22 A COMPARISON OF 24 WEEKS AND 48 WEEKS TREATMENT EFFICACY BETWEEN CLEVUDINE AND ENTECAVIR THERAPY IN TREATMENT-NAIVE PATIENTS WITH CHRONIC HEPATITIS B

Parallel Session 3: FIBROGENESIS S11 (FTC)+TDF after W72 for confirmed HBV DNA above 400 copies (c)/mL (69 IU/mL).Entrance criteria included abnormal ALT and viremia HBV DNA >100,000 copies/mL with Roche COBAS TaqMan assay (LLOQ=169 copies/mL).Results: Eighty-one of 426 patients originally randomized to TDF were cirrhotic (19%), 47 HBeAg-and 34 HBeAg+ with median baseline HBV DNA of 7.58 log 10 copies/mL and ALT of 92 U/L.Similar proportions of cirrhotic and non-cirrhotic patients suppressed HBV DNA to <400 c/mL (69 IU/mL) at W96: 90% versus 85% (ITT) and 97% versus 95% (observed).Among patients remaining on treatment, 83% of cirrhotic and 78% of non-cirrhotic patients had normal ALT at W96 with median values of 30 and 29 U/L, respectively.Of 29 cirrhotic HBeAg+ patients with W96 serology results 9 seroconverted to anti-HBe (31%) and collectively 2 seroconverted to anti-HBs (both genotype D).Grade 3 and 4 adverse events (AEs) occurred in 11% of cirrhotic and 13% of non-cirrhotic patients, serious AEs in 15% and 9%, and Grade 3/4 laboratory abnormalities in 31% and 23%, respectively.One cirrhotic patient developed hepatocellular carcinoma.No cirrhotic patient had a confirmed increase in creatinine of 0.5 mg/dL, creatinine clearance <50 mL/min, or clinically evident hepatic decompensation. Conclusion:The efficacy and safety of TDF at 96 weeks was not influenced by the existence of cirrhosis at onset of therapy and was comparable among cirrhotic and non-cirrhotic patients with good tolerability in both populations.