Department of HIV, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland.
Science Division, Quality of Norms and Standards Department, World Health Organization, Geneva, Switzerland.
J Int AIDS Soc. 2020 Apr;23(4):e25489. doi: 10.1002/jia2.25489.
Several antiretroviral drugs are being considered for the treatment of COVID-19, the disease caused by a newly identified coronavirus, (SARS-CoV-2). We systematically reviewed the clinical outcomes of using antiretroviral drugs for the prevention and treatment of coronaviruses and planned clinical trials.
Three databases were screened from inception to 30 March 2020 for studies reporting clinical outcomes of patients with SARS, MERS or COVID-19 treated with antiretrovirals.
From an initial screen of 433 titles, two randomized trials and 24 observational studies provided clinical outcome data on the use of antiretroviral drugs; most studies reported outcomes using LPV/r as treatment. Of the 21 observational studies reporting treatment outcomes, there were three studies among patients with SARS, six studies among patients with MERS and 12 studies among patients with COVID-19. In one randomized trial 99 patients with severe COVID-19 illness were randomized to receive LPV/r (400/100 mg twice a day) and 100 patients to standard of care for 14 days: LPV/r was not associated with a statistically significant difference in time to clinical improvement, although LPV/r given within 12 days of symptoms was associated with shorter time to clinical improvement; 28 day mortality was numerically lower in the LPV/r group (14/99) compared to the control group (25/100), but this difference was not statistically significant. The second trial found no benefit. The certainty of the evidence for the randomized trials was low. In the observational studies 3 out of 361 patients who received LPV/r died; the certainty of evidence was very low. Three studies reported a possible protective effect of LPV/r as post-exposure prophylaxis. Again, the certainty of the evidence was very low due to uncertainty due to limited sample size.
On the basis of the available evidence it is uncertain whether LPV/r and other antiretrovirals improve clinical outcomes or prevent infection among patients at high risk of acquiring COVID-19.
几种抗逆转录病毒药物正在被考虑用于治疗 COVID-19，这是一种由新型冠状病毒（SARS-CoV-2）引起的疾病。我们系统地回顾了使用抗逆转录病毒药物预防和治疗冠状病毒的临床结果，并计划了临床试验。
从成立到 2020 年 3 月 30 日，我们在三个数据库中筛选了报告 SARS、MERS 或 COVID-19 患者接受抗逆转录病毒治疗的临床结果的研究。
从最初筛选的 433 个标题中，有两项随机试验和 24 项观察性研究提供了关于使用抗逆转录病毒药物的临床结果数据；大多数研究报告了使用 LPV/r 作为治疗的结果。在报告治疗结果的 21 项观察性研究中，有三项研究是针对 SARS 患者，六项研究是针对 MERS 患者，12 项研究是针对 COVID-19 患者。在一项针对 99 例严重 COVID-19 患者的随机试验中，患者被随机分为接受 LPV/r（400/100mg 每日两次）和 100 例接受标准治疗 14 天的组：LPV/r 与临床改善时间无统计学差异，尽管 LPV/r 在症状出现后 12 天内给药与临床改善时间缩短有关；LPV/r 组 28 天死亡率（14/99）低于对照组（25/100），但差异无统计学意义。第二项试验未发现获益。随机试验的证据确定性较低。在观察性研究中，接受 LPV/r 治疗的 361 例患者中有 3 例死亡；证据确定性非常低。三项研究报告了 LPV/r 作为暴露后预防的可能保护作用。同样，由于样本量有限导致的不确定性，证据确定性也非常低。
根据现有证据，尚不确定 LPV/r 和其他抗逆转录病毒药物是否能改善临床结果或预防 COVID-19 高危患者的感染。
