Our dynamic systematic benefit-risk analysis of antiviral drug combination lopinavir-ritonavir for COVID-19 patients has just been published. Our research team found there was no clear benefit for the use of lopinavir-ritonavir compared to standard of care in severe COVID-19.
This semi-quantitative analysis used the Benefit-Risk Action Team (BRAT) framework. The exposure of interest was lopinavir-ritonavir treatment in severe COVID-19 compared to standard of care, placebo or other treatments.
In comparison to standard of care, data for several key benefts and risks were identifed for lopinavir-ritonavir. Risk data suggested a possible decrease in serious adverse events. There was a reduction in acute respiratory distress syndrome with lopinavir-ritonavir in one study. Overall, the benefit-risk profile for lopinavir-ritonavir in severe COVID-19 cannot be considered positive until further efficacy and effectiveness data become available.
Lopinavir-ritonavir (LPVr) is a combination protease inhibitor and nucleoside analogue used for the treatment of HIV, which was thought to have a positive effect in acute respiratory syndrome. Many trials are underway to determine whether lopinavir-ritonavir is an effective treatment for COVID-19 infection, including the RECOVERY trial and the WHO’s SOLIDARITY trial.
This is the third systematic benefit-risk evaluation that we have completed on potential COVID-19 treatments. Our remdesivir evaluation was published in Drug Safety a month ago (available here), while our systematic benefit-risk evaluation of chloroquine/ hydroxychloroquine is awaiting publication (preprint available here).
The lopinavir – ritonavir paper is available here: https://link.springer.com/content/pdf/10.1007/s40264-020-00966-9.pdf