There is no clear benefit of HIV antivirals for COVID-19 patients, says new study by the Drug Safety Research Unit (DSRU) in Southampton. It says that there is no clear benefit of treating COVID-19 patients with the HIV antivirals lopinavir-ritonavir.
Researchers screened more than 460 existing research papers about the combination drugs before fully analysing seven papers to assess the benefits and risks of treating patients with severe COVID-19 with lopinavir-ritonavir.
DSRU researchers noted fewer cases of acute respiratory distress syndrome with lopinavir-ritonavir compared with standard care (13% vs 27%) in one study. There also appeared to be fewer serious adverse events with lopinavir-ritonavir – 20% versus 32% from standard care.
However, the limited amount of data available led researchers to conclude the benefit-risk profile for lopinavir-ritonavir for severe COVID-19 could not be considered ‘positive’ until more efficacy and effectiveness data became available.
The findings echo an announcement from the University of Oxford RECOVERY randomised trial looking at various treatments for COVID-19. Earlier this week (29/6/20) the team said lopinavir-ritonavir did not produce clinical benefits for COVID-19 patients in hospital.
Professor Saad Shakir, Director of the DSRU, said: “The global coronavirus pandemic means we have to find safe and effective treatments fast. Lopinavir-ritonavir are antivirals usually used to treat HIV patients and are now being trialled in several studies on patients with COVID-19.
“This means the known benefits and risks are evolving and our study aims to provide a systematic benefit-risk assessment that can easily be updated to re-evaluate the benefit-risk score when new data becomes available.
“Currently, our research shows no clear benefit in treating severe COVID-19 patients with lopinavir-ritonavir but we will monitor new findings and update our benefit-risk evaluation as soon as these become available.”
DSRU researchers used the Benefit-Risk Action Team (BRAT) framework, which follows the structured format of a qualitative framework but allows flexibility in choice of quantitative assessment for the study. Researchers used existing data from clinical trials and observational studies to assess benefit-risk.
The DSRU team conducts benefit-risk assessments on medicines at the stage of marketing authorisation. Its bespoke protocols are designed to satisfy regulatory requirements and answer any specific questions from the European Medicines Agency or other regulator.
The full study paper is now available in the journal Drug Safety. DSRU is an independent and internationally renowned research unit that monitors, studies and communicates the safety and risk management of medicines.