| ObjectiveChina has 86 million HBV-infected and 9.8 million HCV-infected individuals,making it a high burden country for viral hepatitis B and C.Although effective antiviral treatments are available,it is estimated that the treatment rate for both diseases is low in China,and there is a large gap to achieve the goal of eliminating viral hepatitis as a public health threat by 2030.Currently,China lacks a national and provincial-level monitoring system for antiviral treatment of hepatitis B and C,which makes it difficult to accurately and timely understand the situation of antiviral treatment,and there is an immature mechanism for voluntary screening and referral of infected individuals,an incomplete integrated healthcare system without a closed-loop management,and insufficient public awareness of these diseases.This study aims to use existing medicines utilization databases from all 31(30)provinces to estimate the number of patients receiving antiviral treatment for hepatitis B and C,and to fill the data void on treatment monitoring at national and provincial levels.Furthermore,this study evaluates the effectiveness of medicines policies aimed at promoting antiviral treatment for hepatitis B and C based on changes in standardized treatment numbers over different periods of time,and explores other factors in the healthcare system that may affect antiviral treatment numbers in order to provide evidence-based policy recommendations for promoting targeted antiviral treatment.Additionally,lessons can be learned from policy documents and literature on how other countries have eliminated the public health hazards of viral hepatitis.MethodsUsing the China Hospital Pharmacy Purchase Audit(CHPA)system from IQVIA,we obtained data on the consumption of nucleoside/nucleotide analogues(NAs)for HBV(2013-2021)and direct acting antivirals(DAAs)for HCV(2017-2021)in 31 and 30 provinces,respectively.Based on the drug instructions and HBV and HCV prevention and treatment guidelines,medication consumption data were converted into standardized antiviral treatment numbers for HBV and HCV and panel database were created.Based on the above databases,1)descriptive analysis of the time trends of antiviral medicines usage and standardized antiviral treatment numbers at the national and provincial levels;2)using ordinary least squares regression(OLS)to identify significant years of change in standardized treatment numbers to identify effective policies;3)evaluating the average impact of the implementation of nationwide adoption of the ’4+7’ pilot-pooled procurement prices on standardized antiviral treatment numbers for HBV using multi-time-point double-difference,combined with event research to evaluate their dynamic effects;4)using interrupted time series(ITS)analysis to evaluate the effects of the implementation of the first batch of three DAAs for HCV in the national insurance list in January 2020 and the first batch of self-developed HCV DAAs f in the national insurance list in March 2021 on standardized antiviral treatment numbers for HCV;5)using ITS analysis to evaluate the effects of the implementation of the first national medicines negotiation policy in 2015 and the 4+7 pilot-pooled procurement policy in 2019 on standardized antiviral treatment numbers for HBV at the provincial level;6)using instrumental variable analysis to evaluate the impact of residents’ health literacy on HBV antiviral treatment;7)using latent class trajectory models to explore the growth patterns of HCV antiviral treatment numbers and their influencing factors.Results(1).The number of standardized antiviral treatment for both hepatitis B and C has increased year by year.The antiviral treatment numbers of hepatitis B has increased from 1.03 million in 2013 to 3.22 million in 2021.The antiviral treatment numbers of hepatitis B was low before 2020 but has rapidly increased since then,with 49,592 receiving standardized treatment in 2021.(2).The number of standardized antiviral treatments for hepatitis B significantly increased after 2018,with a 14.74%(0.1474=e0.1375-1,P=0.004)increase in treatment numbers after 2018 compared to before,a 34.35%(0.3435=e0.2953-1,P<0.001)increase after 2019,and a 29.87%(0.2987=e0.2614-1,P=0.006)increase after 2020.However,the increase in treatment numbers in 2021 was not significant.(3).After the 4+7 pilot-pooled procurement,the average increase in number of hepatitis B treatment was 42.35%(0.4235=e0.3531-1,P<0.001),and the dynamic effect fluctuated from 33.22%(0.3322=e0.2868-1,P<0.001)to 53.65%(0.5365=e0.4295-1,P<0.001).(4).The inclusion of the first three DAAs combinations in the national medical insurance increased the number of standardized treatments for hepatitis C by 3,668 people.The policy had an immediate and long-term positive impact on the number of antiviral treatment for hepatitis C,but no significant effect was observed after the inclusion of domestically produced DAAs in March 2021.(5).For every 1%increase in health literacy among residents in each province,the number of hepatitis B patients receiving treatment increased by 7.15%(0.0715=e0.0691-1,P<0.001).(6).The latent class trajectory model divided the growth trend of number of standardized treatment for hepatitis C in 30 provinces into three classes:high-,medium-,and low-level of treatment,which may be related to the economic development level and disease burden of each province.ConclusionIn recent years,under a series of healthcare policies in China,the number of standardized antiviral treatment for hepatitis B and C has continued to increase,with significant increases in 2019 and 2020.However,the treatment rate is still far below the goal that 80%of patients who should be treated.The 4+7 pilot-pooled procurement and the inclusion of antiviral medicines in the national medical insurance policy have significantly increased the number of antiviral treatment.The price of NAs has nearly reached lowest level all of world,but domestically produced DAAs have not formed strong competition with imported products and need to strengthen safety net systems for economically disadvantaged groups.In the current context of low price of medicines,improving the diagnosis and treatment level of primary medical institutions,and forming an integrated medical service system to eliminate the public health risks of viral hepatitis through screening,diagnosis,treatment,follow-up,and monitoring are the next steps to be taken.In addition,improving the level of health literacy among residents and doing a good job of publicity and education play an important role in eliminating viral hepatitis. |
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