Objective To compare the cost-effectiveness of telbivudine-based optimization treatment and entecavir monotherapy in patients with HBeAg-positive chronic hepatitis B (CHB). Methods A Markov model for disease progression of CHB was constructed and cost-effectiveness analysis was conducted to estimate their long-term effects and medical costs. Results There were 36.11 expected life years (ELYs) and 23.08 quality adjusted life years (QALYs) gained from treatment with telbivudine optimization, which were longer than 35.95 ELYs and 23.08 QALYs from entecavir treatment. The total cost of telbivudine optimization was 348 863.62 yuan and that of entecavir treatment 349 279.27 yuan. Each extension of a QALYs required for medical expenses of 15 115.41 yuan in telvivudine optimization, which was cheaper than that in entecavir treatment with 15 225.77 yuan. Conclusions Telbivudine-based optimization treatment shows good cost-effectiveness than entecavir monotherapy. Telbivudine-based optimization treatment can be used as the optimum choice for antiviral therapy in CHB.

OBJECTIVETo evaluate long-term cost-effectiveness of nucleoside analogues and peg-interferon alfa-2a (peg-IFNa2a) for the treatment of chronic hepatitis B (CHB) in hepatitis B e antigen (HBeAg)-negative patients.

METHODSA multi-health slate Markov model was developed based on the disease progression pattern to estimate the long-term effect and medical expense of different treatments for HBeAg-negative CHB.Incremental cost-effectiveness analysis was then carried out.

RESULTSIn comparison with no antiretroviral treatment, all of the antiretroviral treatments were capable of prolonging CHB patients' life years.In particular, entecavir plus adefovir dipivoxil combination therapy showed the best 2 year survival, with expected life-years and quality-adjusted life-years (QALYs) being 19.59 years and 10.12 years, respectively, which were 1.46 years and 1.12 years better than with no antiretroviral treatment. The most cost-effective treatment for HBeAg-negative CHB was lamivudine plus adefovir dipivoxil rescue therapy, as it prolonged survival by 0.95 QALYs with an additional 15459 yuan; the incremental medical cost for gaining 1 QALY was 16273 yuan.

CONCLUSIONAmong the antiretroviral medicines applied as therapy for HBeAg-negative CHB in China, the most effective treatment is entecavir plus adefovir dipivoxil rescue therapy and the most cost-effective treatment is lamivudine plus adefovir dipivoxil rescue therapy.

Adenine ; analogs & derivatives ; Antiviral Agents ; China ; Cost-Benefit Analysis ; Economics, Pharmaceutical ; Guanine ; analogs & derivatives ; Hepatitis B e Antigens ; Hepatitis B, Chronic ; Humans ; Interferon-alpha ; Lamivudine ; Organophosphonates ; Polyethylene Glycols ; Quality-Adjusted Life Years ; Recombinant Proteins

An analytical method was developed for the determination of five carbohydrate impurities in amino acid drug substances by high performance liquid chromatography-evaporative light scattering detection (HPLC-ELSD). Sugar impurities in the amino acid sample were separated and enriched by cation exchange resin. A Lichropher NH2 column (4.6 mm × 250 mm, 5 μm) was used for chromatographic separation, and a gradient elution was performed using acetonitrile-water as mobile phase. The drift tube temperature was 40 oC, the gain value was 8, and nitrogen (350 kPa) was auxiliary gas. Method validation results showed that the limits of detection for fructose, glucose, sucrose, maltose and lactose were in the range of 20.8-75.0 mg/kg and that the limits of quantitation were in the range of 96.2-238.8 mg/kg. Good linear relationship (r ≥ 0.999) were in the linear range for the five sugars, and the recoveries ranged from 84.9%-107.8%. With easy operation, high sensitivity, good precision and reliable accuracy, the method can be used for analysis of residual sugar impurities in amino acid drug bulk drug.