natgillin/translations-raw huggingface dataset:
Victrelis contains lactose.
Zdravilo Victrelis vsebuje laktozo.
In healthy subjects who received 800 mg three times daily alone, boceprevir medicine exposure was characterized by AUC(т) of 6,147 ng
Pri zdravih preiskovancih, ki so prejemali samo 800 mg trikrat na dan, so izpostavljenost boceprevirju opredeljevale AUC(т) 6.147 ng.h/ml, Cmax 1.913 ng/ml in Cmin 90 ng/ml.
• Victrelis is always taken in combination with peginterferon alfa and ribavirin.
• Zdravilo Victrelis se vedno jemlje v kombinaciji s peginterferonom alfa in ribavirinom.
HMG CoA REDUCTASE INHIBITORS Atorvastatin* (atorvastatin 40 mg single dose + Victrelis 800 mg three times daily)
INHIBITORJI HMG CoA REDUKTAZE Atorvastatin* (atorvastatin 40 mg enkratni odmerek + zdravilo Victrelis 800 mg trikrat na dan)
Dose modifications due to anaemia/haemolytic anaemia occurred twice as often in patients treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin (26%) compared to peginterferon alfa-2b and ribavirin alone (13%).
Prilagoditve odmerka zaradi anemije/hemolitične anemije so bile dvakrat pogostejše pri bolnikih, zdravljenih z zdravilom Victrelis ter peginterferonom alfa-2b in ribavirinom (26 %), kot pri tistih, ki so prejemali samo peginterferon alfa-2b in ribavirin (13 %).
No dose adjustment of Victrelis or rilpivirine is recommended.
Prilagoditev odmerka zdravila Victrelis ali rilpivirina ni potrebna.
Individual patients may require additional titration of their methadone dosage when Victrelis is started or stopped to ensure clinical effect of methadone.
V primeru uvedbe ali zaključka zdravljenja z zdravilom Victrelis je lahko pri posameznih bolnikih za zagotovitev kliničnega učinka metadona potrebno dodatno titriranje odmerka metadona.
Stomach and gut: lower stomach pain; pancreatitis Urinary: painful when urinating; burning feeling or difficulty urinating; get up several times during the night to urinate
Želodec in črevo: bolečina v spodnjem delu trebuha, vnetje trebušne slinavke Sečila: bolečine pri uriniranju, pekoč občutek ali težave z uriniranjem, vstajanje večkrat na noč zaradi uriniranja
• have ever had a blood problem such as pancytopenia (a combination of low platelet, red and
• če ste kdaj imeli težave s krvjo, kot je pancitopenija (kombinacija nizkega števila trombocitov,
(CYP3A induction - effect on
(indukcija CYP3A - učinek na
The distribution of subjects by genders was 69% men and 31% women.
Porazdelitev preiskovancev po spolu je bila: 69 % moških in 31 % žensk.
In clinical trials, HCV-RNA in plasma was measured with the Roche COBAS Taqman 2.0 assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
V kliničnih preskušanjih so HCV-RNA v plazmi merili s testom Roche COBAS TaqMan 2.0 z mejo zaznavnosti 9,3 i.e./ml in mejo kvantifikacije 25 i.e./ml.
In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
V kliničnih preskušanjih so HCV-RNA v plazmi merili s testom Roche COBAS TaqMan z mejo zaznavnosti 9,3 i.e./ml in mejo kvantifikacije 25 i.e./ml.
Skin and hair: reddening of the skin; bacterial skin infection Stomach and gut: problems digesting food; vomiting blood; vomiting, diarrhoea, and severe right upper corner stomach (abdominal) pain
Koža, lasje in dlake: pordelost kože, bakterijska okužba kože Želodec in črevo: težave s prebavljanjem hrane, bruhanje krvi, bruhanje, driska, in hude bolečine v desnem zgornjem delu trebuha
The most frequently (> 25% of subjects) detected post-baseline RAVs in these subjects were amino acid substitutions V36M (61%) and R155K (68%) in subjects infected with genotype 1a viruses and T54A (42%), T54S (37%), A156S (26%) and V170A (32%) in subjects infected with genotype 1b
V obdobju po začetku zdravljenja so bile najpogosteje (> 25 % preiskovancev) ugotovljene RAV pri teh preiskovancih zamenjave aminokislin V36M (61 %) in R155K (68 %) pri preiskovancih, okuženih z virusi genotipa 1a, ter T54A (42 %), T54S (37 %), A156S (26 %) in V170A (32 %) pri preiskovancih, okuženih z virusi genotipa 1b.
No dose adjustment is required in these patients and in patients with any degree of renal impairment.
Tem bolnikom in bolnikom z okvaro ledvic (ne glede na stopnjo) odmerka ni treba prilagoditi.
Safety and efficacy of Victrelis, in combination with peginterferon alfa and ribavirin, have not been studied in patients with decompensated cirrhosis.
Varnost in učinkovitost zdravila Victrelis v kombinaciji s peginterferonom alfa in ribavirinom pri bolnikih z dekompenzirano cirozo nista raziskani.
In subjects with < 1-log10 decline in viral load at TW 4 (poor interferon-responsiveness), treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 28 38%, respectively, compared to 4% in subjects treated with standard of care.
TZ dosegli < 1-log10 zmanjšanje virusnega bremena (slaba odzivnost na interferon), so z zdravljenjem s kombinacijo zdravila Victrelis ter peginterferona alfa-2b in ribavirina dosegli delež SVR 28 do 38 % v primerjavi s 4 % pri preiskovancih, zdravljenih s standardnim
† Rates for patients who are previously untreated
† - deleži pri predhodno nezdravljenih
Do not take Victrelis if any of the above apply to you.
Ne vzemite zdravila Victrelis, če kaj od naštetega velja za vas.
Table 8 Sustained Virologic Response (SVR), End of Treatment (EOT) and Relapse in patients who had failed previous therapy (early and late responders)
Preglednica 8 Trajen virološki odziv (SVR), konec zdravljenja (KZ) in recidiv pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno (bolniki z zgodnjim in poznim odzivom)
Dose reduction of Victrelis is not recommended.
Zmanjšanje odmerka zdravila Victrelis ni priporočljivo.
The activity of boceprevir against the HCV genotype 1a replicon was reduced (2- to 6-fold) by the following amino acid substitutions in the NS3 protease domain: V36A/L/M, Q41R, T54A/S, V55A, R155K and V158I.
Učinkovitost boceprevirja proti replikacijski enoti HCV genotipa 1a se je zmanjšala (za 2- do 6-krat) ob naslednjih zamenjavah aminokislin na NS3 domeni proteaze: V36A/L/M, Q41R, T54A/S, V55A, R155K in V158I.
Co-administration of Victrelis with alfuzosin and silodosin is contraindicated (see section 4.3).
Sočasna uporaba zdravila Victrelis z alfuzosinom in silodozinom je kontraindicirana (glejte poglavje 4.3).
The onset of anaemia has been reported with peginterferon alfa and ribavirin therapy by Treatment Week 4.
Med zdravljenjem s peginterferonom alfa in ribavirinom so poročali o nastopu anemije do 4. tedna zdravljenja.
The median times for the most relevant boceprevir-resistant variants observed in genotype 1b patients (> 10%) to become undetectable were as follows: I/V170A, 0.46 years; T54A, 0.47 years; V55A, 0.83 years; A156S, 0.89 years; and T54S, 1.11 years.
Mediani časi, da so nezaznavne postale najpomembnejše na boceprevir odporne variante, so bili pri bolnikih, okuženih z genotipom 1b (>10 %), naslednji: I/V170A - 0,46 let, T54A - 0,47 let, V55A - 0,83 let, A156S - 0,89 let in T54S - 1,11 let.
• Co-administration with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as orally administered midazolam and triazolam, bepridil, pimozide, lurasidone, lumefantrine, halofantrine, tyrosine kinase inhibitors, simvastatin, lovastatin, quetiapine, alfuzosin, silodosin, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine,
• Sočasna uporaba zdravil, katerih očistek je zelo odvisen od CYP3A4/5 in pri katerih je zvišana koncentracija v plazmi povezana z resnimi in/ali življenjsko nevarnimi učinki; takšna zdravila so npr. peroralno uporabljeni midazolam in triazolam, bepridil, pimozid, lurasidon, lumefantrin, halofantrin, zaviralci tirozin-kinaze, simvastatin, lovastatin, kvetiapin, alfuzosin, silodozin in derivati ergot alkaloidov (dihidroergotamin, ergonovin, ergotamin, metilergonovin) (glejte
The addition of Victrelis to peginterferon alfa-2b and ribavirin was associated to higher incidences of increase in uric acid, triglycerides and cholesterol total compared to peginterferon alfa-2b and
Dodatek zdravila Victrelis k peginterferonu alfa-2b in ribavirinu je bil povezan z večjo pojavnostjo povečanih koncentracij sečne kisline, trigliceridov in celokupnega holesterola, v primerjavi z zdravljenjem s samo peginterferonom alfa-2b in ribavirinom.
The median times for the most relevant boceprevir-resistant variants observed in genotype 1a patients (> 10%) to become undetectable were as follows: R155K+V36M, 0.69 years; V36M, 0.89 years; R155K+T54S, 1.05 years; R155K, 1.08 years; and T54S, 1.14 years.
Mediani časi, da so nezaznavne postale najpomembnejše na boceprevir odporne variante, so bili pri bolnikih, okuženih z genotipom 1a (>10 %), naslednji: R155K+V36M - 0,69 let, V36M - 0,89 let, R155K+T54S - 1,05 let, R155K - 1,08 let in T54S - 1,14 let.
The activity of boceprevir against the HCV genotype 1b replicon was reduced (2- to 8-fold) by the following amino acid substitutions in the NS3 protease domain: V36A/M, F43S, T54A/G/S, V55A, R155K/G, V158I, V170M and M175L.
Učinkovitost boceprevirja proti replikacijski enoti HCV genotipa 1b se je zmanjšala (za 2- do 8-krat) ob naslednjih zamenjavah aminokislin na NS3 domeni proteaze: V36A/M, F43S, T54A/G/S, V55A, R155K/G, V158I, V170M in M175L.
There is potential for inhibitors of these transporters to increase concentrations of boceprevir; the clinical implications of these interactions are not known.
Zaviralci teh transporterjev lahko povečajo koncentracije boceprevirja.
The race distribution of subjects was as follows: 82% White, 18% Non-White, 14% Black, 3% Asian, and 1% Multiracial.
Porazdelitev preiskovancev po rasah je bila naslednja: 82 % belcev, 18 % ne-belcev, 14 % črncev, 3 % Azijcev, 1 % večrasnih.
Overall, the presence of baseline RAVs did not appear to have a notable association with treatment response in subjects receiving the combination of boceprevir with peginterferon alfa-2b and ribavirin.
Prisotnost RAV na začetku zdravljenja, kot kaže, ni bila občutno povezana z odzivom na zdravljenje pri preiskovancih, ki so prejemali boceprevir ter peginterferon alfa-2b in ribavirin.
The race distribution of subjects was as follows: 82% White, 14% Black, 2% Asian, 1% multiracial, 1% American Indian or Alaskan Native.
Porazdelitev preiskovancev po rasah je bila naslednja: 82 % belcev, 14 % črncev, 2 % Azijcev, 1 % večrasnih, 1 % ameriških Indijancev ali aljaških domorodcev.
UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47 msd_lietuva@merck.com
UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47 msd_lietuva@merck.com info-msdbg@merck.com
Glomerular filtration rate decreased * Includes adverse reactions which may be serious as assessed by the investigator in clinical trial
Preiskave zmanjšanje telesne mase šum na srcu, povečana srčna frekvenca zmanjšana hitrost glomerulne filtracije * Vključuje neželene učinke, ki so po oceni raziskovalca pri preiskovancih v kliničnem preskušanju
• are taking bepridil, pimozide, lurasidone, oral midazolam, oral triazolam, simvastatin, lovastatin, alfuzosin, silodosin, 'ergot' type medicines (such as dihydro-ergotamine, ergonovine, ergotamine or methylergonovine), lumefantrine, halofantrine, quetiapine, or tyrosine kinase inhibitors.
• če jemljete bepridil, pimozid, lurasidon, peroralni midazolam, peroralni triazolam, simvastatin, lovastatin, alfuzosin, silodozin, zdravila ergotskega tipa (npr. dihidroergotamin, ergonovin, ergotamin ali metilergonovin), lumefantrin, halofantrin, kvetiapin ali zaviralce tirozin-kinaze.
Hepatobiliary disorders Uncommon:
Bolezni imunskega sistema Redki:
Dose adjustments of cyclosporine should be anticipated when administered with Victrelis and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects.
Prilagoditi ga je treba na podlagi natančnega nadzora koncentracije ciklosporina v krvi in pogostih ocen ledvične funkcije ter s ciklosporinom povezanih neželenih učinkov.
Skin and subcutaneous tissue disorders Very common:
Bolezni dihal, prsnega koša in mediastinalnega prostora Zelo pogosti:
Subjects who were not able to enrol in this study within 2 weeks received PR for 4 weeks followed by Victrelis 800 mg three times daily + PR for 44 weeks.
Preiskovanci, vključeni v študijo PROVIDE v dveh tednih po prejetju zadnjega odmerka PR v začetni študiji, so 44 tednov prejemali zdravilo Victrelis 800 mg trikrat na dan + PR. Preiskovanci, ki niso mogli biti vključeni v to študijo v dveh tednih, so 4 tedne prejemali PR in nato 44 tednov zdravilo Victrelis 800 mg trikrat na dan + PR.
Tacrolimus* (tacrolimus 0.5 mg single dose + Victrelis 800 mg single dose)
Takrolimus* (takrolimus 0,5 mg enkratni odmerek + zdravilo Victrelis 800 mg enkratni odmerek).
Decreased appetite* Dehydration*, hyperglycaemia*, hypertriglyceridaemia,
dehidracija*, hiperglikemija*, hipertrigliceridemija, hiperurikemija
What Victrelis looks like and contents of the pack The hard capsules have a yellowish-brown cap with the "MSD" logo printed in red ink and an offwhite body with "314" printed in red ink.
Zgornji del trde kapsule je rumenkasto-rjav in ima z rdečim črnilom natisnjeno oznako "MSD", spodnji del kapsule pa je sivo bel in ima z rdečim črnilom natisnjeno kodo "314".
Anaemia was observed in 49% of subjects treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin compared with 29% of subjects treated with peginterferon alfa-2b and ribavirin alone.
Anemijo so opazili pri 49 % preiskovancev, ki so prejemali zdravilo Victrelis v kombinaciji s peginterferonom alfa-2b in ribavirinom, in pri 29 % preiskovancev, zdravljenih samo s peginterferonom alfa-2b in ribavirinom.
Patients who have failed previous therapy: previous partial responders and relapsers to interferon and
Bolniki, pri katerih predhodno zdravljenje ni bilo uspešno: tisti, ki so se delno odzvali na predhodno zdravljenje, in tisti, ki se jim je bolezen po zdravljenju z interferonom in ribavirinom ponovila
In boceprevir-treated subjects who did not attain sustained virologic response (SVR) for whom samples were analysed, 53% had post
Med preiskovanci, ki so prejemali boceprevir in niso dosegli trajnega virološkega odziva (SVR), a so imeli opravljeno analizo vzorcev, jih je imelo RAV v obdobju po začetku
Caution should be exercised when boceprevir is combined with ketoconazole or azole antifungals (itraconazole, posaconazole, voriconazole).
Pri uporabi kombinacij boceprevirja s ketokonazolom oz. azolnimi antimikotiki (itrakonazolom, posakonazolom, vorikonazolom) je potrebna previdnost.
The distribution of subjects by genders was 37% men and 63% women.
Porazdelitev preiskovancev po spolu je bila: 37 % moških in 63 % žensk.
To obtain the hard capsules the foil of the blister should be peeled off. Victrelis is to be taken orally with food (a meal or light snack).
Zdravilo Victrelis se jemlje peroralno s hrano (obrok ali lahek prigrizek).
Fifty-seven percent (208/368) of subjects in the Victrelis-RGT arm and 56% (204/366) of subjects in the Victrelis-PR48 arm had undetectable HCV-RNA at TW 8 compared with 17% (60/363) of
in 56 % (204/366) preiskovancev iz skupine Victrelis-PR48 je imelo 8.
Goitre, hypothyroidism Hyperthyroidism
golša, hipotiroidizem
All subjects with detectable HCV-RNA in plasma at TW 24 were discontinued from treatment.
TZ zaznavno HCV-RNA v plazmi, je bilo zdravljenje prekinjeno.
(effect on P-gp transport in the
(učinek na prenos s pomočjo P
Platelet counts were decreased for subjects in the Victrelis containing-arms (3%) compared to subjects receiving peginterferon alfa-2b and ribavirin alone (1%).
Število trombocitov se je zmanjšalo pri preiskovancih v skupinah z zdravilom Victrelis (3 %) v primerjavi s preiskovanci, ki so prejemali samo peginterferon alfa-2b in ribavirin (1 %).
No dose adjustment of dabigatran is recommended.
Prilagoditve odmerka dabigatrana ne priporočamo.
- if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom.
Spolnih odnosov z nosečo žensko ne smete imeti brez uporabe kondoma.
The median time for all RAVs to become undetectable was 1.17 years for genotype 1a.
Pri genotipu 1a je bil mediani čas, da so postale nezaznavne vse RAV, 1,17 let.
How to store Victrelis
Shranjevanje zdravila Victrelis
Lopinavir/Ritonavir* (lopinavir 400 mg / ritonavir 100 mg two times daily + Victrelis 800 mg three times daily)
Darunavir/ritonavir* (darunavir 600 mg / ritonavir 100 mg dvakrat na dan + zdravilo Victrelis 800 mg trikrat na dan)
Victrelis is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy (see sections 4.4 and 5.1).
Zdravilo Victrelis je indicirano za zdravljenje kronične okužbe s hepatitisom C genotipa 1 v kombinaciji s peginterferonom alfa in ribavirinom pri odraslih bolnikih s kompenzirano jetrno boleznijo, ki še niso bili zdravljeni ali pri njih predhodno zdravljenje ni bilo uspešno (glejte
Infections and infestations Common:
Motnje reprodukcije in dojk Pogosti:
SVR rates with "missing=failure" approach were nearly identical to those in the table: 37% for Control, 62% for
TS. Deleži SVR s pristopom "manjkajoči = neuspeh" so bili skoraj enaki tistim v preglednici: 37 % v kontrolni skupini, 62 % v skupini Victrelis-RGT, 65 % v skupini Victrelis-PR48.
A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four week lead-in with peginterferon alfa-2b and ribavirin (Modified-Intent-to-Treat population) demonstrated SVR rates of 61% to 67% in the Victreliscontaining arms compared to 22% PR48 control.
Sekundarna analiza preiskovancev, ki so prejeli vsaj en odmerek zdravila Victrelis ali placeba po štirih tednih uvajalnega obdobja s peginterferonom alfa-2b in ribavirinom (Modified Intent to Treat population), je pokazala v skupinah, zdravljenih z zdravilom Victrelis, delež SVR 61 % do 67 % ter 22 % v kontroli PR48.
Victrelis must be administered in combination with peginterferon alfa and ribavirin.
Zdravilo Victrelis je treba uporabiti v kombinaciji s peginterferonom alfa in ribavirinom.
The proportion of subjects who received a transfusion for the management of anaemia was 3% of subjects in the Victrelis-containing arms compared to < 1% of subjects receiving peginterferon alfa-2b and ribavirin alone.
Delež preiskovancev, ki so prejeli transfuzijo za obvladovanje anemije, je bil v skupinah z zdravilom Victrelis 3 %, med preiskovanci, ki so prejemali samo peginterferon alfa-2b in ribavirin, pa < 1 %.
Exposure to atorvastatin was increased when administered with Victrelis.
Izpostavljenost atorvastatinu se je povečala pri sočasni uporabi zdravila Victrelis.
No dose adjustment is necessary when coadministered with Victrelis.
Prilagoditev odmerka pri sočasni uporabi z zdravilom Victrelis ni potrebna.
The addition of Victrelis to peginterferon alfa-2b and ribavirin significantly increased the SVR rates compared to peginterferon alfa-2b and ribavirin alone in the combined cohort (63% to 66% Victreliscontaining arms vs. 38% PR48 control) for randomized subjects who received at least one dose of any study medicine (Full-Analysis-Set population) and decreased the length of therapy to 28 weeks for early responders (see Table 4).
Dodatek zdravila Victrelis peginterferonu alfa-2b in ribavirinu je v kombinirani kohorti pri randomiziranih preiskovancih, ki so prejeli vsaj en odmerek kateregakoli raziskovanega zdravila (Full Analysis Set population), značilno povečal delež SVR v primerjavi s kombinacijo peginterferona alfa2b in ribavirina samo (63 % do 66 % v skupinah bolnikov z zdravilom Victrelis v primerjavi z 38 % v kontrolni skupini PR48) ter je pri preiskovancih z zgodnjim odzivom skrajšal trajanje zdravljenja na 28 tednov (glejte preglednico 4).
Eyes or ears: pink eye; eye pain; deafness; trouble hearing; swelling around the eyelid; increased tearing; fluid draining from the ear or eye; abnormal feeling around the eye, red patch on the white of the eye; yellowing of the white part of the eyes or of the skin Mouth, nose or throat: hoarseness, dry throat or lips; painful or bleeding gums; sensitive tooth or toothache; tongue swollen, discoloured, or has sores; blistering by the tongue; severe pain when swallowing; chest pain close to the lungs; chest pain worsens when taking a deep breath; uncontrolled salivating; overactive thyroid gland Skin and hair: hives; open sore; intolerance to heat; markedly red face; pale face; yellow skin; rash due to sunlight; wound not healing normally Feet or hands or legs or arms: sensation of pain, numbness, tingling or prickling; blood clot in a vein; feeling cold in an arm or leg; painful inflammation of the joints most commonly in the foot (gout)
Oči in ušesa: pordelo oko, bolečine v očeh, gluhost, naglušnost, oteklost okrog vek, močnejše solzenje, tekoč izcedek iz ušesa ali očesa, nenormalen občutek okrog očesa, rdeče lise na očesni beločnici, porumenelost očesne beločnice ali kože Usta, nos in žrelo: hripavost, suho žrelo ali ustnice, boleče ali krvaveče dlesni, občutljivost zob ali zobobol, oteklost jezika, spremenjena barva jezika ali razjede na jeziku, mehurji na jeziku, huda bolečina pri požiranju, bolečina v prsnem košu blizu pljuč, bolečina v prsnem košu, ki se poslabša ob globokem vdihu, nekontrolirano slinjenje, prekomerno delovanje ščitnice Koža, lasje in dlake: koprivnica, odprta razjeda, neprenašanje vročine, izrazito rdeč obraz, bled obraz, porumenelost kože, izpuščaj zaradi sončne svetlobe, rana, ki se ne celi normalno Stopala, dlani, noge ali roke: bolečina, omrtvičenost, mravljinčenje ali zbadanje, krvni strdek v veni, občutek hladu v roki ali nogi, boleče vnetje sklepov, najpogosteje na stopalu (putika)
ethinyl estradiol AUC ↓ 26% ethinyl estradiol Cmax ↓ 21%
etinilestradiol AUC ↓ 26 % etinilestradiol Cmax ↓ 21 %
The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection has not been studied in patients who have failed previous therapy with Victrelis or other HCV protease inhibitors.
Varnost in učinkovitost zdravila Victrelis samega ali v kombinaciji s peginterferonom alfa in ribavirinom za zdravljenje okužbe s kroničnim hepatitisom C genotipa 1 nista raziskani pri bolnikih, pri katerih predhodno zdravljenje z zdravilom Victrelis ali drugimi zaviralci proteaze HCV ni bilo uspešno.
The distribution of subjects by gender was 67% men and 33% women.
Porazdelitev preiskovancev po spolu je bila 67 % moških in 33 % žensk.
Neutropenia
Odpornost
A randomized, parallel-arm, open-label study (P06086) was conducted to compare two strategies for the management of anaemia (use of erythropoietin versus ribavirin dose reduction) in 687 subjects including 60 cirrhotic patients with previously untreated CHC genotype 1 infection who became anaemic during therapy with Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600 1,400 mg
Za primerjavo dveh načinov obvladovanja anemije (uporaba eritropoetina v primerjavi z zmanjšanjem odmerka ribavirina) so izvedli randomizirano, odprto študijo z vzporedno skupino (P06086) pri 687 preiskovancih, vključno s šestdesetimi bolniki s cirozo, s predhodno nezdravljeno okužbo s CHC genotipa 1, ki so med zdravljenjem z zdravilom Victrelis 800 mg peroralno trikrat na dan v kombinaciji s PR [peginterferon alfa-2b 1,5 µg/kg/teden subkutano in ribavirin odvisno od telesne mase (600 - 1.400 mg dvakrat na dan) peroralno, razdeljeno v dva odmerka], postali anemični.
The race distribution of subjects was as follows: 84% white, 13% Black, 2% Asian, and 1% others.
Porazdelitev preiskovancev po rasah je bila: 84 % belcev, 13 % črncev, 2 % Azijcev in 1 % drugih.