[128] PEGINTERFERON o-2b AND RIBAVIRIN FOR 14 OR 24 WEEKS IN PATIENTS WITH HCV GENOTYPE 2 OR 3 AND RAPID VIROLOGICAL RESPONSE. THE NORTH-C TRIAL

GENERAL SESSION 4 & CLOSING 33% (4112) PRC VS. 10% (1/10) PR patients (Figure I ) . PaR achieved EVR of 67% (6/9) for PR, while PRC group could not be evaluated. Safety. Celgosivir combination therapy was well tolerated and resulted in no significant adverse events. There was an increased frequency in mostly m l d diarrhea and flatulence in the celgosivir groups, while fatigue and flu-like symptoms were equally observed in all groups

04

1 (n = 10)

s57

SVR rates in 227 Patients with RVR who received treatment Per protocol (group A, n = ' 2 7 , Group B, " = I o 0 )

Genotype

Group A (14 weeks) Group B (24 weeks)

Viral load

2

3

<400,000 TU/ml

>400,000 TU/ml

26/27 (96%)

87/98 (90%)

33/39 (85%)

66/70 (94%)

22/22 (100%)

70/75(93%)

35/35 (100%)

50/55 (91%)

Conclusion: With a 5% significance level 14 weeks treatment with pegylated interferon alpha 2b and ribavirin is non-inferior to 24 weeks treatment in patients with genotype 2 or 3 and RVR.

\

\ I (n = 12)

-UPR

-1 R

,

0

2

4

6

8

10

12

Time (Weeks)

Conclusion: This study has demonstrated for the first time that treatment with celgosivir, an inhibitor of a-glucosidase I, in combination with peginterferon and ribavirin results in a clinically significant decrease in HCV-RNA in a non-responder patient population highly resistant to prior therapy with peginterferon and ribavirin. Further clinical research on dosing regimen and combination is warranted to optimize the potential of this innovative compound for chronic HCV patients.

11281 PEGINTERFERON a-2b AND RlBAVlRlN FOR 14 OR 24 WEEKS IN PATIENTS WITH HCV GENOTYPE 2 OR 3 AND RAPID VIROLOGICAL RESPONSE. THE NORTH-C TRIAL 0. Dalgard' , K. Bjoro', H. Ring-Larsen3, H. Verbaan4. 'lnf$ctious Disease Depurtment, UlleuBl Uniuersity Hospitul, Oslo; 'Medical Department, Rikshospitalet, Oslo, Noiwuy; Phurnzaceutical Institute, Rigshoyitalet, Copenhagen, Denmurk; 4Depurtment of Gastroenterolgy, Maim@ Uniuersity Hospitul, Mulm@,Sweden E-mail: [email protected] In patients with genotype 213 and rapid virological response (RVR) we previously reported a 90% sustained virological response (SVR) rate after 14 weeks of treatment in a non-randomised trial. Methods: In a randomised, non-inferiority trial 428 treatment naive HCVRNA positive patients with genotype 2 or 3 were enrolled. Patients with RVR (defined as <50 IU/ml after 4 weeks of treatment) were randomised to 14 (group A) or 24 (group B) weeks treatment. Patients were treated with pegylated interferon alpha 2b (1.5 Kg/kg) and ribavirin (800-1400 mg daily). Primary endpoint was SVR. The non-inferiority margin was set to be 10% between the two groups with a one-sided 2.5% significance level. In a post-hoc analysis a one sided 5% significance level was used. Results: RVR was obtained in 298/428 (70%), they were randomised to group A ( n = 149) or group B (n= 149). The median age was 38 years, 65% were men, mean weight was 80kg and genotype 2 was present in 20%. There was no significant difference in the baseline characteristics of the two groups. In an intention-to-treat analysis SVR was observed in 121/149 (81%) of group A and in 131/149 (88%) of group B. The difference A between the two groups was 6.7% (95% CI: -2%,+14%). In a per protocol analysis including only those who received more than 80% of each drug more than 80% ofthe scheduled time and who had HCVRNA measured 24 weeks post treatment, SVR was obtained in 1 15/127 (91%) of group A and 95/100 (95%) of group B (A: 4.4%; 95% C1: -2.2, +11 .O, 90%C1: -1.2,+10.0).