Additional file 1: of Telbivudine versus entecavir in patients with undetectable hepatitis B virus DNA: a randomized trial

Table S1. Serological, virological, and biochemical responses at week 48 by baseline HBeAg-positivity. Table S2. Serological, virological, and biochemical responses at week 48 by status of liver cirrhosis. Table S3. Serological, virological, and biochemical responses at week 48 by gender. Table S4. Characteristics of the patients at virologic breakthrough. (DOCX 51 kb

Model Output.

<p>(A) Simulation of No treatment vs. treatment with entecavir for a Korean CHB population: Model simulation of patient outcomes at year 30 in two hypothetical Korean cohorts of patients with chronic hepatitis B, 60% of whom were HBeAg-positive. A total of 1000 patients were untreated and 1000 patients received entecavir treatment for 5 years (B) Weighted value differentiations between entecavir versus lamivudine or telbivudine: Daily cost savings per patient with chronic hepatitis B (60% with HBeAg-positive CHB) in Korea over a 30-year period by use of entecavir instead of lamivudine or telbivudine assuming an average patient lifespan of 65 years and an average initiation age of 35 years and 5 years of treatment with 74% compliance (histological reversal stops when treatment stops). Sensitivity analysis was conducted within 95% Confidence Interval. (C) Weighted value differentiations between switching to entecavir versus maintaining on lamivudine of suboptimal responders for lamivudine: Daily cost savings per patient with chronic hepatitis B (60% with HBeAg-positive CHB) in Korea over a 30-year period by use of entecavir instead of maintain on lamivudine assuming an average patient lifespan of 65 years and an average initiation age of 35 years and 5 years of treatment with 74% compliance (histological reversal stops when treatment stops). Sensitivity analysis was conducted within 95% Confidence Interval.</p

Model Cost Input.

a<p>Antiviral drug cost not included</p>b<p>Calculated from fibrosis total cost, assuming F0F1/∶F2F3F4 = 1∶1.1 based on guidance of Korean advisory board, In addition, patient ratio is assumed to 1∶1</p>c<p>Calculated from cirrhosis total cost, assuming compensated∶ decompensated  = 1∶2.1 and patient ratio is assumed to be 1∶1.61 based on Yang et al. 2004</p>d<p>Calculated & updated liver transplant surgery cost & post liver transplant cost with Korea organ sharing networks database & Seoul national university organ transfer center data base</p>e<p>Assume about 50% of F0/F1 based on EASL guideline</p>f<p>Only consider direct medical cost of caring disease state</p

Post-TACE response and best response according to the first recurrence patterns using RECIST criteria.

<p>Post-TACE response and best response according to the first recurrence patterns using RECIST criteria.</p

Time-to-progression, time-to-local progression, progression-free-survival and overall survival after TACE among groups.

<p>Time-to-progression, time-to-local progression, progression-free-survival and overall survival after TACE among groups.</p

Model Assumption.

a<p>No patients entered the model in Ishak fibrosis stages F0/F1 or decompensated cirrhosis/HCC/liver transplant/post-liver transplant.</p>b<p>Sensitivity analysis input range for compliance rate 70%∼90%, for annual discount rate 3%∼7%, and for all other variables ±10% standard deviation.</p>c<p>Patients with uncontrolled viral load (HBV DNA level>300 copies/ml).</p>d<p>Patients with controlled viral load (HBV DNA level <300 copies/ml).</p>e<p>Assumptions for the population as a whole. The probability of death was linked to liver histology and not to viral load.</p><p>HBeAg = hepatitis B e antigen; HBsAg = hepatitis B surface antigen, HBV = hepatitis B virus, HCC = hepatocellular carcinoma; CHB = chronic hepatitis B; HIRA = Health Insurance Review & Assessment Service in Korea</p

Kaplan-Meier curves of GE cHCC-CC, PE cHCC-CC and HCC-control.

<p>(A) Time-to-local progression, (B) time-to-progression, (C) progression-free-survival and (D) overall survival. cHCC-CC, combined hepatocellular-cholangiocarcinoma; GE, globally enhancing; PE, peripherally enhancing; HCC, hepatocellular carcinoma.</p

Clinical characteristics of the study patients at the time of first recurrence.

<p>Clinical characteristics of the study patients at the time of first recurrence.</p

Predictive factors of TTP_local and overall survival after TACE in recurred cHCC-CC patients.

<p>Predictive factors of TTP_local and overall survival after TACE in recurred cHCC-CC patients.</p

Baseline characteristics of the study patients according to the recurrence pattern at the time of first recurrence.

<p>Baseline characteristics of the study patients according to the recurrence pattern at the time of first recurrence.</p