Remdesivir recommended to shorten hospital stays
The panel’s recommendations regarding the use of remdesivir “has largely remained the same,” Dr. Gandhi said. Evidence indicates recovery is faster with remdesivir at 10 days vs 15 days in people taking a placebo.
In the ACTT-1 trial , for example, participants in the treatment group recovered in a median 10 days versus 15 days in the placebo group.
Therefore, the IDSA panel continues to recommend remdesivir treatment for hospitalized patients with COVID-19.
“As hospitals around the United States fill up, the IDSA panel believes the effect of remdesivir on speeding up recovery could be an important benefit, and that is why we continue to suggest its use,” Dr. Gandhi said.
When asked about the World Health Organization–sponsored trial that showed no benefit in terms of mortality, he replied, “Remdesivir is not a home run – we need better drugs.”
A recommendation against lopinavir and ritonavir
In contrast, the panel recommends against use of the lopinavir/ritonavir protease inhibitor combination therapy, based in part on data from a preprint of the Solidarity study .
The open-label Solidarity trial in 30 countries, sponsored by WHO, assessed hydroxychloroquine, interferon, lopinavir/ ritonavir, and remdesivir in people hospitalized with COVID-19.
None of these drugs showed an effect on mortality, Dr. Gandhi said. “Better medicines that improve survival are clearly needed.”
Dexamethasone remains the only agent demonstrated to reduce mortality in people hospitalized with COVID-19, he added.
Tocilizumab not for routine use
After critical review of the studies that have emerged since the last IDSA recommendation regarding tocilizumab (Actemra) in September, “the panel still stood with the recommendation against routine use of tocilizumab in hospitalized patients with COVID-19,” Dr. Bhimraj said.
The guidance is based on trials including COVACTA and EMPACTA. Treatment with tocilizumab was not associated with significant differences in mortality. In these and other studies, “we did not really find a significant difference, and that was the reason for the conditional recommendation against routine use of tocilizumab in hospitalized patients,” Dr. Bhimraj said.
Also, although the trials were blinded, “we know treatment with tocilizumab can cause a reduction in C-reactive protein levels,” which could indicate to researchers which participants were receiving active treatment versus placebo, he said.
Jury still out on baricitinib, remdesivir combination
The FDA granted an EUA to the combination of remdesivir and baricitinib (Olumiant) on Nov. 19. However, the IDSA panel is reserving its recommendation on this therapeutic combination until more data emerge.
“We still don’t have complete results of the ACTT-2 study, and the information we do have is what is available in the EUA,” Dr. Bhimraj said. The panel expects to issue guidance once the totality of data become available.
Unanswered questions include why investigators chose a 4-mg dose of baricitinib – twice the 2-mg dose commonly used for treating rheumatoid arthritis – and how many patients in the trial also were treated with steroids.
Dr. Gandhi agreed that the proportion of patients taking a steroid is “really an important consideration.” He added that dexamethasone has become standard of care because it reduces mortality, as well as the number of people requiring oxygen. He said it will be important to know how the baricitinib/remdesivir combination compares with dexamethasone.