natgillin/translations-raw huggingface dataset:
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4% (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4% (8/194) of patients receiving ViraferonPeg in combination with ribavirin.
V študiji 1 (glejte poglavje 5. 1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/ mm3 pri 4% (8/ 194) bolnikov in zmanjšanje števila trombocitov pod 50. 000/ mm3 pri 4% (8/ 194) bolnikov, ki so prejemali zdravilo ViraferonPeg v kombinaciji z ribavirinom.
Anaemia (hemoglobin < 9.4g/dl) was reported in 12% (23/194) of patients treated with ViraferonPeg in combination with ribavirin.
O anemiji (hemoglobin < 9, 4 g/ dl) so poročali pri 12% (23/ 194) bolnikov, zdravljenih z zdravilom ViraferonPeg v kombinaciji z ribavirinom.
Limited safety data (N= 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Za sočasno okužene bolnike s številom celic CD4+ < 200/ µl so na voljo le omejeni podatki o varnosti zdravila (N = 25) (glejte poglavje 4. 4).
Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ViraferonPeg in combination with ribavirin.
Preberite si tudi ustrezne Povzetke glavnih značilnosti zdravila za protiretrovirusna zdravila, ki jih bo bolnik jemal skupaj s terapijo za HCV, da bi se bolj zavedali in bi lahko zdravili toksične učinke vsakega od teh zdravil ter da bi se zavedali potencialnega prekrivanja njihovih toksičnih učinkov z zdravilom ViraferonPeg v kombinaciji z ribavirinom.
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.
The maximum daily dose reported is 1,200 µg for one day.
Največji prijavljeni dnevni odmerek je bil 1200 mcg v enem dnevu.
In general, the adverse events seen in overdose cases involving ViraferonPeg are
Na splošno so neželeni učinki, ki so jih opazili v primerih prevelikega odmerjanja zdravila ViraferonPeg, doslej ustrezali znanemu profilu varnosti zdravila ViraferonPeg, vendar so lahko močnejši.
If available, prescribers are advised to consult with a poison control centre (PCC).
Zdravnikom tudi priporočamo, da se posvetujejo z Centrom za zastrupitve, če le- ta obstaja.
Immunostimulants, Cytokines and immunomodulators, Interferons, Peginterferon alfa-2b, ATC code:
Imunostimulanti, Citokini in imunomodulatorji, Interferoni, Peginterferon alfa- 2b, oznaka ATC:
Recombinant interferon alfa-2b is covalently conjugated with monomethoxy polyethylene glycol at an average degree of substitution of 1 mole of polymer/mole of protein.
Rekombinantni interferon alfa- 2b se kovalentno konjugira z monometoksi polietilenglikolom pri povprečni stopnji substitucije 1 mol polimera na mol beljakovine.
The average molecular mass is approximately 31,300 daltons of which the protein moiety constitutes approximately 19,300.
Povprečna molekulska masa je približno 31. 300 daltonov, od tega 19. 300 daltonov za beljakovinski del.
Interferon alfa-2b In vitro and in vivo studies suggest that the biological activity of ViraferonPeg is derived from its interferon alfa-2b moiety.
Raziskave in vitro in in vivo kažejo, da biološka aktivnost zdravila ViraferonPeg temelji na njegovi komponenti interferona alfa- 2b.
Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface.
Interferoni izvajajo svoje celične učinke z vezavo na specifične membranske receptorje na celični površini.
Studies with other interferons have demonstrated species specificity.
Raziskave drugih interferonov so pokazale vrstno specifičnost, vendar pa so nekatere vrste opic, npr.
However, certain monkey species, e.g., Rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Rhesus, občutljive na farmakodinamično stimulacijo s človeškim interferonom tipa 1.
Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Po vezavi na celično membrano interferon sproži zapleteno zaporedje znotrajceličnih reakcij, ki vključujejo tudi indukcijo nekaterih encimov.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virus- infected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Menijo, da ta je proces vsaj deloma odgovoren za različne celične odzive na interferon, vključno z zaviranjem razmnoževanja virusa v okuženih celicah, supresijo celične proliferacije in imunomodulatorne učinke, npr. okrepitev fagocitozne aktivnosti makrofagov in okrepitev specifične citotoksičnosti limfocitov za tarčne celice.
Recombinant interferon alfa-2b also inhibits viral replication in vitro and in vivo.
Rekombinantni interferon alfa- 2b tudi zavira razmnoževanje virusov in vitro ter in vivo.
Although the exact antiviral mode of action of recombinant interferon alfa-2b is unknown, it appears to alter the host cell metabolism.
Čeprav dejanski mehanizem protivirusnega delovanja rekombinantnega interferona alfa- 2b ni znan, pa kaže, da spremeni celično presnovo gostitelja.
This action inhibits viral replication or if replication occurs, the progeny virions are unable to leave the cell.
To delovanje zavira razmnoževanje virusa, če pa do tega vseeno pride, potomski virioni ne morejo zapustiti celice.
ViraferonPeg ViraferonPeg pharmacodynamics were assessed in a rising single-dose trial in healthy subjects by examining changes in oral temperature, concentrations of effector proteins such as serum neopterin and 2’5’-oligoadenylate synthetase (2’5’-OAS), as well as white cell and neutrophil counts.
ViraferonPeg Farmakodinamiko zdravila ViraferonPeg so ocenjevali v raziskavi pri zdravih preiskovancih z uporabo naraščajočih enkratnih odmerkov in merjenjem sprememb ustne temperature in koncentracije efektorskih proteinov, kot so serumski neopterin ter 2’ 5 ’ - oligoadenilatsintetaze (2’ 5 ’ - OAS), določali pa so tudi število levkocitov in trombocitov.
Subjects treated with ViraferonPeg showed mild dose-related elevations in body temperature.
Pri osebah, ki so bile zdravljene z zdravilom ViraferonPeg, so ugotavljali blago zvišanje telesne temperature.
Following single doses of ViraferonPeg between 0.25 and 2.0 micrograms/kg/week, serum neopterin concentration was increased in a dose-related manner.
Po enkratnih odmerkih zdravila ViraferonPeg med 0, 25 in 2, 0 mikrogramov/ kg na teden se je serumska koncentracija neopterina povečala v odvisnosti od odmerka.
ViraferonPeg clinical trials – Naïve patients Two pivotal trials have been conducted, one (C/I97-010) with ViraferonPeg monotherapy; the other (C/I98-580) with ViraferonPeg in combination with ribavirin.
V prvi (C/ I97- 010) je bilo zdravilo ViraferonPeg uporabljeno kot monoterapija, v drugi (C/ I98- 580) pa v kombinaciji z ribavirinom.
Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction (PCR) assay (> 30 IU/ml), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
V ti raziskavi so vključili bolnike s kroničnim hepatitisom C, potrjenim s pozitivno polimerazno verižno reakcijo (PCR test) na HCV- RNK (> 30 i. e. / ml), izvid jetrne biopsije pa je bil v skladu s histološko diagnozo kroničnega hepatitisa brez ugotovljenih drugih vzrokov za to bolezen in z nenormalnimi vrednostmi serumske ALT.
15 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.
In addition, 303 patients received interferon alfa-2b (3 million International Units [MIU] three times a week) as a comparator.
(mio i. e.) trikrat na teden.
This study showed that ViraferonPeg was superior to interferon alfa-2b (Table 5).
Ta raziskava je potrdila, da je zdravilo ViraferonPeg boljše od interferona alfa- 2b (Preglednica 5).
In the ViraferonPeg combination trial, 1,530 naïve patients were treated for one year with one of the following combination regimens: • ViraferonPeg (1.5 micrograms/kg/week) + ribavirin (800 mg/day), (n = 511). • ViraferonPeg (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) + ribavirin (1,000/1,200 mg/day), (n = 514). • Interferon alfa-2b (3 MIU three times a week) + ribavirin (1,000/1,200 mg/day) (n = 505).
3- krat na teden) + ribavirin (1. 000/ 1. 200 mg/ dan) (n = 505).
In this trial, the combination of ViraferonPeg (1.5 micrograms/kg/week) and ribavirin was significantly more effective than the combination of interferon alfa-2b and ribavirin (Table 5), particularly in patients infected with Genotype 1 (Table 6).
V tej raziskavi je bila kombinacija zdravila ViraferonPeg (1, 5 mikrogramov/ kg/ teden in ribavirina statistično značilno bolj učinkovita od kombinacije interferona alfa- 2b in ribavirina (Preglednica 5), še posebej pri bolnikih, okuženih z genotipom 1 (Preglednica 6).
Sustained response was assessed by the response rate six months after the cessation of treatment.
Stalni virološki odziv so ocenjevali na podlagi odziva šest mesecev po prenehanju zdravljenja.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
16 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 ViraferonPeg 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.
In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received ≤ 10.6 mg/kg ribavirin (Table 6), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Pri bolnikih, ki so prejeli > 10, 6 mg/ kg ribavirina (800 mg odmerek pri tipičnem 75 kg težkem bolniku), je bila stopnja odziva ne glede na genotip ali virusno obremenitev značilno višja kot pri bolnikih, ki so prejeli ≤ 10, 6 mg/ kg ribavirina (Preglednica 6), medtem ko je bila stopnja odziva pri bolnikih, ki so prejeli > 13, 2 mg/ kg ribavirina še večja.
Table 5
ViraferonPeg monoterapija
Response at end of treatment
Odziv na koncu zdravljenja
P 1.5 ViraferonPeg 1.5 micrograms/kg P 1.0 ViraferonPeg 1.0 microgram/kg P 0.5 ViraferonPeg 0.5 microgram/kg I Interferon alfa-2b 3 MIU P 1.5/R P 0.5/R I/R * **
P 1, 5/ R P 0, 5/ R I/ R * **
I/R
ViraferonPeg (1, 5 mikrogramov/ kg) + ribavirin (800 mg) ViraferonPeg (1, 5 to 0, 5 mikrogram/ kg) + ribavirin (1. 000/ 1. 200 mg) Interferon alfa- 2b (3 mio i. e.) + ribavirin (1. 000/ 1. 200 mg) p < 0, 001 P 1, 5 proti I p = 0, 0143 P 1, 5/ R proti I/ R
Table 6
Preglednica
Sustained response rates with ViraferonPeg + ribavirin (by ribavirin dose, genotype and viral load)
6 Trajna stopnja odziva z zdravilom ViraferonPeg + ribavirin (po odmerku ribavirina, genotipu in virusni obremenitvi)
Ribavirin dose (mg/kg)
odmerek P 1, 5/ R P 0, 5/ R Ribavirina (mg/ kg)
All Genotypes
Vsi genotipi Genotip 1 Genotip 1
Genotype 1
≤ > ≤ >
All ≤ 10.6 > 10.6
vsi 10, 6 10, 6 vsi 10, 6 10, 6 vsi
Genotype 1
≤ 600. 000 i. e. / ml Genotip 1
All
10, 6 10, 6 vsi 10, 6
73%
74% 71% 30%
51%
25% 52% 27%
45%
33% 45% 29%
≤ 600,000 IU/ml
> 600. 000 i. e. / ml
27% 25% 27%
25%
29% 17% 29%
17%
79%
> ≤ >
≤ 10.6 > 10.6
10, 6 vsi 10, 6 10, 6
79% 88%
37% 82% 79% 88%
73% 80%
27% 80% 73% 80%
50% 80%
29% 79% 50% 80%
ViraferonPeg (1.5 micrograms/kg) + ribavirin (800 mg) ViraferonPeg (1.5 to 0.5 microgram/kg) + ribavirin (1,000/1,200 mg) Interferon alfa-2b (3 MIU) + ribavirin (1,000/1,200 mg)
ViraferonPeg (1, 5 mikrogramov/ kg) + ribavirin (800 mg) ViraferonPeg (1, 5 to 0, 5 mikrogram/ kg) + ribavirin (1. 000/ 1. 200 mg) Interferon alfa- 2b (3 mio i. e.) + ribavirin (1. 000/ 1. 200 mg)
In the Vir aferonPeg monotherapy study, the Quality of Life was generally less affected by 0.5 microgram/kg of ViraferonPeg than by either 1.0 microgram/kg of ViraferonPeg once weekly or 3 MIU of interferon alfa-2b three times a week.
V raziskavi monoterapije z zdravilom ViraferonPeg je bila kakovost življenja običajno manj zmanjšana pri bolnikih, ki so prejemali po 0, 5 mikrograma/ kg zdravila ViraferonPeg kot pri tistih, ki so prejemali bodisi 1, 0 mikrograma/ kg zdravila ViraferonPeg enkrat na teden ali 3 mio i. e. interferona alfa- 2b trikrat na teden.
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).
17 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).
Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* ViraferonPeg 1.5 μg/kg once weekly plus Ribavirin 800-1,400 mg/day
Virološki odziv ob koncu zdravljenja, trajni virološki odziv in ponovitev bolezni po HCV genotipih in virusni obremenitvi *
End
ViraferonPeg v odmerku 1, 5 μg/ kg enkrat na teden plus Ribavirin v odmerku 800 do 1. 400 mg na dan
HCV 2 ≤ 600,000 IU/ml
Vsi preiskovanci HCV 2 ≤ 600. 000 i. e. / ml > 600. 000 i. e. / ml
100% (42/42) 100% (20/20)
94% (211/ 224) 100% (42/ 42) 100% (20/ 20) 100% (22/ 22)
93% (39/42) 95% (19/20)
81% (182/ 224) 93% (39/ 42) 95% (19/ 20) 91% (20/ 22)
7% (3/42) 5% (1/20)
12% (27/ 224) 7% (3/ 42) 5% (1/ 20)
91% (20/22)
9% (2/ 22)
HCV 3
HCV 3 ≤ 600. 000 i. e. / ml > 600. 000 i. e. / ml
93% (169/182)
93% (169/ 182) 93% (92/ 99) 93% (77/ 83)
79% (143/182)
79% (143/ 182) 86% (85/ 99) 70% (58/ 83)
86% (85/99)
14% (24/ 166) 8% (7/ 91) 23% (17/ 75)
* Any subject with an undetectable HCV-RNA level at the Follow-Up Week 12 visit and missing data at the Follow- Up Week 24 visit was considered a susta ined responder.
* Vsakega preiskovanca z nemerljivo koncentracijo HCV- RNA ob obisku v 12. tednu spremljanja bolnikov ali z manjkajočimi podatki ob obisku v 24. tednu spremljanja bolnikov so šteli med bolnike s stalnim virološkim odzivom.
17 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.
The high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (n=48).
Vmesna analiza je pokazala visoko stopnjo stalnega virološkega odziva pri tej podskupini (n=49), ki je bila tudi prospektivno potrjena (n=48).
Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Omejena količina predhodnih podatkov kaže, da je lahko zdravljenje, ki traja 48 tednov, povezano z večjo stopnjo stalnega virološkega odziva (11/ 11) in z manjšim tveganjem za relaps (0/ 11 v primerjavi s 7/ 96 po 24 tednih zdravljenja).
Predictability of sustained virological response – Naïve patients Virological reponse 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 (Table 8).
Predvidljivost trajnega virološkega odziva - Nezdravljeni bolniki Pokazali so, da je virološki odziv do 12. tedna, opredeljen kot 2- log zmanjšanje virusne obremenitve ali nemerljive koncentracije HCV RNK, dober napovednik za trajen odziv (Preglednica 8).
Table 8
18 Preglednica 8
Predictability of
Predvidljivost trajnega virološkega odziva po odzivu v 12. tednu in genotipu *
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 (> 10, 6 mg/ kg)
Genotype
71% (58/ 82)
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%
48 - tedensko zdravljenje ViraferonPeg 1, 5
ribavirin 800-1,400 mg
+ ribavirin 800 – 1. 400 mg
2 and 3
in 3
Yes 99% (213/215) 83% (177/213)
da 99% (213/ 215)
24-week treatment
24 - tedensko zdravljenje
No 1% (2/215) 50% (1/2)
ne 1% (2/ 215)
* reflects patients with 12 week data available
* odziv pacienta po podatkih v 12- tednu zdravljenja
The negative predictive value for sustained response in patients treated with ViraferonPeg in monotherapy was 98%.
Negativna napovedna vrednost za trajni odziv pri bolnikih, zdravljenih z zdravilom ViraferonPeg v monoterapiji, je bila 98%.
Patients were randomized to receive either ViraferonPeg (1.5 µg/kg/week) plus ribavirin (800 mg/day) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Bolnike so naključno razporedili bodisi v skupino, ki bo prejemala zdravilo ViraferonPeg (1, 5 µg/ kg/ teden) plus ribavirin (800 mg/ dan) ali pa v skupino, ki bo prejemala interferon alfa- 2b (3 milijone i. e. trikrat na teden) in ribavirin (800 mg/ dan) v času 48 tednov, s 6- mesečnim spremljanjem.
Patients were randomized to receive either ViraferonPeg (100 or 150 µg /week based on weight) plus ribavirin (800-1,200 mg/day based on weight) or interferon alfa-2b (3 MIU TIW) plus ribavirin (800-1,200 mg/day based on weight).
Bolnike so naključno razporedili bodisi v skupino, ki bo prejemala zdravilo ViraferonPeg (100 ali 150 µg/ teden glede na telesno maso) in ribavirin (800- 1200 mg/ dan glede na telesno maso) ali pa v skupino, ki bo prejemala interferon alfa- 2b (3 milijone i. e. trikrat na teden) in ribavirin (800- 1200 mg/ dan glede na telesno maso).
The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/ml (Amplicor) who were treated for 24 weeks with a 6-month follow-up period.
Zdravljenje je trajalo 48 tednov, bolnike pa so spremljali 6 mesecev, razen tistih, ki so bili okuženi z genotipoma 2 ali 3 in so imeli virusno breme < 800. 000 i. e. / ml (Amplicor) - te so zdravili 24 tednov in jih spremljali 6 mesecev.
18 Table 9
Študija 11
Sustained virological response based on genotype after ViraferonPeg in combination with Ribavirin in HCV/HIV Co-infected patients Study 11 Study 22 ViraferonPeg Interferon ViraferonPeg Interferon (100 or alfa-2b (1.5 µg/kg/ alfa-2b 150c µg/week) (3 MIU TIW) week) + (3 MIU TIW) + + ribavirin + ribavirin ribavirin ribavirin p (800- (800- p (800 mg) (800 mg) valuea 1,200 mg) d 1,200 mg) d valueb
Interferon
All Genotype 1, 4
ViraferonPeg
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
ViraferonPeg
Genotype 2, 3
(3 milijone i. e.
44% (35/80) 43% (33/76) 0.88 53% (10/19) 47% (7/15)
27% (56/ 205) 20% (41/ 205) 0, 047 44% (23/ 52)
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.
1 Carrat F, Bani-Sadr F, Pol S et al.
2 Laguno M, Murillas J, Blanco J. L in sod.
JAMA 2004; 292(23):
AIDS 2004; 18( 13):
This decline was significant among responders (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Ta upad je bil statistično značilen pri bolnikih, ki so se odzvali na zdravljenje (- 0, 3 pri oceni po Metavirju in - 1, 2 pri oceni po Ishaku) in stabilen (- 0, 1 pri oceni po Metavirju in - 0, 2 pri oceni po Ishaku) pri tistih, ki se niso odzvali na zdravljenje.
ViraferonPeg/ribavirin retreatment of prior treatment failures In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Ponovno zdravljenje z zdravilom ViraferonPeg in ribavirinom po predhodno neuspešnem zdravljenju V neprimerjalnem preskušanju so skupaj 2293 bolnikov z zmerno do hudo fibrozo, pri katerih je bilo predhodno zdravljenje s kombinacijo interferona alfa in ribavirina neuspešno, ponovno zdravili z zdravilom ViraferonPeg v odmerku 1, 5 mikrograma/ kg enkrat na teden subkutano, v kombinaciji z ribavirinom v odmerku, odvisnem od bolnikove telesne mase.
19 Table 10 Rates of Response to retreatment in prior treatment failures
Stopnje odziva na ponovno zdravljenje v primeru, da je bilo prejšnje zdravljenje neuspešno
Patients with undetectable HCV–RNA at treatment Week 12 and SVR upon retreatement Overall
Bolniki, pri katerih je bila vrednost HCV– RNA nemerljiva v 12. tednu zdravljenja in SVR pri ponovnem zdravljenju
Response SVR% (n/ N) Week 12% 99% CI (n/N)
SVR% (n/ N) tednu% (n/ N) 99% IZ
67.7 (203/300) 59.6 (121/203) 50.7, 68.5
67, 7 (203/ 300) 59, 6 (121/ 203) 50, 7, 68, 5
58.1 (200/344) 52.5 (105/200) 43.4, 61.6
58, 1 (200/ 344) 52, 5 (105/ 200) 43, 4, 61, 6
59.7 (129/216) 51.2 (66/129) 39.8, 62.5
59, 7 (129/ 216) 51, 2 (66/ 129) 39, 8, 62, 5
48.6 (122/251) 44.3 (54/122) 32.7, 55.8
48, 6 (122/ 251) 44, 3 (54/ 122) 32, 7, 55, 8
Genotype 2/3 Genotype
Genotip 2/ 3
70.3 (52/74) 56.6, 84.0
70, 3 (52/ 74)
60.0 (9/15) 27.4, 92.6
60, 0 (9/ 15)
46.0 (63/ 137) 35.0, 57.0
46, 0 (63/ 137)
63.5 (61/96) 50.9, 76.2
63, 5 (61/ 96) 50, 9, 76, 2
50.0 (6/12) 12.8, 87.2
50, 0 (6/ 12) 12, 8, 87, 2
HVL (> 600,000 IU/ml)
Začetno virusno breme HVL (> 600. 000 i. e. / ml)
LVL (≤600,000 IU/ml)
LVL (≤600. 000 i. e. / ml)
Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Plazemska vrednost HCV- RNA je bila izmerjena s raziskovalnim kvantitativnim testom polimerazne verižne reakcije v centralnem laboratoriju. * V skupini, ki so jo nameravali zdraviti, je bilo 7 ljudi, pri katerih ni bilo mogoče potrditi najmanj 12 tednov predhodnega zdravljenja.
20 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).