Lopinavir/ritonavir ‘not effective’ for patients hospitalised with COVID-19, third set of RECOVERY trial results show

Results from the ‘Randomised Evaluation of COVID-19 Therapy’ trial have shown that there is no clinical benefit from lopinavir/ritonavir in hospitalised COVID-19 patients when compared with usual care alone.

Kaletra lopanivir/ritonavir

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There was also no evidence of a beneficial effect of lopinavir/ritonavir on the risk of progression to mechanical ventilation or length of hospital stay

An antiviral treatment commonly used to treat HIV has been found to have no beneficial effect in patients hospitalised with COVID-19, according to the third set of results to come out of the ‘Randomised Evaluation of COVID-19 Therapy’ (RECOVERY) trial. 

In a statement published on 29 June 2020, the chief investigators of the RECOVERY trial said a routine review of emerging data had shown that lopinavir/ritonavir had no clinical benefit in hospitalised COVID-19 patients compared to usual care alone.

More than 11,800 patients have been enrolled in the RECOVERY trial so far, 1,596 of which were randomised to the intervention group receiving lopinavir/ritonavir. This group was then compared with 3,376 patients who were randomised to receive usual care alone.

Of the randomised patients, 4% required invasive mechanical ventilation when they entered the trial, 70% required oxygen alone and 26% did not require any respiratory intervention.

Across all patient subgroups, it was found that there was no significant difference between lopinavir/ritonavir and usual care when it came to the number of patients who had died at 28 days (22.1% vs. 21.3%; relative risk 1.04, 95% confidence interval 0.91–1.18).

There was also no evidence of a beneficial effect from the drug combination on the risk of progression to mechanical ventilation or length of hospital stay.

“These preliminary results show that for patients hospitalised with COVID-19 and not on a ventilator, lopinavir/ritonavir is not an effective treatment,” said Peter Horby, professor of emerging infectious diseases and global health in the Nuffield Department of Medicine at the University of Oxford, and chief investigator for the trial.

“In 100 days, the RECOVERY trial has provided results enabling change in global practice three times. This extraordinary national effort has shown that two drugs used to treat hospitalised COVID patients throughout the world —hydroxychloroquine and lopinavir/ritonavir — do not improve survival, while one drug that was not recommended, dexamethasone, saves lives.”

Martin Landray, professor of medicine and epidemiology at the Nuffield Department of Medicine at the University of Oxford, and deputy chief investigator for the trial said that the “clear results” emphasised the value of large randomised clinical trials in differentiating drugs that are hoped to work versus those that are known to work.

“In many countries, current guidelines recommend lopinavir/ritonavir as a treatment for COVID-19. The results from this trial, together with those from other large randomised trials, should inform revisions to those guidelines and changes to the way individual patients are treated,” he said.

RECOVERY continues to enrol patients to allow the study of azithromycin, tocilizumab, and convalescent plasma in the treatment of COVID-19. It is anticipated that other treatments will be included for study in the future.

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Citation
The Pharmaceutical Journal, Lopinavir/ritonavir 'not effective' for patients hospitalised with COVID-19, third set of RECOVERY trial results show;Online:DOI:10.1211/PJ.2020.20208128