi do izgube terapevtskega učinka telaprevirja, zato je treba to kombinacijo uporabljati previdno ali pa poiskati kakšno drugo možnost zdravljenja.
It is not recommended to co-administer fosamprenavir/ritonavir and telaprevir (see section 4.4).
Sočasna uporaba fosamprenavirja/ritonavirja in telaprevirja ni priporočljiva (glejte poglavje 4.4).
The plastic bottle comes with a child resistant cap and should be opened as
Plastenka ima za otroke varno zaporko, ki jo lahko odprete, kot sledi: Plastično navojno zaporko potisnite navzdol in jo pri tem obračajte
Studies using recombinant human CYP supersomes showed that telaprevir was a CYP3A4 inhibitor, and a time- and concentration-dependent inhibition of CYP3A4 by telaprevir was observed in human liver microsomes.
Študije z uporabo rekombinantnih človeških supersomov CYP so pokazale, da je telaprevir zaviralec CYP3A4, v človeških jetrnih mikrosomih pa so opažali od časa in od koncentracije odvisno zavoro CYP3A4 s telaprevirjem, medtem ko in vitro niso opazili zavore izoencimov CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19 CYP2D6 in CYP2E1, povezane s telaprevirjem.
INCIVO treatment completed Permanently discontinue treatment with INCIVO, peginterferon alfa, and ribavirin.
dokončna ukinitev zaključek zdravljenja z zdravilom INCIVO dokončna ukinitev zdravljenje z zdravilom INCIVO, peginterferonom alfa, in ribavirinom.
Caution is warranted and clinical monitoring is recommended when intravenous lidocaine is administered for the treatment of acute ventricular arrhythmia.
Kadar se lidokain uporablja intravensko za zdravljenje akutne ventrikularne aritmije je potrebna previdnost in klinično spremljanje bolnikov je priporočljivo.
Relapse was defined as having less than 25 IU/ml at the planned end of treatment followed by HCV RNA ≥ 25 IU/ml at the last observation within the SVR follow-up visit window.
Ponovitev bolezni je bila določena kot koncentracija HCV RNA pod 25 i.e./ml ob načrtovanem zaključku zdravljenja, ki ji je sledilo povečanje HCV RNK ≥ 25 i.e./ml ob naslednjem obisku (za spremljanje SVR).
Caution is warranted, laboratory and clinical monitoring is recommended.
Priporočljivo je laboratorijsko in klinično spremljanje bolnikov.
itraconazole, ketoconazole, posaconazole,
itrakonazol, ketokonazol, posakonazol, vorikonazol antimikotiki (za zdravljenje glivičnih okužb)
- if you have a wide-spread rash with peeling skin which may be accompanied by fever, flu-like symptoms, painful skin blisters, and blisters in the mouth, eyes, and/or genitals.
- če se ob izpuščaju pojavijo še drugi simptomi kot npr.: - zvišana telesna temperatura - utrujenost - otečen obraz - povečane bezgavke ALI - če imate izpuščaj na več delih telesa in se vam koža lušči, imate zvišano telesno temperaturo, gripi podobne simptome, boleče mehurčke na koži in mehurčke v ustih, očeh in/ali na spolovilih.
Prior partial responders
Bolniki, ki so se prej delno odzvali na
T12/PR48: INCIVO for 12 weeks followed by placebo for 4 weeks, in combination with peginterferon alfa-2a and ribavirin for 48 weeks;
T12/PR48: Jemanje zdravila INCIVO 12 tednov, potem pa jemanje placeba v času 4 tednov, v kombinaciji s peginterferonom alfa-2a in ribavirinom v času 48 tednov;
Insufficient virologic response
Virusni preboj Ponovitev bolezni
T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
T12/PR48: INCIVO 12 tednov skupaj s peginterferonom alfa-2a in ribavirinom (48 tednov), Pbo/PR: placebo 12 tednov skupaj s peginterferonom alfa-2a in ribavirinom (48 tednov)
Treatment-Experienced Patients by Subgroup
SVR pri bolnikih z zaznavno koncentracijo
AUC 0.96 (0.84-1.10) Cmax 0.80 (0.69-0.93) Cmin 1.06 (0.87-1.30)
↔ telaprevirja AUC 0,98 (0,91-1,05) Cmax 0,95 (0,86-1,06)
Resistance
Navzkrižna rezistenca
6.2 Incompatibilities
Linearnost/nelinearnost
BMI ≥ 30 kg/m Baseline HCV RNA ≥ 800,000 IU/ml HCV genotype 1a HCV genotype 1b Baseline liver fibrosis No fibrosis, minimal fibrosis, or portal fibrosis Bridging fibrosis Cirrhosis
Indeks telesne mase (BMI) ≥ 30 kg/m Začetna vrednost HCV RNK ≥ 800.000 i.e./ml
Maraviroc 150 mg twice daily when co-administered with telaprevir.
Ob sočasni uporabi s telaprevirjem je odmerek maraviroka 150 mg dvakrat na dan.
tenofovir disoproxil fumarate*
ZAVIRALCI PROTONSKE ČRPALKE esomeprazol*
INCIVO must not be administered as monotherapy and must only be prescribed in combination with both peginterferon alfa and ribavirin.
Za zagotavljanje učinkovitega zdravljenja, zdravila INCIVO ne smete jemati samega, vedno ga je treba jemati skupaj s peginterferonom alfa in ribavirinom.