Lopinavir-ritonavir does not appear to be an effective treatment for patients hospitalized with coronavirus disease 2019 (COVID-19), according to recently published results of the RECOVERY trial.
Lopinavir-ritonavir, an antiviral medication approved for the treatment of HIV, has been recommended as a therapeutic option for COVID-19 by a number of clinical care guidelines. The RECOVERY trial, which is currently taking place in 176 hospitals across the UK, is the first randomized controlled trial to report on the effects of lopinavir-ritonavir in hospitalized COVID-19 patients.
Preliminary results of the RECOVERY trial, which were made public on June 29, 2020, led the World Health Organization (WHO) to halt treatment with lopinavir-ritonavir in its SOLIDARITY trial. The WHO reported that their interim results were “in line” with findings of the RECOVERY trial.
In the RECOVERY trial, 1616 patients were randomized to receive either lopinavir-ritonavir plus the usual standard of care (n=1616) or the usual standard of care alone (n=3424) between March 19 and June 29, 2020. Patients in the lopinavir-ritonavir group received 400mg of lopinavir and 100mg of ritonavir orally every 12 hours for 10 days or until they were discharged, whichever was sooner. The primary endpoint of the study was 28-day all-cause mortality.
“Overall, 374 (23%) patients allocated to lopinavir–ritonavir and 767 (22%) patients allocated to usual care died within 28 days (rate ratio 1.03, 95% CI, 0.91-1·17; P =.60),” study authors reported. Findings also revealed that lopinavir-ritonavir had no significant effect on the length of a patient’s hospital stay, with 69% of lopinavir-ritonavir patients leaving the hospital within 28 days compared with 70% of patients who received the usual standard of care (rate ratio, 0.98; 95% CI, 0.91-1.05; P =.53).
The median length of stay for both groups was reported to be 11 days (interquartile range: 5 to >28). The study authors also reported that 10% of lopinavir-ritonavir patients required ventilation during the study compared with 9% of patients who received the usual standard of care, suggesting that taking lopinavir-ritonavir did not reduce a patient’s risk of needing to be placed on a ventilator. The authors noted that the study’s results were found to be consistent across all patient subgroups.
“The result from the RECOVERY trial is clear. When combined with findings from an earlier, smaller trial and with the WHO interim results, this provides strong evidence that lopinavir-ritonavir is not an effective treatment for patients hospitalized with COVID-19,” said Professor Peter Horby, from the Nuffield Department of Medicine at the University of Oxford, UK, co-Chief Investigator of the RECOVERY trial.
- Recovery Collaborative Group. Lopinavir–ritonavir in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial [published online October 5, 2020]. The Lancet. 2020. doi: 10.1016/ S0140-6736(20)32013-4.
Horby PW, Landray MJ, et al; Recovery Collaborative Group.
- Lopinavir-ritonavir is not an effective treatment for patients hospitalised with COVID-19. [press release]. New York, NY: The Lancet; October 5, 2020.