026

IS IT POSSIBLE TO IDENTIFY HCV GENOTYPE 1 PATIENTS AT RISK OF RELAPSE? ANALYSIS OF THE CANADIAN PEGASYS EXPANDED ACCESS PROGRAM (EAP)

M Deschênes¹, SS Lee², C Cooper³, P Marotta⁴, VG Bain⁵, M Sherman⁶, L Scully⁹, D Wong⁶, R Balshaw⁷, K Peltekian⁸ on behalf of the Canadian PEGASYS Study Group
¹Royal Victoria Hospital,Montreal, Quebec; ²Univeristy of Calgary, Calgary, Alberta; ³University of Ottawa, Ottawa, Ontario; ⁴London Health Sciences Centre, London, Ontario; ⁵University of Alberta, Edmonton, Alberta; ⁶University Health Network, Toronto, Ontario; ⁷Syreon Corp, Vancouver, British Columbia; ⁸Dalhousie University, Halifax, Nova Scotia; ⁹Ottawa Hospital, Ottawa, Ontario

We aimed to identify predictors of relapse in genotype 1 pts who did not achieve an SVR despite being HCV-RNA negative at end of treatment (EOT).
METHODS: Treatment-naïve genotype 1 pts assigned to PEG-IFNalpha2a + RBV for 48wk were eligible. Only those who were HCV-RNA negative at wk48 were included. In the initial phase, all pts received RBV 800 mg/d, and 1000/1200 mg/d in later phases. Multiple logistic regression was used to identify predictors. Age, gender, ethnicity, BMI, fibrosis score, RBV dose, baseline HCV RNA, change in HCV-RNA to wk12, and interaction between baseline HCV-RNA and change to wk12 were considered. SVR=HCV-RNA <50IU/mL =>20wks after treatment end.
RESULTS: 492 G1 pts were included; 185 (38%) and 307 (62%) received RBV 800 and 1000/1200 mg/d, respectively. 382 (78%) had an SVR. Fifty-seven (31%) and fifty-three (17%) pts treated with RBV 800 and 1000/1200 mg/d, respectively, relapsed. Predictors of relapse included age (OR 1.79 per 10yr increment, 95%CI 1.31-2.44; p=0.0002) Caucasian ethnicity (OR 4.17 vs. nonCaucasian, 95%CI 1.82-10.0; p=0.0008), and RBV dose 800 mg/d (OR 3.93 vs 1200mg/d, 95%CI 1.86-8.3;p=0.0009). Change in HCV-RNA to wk12 was significant in pts with baseline HCV-RNA >75th percentile (2.5x10^{^}6IU/mL) (OR 2.25 per 1-log decrease, 95%CI 1.16-4.37) but not <25th percentile (approximately =2.5x10^{^}5 IU/mL). Thus, pts with high baseline viral loads are more likely to relapse, unless HCV-RNA decreases sharply to wk12.
CONCLUSIONS: Older age, Caucasian ethnicity, suboptimal RBV dose and high baseline HCV-RNA predict relapse in G1 pts.
Funded by Roche, Canada

PREVIOUS NEXT