科研之友
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摘要
BACKGROUND: The introduction of the first direct-acting antiviral agents (DAAs) for the treatment of hepatitis C virus (HCV), telaprevir and boceprevir, marked a unique event in which 2 disease-changing therapies received FDA approval at the same time. Comparative safety and effectiveness data in real-world populations upon which to make formulary decisions did not exist. OBJECTIVE: To describe the implementation, measurement, and outcomes of an enduring population-based approach of surveillance of medication management for HCV. METHODS: The foundation of the population approach to HCV medication management used by the Department of Veterans Affairs (VA) relied upon a basic framework of (a) providing data for effective regional and local management, (b) education and training, (c) real-time oversight and feedback from a higher organization level, and (d) prompt outcome sharing. These population-based processes spanned across the continuum of the direct-acting antiviral oversight process. We used the VA's HCV Clinical Case Registry-which includes pharmacy, laboratory, and diagnosis information for all HCV-infected veterans from all VA facilities-to assess DAA treatment eligibility, DAA uptake and timing, appropriate use of DAAs including HCV RNA monitoring and medication possession ratios (MPR), nonconcordance with guidance for adjunct erythropoiesis-stimulating agent (ESA) and granulocyte colony-stimulating factor (GCSF) use, hematologic adverse effects, discontinuation rates, and early and sustained virologic responses. Training impact was assessed via survey and change in pharmacist scope of practice. RESULTS: One year after FDA approval, DAAs had been prescribed at 120 of 130 VA facilities. Over 680 VA providers participated in live educational training programs including 380 pharmacists, and pharmacists with a scope of practice for HCV increased from 59 to 110 pharmacists (86%). HCV RNA futility testing improved such that only 1%-3% of veterans did not have appropriate testing compared with 15%-17% 6 months earlier. By facility, the median proportion of veterans with MPR >= 0.95 remained 80% for those prescribed boceprevir; for telaprevir, the median proportion was 75% and improved to 80% 6 months later. Nonconcordance with VA medication guidance was as follows: receipt of an ESA without dose reducing ribavirin, 30% boceprevir, 45% telaprevir; ESA initiated with a hemoglobin greater than 10 g/dL, 42% boceprevir, 25% telaprevir; receipt of GCSF with absolute neutrophil count above the criteria threshold, 84%. CONCLUSIONS: This clinically focused, comprehensive, population-based medication management approach affected real-time change in health services, practice, and outcomes evidenced by widespread and rapid DAA uptake, improved HCV RNA monitoring, attention to adherence, and more appropriate management of DAA-related anemia. Timely outcome sharing provided decision makers and clinicians evidence to support current HCV practices.
- 出版日期2014-6
