1053 TREATMENT WITH CLEVUDINE FOR 24 WEEKS RESULTS IN SUSTAINED ANTIVIRAL RESPONSE ASSOCIATED WITH CONTINUED HBsAg DECREASE 24 WEEKS POST-TREATMENT IN HBeAg-POSITIVE PATIENTS

viral replication, with mean maximum reductions in HCVRNA ranging from −0.97 to −2.13 (log10 IU/mL). In this study, the safety and efficacy of FBV in combination with pegylated interferon alfa-2a (pegIFN) and ribavirin (RBV) was evaluated. Methods: Eligible patients (treatment naive, HCV genotype 1) were randomized 1:1:1:1 to receive FBV (200, 300 or 500mg BID) or placebo in combination with pegIFN (180 ug/wk) and RBV (1000/1200mg/day) for 4 weeks. Patients are continuing on open label pegIFN/RBV for an additional 44 weeks. Results from the Week 4 analysis are described here. HCVRNA was measured using the Roche COBAS Taqman (LLD= 25 IU/mL). Results: A total of 35 patients were enrolled and 34 completed Week 4. The majority were Caucasian (69%), genotype 1a (80%) and male (51%). The most frequently reported AEs were headache, fatigue, insomnia and nausea. There were no trends towards increased frequency or severity of AEs with increasing dose of FBV. The incidence and severity of laboratory test abnormalities was similar across treatment groups. There was one treatment-related SAE (elevated creatinine) in the FBV 300mg group, which resolved following IV hydration. No other renal AEs were reported. The mean reduction (log10 IU/mL) in HCVRNA at Day 4 for placebo (n = 8), 200 (n = 10), 300 (n = 9) and 500 (n = 8) mg BID was −0.58, −2.29, −2.72 and −2.83, respectively, and −2.10, −4.46, −4.67 and −3.62 at Day 28. The percent of patients achieving RVR (undetectable HCVRNA by Week 4) for placebo, 200, 300 and 500mg BID was 0%, 60%, 75% and 63%, respectively. Of those patients treated with 200, 300 and 500mg BID who achieved a RVR, 33%, 33% and 80% achieved undetectable HCVRNA within two weeks of treatment, respectively. Conclusions: The addition of FBV to pegIFN/RBV was well tolerated and markedly increased the percentage of patients achieving RVR. Assessment of response to pegIFN/RBV therapy subsequent to Week 4 is ongoing.