natgillin/translations-raw huggingface dataset:
In a phase 2, multicentre, open-label, single arm study, 38 treatment-naïve or pegIFN/RBV treatment experienced, non-cirrhotic subjects with genotype 1 infection who were on stable doses of methadone (N=19) or buprenorphine with or without naloxone (N=19) received 12 weeks of Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin.
bolnikov, že zdravljenih s pegIFN/RBV, brez ciroze in okuženih z genotipom 1, ki so dobivali stabilne odmerke metadona (N = 19) ali buprenorfina, z naloksonom ali brez njega, (N = 19) 12 tednov prejemalo zdravilo Exviera v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem in ribavirinom.
SVR12 for genotype 1-infected peginterferon+ribavirin-experienced subjects in SAPPHIRE-II
SVR12 pri preiskovancih, ki so bili že zdravljeni s peginterferonom+ribavirinom, okuženih z genotipom 1, v preskušanju SAPPHIRE-II
SVR12 for genotype 1-infected subjects with compensated cirrhosis who were treatment-naïve or previously treated with pegIFN/RBV
SVR12 pri preiskovancih, okuženih z genotipom 1, ki so imeli kompenzirano cirozo in še niso bili zdravljeni ali so bili predhodno zdravljeni s pefIFN/RBV.
Mechanism: OATP1B inhibition by paritaprevir.
OATP1B s paritaprevirjem.
Treated subjects (N = 63) had a median age of 51 years (range: 31 to 69); 24% of subjects were Black; 81% of subjects had IL28B non-CC genotype; 19% of subjects had compensated cirrhosis; 67% of subjects were HCV treatment-naïve; 33% of subjects had failed prior treatment with pegIFN/RBV; 89% of subjects had HCV genotype 1a infection.
Mediana starost zdravljenih preiskovancev (N = 63) je bila 51 let (razpon: od 31 do 69); 24 % preiskovancev je bilo črncev, 81 % preiskovancev je imelo genotip IL28B ne-CC, 19 % preiskovancev je imelo kompenzirano cirozo, 67 % preiskovancev še ni bilo zdravljenih zaradi HCV, 33 % preiskovancev je doživelo neuspeh predhodnega zdravljenja pegIFN/RBV, 89 % preiskovancev je imelo okužbo s HCV genotipa 1a.
What you need to know before you take Exviera 3.
Kaj morate vedeti, preden boste vzeli zdravilo Exviera Ne jemljite zdravila Exviera:
CONTRACEPTIVES ethinylestradi ol/ norgestimate 0.035/0.25 m g once daily
0,035/0,25 mg enkrat na dan
Following a 400 mg 14C-dasabuvir dose in humans, unchanged dasabuvir was the major component (approximately
14C-dasabuvirja pri človeku je bil nespremenjeni dasabuvir glavna sestavina (približno 60 %) z zdravilom povezane radioaktivnosti v plazmi.
Adverse reactions identified with Exviera in combination with ombitasvir/paritaprevir/ritonavir or ombitasvir/paritaprevir/ritonavir and ribavirin
Neželeni učinki ugotovljeni z zdravilom Exviera v kombinaciji z ombitasvir/paritaprevir/ritonavir ali z ombitasvir/paritaprevir/ritonavir in ribavirinom
Of the 2,510 HCV genotype 1 infected subjects who were treated with regimens containing dasabuvir, ombitasvir and paritaprevir with or without ribavirin (for 8, 12 or 24 weeks) in Phase 2b and 3 clinical trials, a total of 74 subjects (3%) experienced virologic failure (primarily post-treatment relapse).
V kliničnih študijah Virološki neuspeh (primarni recidiv po zdravljenju) se je v kliničnih preskušanjih faze 2b in 3 pojavil pri skupno 74 od 2.510 preiskovancev (3 %), okuženih s HCV genotipa 1 in zdravljenih s shemami, ki so vsebovale dasabuvir, ombitasvir in paritaprevir z ribavirinom ali brez njega (v obdobju 8, 12 ali 24 tednov).
While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Čeprav ni pričakovati nobenih sprememb v farmakokinetiki varfarina, je priporočljivo skrbno spremljanje mednarodnega normaliziranega razmerja (INR) pri vseh antagonistih vitamina K. To je zaradi sprememb delovanja jeter med zdravljenjem z zdravilom Exviera + ombitasvir/paritap revir/ritonavir.
Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received open-label Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Preiskovanci, randomizirani v placebo skupino, so 12 tednov prejemali placebo, potem pa so 12 tednov odprto prejemali zdravilo Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
Geometric mean Cmax, AUC of multiple doses of Exviera 250 mg twice daily and ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily with food in healthy volunteers
250 mg dvakrat na dan in kombinacijo ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg enkrat na dan s hrano pri zdravih prostovoljcih.
Digoxin 0.5 mg single dose
Alprazolam Posamezen odmerek 0,5 mg
Dasabuvir does not inhibit organic anion transporter (OAT1) in vivo and is not expected to inhibit organic cation transporters (OCT2), organic anion transporters (OAT3), or multidrug and toxin extrusion proteins (MATE1 and MATE2K) at clinically relevant concentrations; therefore, Exviera does not affect medicinal product transport by these proteins.
(OCT2 - organic cation transporters), prenašalce organskih anionov (OAT3) ali ekstruzijskih beljakovin več zdravil in toksinov (MATE1 in MATE2K - multidrug and toxin extrusion proteins).
Co-administration of dasabuvir with ombitasvir/paritaprevir/ritonavir combines three direct-acting antiviral agents with distinct mechanisms of action and non-overlapping resistance profiles to target HCV at multiple steps in the viral lifecycle.
Sočasna uporaba dasabuvirja s kombinacijo ombitasvir/paritaprevir/ritonavir združuje tri direktno delujoča protivirusna zdravila z različnimi mehanizmi delovanja.
TURQUOISE-II- genotype 1, treatment-naïve or peginterferon+ribavirin-experienced subjects with compensated cirrhosis
TURQUOISE-II - še nezdravljeni ali že zdravljeni preiskovanci s peginterferonom+ribavirinom, z genotipom 1 in s cirozo
SAPPHIRE-I was a randomised, global multicentre, double-blind, placebo-controlled trial conducted in 631 treatment-naïve adults with genotype 1 chronic hepatitis C virus infection without cirrhosis.
Preskušanje SAPPHIRE-I je bilo globalno, multicentrično, randomizirano, dvojno slepo in s placebom kontrolirano preskušanje pri 631 še nezdravljenih odraslih, ki so imeli kronično okužbo z virusom hepatitisa C genotipa 1 brez ciroze.
Mechanism: Increase in dasabuvir exposure is due to
Večja izpostavljenost dasabuvirju je posledica zavrtja
Mechanism: CYP3A4 inhibition by ritonavir and UGT inhibition by paritaprevir, ombitasvir and dasabuvir.
CYP3A4 z ritonavirjem in zavrtje UGT s paritaprevirjem, ombitasvirjem in dasabuvirjem
Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Placebo
Skupina A: Exviera in ombitasvir/paritaprevir/ritonavir + RBV Skupina B: Placebo
Subjects randomised to the placebo arm received placebo for 12 weeks, after which they received Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks.
Preiskovanci, randomizirani v placebo skupino, so 12 tednov prejemali placebo, potem pa so 12 tednov prejemali zdravili Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
For subjects who received ribavirin, the ribavirin dose was 1000 mg per day for subjects weighing less than 75 kg or 1200 mg per day for subjects weighing greater than or equal to 75 kg.
oziroma odmerek 1200 mg na dan, če so tehtali 75 kg ali več.
Concomitant use with efavirenz containing regimens is contraindicated (see section 4.3).
Sočasna uporaba režimov zdravljenja, ki vključujejo uporabo efavirenza, je kontraindicirana (glejte poglavje nevirapin etravirin
Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Skupina A: Exviera in ombitasvir/paritaprevir/ritonavir + RBV Skupina B: Exviera in ombitasvir/paritaprevir/ritonavir
Clinical Comments ritonavir.
vključno z ritonavirjem.
Exviera and ombitasvir/paritaprevir/ritonavir with RBV for 12 weeks n/N % 95% CI
Exviera in ombitasvir/paritaprevir/ritonavir z RBV 12 tednov n/N % 95 % IZ
Follow the dosing recommendations in Table 1.
Sočasna okužba s HIV-1 Upoštevajte navodila za odmerjanje v preglednici 1.
Dose normalized cyclosporine ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Za odmerek normalizirana razmerja ciklosporina so prikazana za medsebojno delovanje z zdravilom Exviera + kombinacijo ombitasvir/paritaprevir/ritonavir.
SVR12 for genotype 1b-infected peginterferon+ribavirin-experienced subjects in PEARL II
SVR12 pri preiskovancih, ki so bili že zdravljeni s peginterferonom+ribavirinom, okuženih z genotipom 1b, v preskušanju PEARL II
ANTICONVULSANTS carbamazepine
ANTIEPILEPTIKI karbamazepin
34 subjects (29 with HCV genotype 1a infection and 5 with HCV genotype 1b infection) were enrolled who had not received treatment for HCV infection after transplantation and had a METAVIR fibrosis score of F2 or less.
Vključenih je bilo 34 preiskovancev (29 z okužbo s HCV genotipa 1a in 5 z okužbo s HCV genotipa
Arm B: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (24 weeks)
Skupina B: Exviera in ombitasvir/paritaprevir/ritonavir + RBV (24 tednov)
Croscarmellose sodium Colloidal anhydrous silica (E551) Magnesium stearate (E470b)
6.1 Seznam pomožnih snovi Jedro tablete: mikrokristalna celuloza (E460(i)) laktoza monohidrat kopovidon premreženi natrijev karmelozat koloidni brezvodni silicijev dioksid (E551) magnezijev stearat (E470b)
Mechanism: CYP3A4 induction by phenobarbita l.
Mehanizem: Indukcija CYP3A4 s karbamazepino m
See Table 2 for guidance regarding potential drug interactions and dosing recommendations for Exviera administered with ombitasvir/paritaprevir/ritonavir.
Za smernice o možnih medsebojnih delovanjih zdravil in priporočila za odmerjanje zdravila Exviera, uporabljenega s kombinacijo ombitasvir/paritaprevir/ritonavir, glejte preglednico 2.
Ciclosporin 100 mg dosed alone and 30 mg administered with Exviera + ombitasvir/paritaprevir/ritonavir.
Ciklosporin 100 mg, uporabljen sam, ali 30 mg skupaj z zdravilom Exviera + kombinacijo ombitasvir/paritaprevir/ritonavir.
Clinical Comments possibly due to UGT1A1 inhibition by paritaprevir, ombitasvir and dasabuvir.
Mehanizem: Morda zavrtje UGT1A1 s paritaprevirjem, ombitasvirjem in dasabuvirjem.
800 mg once daily (given at the same time)
800/100 mg enkrat na dan (uporabljeno zvečer)
Dose normalized tacrolimus ratios are shown for interaction with Exviera + ombitasvir/paritaprevir/ritonavir.
Za odmerek normalizirana razmerja takrolimusa so prikazana za medsebojno delovanje z zdravilom Exviera + kombinacijo ombitasvir/paritaprevir/ritonavir.
Emtricitabine/ tenofovir 200 mg once daily/300 mg once daily
200 mg enkrat na dan/300 mg enkrat na dan
In vivo drug interaction studies evaluated the net effect of the combination treatment, including ritonavir.
Možnost vpliva zdravila Exviera na farmakokinetiko drugih zdravil V študijah medsebojnega delovanja zdravil in vivo so ocenili neto učinek kombiniranega zdravljenja,
Mechanism: CYP3A4 induction by enzalutamide or mitotane.
Indukcija CYP3A4 z enzalutamidom ali mitotanom.
Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV
Skupina A: Exviera in ombitasvir/paritaprevir/ritonavir + RBV
Hepatobiliary Disorders: Hepatic decompensation, hepatic failure have been observed during treatment with Exviera with ombitasvir/paritaprevir/ritonavir, with or without ribavirin (see section 4.4).
Neželeni učinki o katerih so poročali po prihodu zdravila na trg Bolezni jeter, žolčnika in žolčevodov: med zdravljenjem z zdravilom Exviera z ombitasvirjem/paritaprevirjem/ritonavirjem z ali brez ribavarina so opazili dekompenzacijo jeter in okvaro jeter (glejte poglavje 4.4).
Concomitant use is contra-indicated (see section 4.3).
Sočasna uporaba je kontraindicirana (glejte poglavje
Exviera and ombitasvir/paritaprevir/ritonavir were given for 12 weeks of treatment in combination with ribavirin.
Zdravilo Exviera in kombinacija ombitasvir/paritaprevir/ritonavir so dobivali 12 tednov v kombinaciji z ribavirinom.
− Tablet core: microcrystalline cellulose (E460(i)), lactose monohydrate, copovidone,
− Jedro tablete: mikrokristalna celuloza (E460(i)), laktoza monohidrat, kopovidon, premreženi natrijev karmelozat, koloidni brezvodni silicijev dioksid (E551), magnezijev stearat (E470b).
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; 19.8% had a body mass index of at least 30 kg/m2; 20.6% had a history of depression or bipolar disorder; 89.6% had IL28B non-CC genotype; 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; 19,8 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 20,6 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 89,6 % jih je imelo genotip IL28B ne-CC; 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.
Exviera safety and efficacy have been established in combination with ombitasvir/ paritaprevir /ritonavir with or without ribavirin.
Sočasna uporaba z drugimi neposredno delujočimi protivirusnimi zdravili proti HCV Varnost in učinkovitost zdravila Exviera sta bili ugotovljeni v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem, z ribavirinom ali brez njega.
Arm A: Exviera and ombitasvir/paritaprevir/ritonavir + RBV (12 weeks)
Skupina A: Exviera in ombitasvir/paritaprevir/ritonavir + RBV (12 tednov)
metabolite were not meaningfully different in subjects with hepatic impairment compared to normal control subjects (see sections 4.2, 4.4 and 4.8).
Vezava dasabuvirja in njegovega presnovka M1 na beljakovine v plazmi se pri preiskovancih z okvaro jeter nista bistveno razlikovali od tistih pri zdravih kontrolnih osebah (glejte poglavja 4.2, 4.4 in 5.2).
Subjects were randomised in a 1:1 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Preiskovanci so bili randomizirani v razmerju 1:1 za 12-tedensko zdravljenje z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
What Exviera contains
Kaj vsebuje zdravilo Exviera
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; 21.8% had a body mass index of at least 30 kg/m2; 12.8% had a history of depression or bipolar disorder; 90.5% had IL28B non-CC genotype; 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; 21,8 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 12,8 % jih je imelo v anamnezi depresijo ali bipolarno motnjo; 90,5 % jih je imelo genotip IL28B ne-CC; 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).
Table 10 shows the SVR12 rates for treatment-experienced subjects with genotype 1-infection receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-II.
Preglednica 10 prikazuje deleže SVR12 pri že zdravljenih preiskovancih, okuženih z genotipom 1, ki so v preskušanju SAPPHIRE-II 12 tednov dobivali zdravilo Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
Atazanavir/ ritonavir 300/100 mg once daily
atazanavir 300 mg enkrat na dan (dan ob istem času)
Subjects were randomised in a 1:2 ratio to receive Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks of treatment.
Preiskovanci so bili randomizirani v razmerju 1:2 za 12-tedensko zdravljenje z zdravilom Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
TURQUOISE-II was a randomised, global multicentre, open-label trial conducted exclusively in 380 genotype 1-infected subjects with compensated cirrhosis (Child-Pugh A) who were either treatmentnaïve or did not achieve SVR with prior treatment with pegIFN/RBV.
Preskušanje TURQUOISE-II je bilo globalno multicentrično, randomizirano, odprto preskušanje izključno pri 380 preiskovancih, okuženih z genotipom 1, ki so imeli kompenzirano cirozo (Child
PEARL-III was a randomised, global multicentre, double-blind, controlled trial conducted in 419 treatment-naïve adults with genotype 1b chronic hepatitis C virus infection without cirrhosis.
Preskušanje PEARL-III je bilo globalno multicentrično, randomizirano, dvojno slepo, kontrolirano preskušanje pri 419 še nezdravljenih odraslih, ki so imeli kronično okužbo z virusom hepatitisa C
Arm B: Exviera and ombitasvir/paritaprevir/ritonavir
Skupina B: Exviera in ombitasvir/paritaprevir/ritonavir
Patients should be informed that fatigue has been reported during treatment with Exviera in combination with ombitasvir/paritaprevir/ritonavir and ribavirin (see section 4.8).
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Bolnikom je treba povedati, da je bila med zdravljenjem z zdravilom Exviera v kombinaciji z ombitasvirjem/paritaprevirjem/ritonavirjem in ribavirinom opisana utrujenost (glejte poglavje 4.8).
In all seven trials, the Exviera dose was 250 mg twice daily and the ombitasvir/paritaprevir/ritonavir dose was 25 mg/150 mg/100 mg once daily.
V vseh sedmih preskušanjih je bil odmerek zdravila Exviera 250 mg dvakrat na dan in odmerek kombinacije ombitasvir/paritaprevir/ritonavir 25/150/100 mg enkrat na dan. Preiskovanci, ki so dobivali ribavirin, so dobivali odmerek 1000 mg ribavirina na dan, če so tehtali manj kot 75 kg,
Plasma protein binding of dasabuvir and its M1
Upoštevaje vezavo na beljakovine in aktivnost M1 proti
No dose adjustment is necessary for emtricitabine/tenofovir and Exviera + ombitasvir/paritaprevir/ ritonavir.
Prilagoditev odmerka ni potrebna za emtricitabin/tenof ovir in kombinacijo Exviera + ombitasvir/paritap revir/ritonavir.
Exviera and ombitasvir/paritaprevir /ritonavir + ribavirin
Exviera in ombitasvir/paritaprevir /ritonavir + ribavirin
Interactions between Exviera with ombitasvir/paritaprevir/ritonavir and other medicinal products
Medsebojna delovanja z drugimi zdravili med uporabo zdravila Exviera s kombinacijo ombitasvir/paritaprevir/ritonavir
Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients when Exviera is used with ribavirin.
Ženske v rodni dobi/kontracepcija pri moških in ženskah Če je zdravilo Exviera uporabljeno z ribavirinom, je potrebna skrajna previdnost, da bi preprečili nosečnost bolnic in partnerk bolnikov.
Treatment duration was fixed in each trial and was not guided by subjects'
Trajanje zdravljenja je bilo v vsakem preskušanju fiksno in ga niso prilagajali koncentraciji HCV RNA pri preiskovancih (algoritem brez upoštevanja odziva).
CYP3A4 inhibition by ritonavir.
Indukcija CYP3A4 s fenobarbitalom.
The pharmacokinetic properties of the combination of Exviera with ombitasvir/paritaprevir/ritonavir have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Table 17 shows mean Cmax and AUC of Exviera 250 mg twice daily with ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily following multiple doses with food in healthy volunteers.
C. Preglednica 16 prikazuje povprečni Cmax in AUC za zdravilo Exviera 250 mg dvakrat na dan s kombinacijo ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg enkrat na dan po večkratnih odmerkih s hrano pri zdravih prostovoljcih.
PEARL-IV was a randomised, global multicentre, double-blind, controlled trial conducted in 305 treatment-naïve adults with genotype 1a chronic hepatitis C virus infection without cirrhosis.
Preskušanje PEARL-IV je bilo globalno, multicentrično, randomizirano, dvojno slepo, kontrolirano preskušanje pri 305 še nezdravljenih odraslih, ki so imeli kronično okužbo z virusom hepatitisa C
Table 7 shows the SVR12 rates for genotype 1-infected, treatment-naïve subjects receiving Exviera and ombitasvir/paritaprevir/ritonavir in combination with ribavirin for 12 weeks in SAPPHIRE-I.
Preglednica 7 prikazuje deleže SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1, ki so v preskušanju SAPPHIRE-I 12 tednov dobivali zdravilo Exviera in ombitasvir/paritaprevir/ritonavir v kombinaciji z ribavirinom.
Table 11 shows the SVR12 rates for genotype 1b-infected, treatment-experienced subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL II.
Preglednica 11 prikazuje deleže SVR12 pri že zdravljenih preiskovancih, okuženih z genotipom 1b, ki so v preskušanju PEARL II 12 tednov dobivali zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
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; 28.4% had a body mass index of at least 30 kg/m2; 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; 81.8% had IL28B non-CC genotype; 24.7% had a history of depression or bipolar disorder; 68.7% had HCV genotype 1a infection, 31.3% had HCV genotype 1b infection.
Zdravljeni preiskovanci (N = 380) so bili mediano stari 58 let (razpon: od 21 do 71); 42,1 % jih še ni bilo zdravljenih, 36,1 % jih predhodno ni imelo odziva na pegIFN/RBV; 8,2 % jih je predhodno imelo delen odziv na pegIFN/RBV in 13,7 % jih je predhodno imelo recidiv ob pegIFN/RBV; 70,3 % je bilo moških; 3,2 % je bilo črncev; 28,4 % jih je imelo indeks telesne mase vsaj 30 kg/m2; 14,7 % jih je imelo število trombocitov manj kot 90 x 109/l; 49,7 % jih je imelo albumin manj kot 40 g/l; 86,1 % jih je imelo izhodiščno koncentracijo HCV RNA vsaj 800.000 i. e./ml; 81,8 % jih je imelo genotip IL28B
No increase in incidence of ALT elevations was observed with other types of systemic estrogens commonly used for hormone replacement therapy (e.g., estradiol and conjugated estrogens).
Z drugimi vrstami sistemskih estrogenov, ki se pogosto uporabljajo za hormonsko nadomestno zdravljenje (npr. z estradiolom in konjugiranimi estrogeni), niso opažali večje incidence zvišanj ALT. Zvišanja ALT so bila praviloma asimptomatska, so se po navadi pojavila v prvih 4
Table 8 shows the SVR12 rates for genotype 1b-infected, treatment-naïve subjects who received Exviera and ombitasvir/paritaprevir/ritonavir with or without ribavirin for 12 weeks in PEARL III.
Preglednica 8 prikazuje deleže SVR12 pri še nezdravljenih preiskovancih, okuženih z genotipom 1b, ki so v preskušanju PEARL III 12 tednov dobivali zdravilo Exviera in kombinacijo ombitasvir/paritaprevir/ritonavir z ribavirinom ali brez njega.
NA Clinical monitoring of
Kumulativne analize kliničnih preskušanj