natgillin/translations-raw huggingface dataset:
Sustained response rates with Viraferon Peg + ribavirin (by ribavirin dose, genotype and viral load)
6 Trajna stopnja odziva z zdravilom ViraferonPeg + ribavirin (po odmerku ribavirina, genotipu in virusni obremenitvi)
62
≤ 600. 000 i. e. / ml Genotip 1
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
65 V ločenem preskušanju je 224 bolnikov z genotipom 2 ali 3 prejemalo ViraferonPeg, 1, 5 mikrograma/ kg subkutano enkrat na teden, skupaj z ribavirinom od 800 mg do 1. 400 mg peroralno v času 6 mesecev (glede na telesno maso - 1. 400 mg za bolnike s telesno maso > 105 kg; vključeni so bili le 3 bolniki) (Preglednica 7).
93% (169/182)
9% (2/ 22)
≤ 600,000 IU/ml
HCV 3 ≤ 600. 000 i. e. / ml > 600. 000 i. e. / ml
63 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600. 000 i. e. / ml), prejemalo ViraferonPeg v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z ribavirinom v odmerku, izračunanem glede na telesno maso.
Predictability of sustained response by viral response at week 12 and genotype*
Virusni odziv v 12. tednu
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 + ribavirin 800-1,400 mg
66 + ribavirin (> 10, 6 mg/ kg) 48 - tedensko zdravljenje ViraferonPeg 1, 5
Genotype Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/110) 0% (0/28) 100% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
+ ribavirin 800 – 1. 400 mg
24-week treatment
2 in 3
No 1% (2/215) 50% (1/2) 50%
da 99% (213/ 215)
* reflects patients
ne 1% (2/ 215)
with 12 week data available
* odziv pacienta po podatkih v 12- tednu zdravljenja
64 Table 9
Študija 11
27% (56/205) 20% (41/205) 0.047 44% (23/52) 21% (9/43) 0.017 17% (21/125) 6% (8/129) 0.006 38% (12/32) 7% (2/27) 0.007
(100 or 150c
Genotype 2, 3
(3 milijone
Histological response Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51%).
67 Histološki odziv na zdravljenje V študiji 1 so biopsijo jeter opravili pred in po zdravljenju - na voljo so podatki za 210 od 412 preiskovancev (51%).
65 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
60.0 (9/15) 27.4, 92.6
60, 0 (9/ 15) 27, 4, 92, 6
66 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Skupaj je imelo v 12. tednu zdravljenja približno 36% (821/ 2286) bolnikov nezaznavne koncentracije HCV- RNA v plazmi, kar so merili z raziskovalnim testom (meja detekcije 125 i. e. / ml).
Following subcutaneous administration, maximal serum concentrations occur between 15-44 hours post-dose, and are sustained for up to 48-72 hours post-dose.
69 Po subkutani uporabi nastopi največja plazemska koncentracija od 15 do 44 ur po odmerku in se ohrani do največ 48 do 72 ur po odmerku.
67 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Odmerek zdravila ViraferonPeg v monoterapiji je treba zmanjšati pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavji 4. 2 in 4. 4).
Effects on fertility have not been determined.
Učinka na plodnost niso
The powder is contained in a 2 ml vial, Type I flint glass, with a butyl rubber stopper in an aluminium flip -off seal with a polypropylene bonnet.
Prašek je na voljo v 2 ml vialah iz kristalnega stekla tipa I, z zamaškom iz butilne gume v aluminijasti zaporki z odmično ploščico in polipropilenskim pokrovčkom.
ViraferonPeg 100 micrograms is supplied as:
ViraferonPeg 100 mikrogramov je na voljo v naslednjih pakiranjih:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 100 micrograms for single use.
ViraferonPeg je na voljo v obliki praška peginterferona alfa- 2b v jakosti 100 mikrogramov za enkratno uporabo.
The reconstituted solution has a concentration of 100 micrograms/0.5 ml.
Koncentracija rekonstituirane raztopine je 100 mikrogramov/ 0, 5 ml.
ViraferonPeg 120 micrograms powder and solvent for solution for injection
ViraferonPeg 120 mikrogramov, prašek in vehikel za raztopino za injiciranje
Each vial of ViraferonPeg, powder for solution for injection contains 120 micrograms of peginterferon alfa-2b as measured on a protein basis.
Vsaka viala zdravila ViraferonPeg, prašek za raztopino za injiciranje, vsebuje 120 mikrogramov peginterferona alfa- 2b, merjeno glede na beljakovine.
Each vial provides 120 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 120 mikrogramov/ 0, 5 ml peginterferona alfa- 2b.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
73 Odmerek za injiciranje Zdravilo ViraferonPeg dajemo enkrat na teden v obliki subkutane injekcije.
71 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Kombinirana terapija ViraferonPeg 1, 5 mikrogramov/ kg na teden skupaj s kapsulami ribavirina.
Early virological response by Week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
74 Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log točki ali doseganje nemerljive količine RNA virusa HCV v serumu, dober napovednik stalnega odziva na zdravljenje.
72 Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
Administer Vial/Pen Once Weekly Strength
Enkrat na teden Jakost vial oz.
Administer Once Weekly
(ml) peresnika (μg/ 0, 5 ml)
73 Combination Therapy Dose Reduction Guidelines
75 Smernice za zmanjšanje odmerka pri kombinirani terapiji
(μg/0.5 ml)
Ciljni zmanjšani odmerek (μg)
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
76 Preglednica 3a Smernice za prilagajanje odmerka za monoterapijo z zdravilom ViraferonPeg Laboratorijske
74 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Zmanjšanje odmerka pri bolnikih, ki jemljejo 0, 5 μg/ kg zdravila ViraferonPeg v monoterapiji, mora biti doseženo z zmanjšanjem predpisanega volumna za pol.
Use in hepatic impairment:
77 Uporaba pri jetrni okvari:
Acute hypersensitivity:
78 Akutna preobčutljivost:
76 Hydration:
Hidracija:
Metabolic disturbances:
79 Presnovne motnje:
77 Haematological abnormalities in HCV/HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
Other:
80 Drugo:
Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV, although the exact mechanism remains to be elucidated.
81 Kadar je bil zidovudin vključen v shemo zdravljenja okužbe s HIV, so poročali o poslabšanju anemije zaradi jemanja ribavirina, čeprav natančen mehanizem tega pojava ni znan.
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
82 Preglednica 4 Neželeni učinki, o katerih so poročali v kliničnih preskušanjih ali v času postmarketinškega spremljanja bolnikov, zdravljenih z interferonom alfa- 2b, vključno z monoterapijo z zdravilom ViraferonPeg ali s kombinirano terapijo z zdravilom ViraferonPeg in ribavirinom
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 81
sinusitis, bronhitis, disfonija, epistaksa, rinitis, bolezni dihal, kongestija nosne sluznice, rinoreja, neproduktiven kašelj
Stevens Johnson syndrome, toxic epidermal necrolysis, injection site necrosis, erythema multiforme
Stevens- Johnsonov sindrom, toksična epidermalna nekroliza, nekroza na mestu injiciranja, multiformni eritem
Very common:
84 Bolezni mišično- skeletnega sistema in vezivnega tkiva Zelo pogosti:
82 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
V neki klinični raziskavi je imelo približno 1, 2% bolnikov, zdravljenih z zdravilom ViraferonPeg ali z interferonom alfa- 2b v kombinaciji z ribavirinom med zdravljenjem smrtno nevarne duševne pojave.
HCV/HIV co-infected patients For HCV/HIV co-infected patients receiving ViraferonPeg in combination with ribavirin, other undesirable effects (that were not reported in mono-infected patients) which have been reported in the larger studies with a frequency > 5% were: oral candidiasis (14%), lipodystrophy acquired (13%), CD4 lymphocytes decreased (8%), appetite decreased (8%), gamma-glutamyltransferase increased (9%), back pain (5%), blood amylase increased (6%), blood lactic acid increased (5%), cytolytic hepatitis (6%), lipase increased (6%) and pain in limb (6%).
Bolniki, ki so bili sočasno okuženi s HCV in HIV in so prejemali zdravilo ViraferonPeg v kombinaciji z ribavirinom, so imeli naslednje dodatne neželene učinke, ki jih niso opažali pri bolnikih z eno samo okužbo, v študijah pa so jih prijavljali s pogostnostjo > 5%: peroralna kandidiaza (14%), pridobljena lipodistrofija (13%), zmanjšano število limfocitov CD4 (8%), zmanjšan tek (8%), zvišana vrednost
83 Doses up to 10.5 times the intended dose have been reported.
Poročali so o zaužitju odmerkov tudi do 10, 5- kratnika odmerka, ki ga je bolnik nameraval vzeti.
84 In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
V raziskavi monoterapije z zdravilom ViraferonPeg je skupno 916 predhodno nezdravljenih bolnikov s kroničnim hepatitisom C eno leto prejemalo zdravilo ViraferonPeg v odmerku 0, 5, 1, 0 ali 1, 5 mikrogramov/ kg/ teden, nato pa so jih spremljali še 6 mesecev.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
87 HCV genotip in virusna obremenitev na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
Table 5
Preglednica 5 Trajni virološki odziv (% HCV negativnih bolnikov)
Sustained virological response (% patients HCV negative Viraferon Peg monotherapy
ViraferonPeg monoterapija
85
≤ 600. 000 i. e. / ml Genotip 1
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
88 V ločenem preskušanju je 224 bolnikov z genotipom 2 ali 3 prejemalo ViraferonPeg, 1, 5 mikrograma/ kg subkutano enkrat na teden, skupaj z ribavirinom od 800 mg do 1. 400 mg peroralno v času 6 mesecev (glede na telesno maso - 1. 400 mg za bolnike s telesno maso > 105 kg; vključeni so bili le 3 bolniki) (Preglednica 7).
12% (2 7/224)
48 - tedensko zdravljenje ViraferonPeg 1, 5
HCV 2 ≤ 600,000 IU/ml
ne 25% (28/ 110)
86 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
ost pa
Genotype Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/110) 0% (0/28) 100% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
21% (9/ 43)
87 Table 9
Genotip 2, 3
MIU = million international units; TIW = three times a week. a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week ViraferonPeg and subjects ≥ 75 kg received 150 µg/week ViraferonPeg. d: ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1, 200 mg for patients > 75 kg.
2839- 2848.
88 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
46.0 (63/137) 35.0, 57.0
46, 0 (63/ 137)
73.0 (135/185) 6 4.6, 81.4
73, 0 (135/ 185) 64, 6, 81, 4
89 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Skupaj je imelo v 12. tednu zdravljenja približno 36% (821/ 2286) bolnikov nezaznavne koncentracije HCV- RNA v plazmi, kar so merili z raziskovalnim testom (meja detekcije 125 i. e. / ml).
5.2 Pharmacokinetic properties
92 5. 2 Farmakokinetične lastnosti
90 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Odmerek zdravila ViraferonPeg v monoterapiji je treba zmanjšati pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavji 4. 2 in 4. 4).
5.3 Preclinical safety data
93 5. 3 Predklinični podatki o varnosti
6.5 Nature and contents of container
94 6. 5 Vrsta ovojnine in vsebina
ViraferonPeg 120 micrograms is supplied as:
ViraferonPeg 120 mikrogramov je na voljo v naslednjih pakiranjih:
ViraferonPeg is supplied as a powder of peginterferon alfa-2b at a strength of 120 micrograms for single use.
ViraferonPeg je na voljo v obliki praška peginterferona alfa- 2b v jakosti 120 mikrogramov za enkratno uporabo.
The reconstituted solution has a concentration of 120 micrograms/0.5 ml.
Koncentracija rekonstituirane raztopine je 120 mikrogramov/ 0, 5 ml.
ViraferonPeg 150 micrograms powder and solvent for solution for injection
ViraferonPeg 150 mikrogramov, prašek in vehikel za raztopino za injiciranje
Each vial of ViraferonPeg, powder for solution for injection contains 150 micrograms of peginterferon alfa-2b as measured on a protein basis.
Vsaka viala zdravila ViraferonPeg, prašek za raztopino za injiciranje, vsebuje 150 mikrogramov peginterferona alfa- 2b, merjeno glede na beljakovine.
Each vial provides 150 micrograms/0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Po rekonstituciji v skladu z navodili vsebuje vsaka viala 150 mikrogramov/ 0, 5 ml peginterferona alfa- 2b.
Dose to be administered ViraferonPeg should be administered as a once weekly subcutaneous injection.
97 Odmerek za injiciranje Zdravilo ViraferonPeg dajemo enkrat na teden v obliki subkutane injekcije.
94 Combination therapy ViraferonPeg 1.5 micrograms/kg/week in combination with ribavirin capsules.
Kombinirana terapija ViraferonPeg 1, 5 mikrogramov/ kg na teden skupaj s kapsulami ribavirina.
Early virological response by Week 12, defined as a 2 log viral load decrease or undetectable levels of HCV-RNA, has been shown to be predictive for sustained response.
98 Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2 log točki ali doseganje nemerljive količine RNA virusa HCV v serumu, dober napovednik stalnega odziva na zdravljenje.
95 Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
The lowest vial or pen strength available is 50 μg/ 0.5 ml; therefore for patients prescribed 0.5 μ g/ kg/week, doses must be adjusted by volume as shown in Table 2.
Bolnikom, ki jim predpišete odmerek 0, 5 μg/ kg/ teden, morate torej volumsko prilagoditi odmerek, kot je prikazano v Preglednici 2.
96 Combination Therapy Dose Reduction Guidelines
99 Smernice za zmanjšanje odmerka pri kombinirani terapiji
g/dl decrease in haemoglobin during any four week period during treatment (permanent dose reduction) -< 1.5 x 109/l -< 0.7 5 x 109/l 9
kateremkoli štiritedenskem obdobju med
-< 50 x 10 /l - -> 5 mg/dl -
< 1, 5 x 109/ l < 0, 75 x 109/ l 9
ViraferonPeg Monotherapy Dose Reduction Guidelines
100 Smernice za zmanjšanje odmerka zdravila ViraferonPeg pri monoterapiji
Table 3a Dose modification guidelines for ViraferonPeg monotherapy
Preglednica 3a Smernice za prilagajanje odmerka za monoterapijo z zdravilom ViraferonPeg Laboratorijske
97 Dose reduction for patients who use 0.5 μg/kg ViraferonPeg monotherapy must be accomplished by reducing the prescribed volume by one-half.
Zmanjšanje odmerka pri bolnikih, ki jemljejo 0, 5 μg/ kg zdravila ViraferonPeg v monoterapiji, mora biti doseženo z zmanjšanjem predpisanega volumna za pol.
Combination therapy:
101 Kombinirana terapija:
4.3 Contra indications
4. 3 Kontraindikacije
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Podatek o tem, ali je pred začetkom zdravljenja potrebna biopsija jeter, najdete v tekočih 102 smernicah za zdravljenje.
99 Hydration:
Hidracija:
In the presence of thyroid dysfunction, ViraferonPeg treatment may be continued if TSH levels can be maintained in the normal range by medication.
103 z zdravilom ViraferonPeg nadaljujete, če lahko ohranjate vrednosti TSH v normalnem razponu z zdravili.
100 Haematological abnormalities in HCV/HIV co-infected patients:
Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
104 povezana s povečano pogostnostjo zavrnitve ledvičnega presadka.
Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see ribavirin SPC).
105 mitohondrijske toksičnosti, še posebej v obliki laktacidoze in pankreatitisa, in nekateri od njih so vodili do bolnikove smrti (glejte SPC za ribavirin).
Adverse reactions reported in clinical trials or through post-marketing surveillance in patients treated with interferon alfa-2b, including ViraferonPeg monotherapy or ViraferonPeg + ribavirin.
106 Preglednica 4 Neželeni učinki, o katerih so poročali v kliničnih preskušanjih ali v času postmarketinškega spremljanja bolnikov, zdravljenih z interferonom alfa- 2b, vključno z monoterapijo z zdravilom ViraferonPeg ali s kombinirano terapijo z zdravilom ViraferonPeg in ribavirinom
Frequency not known:
107 Pogostnost ni znana:
Sinusitis, bronchitis, dysphonia, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough 104
sinusitis, bronhitis, disfonija, epistaksa, rinitis, bolezni dihal, kongestija nosne sluznice, rinoreja, neproduktiven kašelj
Stevens Johnson syndrome, toxic epidermal necrolysis, injection site necrosis, erythema multiforme
Stevens- Johnsonov sindrom, toksična epidermalna nekroliza, nekroza na mestu injiciranja, multiformni eritem 108
105 In a clinical trial, approximately 1.2% of patients treated with ViraferonPeg or interferon alfa-2b in combination with ribavirin reported life-threatening psychiatric events during treatment.
V neki klinični raziskavi je imelo približno 1, 2% bolnikov, zdravljenih z zdravilom ViraferonPeg ali z interferonom alfa- 2b v kombinaciji z ribavirinom med zdravljenjem smrtno nevarne duševne pojave.
Mitochondrial toxicity:
109 Toksičnost za mitohondrije:
106 Doses up to 10.5 times the intended dose have been reported.
Poročali so o zaužitju odmerkov tudi do 10, 5- kratnika odmerka, ki ga je bolnik nameraval vzeti.
107 In the ViraferonPeg monotherapy trial, a total of 916 naïve chronic hepatitis C patients were treated with ViraferonPeg (0.5, 1.0 or 1.5 micrograms/kg/week) for one year with a follow-up period of six months.
V raziskavi monoterapije z zdravilom ViraferonPeg je skupno 916 predhodno nezdravljenih bolnikov s kroničnim hepatitisom C eno leto prejemalo zdravilo ViraferonPeg v odmerku 0, 5, 1, 0 ali 1, 5 mikrogramov/ kg/ teden, nato pa so jih spremljali še 6 mesecev.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
111 HCV genotip in virusna obremenitev na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
However, response rates in this trial were shown to be dependent also on the dose of ribavirin administered in combination with Viraferon Peg or interferon alfa-2b.
Vendar pa se je pokazalo, da je bila stopnja odziva v tej raziskavi odvisna tudi od odmerka ribavirina, prejetega v kombinaciji z zdravilom ViraferonPeg ali interferonom alfa - 2b.
108
≤ 600. 000 i. e. / ml Genotip 1
In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
112 V ločenem preskušanju je 224 bolnikov z genotipom 2 ali 3 prejemalo ViraferonPeg, 1, 5 mikrograma/ kg subkutano enkrat na teden, skupaj z ribavirinom od 800 mg do 1. 400 mg peroralno v času 6 mesecev (glede na telesno maso - 1. 400 mg za bolnike s telesno maso > 105 kg; vključeni so bili le 3 bolniki) (Preglednica 7).
109 In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
V neprimerjalnem preskušanju je 235 bolnikov, ki so bili okuženi z virusom genotipa 1 in so imeli majhno virusno obremenitev (< 600. 000 i. e. / ml), prejemalo ViraferonPeg v odmerku 1, 5 mikrograma/ kg subkutano enkrat na teden, v kombinaciji z ribavirinom v odmerku, izračunanem glede na telesno maso.
Predictability of sustained response by viral response at week 12 and genotype *
Predvidljivost trajnega virološkega odziva po odzivu v 12. tednu in genotipu *
Treatment ViraferonPeg 1.5 + ribavirin (> 10.6 mg/kg) 48-week treatment ViraferonPeg 1.5 + ribavirin 800-1,400 mg
Zdravljenje ViraferonPeg 1, 5
Genotype Viral response Sustained response Negative predictive value at week 12 1 Yes 75% (82/110) 71% (58/82) ---- No 25% (28/110) 0% (0/28) 100% 2 and 3 Yes 99% (213/215) 83% (177/213) ----
113 + ribavirin (> 10, 6 mg/ kg) 48 - tedensko zdravljenje ViraferonPeg 1, 5
110 Table 9
Študija 11
27% (56/205) 20% (4 1/205) 0.047 44% (23/52) 21% (9/43) 0.017 17% (21/125) 6% (8/129) 0.006 38% (12/32) 7% (2/27) 0.007
(100 or 150c
Histological response Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51%).
114 Histološki odziv na zdravljenje V študiji 1 so biopsijo jeter opravili pred in po zdravljenju - na voljo so podatki za 210 od 412 preiskovancev (51%).
111 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
112 Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Skupaj je imelo v 12. tednu zdravljenja približno 36% (821/ 2286) bolnikov nezaznavne koncentracije HCV- RNA v plazmi, kar so merili z raziskovalnim testom (meja detekcije 125 i. e. / ml).
Following subcutaneous administration, maximal serum concentrations occur between 15-44 hours post-dose, and are sustained for up to 48-72 hours post-dose.
116 Po subkutani uporabi nastopi največja plazemska koncentracija od 15 do 44 ur po odmerku in se ohrani do največ 48 do 72 ur po odmerku.
113 ViraferonPeg for monotherapy should be reduced in patients with moderate or severe renal impairment (see sections 4.2 and 4.4).
Odmerek zdravila ViraferonPeg v monoterapiji je treba zmanjšati pri bolnikih z zmerno ali hudo ledvično okvaro (glejte poglavji 4. 2 in 4. 4).