Fundação Oswaldo Cruz, Escola Nacional de Saúde Pública Sergio Arouca, Rio de Janeiro, RJ, Brazil.
Universidade Federal do Estado do Rio de Janeiro, Instituto de Saúde Coletiva, Rio de Janeiro, RJ, Brazil.
PLoS One. 2020 Feb 21;15(2):e0229143. doi: 10.1371/journal.pone.0229143. eCollection 2020.
Direct-acting agents (DAAs) for hepatitis C virus (HCV) treatment are safe and highly effective. Few studies described the sustained virologic response rates of treatment conducted by non-specialists. We performed a systematic review and meta-analysis to evaluate the effectiveness of decentralized strategies of HCV treatment with DAAs. PubMed, Embase, Scopus and LILACS were searched until March-2019. Studies were screened by two researchers according to the following inclusion criteria: HCV treatment using DAAs on real-life cohort studies or clinical trials conducted by non-specialized health personnel. The primary endpoint was the sustained virologic response rate at week 12 after the end-of-treatment (SVR12), which is binary at the patient level. Data were extracted in duplicate using electronic-forms and quality appraisal was performed with the NIH Quality Assessment Tool. Heterogeneity was assessed by I2 statistics. Random-effects meta-analysis models were used for pooling SVR12 rates. Publication bias was assessed using funnel plots. Among the 130 selected studies, nine papers were included for quantitative synthesis. The quality-appraisal was good for two, fair for three and poor for four studies. The pooled relative risk (RR) of SVR12 was not statistically different between decentralized strategy and treatment by specialists [RR = 1.05; 95% confidence interval (95% CI): 0.98-1.1; I2 = 45% (95% CI: 0-84%), p = 0.145]. SVR12 rate for decentralized HCV treatment was 81% [SVR12 95% CI: 72-89%; I2 = 93% (95% CI: 88-96%)] and 95% [SVR12 95%CI: 92-98%; I2 = 77% (95% CI: 52-89%)] with intention to treat analysis and per-protocol analysis, respectively. SVR12 rates using DAAs managed by non-specialized health personnel were satisfactory and similar to those obtained by specialists. This new delivery strategy can improve access to HCV treatment, especially in resource-limited settings. PROSPERO #: CRD42019122609.
直接作用抗病毒药物（DAA）治疗丙型肝炎（HCV）安全且高效。少数研究描述了非专业人员进行的治疗的持续病毒学应答率。我们进行了系统评价和荟萃分析，以评估 DAA 去中心化治疗策略的有效性。检索了 PubMed、Embase、Scopus 和 LILACS，截止日期为 2019 年 3 月。研究由两名研究人员根据以下纳入标准进行筛选：使用 DAA 的 HCV 治疗，真实队列研究或非专业卫生人员进行的临床试验。主要终点是治疗结束后 12 周的持续病毒学应答率（SVR12），这是患者水平上的二分变量。使用电子表格重复提取数据，并使用 NIH 质量评估工具进行质量评估。使用 I2 统计评估异质性。使用随机效应荟萃分析模型对 SVR12 率进行汇总。使用漏斗图评估发表偏倚。在 130 项选定研究中，有 9 篇论文纳入定量综合分析。其中两项研究的质量评估为良好，三项为中等，四项为较差。去中心化策略与专家治疗之间的 SVR12 汇总相对风险（RR）无统计学差异[RR = 1.05；95%置信区间（95%CI）：0.98-1.1；I2 = 45%（95%CI：0-84%），p = 0.145]。去中心化 HCV 治疗的 SVR12 率为 81%[SVR12 95%CI：72-89%；I2 = 93%（95%CI：88-96%）]和 95%[SVR12 95%CI：92-98%；I2 = 77%（95%CI：52-89%）]，意向治疗分析和方案分析分别。非专业卫生人员管理的 DAA 的 SVR12 率令人满意，与专家获得的结果相似。这种新的治疗策略可以提高 HCV 治疗的可及性，特别是在资源有限的环境中。PROSPERO 注册号：CRD42019122609。
