Faculty of Health, Queensland University of Technology , Brisbane, Australia.
Expert Opin Investig Drugs. 2020 Aug;29(8):793-796. doi: 10.1080/13543784.2020.1777277. Epub 2020 Jun 12.
Lopinavir in combination with ritonavir is approved for the treatment of HIV and has recently been subject to a clinical trial in severe COVID-19.
This evaluation is of LOTUS China (the Lopinavir Trial for Suppression of SARS-Cov-2 in China), which was a randomized trial in hospitalized subjects with COVID-9 in a respiratory sample and pneumonia. As, in severe COVID-19, lopinavir/ritonavir had no beneficial effects but increased gastrointestinal adverse effects, this combination should not be used at this stage of COVID-19.
In my opinion, the rationale for undertaking a trial of lopinavir/ritonavir in COVID-19 was poor. The analysis of a modified intention to treat group analysis in LOTUS China may have introduced bias. After LOTUS China, there is probably no future for lopinavir in the treatment of severe COVID-19, but some clinical trials for prevention or in various stages of COVID-19 have recently started or are ongoing. The major limitation of these trials is that as lopinavir does not inhibit COVID-19, it is unlikely to prevent infection, reduce viral load, or reduce the severity. However, these trials may be worthwhile in finally determining whether lopinavir has any role in preventing or treating COVID-19.
洛匹那韦与利托那韦的联合制剂已被批准用于治疗 HIV,最近已在严重 COVID-19 中进行临床试验。
本文评估的是 LOTUS China(洛匹那韦在中国抑制 SARS-CoV-2 的试验),这是一项针对呼吸道样本和肺炎中 COVID-9 住院患者的随机试验。由于在严重 COVID-19 中,洛匹那韦/利托那韦没有有益效果,但会增加胃肠道不良反应,因此在 COVID-19 的现阶段不应使用这种联合用药。
在我看来,在 COVID-19 中开展洛匹那韦/利托那韦试验的理由并不充分。LOTUS China 中对修改后的意向治疗组分析可能引入了偏倚。在 LOTUS China 之后,洛匹那韦治疗严重 COVID-19 的前景可能不大,但最近已经开始或正在进行一些用于预防或治疗 COVID-19 不同阶段的临床试验。这些试验的主要局限性在于,由于洛匹那韦不能抑制 COVID-19,因此不太可能预防感染、降低病毒载量或减轻病情。然而,这些试验最终可能会确定洛匹那韦在预防或治疗 COVID-19 方面是否有任何作用。