Jayasekera Channa R, Perumpail Ryan B, Chao David T, Pham Edward A, Aggarwal Avin, Wong Robert J, Ahmed Aijaz
Dig Dis Sci. 2015 Dec;60(12):3552-7. doi: 10.1007/s10620-015-3911-6.
Despite the availability of safe and effective direct-acting antiviral drugs (DAAs), the vast majority of patients with chronic hepatitis C (HCV) in the USA remain untreated, in part due to lack of access to specialist providers.
To determine the effectiveness of DAA-based treatment in medically underserved areas in California, in a healthcare model dependent on task-shifting--wherein a visiting hepatologist assesses patients for treatment eligibility, but subsequent routine follow-up evaluation of patients prescribed treatment is devolved to a part-time licensed vocational nurse under remote supervision of the hepatologist.
We retrospectively determined rates of sustained virologic response 12 weeks after treatment completion (SVR-12), adverse events, and treatment discontinuations in patients who received sofosbuvir-based DAA regimens between December 2013 and November 2014.
Despite limited specialist provider involvement in medically underserved areas, all but two of 58 patients completed treatment, and 88 % of patients achieved the curative endpoint of undetectable HCV RNA 12 weeks after completing treatment (sustained virologic response, SVR-12). Almost 80 % of patients with cirrhosis and 85 % of patients with prior treatment experience achieved SVR-12.
Treatment effectiveness with sofosbuvir-based regimens in medically underserved areas utilizing task-shifting from a specialist to a mid-level provider is comparable to those achieved in pivotal clinical trials for these regimens, and to “real-world” experiences of tertiary care centers in the USA.
尽管有安全有效的直接抗病毒药物（DAA），但美国绝大多数慢性丙型肝炎（HCV）患者仍未接受治疗，部分原因是难以获得专科医生的服务。
在一种依赖任务转移的医疗模式下，确定基于DAA的治疗在加利福尼亚州医疗服务不足地区的有效性。在这种模式中，出诊的肝病专家评估患者的治疗资格，但后续对接受治疗的患者的常规随访评估则下放给一名兼职执业职业护士，由肝病专家进行远程监督。
我们回顾性地确定了2013年12月至2014年11月期间接受基于索磷布韦的DAA治疗方案的患者在治疗完成后12周的持续病毒学应答率（SVR-12）、不良事件和治疗中断情况。
尽管专科医生在医疗服务不足地区的参与有限，但58例患者中除2例之外均完成了治疗，88%的患者在完成治疗12周后达到了HCV RNA检测不到的治愈终点（持续病毒学应答，SVR-12）。近80%的肝硬化患者和85%有既往治疗经历的患者实现了SVR-12。
在医疗服务不足地区，利用从专科医生到中级医疗人员的任务转移模式，基于索磷布韦的治疗方案的有效性与这些方案在关键临床试验中所取得的效果相当，也与美国三级医疗中心的“真实世界”经验相当。
