| Objectives:Chronic hepatitis B(CHB),which endangers human health and imposes a heavy economic burden on patients,is one of the serious public health problems in China.Antiviral therapy is the most effective treatment for CHB.Interferon(IFN)and nucleos(t)ide analogues(NAs)are the main drugs for antiviral therapy.However,the long-term effects and economic effects of different antiviral drug treatment regimens are not clear.Therefore,scientific and reasonable evaluation of the impact of antiviral therapy on the progression of chronic hepatitis B disease and cost-effectiveness are premise of work.Based on the data of the hospital electronic medical records is easily accessible and can reflect the characteristics of a real word,it has become an ideal data source for the comparison of efficacy and the evaluation of health economics.However,the medical cost data has the characteristic of peak distribution and censoring,and the diversity of disease characteristics and treatment options in study due to nonrandom selection brings difficulties to statistical analysis.This study was aimed to explore the progress of patients with chronic hepatitis B receiving diffierent antiviral treatments by using adjusted Kaplan-Meier method and Cox regress model based on propensity score(PS)model.Furthermore,we used simple weighted estimators based on PS to estimate the long-term cost-effectiveness of the current treatment strategies for CHB patients in China.It can help decision makers to develop reasonable and reliable medical and health services and budget planning.Provide scientific and reasonable data for clinical diagnosis and treatment of CHB.Methods:This retrospective cohort study included 1626 CHB patients who received monotherapy or combined antiviral therapy at the Eighth People's Hospital of Guangzhou from January 1,2008 to December 31,2016.The demographic characteristics of the different antiviral treatment in patient with CHB,the antiviral treatment strategies(includes Interferon(IFN),Adefovir Dipivoxil(ADV),Lamivudine(LAM),Telbivudine(LdT),Entecavir(ETV),ETV+ADV,and LAM+ADV treatment),the cost,and the results of the laboratory tests on admission were described.The survival analysis was used to compare the disease progression(progression to cirrhosis/liver cancer)of CHB patients under different antiviral treatments.Incremental cost-effectiveness ratio(ICER)and net monetary benefit(NMB)were used to analyze the cost-effectiveness of different antiviral treatments and the willingness to pay(WTP)was taken to be?155594 per life-year(3x per capita gross domestic product in 2016).The simple weighted method was used to estimate treatment effects and medical costs under informative censoring.Inverse probability weighting estimation based on propensity scores was used to adjust for potential confounding in observational data.Costs were discounted at 5%per annum.Results:Among the 1626 patients with CHB were analyzed in this study,male dominated(72.94%),mean age was 34.29±10.63 years;Most patients with baseline HBV DNA>10~6 IU/mL(53.99%)and there were 64.39%of patients with abnormal baseline ALT;HBeAg positive patients accounted for 62.30%;194 patients eventually developed cirrhosis and 7 patients developed liver cancer.In this study,CHB patients treated by IFN(n=192),ADV(n=250),LAM(n=80),LdT(n=178),ETV(n=625),ETV+ADV(n=139),LAM+ADV(n=162),respectively.Survival analysis showed that the 3-year cumulative incidence of disease progression in different antiviral treatment groups was1.61%-11.79%,the 5-year cumulative incidence was 2.06%-17.79%,and the8-year cumulative incidence was 2.92%-40.63%.The incidence of disease progression in the IFN,ETV,ETV+ADV and LAM+ADV antiviral treatment groups was lower than that in the ADV,LAM and LdT groups.Multivariate Cox regression analysis showed that IFN[Hazard Ratio(HR):0.34,95%Confidence interval(CI):0.15-0.77],ETV[HR:0.68,95%CI:0.47-0.97],ETV+ADV[HR:0.42,95%CI:0.23-0.77],LAM+ADV[HR:0.24,95%CI:0.12-0.49]were reduced the risk of disease progression compared with the ADV.This study evaluated cost-effectiveness of antiviral costs and total costs for3 years,5 years,and 8 years for 7 antiviral treatment strategies.Comparaed with ADV,ETV,IFN,LAM+ADV,and ETV+ADV strategies produced better effectiveness in 3 years of treatment and LAM and LdT strategies produced worse results.Compared with the ADV monotherapy,ICERs of ETV,LAM+ADV and ETV+ADV(26534.63 Chinese yuan(CNY)/year,28231.21 CNY/year and 36031.42 CNY/year,respectively)treatment strategies were all lower than the willingness to pay threshold of 155594CNY/year and ICERs of IFN(147993.98 CNY/year)was higher than WTP.IFN,LAM,LdT,ETV,LAM+ADV,and ETV+ADV treatment regimens produced better results than ADV treatment regimens in the 5 years of treatment.ADV monotherapy as a reference,LAM produced ICER(142614.00 CNY/year)is at the threshold of WTP.ICERs of IFN,LdT,ETV,ADV+ETV,LAM+ADV(57764.72 CNY/year,15940.20 CNY/year,4244.73CNY/year,17492.91 CNY/year,19547.89 CNY/year,respectively)are lower than the threshold of WTP.In the 8 years of treatment,LAM,LdT,and ETV treatment strategies were better than the ADV monotherapy,with lower total cost.In addition,the ICERs produced by IFN(16125.97 CNY/year),ETV+ADV(2977.84 CNY/year)and LAM+ADV(3875.35 CNY/year)were lower than WTP.Further comparison of the net monetary benefit of the treatment options found that,the NMB of LAM+ADV was the highest at 3 years(14347.51CNY)and 5 years(44192.35 CNY).The 8 years NMB of IFN(167361.60CNY)was slightly higher than the LAM+ADV(159304.60 CNY).Conclusion:Among the 7 treatment options,IFN and ETV monotherapy,ETV+ADV and LAM+ADV initial combination therapy would improve the survival outcome of patients with chronic hepatitis B.Compared with NAs treatment regimens,IFN would no be cost-effectiveness in short-term treatment(3 years and 5 years),but was the cost-effective treatment in long-term treatment(8years)Program.In the NAs treatment regimen,LAM+ADV was the most cost-effective treatment option in 3,5,and 8 years of treatment,followed by ETV+ADV and ETV. |
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