natgillin/translations-raw huggingface dataset:
non-
Brez ciroze in s cirozo
cirrhotic and cirrhotic cirrhotic
S cirozo
Study NV15496 +
Študija NV15496 +
Study NV15495 Study
Študija NV15495
Study NV15496 + Study NV15495 Study
Študija NV15496 + Študija NV15495 Študija
Pegasys 180 mcg
Pegasys 180 μg
Interferon Pegasys Interferon Pegasys Pegasys alfa-2a 180 mcg alfa-2a 180 mcg 180 mcg
alfa- 2a
Interferon alfa-2b
alfa- 2b
6 MIU/
180 μg
3 MIU 3 MIU & & &
6 mio i. e. / 3 mio i. e. in
3 MIU &
3 mio i. e. in
3 MIU
3 mio i. e.
Ribavirin Ribavirin 1000/ 1200 1000/ 1200 mg mg
1. 000/ 1. 200
Ribavirin 1000/ 1200 mg
1. 000/ 1. 200
(N=701)
1. 000/ 1. 200
(N=87)
(n = 88)
(N=88)
(n = 444)
(N=436) (N=453)
(n = 701)
(N=444)
(n = 87)
Response
(n = 436)
48 weeks
(n = 453)
48 weeks 48
48 tednov 48 tednov
weeks 48 weeks 48
48 tednov
weeks 48 weeks
Odziv na
at End of Treatment
48 tednov 48 tednov
55 - 69%
55 –
Overall
zdravljenja
Sustained Response
Celokupen trajni odziv
* 95% CI for difference:
* 95% CI za razliko:
11% to 33% ** 95% CI for difference:
11% do 33% ** 95% CI za razliko:
3% to 16%
3% do 16%
p-value (stratified Cochran-Mantel-Haenszel test) = 0.001 p-value (stratified Cochran-Mantel-Haenszel test)=0.003
p- vrednost (stratificiran Cochran- Mantel- Haenszlov test) = 0, 001 p- vrednost (stratificiran Cochran- Mantel- Haenszlov test) = 0, 003
The virological responses of HCV monoinfected patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load and in relation to genotype, pre-treatment viral load and rapid virological response at week 4 are summarised in Table 7 and Table 8, respectively.
19 Virološki odzivi bolnikov, okuženih le s HCV, ki so se zdravili le z zdravilom Pegasys, in bolnikov, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v odvisnosti od genotipa in virusnega bremena pred začetkom zdravljenja ter v odvisnosti od genotipa, virusnega bremena pred začetkom zdravljenja in hitrega virološkega odziva v 4. tednu, prikazani v preglednicah 7 in 8.
The results of study NV15942 provide the rationale for recommending treatment regimens based on genotype, baseline viral load and virological response at week 4 (see Tables 1, 7 and 8).
Rezultati študije NV15942 predstavljajo osnovo za priporočila za zdravljenje v odvisnosti od genotipa, virusnega bremena pred začetkom zdravljenja in virološkega odziva v 4. tednu (glejte preglednice 1, 7 in 8).
The difference between treatment regimens was in general not influenced by presence/ absence of cirrhosis; therefore treatment recommendations for genotype 1, 2 or 3 are independent of this baseline characteristic.
Prisotnost ali odsotnost ciroze v splošnem na razlike med shemami zdravljenja ni imela vpliva, zato so priporočila za zdravljenje za genotipe 1, 2 ali 3 neodvisna od te osnovne značilnosti.
19 Table 7:
Preglednica 7.
Sustained Virological Response Based on Genotype and Pre-treatment Viral Load after Pegasys Combination Therapy with Ribavirin in HCV Patients
Trajni virološki odziv v povezavi z genotipom in virusnim bremenom pred začetkom zdravljenja po kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom pri bolnikih s HCV.
Pegasys Pegasys Pegasys Pegasys Pegasys 180 mcg 180 mcg 180 mcg 180 mcg 180 mcg
Pegasys Pegasys Pegasys Pegasys Pegasys 180 μg 180 μg 180 μg 180 μg 180 μg in in in in in
Interferon alfa-2b 3 MIU
Interferon alfa- 2b 3 mio i. e. in ribavirin
& & & & &
ribavirin ribavirin ribavirin ribavirin
&
ribavirin
Ribavirin
1. 000/ 1. 200 mg
1000/ 1200 mg 800 mg 1000/ 1200 mg 1000/ 1200 mg
1. 000/ 1. 200 mg 800 mg 1. 000/ 1. 200 mg
1000/ 1200 mg
1. 000/ 1. 200 mg
24 weeks 24 weeks
24 tednov 24 tednov
48 weeks 48 weeks 48 weeks
48 tednov 48 tednov
Genotype 1 Low viral load High viral load
Genotip 1 Nizko virusno
Genotype 2/ 3 Low viral load High viral load Genotype 4
Genotip 2/ 3 Nizko virusno
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL * Pegasys 180 mcg ribavirin 1000/ 1200 mg, 48 w vs.
breme Visoko virusno
Pegasys 180 mcg ribavirin 800 mg, 48 w:
80% (78/ 97)
P-value (stratified Cochran-Mantel-Haenszel test) = 0.002.
(0/ 5)
The possibility to consider shortening treatment duration to 24 weeks in genotype 1 and 4 patients was examined based on a sustained rapid virological response observed in patients with rapid virological response at week 4 in studies NV15942 and ML17131 (see Table 8).
(8/ 12)
Table 8:
(5/ 8)
Sustained Virological Response Based on Rapid Viral Response at week 4 for Genotype 1 and 4 after Pegasys Combination Therapy with Ribavirin in HCV Patients
Trajni virološki odziv v povezavi s hitrim virološkim odzivom v 4. tednu za genotipa 1 in 4 po kombiniranem zdravljenju z zdravilom Pegasys in ribavirinom pri bolnikih s HCV.
Pegasys 180 mcg &
Pegasys 180 μg in
Ribavirin Ribavirin
ribavirin ribavirin
1000/ 1200 mg 24 weeks
Genotip 1, hiter virološki odziv
1000/ 1200 mg 48 weeks
1. 000/ 1. 200 mg 1. 000/ 1. 200 mg 24 tednov 48 tednov 90% (28/ 31) 92% (47/ 51)
1000/ 1200 mg 24 weeks
1. 000/ 1. 200 mg 24 tednov 77% (59/ 77)
Genotype 1 RVR Low viral load High viral load Genotype 1 non RVR Low viral load High viral load
nizko virusno breme visoko virusno breme Genotip 1, brez hitrega virološkega odziva
90% (28/ 31) 93% (25/ 27) 75% (3/ 4) 24% (21/ 87) 27% (12/ 44) 21% (9/ 43)
93% (25/ 27) 96% (26/ 27) 75% (3/ 4) 88% (21/ 24) 24% (21/ 87) 43% (95/ 220)
Genotype 4 RVR
nizko virusno breme visoko virusno breme Genotip 4, hiter virološki odziv
(5/ 6)
27% (12/ 44) 50% (31/ 62) 21% (9/ 43) 41% (64/ 158) (5/ 6) (5/ 5)
92% (22/ 24)
- - 92% (22/ 24)
(4/ 6)
(3/ 6) (4/ 6)
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24
Nizko virusno breme = ≤ 800. 000 i. e. / ml; visoko virusno breme = > 800. 000 i. e. / ml Hiter virološki odziv = nemerljiva koncentracija HCV RNA v tednu 4 in nemerljiva koncentracija HCV RNA v tednu 24
20 Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 9).
Čeprav so podatki omejeni, kažejo na to, da je skrajšanje zdravljenja na 24 tednov lahko povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 9).
Table 9:
Preglednica 9.
Relapse of Virological Response at the End of Treatment for Rapid Virological Response Population
Ponovitev bolezni ob koncu zdravljenja za bolnike s hitrim virološkim odzivom.
Study NV15801
Študija NV15801 Pegasys
Pegasys 180 mcg &
180 μg
Ribavirin Ribavirin
1. 000/ 1. 200 mg
1000/ 1200 mg 1000/ 1200 mg 24 weeks 48 weeks
1. 000/ 1. 200 mg
1000/ 1200 mg 48 weeks
48 tednov
Genotype 1 RVR
Genotip 1, hiter virološki odziv
6.7% (2/ 30) 4.3% (2/ 47)
4, 3% (2/ 47)
Low viral load High viral load Genotype 4 RVR
nizko virusno breme visoko virusno breme Genotip 4, hiter virološki odziv
3.8% (1/ 26) 0% (0/ 25) 25% (1/ 4) 9.1% (2/ 22) (0/ 5) (0/ 5)
0% (0/ 25) 9, 1% (2/ 22) (0/ 5)
The possibility of shortening treatment duration to 16 weeks in genotype 2 or 3 patients was examined based on a sustained virological response observed in patients with rapid virological response by week 4 in study NV17317 (see Table 10).
V študiji NV17317 so proučevali možnost skrajšanja zdravljenja bolnikov okuženih z genotipom 2 ali 3 na 16 tednov, glede na trajni virološki odziv, opažen pri bolnikih, ki so imeli hiter virološki odziv v 4. tednu zdravljenja (glejte preglednico 10).
In study NV17317 in patients infected with viral genotype 2 or 3, all patients received Pegasys 180 μ g sc qw and a ribavirin dose of 800 mg and were randomized to treatment for either 16 or 24 weeks.
Randomizirani so bili v 24 - ali 16 - tedensko zdravljenje.
Overall treatment for 16 weeks resulted in lower sustained viral response (65%) than treatment for 24 weeks (76%) (p < 0.0001).
Celokupno je bil trajni virološki odziv pri 16- tedenskem zdravljenju manjši (65%) kot pri 24- tedenskem zdravljenju (76%) (p < 0, 0001).
The sustained viral response achieved with 16 weeks of treatment and with 24 weeks of treatment was also examined in a retrospective subgroup analysis of patients who were HCV RNA negative by week 4 and had a LVL at baseline (see Table 10).
V retrospektivni analizi podskupine bolnikov, ki so bili HCV RNA negativni do 4. tedna in so imeli pred začetkom zdravljenja nizko virusno breme, so preučili tudi trajni virološki odziv dosežen s 16 - tedenskim in 24- tedenskim zdravljenjem (glejte preglednico 10).
Table 10:
21 Preglednica 10.
Sustained Virological Response Overall and Based on Rapid Viral Response by Week 4 for Genotype 2 or 3 after Pegasys Combination Therapy with Ribavirin in HCV Patients Study NV17317
Študija NV17317
Pegasys Pegasys 180 mcg 180 mcg & &
Pegasys 180 μg Pegasys 180 μg Razlika med in in zdravljenjema ribavirin ribavirin (95 -% interval 800 mg 800 mg zaupanja) 16 tednov 24 tednov
76% (478/ 630)
p- vrednost
Genotype 2 or 3 RVR
Genotip 2 ali 3 Genotip 2 ali 3, hiter virološki odziv
82% (378/ 461)
65% (443/ 679) 82% (378/ 461)
[-12.8%; - P=0.0006 3.7%] P=0.11
76% (478/ 630) - 10, 6% [- 15, 5%; p < 0, 0001 - 0, 06%] p = 0, 0006 90% (370/ 410) - 8, 2% [- 12, 8%; - 3, 7%]
-5.4% [-12%;
- 5, 4% [- 12%; 94% (141/ 150)
P=0.002
p = 0, 11
(147/ 166)
89% (147/ 166) nizko virusno 0, 9%] breme
-9.7% [-15.9%; -
p = 0, 002 - 9, 7% [- 15, 9%; 88% (229/ 260) 78% (231/ 295) visoko virusno - 3, 6%] breme
Low viral load= ≤ 800,000 IU/ mL; High viral load= > 800,000 IU/ mL RVR = rapid viral response (HCV RNA undetectable) at week 4
Nizko virusno breme = ≤ 800. 000 i. e. / ml; visoko virusno breme = > 800. 000 i. e. / ml Hiter virološki odziv = nemerljiva koncentracija HCV RNA v 4. tednu
21 The data indicated that shortening treatment to 16 weeks is associated with a higher risk of relapse (see Table 11).
Podatki kažejo, da je skrajšanje zdravljenja na 16 tednov povezano z večjim tveganjem za ponovitev bolezni (glejte preglednico 11).
Table 11:
Preglednica 11.
Relapse of Virological Response after the End of Treatment in Genotype 2 or 3 Patients with a Rapid Viral Response Study NV17317
Ponovitev bolezni po končanem zdravljenju bolnikov z genotipom 2 ali 3 in hitrim virološkim odzivom.
Pegasys Pegasys
Študija NV17317
180
Pegasys 180 μg in
mcg 180 mcg & &
Pegasys 180 μg
difference 95%CI
p- vrednost
Ribavirin 800 mg 16 weeks
in 800 mg tednov
Ribavirin 800 mg 24 weeks
in ribavirin 800 mg
Genotype 2 or 3
24 tednov Genotip 2 ali 3, hiter virološki odziv
9.3% [5.2%;
6% (23/ 386) 9, 3% [5, 2%; 13, 6%]
RVR
nizko virusno breme
P=0.04
p = 0, 04
P=0.0002
p = 0, 0002
17.4%]
11, 5% [5, 6%; 17, 4%]
Superior efficacy of Pegasys compared to interferon alfa-2a was demonstrated also in terms of histological response, including patients with cirrhosis and/ or HIV-HCV co-infection.
Večja učinkovitost zdravila Pegasys v primerjavi z interferonom alfa- 2a se je pokazala tudi v smislu histološkega odziva, vključno pri bolnikih s cirozo in/ ali sočasno okužbo s HIV in HCV.
Chronic hepatitis C prior treatment non-responder patients In study MV17150, patients who were non-responders to previous therapy with pegylated interferon alfa-2b plus ribavirin were randomized to four different treatments: • Pegasys 360 mcg/ week for 12 weeks, followed by 180 mcg/ week for a further 60 weeks • Pegasys 360 mcg/ week for 12 weeks, followed by 180 mcg/ week for a further 36 weeks • Pegasys 180 mcg/ week for 72 weeks • Pegasys 180 mcg/ week for 48 weeks All patients received ribavirin (1000 or 1200 mg/ day) in combination with Pegasys.
Vsi bolniki so v kombinaciji z zdravilom Pegasys prejeli ribavirin (1000 ali 1200 mg/ dan).
Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response.
Multipla regresija in skupna analiza skupin, s katerima so ocenjevali vpliv trajanja zdravljenja in uporabe indukcijskega odmerjanja, je jasno pokazala, da je 72- tedensko zdravljenje primarno gonilo za dosego trajnega virološkega odziva.
Differences in sustained virological response (SVR) based on treatment duration, demographics and best responses to previous treatment are displayed in Table 12.
Razlike v trajnem virološkem odzivu glede na trajanje zdravljenja, demografijo in najboljši odziv na prejšnje zdravljenje so prikazane v preglednici 12.
22 Table 12:
Preglednica 12.
Week 12 Virological Response (VR) and Sustained Virological Response (SVR) in Patients with Virological Response at Week 12 after Treatment with Pegasys and Ribavirin Combination Therapy in Nonresponders to Peginterferon alfa-2b plus Ribavirin.
Zdravili so bolnike, ki se na prejšnje zdravljenje s peginterferonom alfa- 2b in ribavirinom niso odzvali.
Pegasys 360/ 180 or Pegasys 360/ 180 or 180 μ g 180 μ g & & Ribavirin 1000/ 1200 Ribavirin mg 1000/ 1200 mg 72 or 48 Weeks 72 Weeks (N = 942) (N = 473) Pts with SVR in Pts with VR at Wk 12 a VR at Wk 12 b (N = 876) (N = 100)
360/ 180 ali Pegasys 360/ 180 180 μg ali 180 μg in in
Pegasys 360/ 180 or 180 μ g & Ribavirin 1000/ 1200 mg 48 Weeks (N = 469) SVR in Pts with VR at Wk 12 b (N = 57)
Pegasys 360/ 180 ali 180 μg in
Overall Low viral load High viral load Genotype 1/ 4 Low viral load High viral load Genotype 2/ 3 Low viral load High viral load Cirrhosis Status
Nizko virusno breme Visoko virusno breme Genotip 1/ 4
18% (157/ 876) 57% (57/ 100) 35% (56/ 159) 63% (22/ 35) 14% (97/ 686) 54% (34/ 63) 17% (140/ 846) 55% (52/ 94) 35% (54/ 154) 63% (22/ 35) 13% (84/ 663) 52% (30/ 58) 58% (15/ 26) (4/ 5) (2/ 5) — (11/ 19) (3/ 4)
(56/ 159) (97/ 686) (140/ 846)
Cirrhosis Noncirrhosis Best Response during Previous Treatment
Nizko virusno breme Visoko virusno breme
8% (19/ 239) (6/ 13) 22% (137/ 633) 59% (51/ 87)
35% 13%
≥ 2log10 decline in HCV RNA < 2log10 decline in HCV RNA Missing best previous response
≥ 2 log10 znižanje HCV RNA < 2 log10 znižanje HCV RNA
28% (34/ 121) 68% (15/ 22) 12% (39/ 323) 64% (16/ 25) 19% (84/ 432) 49% (26/ 53)
28% (34/ 121) 12% (39/ 323)
High viral load = > 800,000 IU/ mL, low viral load = ≤ 800,000 IU/ mL. a Patients who achieved viral suppression (undetectable HCV RNA, < 50 IU/ mL) at week 12 were considered to have a virological response at week 12.
Za bolnike, ki so dosegli virusno supresijo (nemerljiva koncentracija HCV RNA, < 50 i. e. / ml) v 12. tednu, so smatrali, da imajo virološki odziv v 12. tednu.
Patients missing HCV RNA results at week 12 have been excluded from the analysis. b Patients who achieved viral suppression at week 12 but were missing HCV RNA results at the end of follow-up were considered to be nonresponders
Bolnike, ki so dosegli virusno supresijo v 12. tednu, a podatkov o njihovi koncentraciji HCV RNA na koncu spremljanja ni bilo, so smatrali za neodzivne.
In the HALT-C study, patients with chronic hepatitis C and advanced fibrosis or cirrhosis who were non-responders to previous treatment with interferon alfa or pegylated interferon alfa monotherapy or in combination therapy with ribavirin were treated with Pegasys 180 mcg/ week and ribavirin 1000/ 1200 mg daily.
V študiji HALT- C so bolnike s kroničnim hepatitisom C in napredovalo fibrozo ali cirozo, ki se niso odzvali na prejšnje samostojno zdravljenje z interferonom alfa ali pegiliranim interferonom alfa oziroma zdravljenje v kombinaciji z ribavirinom, zdravili z zdravilom Pegasys 180
Patients who achieved undetectable levels of HCV RNA after 20 weeks of treatment remained on Pegasys plus ribavirin combination therapy for a total of 48 weeks and were then followed for 24 weeks after the end of treatment.
Bolniki, pri katerih je bila po 20 tednih zdravljenja koncentracija HCV RNA nemerljiva, so nadaljevali z zdravljenjem s kombinacijo zdravila Pegasys in ribavirina.
The probability for sustained virological response varied depending upon the previous treatment regimen; see Table 13.
Verjetnost trajnega virološkega odziva je bila različna glede na prejšnjo shemo zdravljenja (glejte preglednico 13).
Table 13 Sustained Virological Response in HALT-C by Previous Treatment Regimen in Non-responder Population Previous Treatment
Preglednica 13.
Ribavirin 1000/ 1200 mg 48 weeks Interferon Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin
Trajni virološki odziv v študiji HALT- C glede na prejšnjo shemo zdravljenja pri bolnikih, ki se na prejšnje zdravljenje niso odzvali.
27% (70/ 255) 34% (13/ 38) 13% (90/ 692) 11% (7/ 61)
Pegasys 180 μg Prejšnje zdravljenje in ribavirin 1000/ 1200 mg 48 tednov 27% (70/ 255) Interferon 34% (13/ 38) Pegiliran interferon 13% (90/ 692) Interferon in ribavirin 11% (7/ 61) Pegiliran interferon in ribavirin
23 HIV-HCV co-infected patients The virological responses of patients treated with Pegasys monotherapy and with Pegasys and ribavirin combination therapy in relation to genotype and pre-treatment viral load for HIV-HCV co- infected patients are summarised below in Table 14.
Bolniki sočasno okuženi s HIV in HCV Virološki odzivi bolnikov, zdravljenih le z zdravilom Pegasys, in bolnikov, ki so se zdravili z zdravilom Pegasys v kombinaciji z ribavirinom, so v povezavi z genotipom in virusnim bremenom pred začetkom zdravljenja za bolnike, okužene s HCV in HIV, prikazani v preglednici 14.
Table 14:
Preglednica 14.
Sustained Virological Response based on Genotype and Pre-treatment Viral Load after Pegasys Combination Therapy with Ribavirin in HIV-HCV Co-infected Patients Study NR15961
Študija NR15961
Interferon alfa-2a 3 MIU &
Interferon alfa- 2a 3 mio i. e. in
Ribavirin 800 mg 48 weeks
ribavirin 800 mg
Genotype 1 Low viral load High viral load
Genotip 1
Genotype 2-3 Low viral load High viral load
Nizko virusno breme Visoko virusno breme
Odds Ratio (95% CI) = 0.53 (0.33 to 0.85), … P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0084
Nizko virusno breme = ≤ 800. 000 i. e. / ml; visoko virusno breme = > 800. 000 i. e. / ml * Zdravilo Pegasys 180 μg, ribavirin 800 mg v primerjavi z interferonom alfa- 2a 3 mio i. e. in ribavirinom 800 mg: razmerje (95% CI) = 5, 40 (3, 42 do 8, 54), …. p- vrednost (stratificiran Cochran- Mantel- Haenszlov test) = < 0, 0001 * Zdravilo Pegasys 180 μg, ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 μg: razmerje (95% CI) = 2, 89 (1, 93 do 4, 32), …. p- vrednost (stratificiran Cochran- Mantel- Haenszlov test) = < 0, 0001 * Interferon alfa- 2a 3 mio i. e. ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 mcg: razmerje (95% CI) = 0, 53 (0, 33 do 0, 85), … p- vrednost (stratificiran Cochran- Mantel- Haenszlov test) = < 0, 0084
HCV patients with normal ALT In study NR16071, HCV patients with normal ALT values were randomised to receive Pegasys 180 micrograms/ week and ribavirin 800 milligrams/ day for either 24 or 48 weeks followed by a 24 week treatment free follow-up period or no treatment for 72 weeks.
Bolniki s HCV z normalnimi vrednostmi ALT V študiji NR16071 so randomizirani bolniki s HCV, ki so imeli normalne vrednosti ALT, prejemali zdravilo Pegasys v odmerku 180 mikrogramov na teden in 800 miligramov ribavirina na dan 24 ali 48 tednov, ki jim je sledilo 24- tedensko obdobje sledenja brez zdravljenja ali 72 tednov brez zdravljenja.
The SVRs reported in the treatment arms of this study were similar to the corresponding treatment arms from study NV15942.
Trajni virološki odziv, o katerem so poročali v skupinah bolnikov te študije je bil podoben kot v primerljivih skupinah bolnikov študije NV15942.
Following a single subcutaneous injection of Pegasys 180 micrograms in healthy subjects, serum concentrations of peginterferon alfa-2a are measurable within 3 to 6 hours.
Po enkratni subkutani injekciji 180 mikrogramov zdravila Pegasys pri zdravih prostovoljcih so serumske koncentracije peginterferona alfa- 2a lahko merili v 3 do 6 urah.
Within 24 hours, about 80% of the peak serum concentration is reached.
V 24 urah dosežemo 80% največje plazemske koncentracije.
The absolute bioavailability of Pegasys is 84% and is similar to that seen with interferon alfa-2a.
Absolutna biološka uporabnost zdravila Pegasys je 84% in je podobna kot pri interferonu alfa- 2a.
Peginterferon alfa-2a is found predominantly in the bloodstream and extracellular fluid as seen by the volume of distribution at steady-state (Vd) of 6 to 14 litres in humans after intravenous administration.
Peginterferon alfa- 2a najdemo večinoma v krvnem obtoku in ekstracelularni tekočini, volumen porazdelitve v stanju dinamičnega ravnovesja (Vd) je od 6 do 14 litrov pri ljudeh po intravenskem dajanju.
From mass balance, tissue distribution and whole body autoradioluminography studies performed in rats, peginterferon alfa-2a is distributed to the liver, kidney and bone marrow in addition to being highly concentrated in the blood.
Raziskave masnega ravnovesja, porazdelitve po tkivih in raziskave avtoradioluminografije celega telesa pri podganah so pokazale, da se peginterferon alfa- 2a porazdeljuje v jetra, ledvice in kostni mozeg poleg tega, da je visoko koncentriran v krvi.
The metabolism of Pegasys is not fully characterised; however studies in rats indicate that the kidney is a major organ for excretion of radiolabelled material.
Raziskave, ki so jih opravili na podganah, nakazujejo, da so ledvice glavni organ za izločanje radioaktivno označene snovi.
In humans, the systemic clearance of peginterferon alfa-2a is about 100-fold lower than that of the native interferon alfa-2a.
Pri ljudeh je sistemski očistek peginterferona alfa- 2a približno 100- krat nižji od očistka naravnega interferona alfa- 2a.
After intravenous administration, the terminal half-life of peginterferon alfa-2a in healthy subjects is approximately 60 to 80 hours compared to values of 3-4 hours for standard interferon.
Po intravenskem dajanju je končna razpolovna doba peginterferona alfa- 2a pri zdravih ljudeh približno 60 do 80 ur v primerjavi s 3 do 4 urami pri standardnem interferonu.
24 Dose-proportional increases in exposure of Pegasys are seen in healthy subjects and in patients with chronic hepatitis B or C after once-weekly dosing.
Povečanje izpostavljenosti zdravila Pegasys v odvisnosti od odmerka so opazili tako pri zdravih ljudeh kot tudi pri bolnikih s kroničnim hepatitisom B ali C po odmerjanju enkrat na teden.
In chronic hepatitis B or C patients, peginterferon alfa-2a serum concentrations accumulate 2 to 3 fold after 6 to 8 weeks of once weekly dosing compared to single dose values.
Pri bolnikih s kroničnim hepatitisom B ali C prihaja po 6 do 8 tednih zdravljenja do 2 - do 3- kratne kumulacije serumskih koncentracij peginterferona alfa- 2a po odmerjanju enkrat na teden v primerjavi z vrednostmi enkratnega odmerka.
The peak to trough ratio after 48 weeks of treatment is about 1.5 to 2.
Po 48 tednih zdravljenja je razmerje med C∞max in C∞min približno 1, 5 do 2.
Peginterferon alfa-2a serum concentrations are sustained throughout one full week (168 hours).
Koncentracije peginterferona alfa- 2a v serumu so bile nespremenjene en teden (168 ur).
Patients with renal impairment Renal impairment is associated with slightly decreased CL/ F and prolonged half-life.
Bolniki z motenim ledvičnim delovanjem Motnja ledvičnega delovanja je povezana z rahlim znižanjem razmerja Cl/ F (očistek/ filtracija) in podaljšano razpolovno dobo.
In patients (n=3) with CLcrea between 20 and 40 ml/ min, the average CL/ F is reduced by 25% compared with patients with normal renal function.
Pri bolnikih (n = 3) s kreatininskim očistkom med 20 in 40 ml/ min, je povprečno razmerje Cl/ F manjše za 25% v primerjavi z bolniki, ki imajo normalno ledvično delovanje.
In patients with end stage renal disease undergoing haemodialysis, there is a 25% to 45% reduction in the clearance, and doses of 135 micrograms result in similar exposure as 180 micrograms doses in patients with normal renal function (see section 4.2).
Pri bolnikih z normalnim ledvičnim delovanjem je po odmerku 135 mikrogramov izpostavljenost podobna kot pri odmerku 180 mikrogramov (glejte poglavje 4. 2).
Gender The pharmacokinetics of Pegasys after single subcutaneous injections were comparable between male and female healthy subjects.
Spol Farmakokinetika zdravila Pegasys je bila po enkratni podkožni injekciji med zdravimi moškimi in ženskami primerljiva.