FIND, Geneva, Switzerland.
FIND, Geneva, Switzerland
BMJ Open. 2021 Dec 24;11(12):e055142. doi: 10.1136/bmjopen-2021-055142.
To achieve the elimination of hepatitis C virus (HCV), substantial scale-up in access to testing and treatment is needed. This will require innovation and simplification of the care pathway, through decentralisation of testing and treatment to primary care settings and task-shifting to non-specialists. The objective of this study was to evaluate the feasibility and effectiveness of decentralisation of HCV testing and treatment using rapid diagnostic tests (RDTs) in primary healthcare clinics (PHCs) among high-risk populations, with referral of seropositive patients for confirmatory viral load testing and treatment.
This observational study was conducted between December 2018 and October 2019 at 25 PHCs in three regions in Malaysia. Each PHC was linked to one or more hospitals, for referral of seropositive participants for confirmatory testing and pretreatment evaluation. Treatment was provided in PHCs for non-cirrhotic patients and at hospitals for cirrhotic patients.
During the study period, a total of 15 366 adults were screened at the 25 PHCs, using RDTs for HCV antibodies. Of the 2020 (13.2%) HCV antibody-positive participants, 1481/2020 (73.3%) had a confirmatory viral load test, 1241/1481 (83.8%) were HCV RNA-positive, 991/1241 (79.9%) completed pretreatment assessment, 632/991 (63.8%) initiated treatment, 518/632 (82.0%) completed treatment, 352/518 (68.0%) were eligible for a sustained virological response (SVR) cure assessment, 209/352 (59.4%) had an SVR cure assessment, and SVR was achieved in 202/209 (96.7%) patients. A significantly higher proportion of patients referred to PHCs initiated treatment compared with those who had treatment initiated at hospitals (71.0% vs 48.8%, p<0.001).
This study demonstrated the effectiveness and feasibility of a simplified decentralised HCV testing and treatment model in primary healthcare settings, targeting high-risk groups in Malaysia. There were good outcomes across most steps of the cascade of care when treatment was provided at PHCs compared with hospitals.
为了实现消除丙型肝炎病毒（HCV）的目标，需要大规模扩大检测和治疗的范围。这将需要通过将检测和治疗下放到基层医疗机构并将任务转移给非专业人员，对护理途径进行创新和简化。本研究的目的是评估在高风险人群中使用快速诊断检测（RDT）在基层医疗诊所（PHC）中进行 HCV 检测和治疗的可行性和有效性，对血清阳性患者进行确认性病毒载量检测和治疗。
本观察性研究于 2018 年 12 月至 2019 年 10 月在马来西亚三个地区的 25 个 PHC 进行。每个 PHC 都与一家或多家医院相连，用于对血清阳性参与者进行确认性检测和治疗前评估。对于非肝硬化患者在 PHC 提供治疗，对于肝硬化患者在医院提供治疗。
在研究期间，在 25 个 PHC 共筛查了 15366 名成年人，使用 HCV 抗体 RDT 进行检测。在 2020 名（13.2%）HCV 抗体阳性参与者中，1481/2020（73.3%）进行了确认性病毒载量检测，1241/1481（83.8%）HCV RNA 阳性，991/1241（79.9%）完成了治疗前评估，632/991（63.8%）开始治疗，518/632（82.0%）完成治疗，352/518（68.0%）有资格进行持续病毒学应答（SVR）治愈评估，209/352（59.4%）进行了 SVR 治愈评估，202/209（96.7%）患者获得 SVR。与在医院开始治疗的患者相比，转诊到 PHC 的患者开始治疗的比例显著更高（71.0%比 48.8%，p<0.001）。
本研究证明了简化的 HCV 检测和治疗模型在基层医疗环境中的有效性和可行性，针对马来西亚的高危人群。与在医院相比，在 PHC 提供治疗时，护理途径的大多数步骤都有较好的结果。
