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PLoS One. 2017 Jul 13;12(7):e0179764. doi: 10.1371/journal.pone.0179764. eCollection 2017.
2
Real-World Single-Center Experience with Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Patients.索磷布韦为基础方案治疗慢性丙型肝炎基因 1 型患者的真实世界单中心经验。
Gut Liver. 2017 Sep 15;11(5):711-720. doi: 10.5009/gnl16447.
3
Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review.丙型肝炎病毒感染的口服直接作用抗病毒药物治疗:一项系统评价
Ann Intern Med. 2017 May 2;166(9):637-648. doi: 10.7326/M16-2575. Epub 2017 Mar 21.
4
Systematic review: interferon-free regimens for patients with HCV-related Child C cirrhosis.系统评价:无干扰素方案治疗丙型肝炎相关 C 型肝硬化患者。
Aliment Pharmacol Ther. 2017 May;45(9):1193-1200. doi: 10.1111/apt.14017. Epub 2017 Mar 6.
5
Real-world effectiveness and predictors of sustained virological response with all-oral therapy in 21,242 hepatitis C genotype-1 patients.21242例丙型肝炎基因1型患者接受全口服治疗的真实世界疗效及持续病毒学应答的预测因素
Antivir Ther. 2017;22(6):481-493. doi: 10.3851/IMP3117. Epub 2016 Dec 9.
6
The effects of alcohol on spontaneous clearance of acute hepatitis C virus infection in females versus males.酒精对女性和男性急性丙型肝炎病毒感染自发清除的影响。
Drug Alcohol Depend. 2016 Dec 1;169:156-162. doi: 10.1016/j.drugalcdep.2016.10.024. Epub 2016 Oct 26.
7
All-oral direct-acting antiviral therapy in HCV-advanced liver disease is effective in real-world practice: observations through HCV-TARGET database.直接作用抗病毒药物的全口服方案治疗慢性丙型肝炎合并晚期肝病的疗效:来自 HCV-TARGET 数据库的真实世界观察。
Aliment Pharmacol Ther. 2017 Jan;45(1):115-126. doi: 10.1111/apt.13823. Epub 2016 Oct 28.
8
Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of Patients With Hepatitis C in the Veterans Affairs National Health Care System.索非布韦、来迪帕司韦/索非布韦、或帕利瑞韦/利托那韦/奥比他韦与达沙布韦治疗方案在退伍军人事务部国家医疗保健系统中治疗丙型肝炎患者的有效性。
Gastroenterology. 2016 Sep;151(3):457-471.e5. doi: 10.1053/j.gastro.2016.05.049. Epub 2016 Jun 4.
9
Systematic review: current concepts and challenges for the direct-acting antiviral era in hepatitis C cirrhosis.系统评价:丙型肝炎肝硬化直接作用抗病毒时代的现状概念和挑战。
Aliment Pharmacol Ther. 2016 Jun;43(12):1276-92. doi: 10.1111/apt.13633. Epub 2016 Apr 18.
10
Simeprevir plus sofosbuvir in patients with chronic hepatitis C virus genotype 1 infection and cirrhosis: A phase 3 study (OPTIMIST-2).西米普明联合索磷布韦治疗慢性丙型肝炎病毒1型感染合并肝硬化患者:一项3期研究(OPTIMIST-2)。
Hepatology. 2016 Aug;64(2):360-9. doi: 10.1002/hep.28422. Epub 2016 Feb 19.

俄克拉荷马州医疗补助计划中直接作用抗病毒药物治疗慢性丙型肝炎感染的持续病毒学应答率和成本。

Sustained Virologic Response and Costs Associated with Direct-Acting Antivirals for Chronic Hepatitis C Infection in Oklahoma Medicaid.

机构信息

1 University of Oklahoma College of Pharmacy, Oklahoma City.

2 University of Oklahoma College of Public Health, Oklahoma City.

出版信息

J Manag Care Spec Pharm. 2018 Jul;24(7):664-676. doi: 10.18553/jmcp.2018.24.7.664.

DOI:10.18553/jmcp.2018.24.7.664
PMID:29952711
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10398076/
Abstract

BACKGROUND

Outcomes involving newer direct-acting antiviral (DAA) hepatitis C virus (HCV) regimens have not been studied extensively among the Medicaid population.

OBJECTIVE

To assess clinical (treatment failure) and economic outcomes for chronic HCV-infected Oklahoma Medicaid members following treatment with DAAs and to measure associations with patient, treatment, and clinical characteristics.

METHODS

This cross-sectional study used Oklahoma Medicaid pharmacy and medical claims data for adult members who used a newer DAA agent and had reported a successful or failed sustained virological response rate 12 weeks after therapy completion (SVR12) from January 1, 2014, to June 30, 2016. Multivariable logistic and gamma regressions assessed predictors of SVR12 failure and costs controlling for member demographics (i.e., age, sex, race, rural residence); type of DAA and adherence; clinical characteristics (e.g., comorbid conditions, advanced liver disease); and the implementation of changes to a prior authorization program.

RESULTS

Of 934 Medicaid members eligible for treatment with DAAs between January 1, 2014, and June 30, 2016, 906 received DAA treatment, 40.6% (368/906) had reported SVR12 outcomes, and 59.4% (n = 538) did not have a reported SVR recorded. Of those with reported SVR12 outcomes, patients were 53.1 ± 9.7 years of age, 51.1% were male, 8.4% had SVR12 failure, and each member had mean costs of $140,283 ± $52,779. Multivariable analyses indicated higher odds of SVR12 failure was independently associated with cirrhosis (OR [decompensated] = 6.69 and OR [compensated] = 3.52, P < 0.001), while males had higher odds of failure than females (OR = 3.34, P < 0.010). No significant difference in SVR12 failure was noted, according to DAA type or a medication adherence threshold of > 95%. Ledipasvir/sofosbuvir was independently associated with lower costs (exp[b] = 0.81; P < 0.001) compared with sofosbuvir, while higher costs were associated with decompensated cirrhosis (exp[b] = 1.22; P < 0.001) and treatment failure (exp[b] = 1.18, P < 0.010). In an analysis including members without reported SVR12 outcomes, decompensated and compensated cirrhosis had lower odds (P < 0.001) of no reported SVR12 from ambulatory clinic settings.

CONCLUSIONS

Almost 60% of Medicaid members receiving DAA treatment did not have a final reported SVR12 outcome. Among those with viral load measurements, treatment success was high and both decompensated and compensated cirrhosis were independently associated with significantly higher odds of treatment failure. Addressing a loss to follow-up among HCV patients and curtailing the development of cirrhosis to improve treatment success may warrant interventions that improve access to care and remove barriers that impede treatment initiation and completion.

DISCLOSURES

No outside funding supported this study. Pham, Keast, Holderread, Nesser, and Skrepnek disclose either employment by the Oklahoma Health Care Authority or contractual work for this employer. Pham discloses fellowship funding from Purdue Pharma unrelated to this study. Keast and Skrepnek disclose research grant funding from Gilead Sciences and Abbvie. Holderread also reports grant funding from Gilead Sciences and fees from PRIME Education. Thompson, Farmer, and Rathbun have nothing to disclose.

摘要

背景

在医疗补助(Medicaid)人群中,尚未广泛研究涉及新型直接作用抗病毒(DAA)丙型肝炎病毒(HCV)方案的结局。

目的

评估俄克拉荷马州医疗补助慢性 HCV 感染成员接受 DAA 治疗后的临床(治疗失败)和经济结局,并测量与患者、治疗和临床特征的关联。

方法

本横断面研究使用俄克拉荷马州医疗补助药房和医疗索赔数据,纳入自 2014 年 1 月 1 日至 2016 年 6 月 30 日期间使用新型 DAA 药物且治疗完成后 12 周(SVR12)时报告成功或失败持续病毒学应答率的成年成员。多变量逻辑和伽马回归评估了 SVR12 失败和成本的预测因子,控制了成员的人口统计学特征(即年龄、性别、种族、农村居住);DAA 和依从性的类型;临床特征(如合并症、晚期肝病);以及对先前授权计划的变更的实施。

结果

在 2014 年 1 月 1 日至 2016 年 6 月 30 日期间有资格接受 DAA 治疗的 934 名医疗补助成员中,906 名接受了 DAA 治疗,40.6%(368/906)报告了 SVR12 结局,59.4%(n=538)未报告 SVR 记录。在有报告 SVR12 结局的患者中,患者年龄为 53.1±9.7 岁,51.1%为男性,8.4%治疗失败,每位患者的平均费用为 140283±52779 美元。多变量分析表明,SVR12 失败的可能性更高,与肝硬化独立相关(代偿失调的 OR [值] =6.69,代偿失调的 OR [值] =3.52,P <0.001),而男性比女性更有可能失败(OR =3.34,P <0.010)。根据 DAA 类型或 >95%的药物依从性阈值,SVR12 失败的发生率无显著差异。与索非布韦相比,利巴韦林/索非布韦独立与较低的成本相关(exp[b]=0.81;P <0.001),而失代偿性肝硬化(exp[b]=1.22;P <0.001)和治疗失败(exp[b]=1.18,P <0.010)与较高的成本相关。在包括无报告 SVR12 结局的成员的分析中,失代偿和代偿性肝硬化在门诊环境中报告无 SVR12 的可能性较低(P <0.001)。

结论

近 60%接受 DAA 治疗的医疗补助成员没有最终报告 SVR12 结果。在有病毒载量测量的患者中,治疗成功率很高,失代偿和代偿性肝硬化均与治疗失败的风险显著增加独立相关。解决 HCV 患者的失访问题,并遏制肝硬化的发展以提高治疗成功率,可能需要采取改善获得医疗保健的机会和消除妨碍治疗启动和完成的障碍的干预措施。

披露

本研究无外部资金支持。Pham、Keast、Holderread、Nesser 和 Skrepnek 要么受雇于俄克拉荷马州卫生保健管理局,要么与该雇主签订合同。Pham 披露了与 Purdue Pharma 无关的普渡制药奖学金。Keast 和 Skrepnek 报告了从 Gilead Sciences 和 Abbvie 获得研究资助。Holderread 还报告了从 Gilead Sciences 获得资助和从 PRIME Education 获得费用。Thompson、Farmer 和 Rathbun 没有要披露的内容。