State Medicaid Reimbursement for Medications for Chronic Hepatitis C Infection from 2012 through 2015

Background

New direct-acting antivirals (DAAs) can cure chronic hepatitis C virus (HCV) infection. High DAA prices combined with a large number of patients needing treatment may pose substantial economic burden on health systems.

Cost-Utility of Elbasvir/Grazoprevir in Patients with Chronic Hepatitis C Genotype 1 Infection

Objective

To evaluate the cost-utility of treatment with elbasvir/grazoprevir (EBR/GZR) regimens compared with ledipasvir/sofosbuvir (LDV/SOF), ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3D ± RBV), and sofosbuvir/velpatasvir (SOF/VEL) in patients with chronic hepatitis C genotype (GT) 1 infection.

Standardized Prevalence Ratios for Chronic Hepatitis C Virus Infection Among Adult Japanese Hemodialysis Patients

Background

Many studies have estimated the prevalence of anti-hepatitis C virus (HCV) antibody among hemodialysis (HD) patients; however, the prevalence of HCV core antigen—which indicates the presence of chronic HCV infection—is not known.

Methods

Standardized prevalence ratios (SPRs) for anti-HCV antibody and HCV core antigen among HD patients (n = 1214) were calculated on the basis of data from the general population (n = 22 472) living in the same area.

Results

The prevalences of anti-HCV antibody and HCV core antigen were 12.5% and 7.8%, respectively, in male hemodialysis patients, and 8.5% and 4.1% in female hemodialysis patients. The SPRs (95% confidence interval) for anti-HCV antibody and HCV core antigen were 8.39 (6.72–10.1) and 12.9 (9.66–16.1), respectively, in males, and 5.42 (3.67–7.17) and 8.77 (4.72–12.8) in females.

Conclusions

The prevalences of chronic HCV infection among male and female HD patients were 13-fold and 9-fold, respectively, those of the population-based controls. Further studies should therefore be conducted to determine the extent of chronic HCV infection among HD patients in other populations and to determine whether chronic HCV infection contributes to increased mortality in HD patients.Key words: hepatitis C virus infection, hemodialysis, standardized prevalence ratio (SPR), population-based study, cross-sectional analysis     

慢性乙型肝炎患者产生自身免疫的研究

目的 探讨乙型肝炎病毒(HBV)感染后导致机体产生自身免疫的情况.方法 采用日立7600全自动生化分析仪检测166例慢性乙型肝炎患者(CHB)的丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TBil)、直接胆红素(DBil)、白球蛋白比值(A/G)、碱性磷酸酶(ALP)及γ谷氨酰晦(γ-GT);HBV-DNA含量的检测采用实时荧光定量PCR方法;采用间接免疫荧光法、放射免疫法分别检测抗核抗体(ANA)及抗双链DNA抗体(Ads-DNA).结果 166例CHB患者血清中总自身抗体检出率为36.7%,显著高于正常对照组(P<0.01),且分布以低滴度为主;ANA阳性组的ALT、AST显著高于ANA阴性组(P<0.05),而A/G比值明显低于ANA阴性组(P<0.05);ANA阳性组的HBV-DNA含量显著高于ANA阴性组(P<0.01),且随着HBV-DNA拷贝数的升高,CHB患者ANA的阳性率亦随之升高,差异有统计学意义(P<0.01).结论 HBV感染可导致自身免疫的发生;HBV感染引发的自身免疫性反应与CHB患者的肝功能损害程度和病毒复制水平有关.     

A randomized trial to evaluate the effectiveness of a Medicaid HMO

The value of health-care services used by AFDC Medicaid patients receiving care in a voluntary enrollment HMO is contrasted with that of health care services used by Medicaid patients receiving fee-for-service (FFS) care. The randomized assignment of Medicaid recipients to the HMO or to FFS allows the authors to conclude that the apparent lower use of HMO enrollees results from the HMO's selection of patients with lower needs for care rather than from technical efficiency. Patients had lower use while in the HMO, but disenrollees and those who refused enrollment had significantly higher use than FFS participants. In contrast to the effect of HMOs on non-Medicaid populations, the Medicaid HMO studied provided significantly fewer outpatient services, but the same level of inpatient services as the FFS sector. Overall, voluntary enrollment of Medicaid eligibles into the HMO resulted in higher state expenditures for Medicaid because of favorable selection.     

Medicaid beneficiaries' experiences in HMO and fee-for-service health care

How do HMO-enrolled Medicaid beneficiaries' ratings of access to, and satisfaction with, their health care compare with the ratings of those beneficiaries receiving care in fee-for-service settings? Do poor single mothers report differences in access to, and satisfaction with, their HMO health care compared with those living in other family structures? These questions were examined with survey data from 961 California Medicaid recipients in 1991. Medicaid recipients enrolled in HMOs reported more difficulty gaining access to, and less satisfaction with, various aspects of the health care system. HMO-enrolled single mothers reported particularly negative experiences with their health care. The findings suggest a potential lack of fit between the health needs of the poor and the aims of managed health care.     

Intrafamilial Transmission of Hepatitis C Virus Infection

Background: The role of intrafamilial HCV transmission is still controversial. Methods: An overall sample of 2856 consecutive HCV-infected patients was studied. All index cases were interviewed to identify potential risk factors for transmission and underwent the following tests: HBsAg, anti-HBc, HIV, and, qualitative HCV-RNA and genotyping. Results: Coinfection with HBsAg was recorded in 4.7%, and with HIV in 2.6% of the HCV-infected index cases. Anti-HCV was detected in 2.1% of the members of their original families, and in 13.8% of 2662 sexual partners. The overall rate of infection for offspring was 2.3%, but the risk was significantly higher when the index case was female. The risk for sexual partners was significantly higher when the risk factor for the index case was intravenous drug (IVD) use rather than blood transfusion. Logistic regression analysis showed that female gender and drug addiction in sexual partners of index case were independent factors significantly associated with HCV transmission to sexual partners. Conclusions: Among all family members of index cases, sexual partners of IVD users were at greatest risk of HCV infection. Sexual transmission may not be the main route of transmission though, since IVD use in the sexual partners themselves was independently associated with HCV infection.     

吸毒人员中丙型肝炎病毒感染状况及其影响因素

目的 了解吸毒人群中丙型肝炎病毒（HCV）感染状况及其影响因素,为HCV感染的防制提供科学依据.方法 采用现况研究,随机抽取长沙和株州市2个戒毒所吸毒人员为调查对象,以面对面的问卷调查收集吸毒人员的有关资料,并采集血标本772份,用酶联免疫吸附试验（ELISA法）检测血清中抗-HCV.采用SPSS 13.0软件进行统计学分析.结果 772名吸毒人员中检出阳性人数662人,总感染率为85.75%;单因素分析：不同性别（χ^212.03,P＜0.01）,不同年龄（χ^27.56,P＜0.05）,不同吸毒方式（χ^2119.80,P＜0.01）,不同静脉注射时间（χ^29.42,P＜0.01）,是否共用注射针头（χ^216.24,P＜0.01）,注射针筒不同清洗用水（χ^27.49,P＜0.05）,不同入所次数（χ^229.34,P＜0.01）的HCV感染率差异有统计学意义.多因素分析：吸毒人员中HCV的感染与性别、吸毒方式、注射针筒清洗用水、静脉注射时间有关.结论 吸毒人员是HCV感染的高危人群.HCV感染的影响因素有性别、吸毒方式、注射针筒清洗用水和静脉注射时间.     

血清半乳糖凝集素-3水平在HBV感染中的作用

目的:探讨血清半乳糖凝集素-3水平对区分和监测慢性乙型肝炎病毒(HBV)活动是否有益.方法:50例慢性乙型肝炎(CHB)患者和45例HBV携带者.另选取50例同期健康体检者为对照组.肝功能及凝血功能等临床项目通过全自动生化分析仪检测.血清半乳糖凝集素-3水平使用定量酶联免疫吸附试剂盒测定.结果:CHB组血清半乳糖凝集素-3水平显著高于HBV携带组和对照组[(16.59±3.46)ng/mL vs(1.1±0.3)ng/mL和(0.7±0.5)ng/mL,P<0.000];CHB组ALT水平显著高于HBV携带组和对照组[(100.14±9.76)U/L vs(20.13±3.28)U/L和(18.44±2.54)U/L,P<0.000].相关性分析显示CHB组血清半乳糖凝集素-3与ALT水平显著相关(r=0.82,P<0.001).结论:半乳糖凝集素-3可能是预测HBV感染活动的有用指标.     

Cost-Effectiveness Analysis of Boceprevir for the Treatment of Chronic Hepatitis C Virus Genotype 1 Infection in Portugal

Background

The recent approval of two protease inhibitors, boceprevir and telaprevir, is likely to change the management of chronic hepatitis C virus (HCV) genotype 1 infection.

Objectives

We evaluated the long-term clinical outcomes and the cost effectiveness of therapeutic strategies using boceprevir with peginterferon plus ribavirin (PR) in comparison with PR alone for treating HCV genotype 1 infection in Portugal.

Methods

A Markov model was developed to project the expected lifetime costs and quality-adjusted life-years (QALYs) associated with PR alone and the treatment strategies outlined by the European Medicines Agency in the boceprevir summary of product characteristics. The boceprevir-based therapeutic strategies differ according to whether or not the patient was previously treated and whether or not the patient had compensated cirrhosis. The model simulated the experience of a series of cohorts of chronically HCV-infected patients (each defined by age, sex, race and fibrosis score). All treatment-related inputs were obtained from boceprevir clinical trials – SPRINT-2, RESPOND-2 and PROVIDE. Estimates of the natural history parameters and health state utilities were based on published studies. Portugal-specific annual direct costs of HCV health states were estimated by convening a panel of experts to derive health state resource use and multiplying the results by national unit costs. The model was developed from a healthcare system perspective with a timeframe corresponding to the remaining duration of the patients’ lifetimes. Both future costs and QALYs were discounted at 5 %. To test the robustness of the conclusions, we conducted deterministic and probabilistic sensitivity analyses.

Results

In comparison with the treatment with PR alone, boceprevir-based regimens were projected to reduce the lifetime incidence of advanced liver disease, liver transplantation, and liver-related death by 45–51 % and increase life expectancy by 2.3–4.3 years. Although the addition of BOC increased treatment costs by €13,300–€19,700, the reduction of disease burden resulted in a decrease of €5,400–€9,000 in discounted health state costs and an increase of 0.68–1.23 in discounted QALYs per patient. The incremental cost-effectiveness ratios of the boceprevir-based regimens compared with PR among previously untreated and previously treated patients were €11,600/QALY and €8,700/QALY, respectively. The results were most sensitive to variations in sustained virologic response rates, discount rates and age at treatment.

Conclusions

Adding boceprevir to PR was projected to reduce the number of liver complications and liver-related deaths, and to be cost effective in treating both previously untreated and treated patients.     

125例慢性乙肝病毒感染住院患者临床特征分析

目的通过调查分析某院慢性HBV感染住院患者的临床特征,为制定传染病防制对策提供参考依据。方法采用回顾性描述研究的方法,调查患者的一般情况、临床表现、病程、外周血血小板检测结果等。结果慢性乙肝的发病年龄以20~35岁居多,肝硬化和肝癌均在35岁以上;临床表现:慢性乙肝以乏力、纳差为主,肝硬化除乏力纳差外,腹胀明显,肝癌除乏力外,肝区痛较为突出;三者均有不同程度的外周血血小板减少,特别是肝硬化患者血小板减少最为明显。结论慢性HBV感染危害大,应积极推广成年人乙肝疫苗的预防接种;定期作好健康体检,及早诊断,及时治疗,以阻断HBV的持续感染。     

Cost-Effectiveness of Boceprevir in Patients Previously Treated for Chronic Hepatitis C Genotype 1 Infection in the United States

ObjectivesThe phase 3 trial, Serine Protease Inhibitor Boceprevir and PegIntron/Rebetol-2 (RESPOND-2), demonstrated that the addition of boceprevir (BOC) to peginterferon-ribavirin (PR) resulted in significantly higher rates of sustained virologic response (SVR) in previously treated patients with chronic hepatitis C virus (HCV) genotype-1 infection as compared with PR alone. We evaluated the cost-effectiveness of treatment with BOC in previously treated patients with chronic hepatitis C in the United States using treatment-related data from RESPOND-2 and PROVIDE studies.MethodsWe developed a Markov cohort model to project the burden of HCV disease, lifetime costs, and quality-adjusted life-years associated with PR and two BOC-based therapies—response-guided therapy (BOC/RGT) and fixed-duration therapy for 48 weeks (BOC/PR48). We estimated treatment-related inputs (efficacy, adverse events, and discontinuations) from clinical trials and obtained disease progression rates, costs, and quality-of-life data from published studies. We estimated the incremental cost-effectiveness ratio (ICER) for BOC-based regimens as studied in RESPOND-2, as well as by patient’s prior response to treatment and the IL-28B genotype.ResultsBOC-based regimens were projected to reduce the lifetime incidence of liver-related complications by 43% to 53% in comparison with treatment with PR. The ICER of BOC/RGT in comparison with that of PR was $30,200, and the ICER of BOC/PR48 in comparison with that of BOC/RGT was $91,500. At a willingness-to-pay threshold of $50,000, the probabilities of BOC/RGT and BOC/PR48 being the preferred option were 0.74 and 0.25, respectively.ConclusionsIn patients previously treated for chronic HCV genotype-1 infection, BOC was projected to increase quality-adjusted life-years and reduce the lifetime incidence of liver complications. In addition, BOC-based therapies were projected to be cost-effective in comparison with PR alone at commonly used willingness-to-pay thresholds.     

单采浆还输血球献血员中的丙型肝炎病毒感染的调查报告

对６２１名单采浆ＨＢｓＡｇ阴性献血员及３５４名ＨＢｓＡｇ阴性非献血者和１２４名单采浆ＨＢｓＡｇ阳性献血员及１２４名ＨＢｓＡｇ阳性非献血者进行调查，结果－ＨＣＶ阳性率分别为８４．２２％（５２３／６２１）、０．８５％（３／３５４）、４１．９４％（５２／１２４）、１．６１％（２／１２４），肝炎现患率分别为３４．９４％（２１７／６２１）、１．９８％（７／３５４）、１８．５５％（２３／１２４）、４．８４％（６／１２４）。调查结果表明，ＨＣＶ的感染和丙型肝炎的流行主要发生在单采浆还输血球献血员中。提示在单采浆还输血球过程中应注意避免医源性交叉感染以及对所有献血员、输成分血和用于制备注射用制品的血浆检测抗－ＨＣＶ是非常必要的。在血浆制品的制备工艺中能否将ＨＣＶ全部灭活是一个十分值得重视的问题。     

一起丙型肝炎感染事件引发的思考

回顾某县医院血透室丙型肝炎病毒感染事件,分析事件发生原因。建议:一是加强基层医院从业人员技能培训,加强自查及行业督查,提高感染科执行力和管理能力;二是医护人员应树立标准预防理念,严格规范操作,严防类似感染事件再次发生。