Sustained off-therapy response (SR) was defined as HBV DNA <2,000 IU/mL combined with normal ALT at 12 months post-therapy. Results: Mean±SD age at baseline was 42±1
1 years and 75% of the patients were males. Mean baseline HBV DNA and HBsAg levels were 5.4±1.4 log10 IU/ml and 3.5±0.6 log10 IU/ml, respectively. Of the 95 patients, 22 (23%) achieved SR and 9 (9.5%) lost HBsAg. HBsAg decline was more profound in responders than in non-responders. HBsAg decline ≧10% from baseline to week 12 was not significantly associated with SR [OR:2.196 (0.740-6.519), p=0.169]. In contrast, HBsAg Torin 1 cost decline >10% from baseline to week 24 was found significantly more frequently in patients with than without SR [81% (17/21) vs 37% (21/57); OR:7.286 (2.162-24.552), p=0.001]. The predictability of the PARC selleck products rule based on HBsAg and HBV DNA levels at 12 weeks was evaluated in a subset of 47 patients with available data [SR: 13/47 (28%)]. Of them, 60% (28/47) did not have any HBsAg decline and 1 7% (8/47) did not have both any HBsAg decline and decline of HBV DNA >2 log 10. Of the latter 8 patients who fulfilled the PARC stopping rule, none achieved SR [Negative Predictive Value (NPV): 1 00%]. Of the 39 patients who did not fulfill the PARC stopping rule, 24 (62%) had HBsAg decline ≧10% at 24 weeks with 12/24 (50%) achieving SR,
while 15 (38%) had HBsAg decline <10% at 24 weeks with only 1/15 (7%) achieved SR (NPV: 93%). Conclusions: In HBeAg-negative, predominantly genotype D, CHB patients treated with peg-interferon-alfa-2a, HBsAg decline >1 0% at 24 weeks is associated with significantly higher probability of SR at 12 months post-therapy. The combination of HBsAg and HBV DNA levels at week 12 with HBsAg decline at week 24 can identify patients with no or a very low chance of SR leading to
early discontinuation of an unsuccessful regimen in almost 50% of patients or more importantly in almost Florfenicol 2/3 of patients without SR. Disclosures: Ioannis Goulis – Consulting: MSD, Gilead Sciences, Novartis, Janssen-Cilag; Grant/Research Support: BMS, Roche; Speaking and Teaching: BMS, MSD, Gilead Sciences, Novartis, Janssen-Cilag, Roche Melanie Deutsch – Consulting: MSD Konstantinos Mimidis – Advisory Committees or Review Panels: ROCHE, MSD, NOVARTIS; Grant/Research Support: GILEAD Sokratis Koulouris – Employment: Roche Hellas George Bakalos – Employment: Roche Hellas SA George V. Papatheodoridis – Advisory Committees or Review Panels: Janssen, Abbott, Boehringer, Novartis, BMS, Gilead, Roche; Consulting: Roche; Grant/Research Support: BMS, Gilead, Roche; Speaking and Teaching: Janssen, Novartis, BMS, Gilead, Roche, MSD The following people have nothing to disclose: Stylianos Karatapanis, Evangelos A. Akriviadis, George N. Dalekos, Maria Raptopoulou-Gigi, Georgios Germani-dis, Christos K.