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valuea
pα

p valuea
Τιμή pα

p-valuea
p-valueγ

p-valuea, b
Τιμή pα, β

or; 95% ci; p valuea
or, 95% ci, τιμή p a

p-valuea (2-sided)
Τιμή pα (αμφίπλευρη)

n = 391 n = 195 p-valuea 1.21 2.32 0.012 0.63 1.14 0.029 0.58 1.18 0.009
n = 391 n = 195 1, 21 2, 32 0, 012 0, 63 1, 14 0, 029 0, 58 1, 18 0, 009

ribavirin ribavirin p (800- (800- (800 mg) (800 mg) valuea 1,200 mg) d
pegintron Ιντερφερόνη pegintron

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.the overall sustained response rate after a 24-week treatment duration was 50%.forty-one percent of subjects (97/235) had nondetectable plasma hcv-rna levels at week 4 and week 24 of therapy.in this subgroup, there was a 92% (89/97) sustained virological response rate.the high sustained response rate in this subgroup of patients was identified in an interim analysis (n=49) and prospectively confirmed (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) .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) .table 8 treatmentviraferonpeg 1.5 + ribavirin ( 10.6 mg/kg) 48-week treatment viraferonpeg 1.5 + ribavirin 800-1,400 mg 24-week treatment * reflects patientspredictability of sustained response by viral response at week 12 and genotype*genotype viral response sustained response negative predictive value at week 121 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) ----no 1% (2/215) 50% (1/2) 50%with 12 week data availablethe negative predictive value for sustained response in patients treated with viraferonpeg in monotherapy was 98%.hcv/hiv co-infected patients143 two trials have been conducted in patients co-infected with hiv and hcv.the response to treatment in both of these trials is presented in table 9.study 1 (ribavic; p01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis c who were co-infected with hiv.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.study 2 (p02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis c who were co-infected with hiv.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) .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.table 9all genotype 1, 4 genotype 2, 3sustained 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 150c µg/week) (3 miu tiw) (1.5 µg/kg/alfa-2b week) + (3 miu tiw) + + ribavirin + ribavirin p ribavirin ribavirin (800-(800-p valueb 1,200 mg)d 1,200 mg)d valuea (800 mg) (800 mg) 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 44% (35/80) 43% (33/76) 0.88 53% (10/19) 47% (7/15)
+ ριμπαβιρίνη (800 -1. 200 mg) δ+ριμπαβιρίνη (800 -1. 200 mg) δτιμή pβΌλοι οι ασθενείς27% (56/205)20% (41/205)0, 04744% (23/52)21% (9/43)0, 017Γονότυπος 1, 417% (21/125)6% (8/129)0, 00638% (12/32)7% (2/27)0, 007Γονότυπος 2, 344% (35/80)43% (33/76)0, 8853% (10/19)47% (7/15)