Cambodia Mission, Médecins Sans Frontières, Phnom Penh, Cambodia; Field Epidemiology and Training Department, Epicentre, Paris, France.
Cambodia Mission, Médecins Sans Frontières, Phnom Penh, Cambodia; Disease Elimintion, Burnet Institute, Melbourne, VIC, Australia.
Lancet Gastroenterol Hepatol. 2021 May;6(5):371-380. doi: 10.1016/S2468-1253(21)00012-1. Epub 2021 Mar 19.
Direct-acting antiviral treatment for hepatitis C virus (HCV) has provided the opportunity for simplified models of care delivered in decentralised settings by non-specialist clinical personnel. However, in low-income and middle-income countries, increasing overall access to HCV care remains an ongoing issue, particularly for populations outside of urban centres. We therefore aimed to implement a simplified model of HCV care via decentralised health services within a rural health operational district in Battambang province, Cambodia.
The study cohort included adult residents (≥18 years) of the health operational district of Moung Russei who were voluntarily screened at 13 local health centres. Serology testing was done by a rapid diagnostic test using SD Bioline HCV (SD Bioline HCV, Standard Diagnostics, South Korea) with capillary blood. HCV viral load testing was done by GeneXpert (Cepheid, Sunnyvale, CA, USA). Viraemic patients (HCV viral load ≥10 IU/mL) received pretreatment assessment by a general physician and minimal treatment evaluation tests at the health operational district referral hospital. Viraemic patients who did not have additional complications received all HCV care follow-up at the local health centres, provided by nursing staff, and patients who had decompensated cirrhosis, previously treated with a direct-acting antiviral, HBV co-infection, or other comorbidities requiring observation continued receiving care at the referral hospital with a general physician. Patients deemed eligible for treatment were prescribed oral sofosbuvir (400 mg) and daclatasvir (60 mg) once a day for 12 weeks, or 24 weeks for patients with decompensated cirrhosis or those previously treated with a direct-acting antiviral. HCV cure was defined as sustained virological response at 12 weeks after treatment (HCV viral load <10 IU/mL). Patients were assessed for serious and non-serious adverse events at any time between treatment initiation and 12 weeks post-treatment testing.
Between March 12, 2018, and Jan 18, 2019, 10 425 residents (ie, 7·6% of the estimated 136 571 adults in the health operational district of Moung Russei) were screened. Of those patients screened, the median age was 44 years (IQR 31-55) and 778 (7·5%) were HCV-antibody positive. 761 (97·8%) of 778 antibody-positive patients received HCV viral load testing, and 540 (71·0%) of those tested were HCV viraemic. Among these 540 patients, linkage to treatment and follow-up care was high, with 533 (98·7%) attending a baseline consultation at the HCV clinic, of whom 530 (99·4%) initiated treatment. 485 (91·5%) of 530 patients who initiated treatment received follow-up at a health centre and 45 (8·5%) were followed up at the referral hospital. Of the 530 patients who initiated direct-acting antiviral therapy, 515 (97·2%) completed treatment. Subsequently, 466 (90·5%) of 515 patients completed follow-up, and 459 (98·5%) of 466 achieved a sustained virological response at 12 weeks after treatment. Two (0·4%) adverse events (fatigue [n=1] and stomach upset [n=1]) and five (0·9%) serious adverse events (infection [n=2], cardiovascular disease [n=1], and panic attack [n=1], with data missing for one of the causes of serious adverse events) were reported among patients who initiated treatment. All serious adverse events were deemed to be unrelated to therapy.
This pilot project showed that a highly simplified, decentralised model of HCV care can be integrated within a rural public health system in a low-income or middle-income country, while maintaining high patient retention, treatment efficacy, and safety. The project delivered care via accessible, decentralised primary health centres, using non-specialist clinical staff, thereby enhancing the efficient use of limited resources and maximising the potential to test and treat individuals living with HCV infection.
Médecins Sans Frontières.
直接作用抗病毒药物治疗丙型肝炎病毒（HCV）为非专科临床医务人员在分散环境中提供简化的护理模式提供了机会。然而，在低收入和中等收入国家，特别是在城市中心以外的人群中，增加整体 HCV 护理的可及性仍然是一个持续存在的问题。因此，我们旨在通过柬埔寨马德望省莫鲁塞伊农村卫生运营区的分散卫生服务实施 HCV 护理简化模式。
研究队列包括自愿在 13 个当地卫生中心接受筛查的莫鲁塞伊卫生运营区成年居民（≥18 岁）。使用 SD Bioline HCV（SD Bioline HCV，Standard Diagnostics，韩国）和毛细血管血进行快速诊断测试进行血清学检测。使用 GeneXpert（Cepheid，Sunnyvale，CA，USA）进行 HCV 病毒载量检测。病毒血症患者（HCV 病毒载量≥10 IU/mL）在卫生运营区转诊医院接受全科医生的治疗前评估和最低治疗评估测试。没有其他并发症的病毒血症患者在当地卫生中心接受所有 HCV 护理随访，由护理人员提供，代偿性肝硬化、先前接受直接作用抗病毒药物治疗、HBV 合并感染或需要观察的其他合并症的患者继续在转诊医院接受全科医生的护理。符合治疗条件的患者每天服用口服索磷布韦（400mg）和达卡他韦（60mg）治疗 12 周，或对失代偿性肝硬化或先前接受直接作用抗病毒药物治疗的患者治疗 24 周。持续病毒学应答定义为治疗后 12 周时 HCV 病毒载量<10 IU/mL。在治疗开始至治疗后 12 周检测之间的任何时间，评估患者的严重和非严重不良事件。
2018 年 3 月 12 日至 2019 年 1 月 18 日，筛查了 10425 名居民（即莫鲁塞伊卫生运营区估计的 136571 名成年人中的 7.6%）。在接受筛查的患者中，中位年龄为 44 岁（IQR 31-55），778 人（7.5%）抗 HCV 抗体阳性。778 名抗体阳性患者中 761 人（97.8%）接受 HCV 病毒载量检测，其中 540 人（71.0%）检测呈 HCV 病毒血症。在这 540 名患者中，与治疗和随访护理的联系率很高，540 名患者中有 533 名（98.7%）在 HCV 诊所进行了基线咨询，其中 530 名（99.4%）开始治疗。530 名开始治疗的患者中，530 名（99.4%）中有 533 名（98.7%）参加了基线咨询，其中 530 名（99.4%）开始治疗。530 名开始直接作用抗病毒治疗的患者中，515 名（97.2%）完成治疗。随后，466 名（90.5%）接受治疗的患者在卫生中心接受了随访，45 名（8.5%）在转诊医院接受了随访。在接受直接作用抗病毒药物治疗的 530 名患者中，466 名（90.5%）完成了随访，459 名（98.5%）在治疗后 12 周时实现了持续病毒学应答。在开始治疗的患者中报告了 2 例（0.4%）不良事件（疲劳[n=1]和胃部不适[n=1]）和 5 例（0.9%）严重不良事件（感染[n=2]、心血管疾病[n=1]和惊恐发作[n=1]，其中 1 例严重不良事件的原因数据缺失）。所有严重不良事件均被认为与治疗无关。
该试点项目表明，在低收入或中等收入国家，一种高度简化的、分散的 HCV 护理模式可以整合到农村公共卫生系统中，同时保持高患者保留率、治疗效果和安全性。该项目通过可及性强的分散初级卫生中心，利用非专科临床人员提供护理，从而提高了有限资源的有效利用，并最大限度地提高了检测和治疗 HCV 感染患者的潜力。
无国界医生组织。
