P1060 ASSOCIATION BETWEEN GENOTYPE AND BASELINE HBsAg LEVELS AND THE HBsAg LEVELS AT HBeAg SEROCLEARANCE IN HBeAg-POSITIVE CHRONIC HEPATITIS B PATIENTS TREATED WITH ENTECAVIR

POSTERS 3 months, abdominal ultrasound scan every 6 months and upper GI endoscopy according to Baveno guidelines. None of the patients were on beta-blockers prophylaxis. Results: During 109 (12–174) months of treatment, pre-existing EV regressed in 17 (63%) patients, remained unchanged in 8 (30%) and increased in size in 2 (7%), whereas de-novo EV developed in 5 (6%) (4 F1 and 1 F2) of the 80 EV-free patients at baseline. Overall, the 10-year rates of EV regression, progression and de novo onset were 80%, 12% and 8%. Six of 7 (86%) EV progressors had either a clinical breakthrough due to LMV-R and/or developed a hepatocellular carcinoma (HCC). While no patient bled from ruptured EV, 28 patients developed HCC with a 10-year cumulative probability of 28% (2.8% per year). The 10-year cumulative rates of overall and liver-related survival were 89% and 91%, respectively. Conclusions: Long-term suppression of HBV by nucleos(t)ide analogs minimizes the risk of de-novo EV and EV progression in compensated cirrhotics, leaving however HCC incidence rates unaffected. P1060 ASSOCIATION BETWEEN GENOTYPE AND BASELINE HBsAg LEVELS AND THE HBsAg LEVELS AT HBeAg SEROCLEARANCE IN HBeAg-POSITIVE CHRONIC HEPATITIS B PATIENTS TREATED WITH ENTECAVIR C.-Y. Peng, H.-C. Lai, W.-P. Su, C.-H. Lin, P.-H. Chuang, S.-H. Chen. Division of Hepatogastroenterology, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan E-mail: [email protected] Background and Aims: The association between baseline quantitative serum hepatitis B surface antigen (HBsAg) levels and the HBsAg levels at HBeAg seroclearance in genotype B (GB) or C (GC) infected HBeAg-positive chronic hepatitis B patients undergoing entecavir (ETV) therapy remains unclear. Methods: We enrolled 134 treatment-naïve HBeAg-positive patients with ETV therapy for >1 year. Serum HBsAg levels were quantified using the Abbott Architect HBsAg QT assay. Results: At baseline: median age 41 years, 73.1% men, 49.6% GB, 24.6% cirrhosis, median ALT 108 IU/L, HBV-DNA 8.06 log10 copies/mL, and HBsAg 3.59 log10 IU/mL. Sixty-five out of 134 (48.5%) patients achieved HBeAg seroclearance during a median treatment duration of 45.6±18.6 months. Cirrhosis (HR = 3.271, P = 0.0196), ALT ≥120 IU/L (HR = 2.790, P = 0.0074) and baseline HBsAg between 5000 and 16,000 IU/mL (HR = 3.616, P = 0.0059) were independent predictors of HBeAg seroclearance. The cumulative HBeAg seroclearance rates after 5 years of therapy in non-cirrhotic patients (N = 101) with baseline HBsAg ≥16,000, 5000–16,000, and <5000 IU/mL were 50%, 90%, and 65.2%, respectively (P = 0.0231). As compared to GC, GB infected patients had a higher HBsAg level at baseline (3.81±0.74 vs 3.54±0.92), a significantly greater median HBsAg decline from baseline (0.79±1.58 vs 0.27±0.41), and a significantly lower HBsAg level at HBeAg seroclearance (2.77±0.68 vs 3.24±0.80). The HBsAg level at HBeAg seroclearance was significantly higher in patients with baseline HBsAg 5000– 16,000 IU/mL than patients with HBsAg <5000 or >16,000 IU/mL (GB 3.13±1.06 vs 2.68±0.45; GC 3.65±0.38 vs 3.07±0.37).

Conclusions: During ETV therapy, the HBsAg levels at HBeAg seroclearance were significantly higher in GC infected patients and in patients with baseline HBsAg between 5000 and 16,000 IU/mL. P1061 LONG-TERM TREATMENT WITH TENOFOVIR IN TREATMENT-NAIVE OR -EXPERIENCED CHB PATIENTS IS EFFECTIVE AND WELL TOLERATED IN REAL-LIFE PRACTICE: 3 YEARS RESULTS OF THE VIREAL STUDY G.-P. Pageaux1 , F. Zoulim2 , X. Causse3 , D. Larrey1 , D. Ouzan4 , R. Truchi5 , A. Pauwels6 , D. Guyader7 , V. De Ledinghen8 , J.-P. Zarski9 , J.-F. Cadranel10 , V. Tilliet11 , C. Stern11 , O. Libert11 , P. Marcellin12 , VIREAL Group. 1 CHU Saint-Eloi, Montpellier, 2 CHU Croix Rousse, Lyon, 3 CHR Orl´eans, Orl´eans, 4 Institut Arnault Tzanck, Saint-Laurent du Var, 5 CHU Nice, Nice, 6 CH, Gonnesse, 7 CHU Rennes, Rennes, 8 CHU Bordeaux, Pessac, 9 CHU de Grenoble, Grenoble, 10 CH, Creil, 11 Gilead Sciences, Boulogne-Billancourt, 12 CHU Beaujon, Clichy, France E-mail: [email protected] Background and Aims: Phase III trials have reported high virological response (VR) and favorable safety profile of Tenofovir DF (TDF) both in treatment-naïve (TN) and -experienced (TE) CHB patients. Long-term data in daily practice are still limited. The aim was to analyze the 3-year data on the efficacy and tolerability of TDF in a real-life cohort, in TN and TE patients. Methods: 440 monoinfected TDF-naïve CHB patients were prospectively enrolled into a French real-life multicenter cohort (VIREAL). Clinical, serological and virological data were collected at baseline and every 6 months. Analyses performed in TN (n = 182) and TE (n = 258) at 3-year. VR: HBV-DNA <69 IU/mL. Results: Baseline characteristics (n = 440): mean age 45±14 years, 71% male, 43% abnormal ALT, 74% HBeAg-negative, 33% advanced fibrosis (F3/F4 assessed by biopsy). 59% TE. Similar VR in TN and TE after 3 years:94% (95/101) vs 97% (153/158). VR were ADV+LAM:99% (90/91) and ETV:88% (21/24). HBsAg loss was observed in 11 patients. 3 cases of HCC were reported (3 cirrhotics at baseline). No major safety issues were reported. The most common AE were asthenia (n = 14) and gastrointestinal disorders: abdominal pain (n = 14), nausea (n = 7), vomiting (n = 7), diarrhea (n = 6). GFR remained stable in TN and TE. Mean GFR in ADV+LAM-experienced patients was 91, 87, 86 and 90 mL/min at baseline, 1, 2 and 3 years, respectively. Conclusions: After 3 years in real-life practice, TDF treatment was associated with a high VR, low number of HCC in accordance with the phase III studies. TDF presented a favorable safety profile in TN and TE, including ADV+LAM-experienced.

Table (abstract P1060): HBsAg levels at baseline and at HBeAg clearance HBsAg (baseline)

Total (N = 65) <5000 IU/mL (N = 34) 5000–16,000 IU/mL (N = 19) >16,000 IU/mL (N = 12)

At baseline (log10 IU/mL)

Decline from baseline (log10 IU/mL)

At HBeAg seroclearance log10 IU/mL)

All

Genotype B

Genotype C

All

Genotype B

Genotype C

All

Genotype B

Genotype C

3.59±0.82 3.25±0.79 3.95±0.23 4.39±0.36

3.81±0.74A 3.22±1.13 3.92±0.25 4.46±0.41

3.54±0.92A 3.28±0.65 4.03±0.21 4.27±0.03

0.45±0.87 0.21±0.73 0.39±0.76 1.75±1.07

0.79±1.58B 0.47±0.99 0.77±0.88 1.82±0.36

0.27±0.41B 0.21±0.45 0.27±0.31 1.02±0.95

3.08±0.82 2.84±0.69 3.57±0.81 3.04±0.93

2.77±0.68C 2.67±0.49D 3.13±1.06D 2.70±1.04D

3.24±0.80C 3.06±0.60E 3.65±0.38E 3.25±0.91E

Wilcoxon rank sum test: A: P = 0.0928; B: P = 0.0066; C: P = 0.0442; D: P = 0.0493; E: P = 0.0008. S430

Journal of Hepatology 2014 vol. 60 | S361–S522