natgillin/translations-raw huggingface dataset:
In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens: • Rebetol (800 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week) (n = 511). • Rebetol (1,000/1,200 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) (n = 514). • Rebetol (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n = 505).
Kliinilises uuringus C/ I98- 580 raviti 1530 eelnevalt ravi mittesaanud patsienti 1 aasta jooksul ühega järgnevatest kombinatsioonirežiimidest: • Rebetol (800 mg/ päevas) + peginterferoon alfa- 2b (1, 5 mikrogrammi/ kg/ nädalas) (n = 511). • Rebetol (1000/ 1200 mg/ päevas) + peginterferoon alfa- 2b (1, 5 mikrogrammi/ kg/ nädalas ühe kuu jooksul, millele järgnes 0, 5 mikrogrammi/ kg/ nädalas 11 kuu jooksul) (n = 514). • Rebetol (1000/ 1200 mg/ päevas) + interferoon alfa- 2b (3 miljonit RÜ 3 korda nädalas) (n = 505).
16 In this trial, the combination of Rebetol and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of Rebetol and interferon alfa-2b, particularly in patients infected with Genotype 1.
Selles uuringus oli Rebetol ja peginterferoon alfa- 2b kombinatsioonravi märgatavalt efektiivsem kui Rebetol ja interferoon alfa- 2b kombinatsioonravi, eriti genotüübi 1 puhul.
However, response rates in this trial were shown to be dependent also on the dose of Rebetol administered in combination with peginterferon alfa-2b or interferon alfa-2b.
Antud uuring näitas, et ravitulemust mõjutab ka peginterferooniga alfa- 2b või interferooniga alfa- 2b kombinatsioonis manustatava Rebetol’ i annus.
In those patients that received > 10.6 mg/kg Rebetol (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 Rebetol (Table 6), while response rates in patients that received > 13.2 mg/kg Rebetol were even higher.
Kõige kõrgem ravivastus oli patsientidel, kes said Rebetol’ i > 13, 2 mg/ kg.
Sustained response rates with Rebetol + peginterferon alfa-2b (by Rebetol dose [mg/kg], genotype and viral load)
Rebetol’ i + peginterferoon alfa- 2b püsiv ravivastus (Rebetol annuse [mg/ kg], genotüübi ja viiruskoopiate arvu järgi)
Rebetol dose (mg/kg)
Rebetol’ i annus (mg/ kg)
All Genotypes Genotype 1 Genotype 1
Kõik genotüübid
≤ > ≤ >
Kõik ≤ 10, 6 > 10, 6
All 10.6 10.6 All 10.6 10.6 All
Kõik ≤ 10, 6 > 10, 6
54% 50% 61% 42% 38% 48% 73%
42% 38% 48%
47% 41% 48% 34% 25% 34% 51%
34% 25% 34%
47% 27% 47% 33% 20% 34% 45%
33% 20% 34%
≤ 600,000 IU/ml Genotype 1
Genotüüp 1 ≤ 600000 RÜ/ ml
10.6 10.6 All
Kõik ≤ 10, 6 > 10, 6
74% 71% 30%
73% 74% 71%
25% 52% 27%
51% 25% 52%
33% 45% 29%
45% 33% 45%
> 600,000 IU/ml Genotype 2/3
Genotüüp 1 > 600000 RÜ/ ml
10.6 10.6 All 10.6 10.6
Kõik ≤ 10, 6 > 10, 6
27% 37% 82% 79% 88%
82% 79% 88%
25% 27% 80% 73% 80%
80% 73% 80%
17% 29% 79% 50% 80%
79% 50% 80%
P1.5/R P0.5/R I/R
P1, 5/ R P0, 5/ R I/ R
Rebetol (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) Rebetol (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) Rebetol (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
RÜ)
In a separate trial, 224 patients with genotype 2 or 3 received peginterferon alfa-2b, 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).
Eraldi uuringus said 224 patsienti, genotüübiga 2 või 3, peginterferooni alfa- 2b 1, 5 mikrogrammi/ kg nahaalusi üks kord nädalas, kombinatsioonis Rebetol’ iga 800… 1400 mg suukaudselt 6 kuud (vastavalt kehakaalule, kusjuures ainult kolm patsienti kehakaaluga > 105 kg said 1400 mg annuse) (tabel 7).
Virologic Response at End of Treatment, Sustained Virologic Response and Relapse by HCV Genotype and Viral Load* Rebetol 800-1,400 mg/day Plus peginterferon alfa-2b 1.5 μg/kg Once Weekly
Viroloogiline ravivastus ravi lõpus, püsiv virologiline ravivastus ja retsidiiv HCV genotüübi ja viiruskoopiate arvu järgi *
End
peginterferoon alfa- 2b 1, 5 μg/ kg üks kord nädalas + Rebetol 800… 1400 mg/ päevas
All Subjects
Kõik uuritavad
% (211/224)
94% (211/ 224)
81% (182/224)
81% (182/ 224)
12%
12
93% (169/182)
% (27/ 224)
≤ 600,000 IU/ml
HCV 2 ≤ 600000 RÜ/ ml > 600000 RÜ/ ml
93% (92/99)
100% (42/ 42) 100% (20/ 20) 100% (22/ 22)
86% (85/99)
93% (39/ 42) 95% (19/ 20) 91% (20/ 22)
8% (7/91)
7% (3/ 42) 5% (1/ 20) 9% (2/ 22)
> 600,000 IU/ml
HCV 3 ≤ 600000 RÜ/ ml > 600000 RÜ/ ml
93% (77/83)
93% (169/ 182) 93% (92/ 99) 93% (77/ 83)
70% (58/83)
79% (143/ 182) 86% (85/ 99) 70% (58/ 83)
23% (17/75)
14% (24/ 166) 8% (7/ 91) 23% (17/ 75)
In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
Mitte võrdlevas uuringus said 235 patsienti genotüübiga 1 ning madala viiruskoopiate arvuga (< 600000 RÜ/ ml) peginterferooni alfa- 2b 1, 5 mikrogrammi/ kg nahaalusi üks kord nädalas, kombinatsioonis kehakaalule kohandatud Rebetol’ iga.
The overall sustained response rate after a 24-week treatment duration was 50%.
Üldine püsiva ravivastuse määr pärast 24- ndat ravinädalat oli 50%.
Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at Week 4 and Week 24 of therapy.
Neljakümne ühel protsendil patsientidest (97/ 235) oli HCV- RNA 4- ndal ja 24 - ndal ravinädalal allpool määramispiiri.
Predictability of sustained virological response in naïve patients 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 (Table 8).
Püsiva viroloogilise ravivastuse ennustatavus eelnevalt ravimata patsientidel Viroloogiline ravivastus 12- ndal nädalal, mis on defineeritud kui viiruskoopiate arvu vähenemine kahe astme võrra logaritmilisel skaalal või HCV- RNA muutumine negatiivseks (allpool määramispiiri), ennustab püsiva ravivastuse saamise tõenäosuslikkust (Tabel 8).
Predictability of sustained response by viral response at week 12 and genotype*
Püsiva ravivastuse ennustatavus 12- nda nädala viroloogilise ravivastuse ja genotüübi järgi *
Treatment
Ravi Rebetol (> 10, 6
Genotype Viral response at Sustained response Negative week 12 predictive value
Genotüüp 12- nda nädala Püsiv ravivastus Negatiivne viroloogiline ennustatavuse ravivastus määr 1 Jah 75% (82/ 110) 71% (58/ 82) ----
71% (58/82)
mg/ kg) +
0% (0/28)
Ei 25% (28/ 110) 0% (0/ 28) 100%
Rebetol 800-1400 mg 2 and 3 +peginterferon alfa-2b
peginterferoon alfa - 2b 1, 5 48- nädalane ravi Rebetol 800 – 1400 2 ja 3 mg + peginterferoon
Yes 99% (213/215) 83%
Jah 99% (213/ 215)
(177/213)
83% (177/ 213)
1.5 24-week treatment *reflects patients with 12 week data available
alfa- 2b 1, 5 24- nädalane ravi
No 1% (2/215)
Ei 1% (2/ 215)
50% (1/2)
50% (1/ 2)
Patients were randomized to receive either Rebetol (800 mg/day) plus peginterferon alfa-2b (1.5 µg/kg/week) or Rebetol (800 mg/day) plus interferon alfa-2b (3 MIU TIW) for 48 weeks with a follow-up period of 6 months.
RÜ TIW) 48 nädala jooksul, millele järgnes 6- kuuline jälgimisperiood.
Patients were randomized to receive either Rebetol (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 µg/week based on weight) or Rebetol (800- 1,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
RÜ TIW).
The duration of therapy was 18 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.
Ravi kestus oli 48 nädalat, millele järgnes 6- kuuline jälgimisperiood, väljaarvatud patsiendid genotüüpidega 2 või 3 ja viiruskoopiate arvuga < 800 000 RÜ/ ml (Amplicor), keda raviti 24 nädalat, millele järgnes 6- kuuline jälgimisperiood.
Table 9 Sustained virological response based on genotype after Rebetol in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Tabel 9 Püsiv viroloogiline ravivastus genotüübi järgi HCV/ HIV koinfitseerunud patsientidel pärast Rebetol’ i manustamist kombinatsioonis peginterferooniga alfa- 2b
Study 22
Rebetol
Rebetol (800- Rebetol (800-
Rebetol (800 -
(800 mg/day)
1200 mg/ öö
1,200 mg/day) 1,200 mg/day) d d
mg/ ööpäevas) mg/ ööpäevas)
+
d
Rebetol
päevas) d
+
+ +
peginterferon (800 mg/day) + peginterferon
ööpäevas)
alfa-2b
peg
Interferon alfa-
interferoon interferoon
alfa-2b (100
+
Interferon
interferoon
(1.5 µg /kg/
alfa- 2b alfa- 2b
2b (3 MIU
alfa- 2b alfa- 2b peginterferoon alfa- 2b
or 150c
(1, 5 µg/ kg /
alfa-2 b
(3 milj.
b
RÜ
week)
väärt
TIW)
nädalas)
value a
TIW)
µg/week)
väärtusa 150cµg/ nädalas) TI
(3 MIU TIW) value
TIW) väärtusa 150cµg/ nädalas) TIW)
All Genotype 1, 17 4
Kõik Genotüüp 1, 4
27% (56/205) 20%% (21/125)
27% (56/ 205) 20% 17% (21/ 125)
(41/205) 0.047 6% (8/129)
(41/ 205) 6% (8/ 129)
44% (23/52) 0.006 38% (12/32)
44% (23/ 52) 38% (12/ 32)
21% (9/43) 7% (2/27)
21% (9/ 43) 0, 017 7% (2/ 27) 0, 007
0.017 0.007
Genotüüp 2, 3
Genotype 2, 44% (35/80) 3
44% (35/ 80)
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 peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b. d:
RÜ = rahvusvaheline ühik; TIW = kolm korda nädalas. a: p väärtus põhineb Cochran- Mantel Haenszel Chi ruudu testil. b: p väärtus põhineb chi- ruudu testil. c: patsiendid < 75 kg said peginterferooni alfa- 2b 100 µg/ nädalas ja patsiendid ≥ 75 kg said peginterferooni alfa- 2b 150 µg/ nädalas. d:
Rebetol dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Rebetol annus oli 800 mg < 60 kg patsiendi kohta, 1000 mg 60- 75 kg patsiendi kohta ja 1200 mg > 75 kg patsiendi kohta.
Histological response Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51%).
Histoloogiline ravivastus Uuringus 1 võeti maksa biopsiad enne ja pärast ravi 210- lt patsiendilt 420- st (51%).
Both the Metavir score and Ishak grade decreased among subjects treated with Rebetol in combination with peginterferon alfa-2b.
Nii Metavir skoor kui ka Ishak aste vähenesid patsientidel, kes said Rebetol’ i kombinatsioonis peginterferooniga alfa- 2b.
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.
Langus oli märkimisväärne ravivastuse saavutanud patsientidel (- 0, 3 Metavir ja - 1, 2 Ishak) ning stabiilne (- 0, 1 Metavir ja - 0, 2 Ishak) ravivastust mittesaavutanud patsientide seas.
Previous treatment failure patients Retreatment of prior treatment failures (relapse and non-responder patients) with peginterferon alfa- 2b in combination with Rebetol 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 peginterferon alfa 2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
Patsiendid, kellel eelnev ravi on ebaõnnestunud Korduv peginterferoon alfa- 2b ja Rebetol’ i kombinatsioonravi patsientidel, kellel eelnev ravi on ebaõnnestunud (retsidiiviga ning ravivastust mittesaavutanud patsiendid) Mittevõrdlevas uuringus, kus osales 2993 mõõduka kuni raskekujulise fibroosiga patsienti, kellel eelnev ravi alfa interferooni/ ribaviriiniga oli ebaõnnestunud, manustati patsientidele korduva ravi käigus üks kord nädalas subkutaanselt peginterferooni alfa- 2b 1, 5 mikrogrammi/ kg kohta, kombineerituna kehakaalu järgi kohandatud Rebetol’ iga.
Patients who were HCV-RNA negative at Treatment Week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Patsiendid, kelle HCV- RNA oli negatiivne 12. - ks ravinädalaks jätkasid ravi kuni 48 nädalani ning neid jälgiti 24 nädalat pärast ravi lõppu.
Response Week 12 was defined as undetectable HCV- RNA after 12 weeks of treatment.
12. ravinädala vastusena defineeriti olukord, kus HCV- RNA oli allpool määramispiiri pärast 12. ravinädalat.
Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 10).
19 defineeritakse olukord, kus HCV- RNA on allpool määramispiiri 24. - ks nädalaks pärast ravi lõppu (Tabel 10).
Table 10 Rates of Response to retreatment in prior treatment failures
Ravivastuse määrad korduva ravi korral, juhul kui eelnev ravi on ebaõnnestunud
Patients with undetectable HCV–RNA 19 at treatment Week 12 and SVR upon retreatement Overall
Patsiendid, kellel HCV- RNA oli allpool määramispiiri 12. ravinädalal ja PVR korduva ravi korral
interferon alpha/ribavirin
interferoon alfa/ ribaviriin
peginterferon alpha/ribavirin
peginterferoon alfa/ ribaviriin
Population*
populatsioon *
Response Week 12% (n/N)
Vastus 12. nädal% (n/ N)
SVR% (n/ N) 99% CI
PVR% (n/ N) 99% CI
Response SVR% (n/N) Week 12% 99% CI (n/N)
Vastus PVR% (n/ N) 12. nädal% 99% CI (n/ N)
SVR% (n/N) 99% CI
PVR% (n/ N) 99% CI
Overall Prior Response
Üldine Eelnev vastus
38.6 (549/1,423) 59.4 (326/549) 54.0,64.8
38, 6 (549/ 1423) 59, 4 (326/ 549) 54, 0; 64, 8
31.5 (272/863) 50.4 (137/272) 42.6, 58.2
31, 5 (272/ 863) 50, 4 (137/ 272) 42, 6; 58, 2
21.7 (497/2,293) 19.5, 23.9
21, 7 (497/ 2293) 19, 5; 23, 9
59.6 (121/203) 50.7, 68.5
67, 7 (203/ 300) 59, 6 (121/ 203) 50, 7; 68, 5
52.5 (105/200) 43.4, 61.6
58, 1 (200/ 344) 52, 5 (105/ 200) 43, 4; 61, 6
37.7 (243/645) 32.8, 42.6
37, 7 (243/ 645) 32, 8; 42, 6
Genotype 1/4
Genotüüp 1/ 4
51.2 (66/129) 39.8, 62.5
59, 7 (129/ 216) 51, 2 (66/ 129) 39, 8; 62, 5
44.3 (54/122) 32.7, 55.8
48, 6 (122/ 251) 44, 3 (54/ 122) 32, 7; 55, 8
28.6 (134/468) 23.3, 34.0
28, 6 (134/ 468) 23, 3; 34, 0
73.6 (53/72) (60.2, 87.0)
88, 9 (72/ 81) 73, 6 (53/ 72) 60, 2; 87, 0
64.9 (50/77) 50.9, 78.9
83, 7 (77/ 92) 64, 9 (50/ 77) 50, 9; 78, 9
61.3 (106/173) 51.7, 70.8
61, 3 (106/ 173) 51, 7; 70, 8
57.0 (147/258) 49.0, 64.9
28, 6 (258/ 903) 57, 0 (147/ 258) 49, 0; 64, 9
44.1 (26/59) 27.4, 60.7
12, 4 (59/ 476) 44, 1 (26/ 59) 27, 4; 60, 7
13.6 (188/1,385) 11.2, 15.9
13, 6 (188/ 1385) 11, 2; 15, 9
51.6 (94/182) 42.1, 61.2
23, 0 (182/ 790) 51, 6 (94/ 182) 42, 1; 61, 2
9.9 (44/446)
9, 9 (44/ 446) 38, 6 (17/ 44) 19, 7; 57, 5
9.9 (123/1,242) 7.7, 12.1
9, 9 (123/ 1242) 7, 7; 12, 1
Genotype 2/3 Genotype
Genotüüp 2/ 3 Genotüüp
70.3 (52/74) 56.6, 84.0
67, 9 (74/ 109) 70, 3 (52/ 74) 56, 6; 84, 0
60.0 (9/ 15) 27.4, 92.6
53, 6 (15/ 28) 60, 0 (9/ 15) 27, 4; 92, 6
46.0 (63/137) 35.0, 57.0
46, 0 (63/ 137) 35, 0; 57, 0
51.3 (176/343) 44.4, 58.3
30, 2 (343/ 1135) 51, 3 (176/ 343) 44, 4; 58, 3
42.6 (69/162) 32.6, 52.6
23, 0 (162/ 704) 42, 6 (69/ 162) 32, 6; 52, 6
14.6 (270/1,846) 12.5, 16.7
14, 6 (270/ 1846) 12, 5; 16, 7
2/3
2/ 3
73.0 (135/185) 64.6, 81.4
77, 1 (185/ 240) 73, 0 (135/ 185) 64, 6; 81, 4
75.6 (96/127) 63.5 (61/96) 50.9, 76.2
75, 6 (96/ 127) 63, 5 (61/ 96) 50, 9; 76, 2
55.3 (203/367) 48.6, 62.0
55, 3 (203/ 367) 48, 6; 62, 0
4
4 METAVIR fibroosi skoor
44.4 (12/27) 50.0 (6/12) 12.8, 87.2
42, 5 (17/ 40) 70, 6 (12/ 17) 42, 1; 99, 1
28.4 (19/67) 14.2, 42.5
44, 4 (12/ 27) 50, 0 (6/ 12) 12, 8; 87, 2
METAVIR Fibrosis score
28, 4 (19/ 67) 14, 2; 42, 5
66.8 (129/193) 58.1, 75.6
46, 0 (193/ 420) 66, 8 (129/ 193) 58, 1; 75, 6
57.7 (45/78) 43.3, 72.1
33, 6 (78/ 232) 57, 7 (45/ 78) 43, 3; 72, 1
29.2 (191/653) 24.7, 33.8
29, 2 (191/ 653) 24, 7; 33, 8
62.6 (102/163) 52.8, 72.3
38, 0 (163/ 429) 62, 6 (102/ 163) 52, 8; 72, 3
21.9 (147/672) 17.8, 26.0
32, 4 (78/ 241) 51, 3 (40/ 78) 36, 7; 65, 9
44.8 (52/116) 32.9, 56.7
21, 9 (147/ 672) 17, 8; 26, 0
16.5 (159/966) 13.4, 19.5
F4 Viiruse kontsentratsioon enne ravi algust
Baseline Viral Load HVL (> 600,000 IU/ml)
33, 6 (192/ 572) 49, 5 (95/ 192) 40, 2; 58, 8
56.1 (157/280) 48.4, 63.7
29, 7 (116/ 390) 44, 8 (52/ 116) 32, 9; 56, 7
41.4 (63/152) 31.2, 51.7
16, 5 (159/ 966) 13, 4; 19, 5
LVL (≤600,000 IU/ml)
HVL (> 600000 RÜ/ ml) LVL (≤600000 RÜ/ ml)
62.8 (169/269) 55.2, 70.4
32, 4 (280/ 864) 56, 1 (157/ 280) 48, 4; 63, 7 48, 3 (269/ 557) 62, 8 (169/ 269) 55, 2; 70, 4
61.0 (72/118) 49.5, 72.6
26, 5 (152/ 573) 41, 4 (63/ 152) 31, 2; 51, 7 41, 0 (118/ 288) 61, 0 (72/ 118) 49, 5; 72, 6
30.2 (256/848) 26.1, 34.2
16, 6 (239/ 1441) 14, 1; 19, 1 30, 2 (256/ 848) 26, 1; 34, 2
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.
Seerumi HCV- RNA- d mõõdetakse tsentraalses laboratooriumis teadusliku kvantitatiivse polümeraasi ahelreaktsiooni analüüsil * Ravi märklaudpopulatsioon hõlmab 7 patsienti, kellel ei suudetud tõestada, et nad said eelnevat vähemalt 12- nädalast ravi.
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).
Teadusliku analüüsi tulemusena (tuvastamise piir 125 RÜ/ ml) leiti, et kokkuvõttes oli ligikaudu 36% (821/ 2286) - l patsientidest 12- ndaks ravinädalaks plasma HCV/ RNA tase allpool määramispiiri.
In this subgroup, there was a 56% (463/823) sustained virological response rate.
Selles alagrupis oli püsiva viroloogilise ravivastuse määr 56% (463/ 823).
For patients with prior failure on therapy with nonpegylated interferon or pegylated interferon and negative at Week 12, the sustained response rates were 59% and 50%, respectively.
20 mittepegüleeritud interferooniga või pegüleeritud interferooniga oli ebaõnnestunud ja kelle seerumi HCV- RNA oli negatiivne 12- ndaks nädalaks, olid püsiva ravivastuse määrad vastavalt 59% ja 50%.
Among 480 patients with > 2 log viral reduction but detectable virus at Week 12, altogether 188 patients continued therapy.
480 patsiendist, kellel esines viiruskoopiate arvu vähenemine > 2 astme võrra, kuid kellel oli 12. nädalal määratavas koguses viiruskoopiaid, jätkas ravi kokku 188 patsienti.
In those patients the SVR was 12%.
Nendel patsientidel oli SVR 12%.
20 Non-responders to prior therapy with pegylated interferon alpha/ribavirin were less likely to achieve a Week 12 response to retreatment than non-responders to nonpegylated interferon alpha/ribavirin (12.4% vs.
Eelnenud pegüleeritud interferoon alfa/ ribaviriini ravile mitteallunud patsientide puhul oli ravivastuse saavutamine korduva ravi 12. ravinädalal vähem tõenäoline kui mittepegüleeritud interferoon alfa/ ribaviriini ravile mitteallunud patsientide puhul (12, 4% vs.
28.6%).
28, 6%).
However, if a Week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
Kui siiski saavutati vastus 12. ravinädalal, oli erinevus PVR- is väike, sõltumata eelnevast ravist või eelnevast vastusest.
Retreatment of relapse patients with Rebetol and interferon alfa-2b combination treatment Two trials examined the use of Rebetol and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
345 kroonilise C- hepatiidiga patsienti, kellel interferoonravi järgselt tekkis retsidiiv, said 6 kuud ravi ja olid ravijärgselt 6 kuud jälgimisel.
Combination therapy with Rebetol and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49% vs 5%, p < 0.0001).
Kombinatsioonravi Rebetol + interferoon alfa- 2b andis 10 korda kõrgema püsiva viroloogilise vastuse võrreldes interferoon alfa- 2b monoraviga (49% vs 5%, p < 0, 0001).
This benefit was maintained irrespective of standard predictors of response to interferon alfa-2b such as virus level, HCV genotype and histological staging.
See eelis säilis sõltumata standardsetest interferoon alfa- 2b ravitulemust mõjutavatest teguritest, nagu viirusekoopiate hulk, HCV genotüüp ja histoloogiline staadium.
Long-term efficacy data Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with nonpegylated interferon alfa-2b (with or without Rebetol) and pegylated interferon alfa- 2b (with or without Rebetol), respectively.
Pika- ajalise efektiivsuse andmed Kahte laiaulatuslikku pikaajalisse ravijärgsesse jälgimisuuringusse kaasati 1071 patsienti ja 567 patsienti, kes olid eelnenud uuringutes ravi saanud vastavalt kas mitte- pegüleeritud interferooniga alfa- 2b (koos Rebetol’ iga või ilma) ning pegüleeritud interferooniga alfa- 2b (koos Rebetol’ iga või ilma).
At least 5 years of long-term follow-up was completed after treatment in 462 patients and 327 patients, respectively.
Vähemalt 5 aastat kestnud pika- ajaline ravijärgne jälgimisperiood viidi läbi vastavalt 462 patsiendil ning 327 patsiendil.
12 out of 492 sustained responders and only 3 out of 366 sustained responders relapsed, respectively, in the studies.
Uuringutes esines retsidiiv vastavalt 12- l püsiva ravivastusega patsiendil 492- st ning ainult 3- l püsiva ravivastusega patsiendil 366- st.
The Kaplan-Meier estimate for continued sustained response over 5 years is 97% (95% CI:
Kaplan- Meieri hinnang üle 5 aasta kestva püsiva ravivastuse kohta on 97% (95% CI:
95-99%) for patients receiving nonpegylated interferon alfa-2b (with or without Rebetol), and is 99% (95% CI:
95- 99%) neil patsientidel, kes said mitte- pegüleeritud interferooni alfa- 2b (koos Rebetol’ iga või ilma) ja 99% (95% CI:
98-100%) for patients receiving pegylated interferon alfa-2b (with or without Rebetol).
98- 100%) neil patsientidel, kes said pegüleeritud interferooni alfa- 2b (koos Rebetol’ iga või ilma).
SVR after treatment of chronic HCV with interferon alfa-2b (pegylated and nonpegylated,with or without Rebetol) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical'cure' from chronic HCV.
Kroonilise C- hepatiidi interferooniga alfa- 2b (pegüleeritud ja mitte- pegüleeritud, koos Rebetol’ iga või ilma) ravi käigus saavutatud püsiva viroloogilise ravivastuse (PVR) tulemuseks on pika- ajaline viirusevaba seisund, mis avaldub maksa infektsiooni lahenemises ning kroonilise C- hepatiidi kliinilises paranemises.
Rebetol clinical trials in children and adolescents:
Rebetol’ i kliinilised uuringud lastel ja noorukitel:
Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Rebetol 15 mg/kg per day plus interferon alfa-2b 3 MIU/m2 3 times a week for 1 year followed by 6 months follow-up after treatment.
Kahes multitsentrilises uuringus osalenud 3 kuni 16 aastased lapsed ja noorukid, kompenseeritud kroonilise C- hepatiidiga ja tuvastatava HCV RNA- ga (määratud tsentraalses laboratooriumis teadusliku RT- PCR meetodiga), said 1 aasta jooksul ravi Rebetol’ iga 15 mg/ kg ööpäevas ja interferooniga alfa- 2b 3 miljonit RÜ/ m2 kolm korda nädalas, millele järgnes 6- kuuline jälgimisperiood.
57% male, 80% Caucasian, and 78% genotype 1, 64% ≤ 12 years of age.
57% meessoost, 80% valge rassi esindajaid, 78% genotüübiga 1 ja 64% ≤ 12 aastased.
The population enrolled mainly consisted in children with mild to moderate hepatitis C.
Uuritav populatsioon koosnes peamiselt kerge või mõõduka C - hepatiidiga lastest.
Study results are summarized in Table 11.
21 Uuringu tulemused on summeeritud tabelis 11.
Table 11.
Tabel 11
Virological response in previously untreated children and adolescents Rebetol 15 mg/kg/day + interferon alfa-2b 3 MIU/m2 3 times a week
Viroloogiline ravivastus: eelnevalt ravimata lapsed ja noorukid Rebetol 15 mg/ kg/ ööpäevas + interferoon alfa- 2b 3 miljonit RÜ/ m2 3 korda nädalas
21 Genotype 2/3/4 (n=26) * Number (%) of patients
Genotüüp 2/ 3/ 4 (n=26) * Patsientide arv (%)