Study Finds COVID-19 Therapies Cause Few Serious Adverse Effects
However, patients should still be monitored for potential serious adverse effects, as investigators identified potential new concerns.
COVID-19 therapies cause few serious adverse effects, according to new data from the Keck School of Medicine of the University of Southern California. The FDA approved or authorized multiple treatment options over the last 4 years, including antiviral drugs and monoclonal antibodies for treating COVID-19.1,2
However, patients should still be monitored for potential serious adverse effects, as investigators identified potential new concerns. | Image Credit: bizoo_n - stock.adobe.com
“Given the unique nature of the pandemic and the rapid production of treatments for COVID-19, the findings are very reassuring,” Jeffrey Klausner, MD, MPH, professor of clinical population and public health sciences in the Keck School of Medicine, said in a news release.1 “With a severe public health emergency like COVID-19, it is critical that there exists a government compensation program for treatment-related injuries that is based on the best scientific evidence. Now, we know with additional certainty that the treatments are safe without a high frequency of serious [adverse] effects.”
There are 3 treatments approved specifically for COVID-19, which include nirmatrelvir with ritonavir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio). Nirmatrelvir with ritonavir is indicated for adults and children 12 years and older and must be taken within 5 days of when symptoms start. The drug is taken orally. Remdesivir is indicated for adults and children and is an intravenous infusion for 3 consecutive days. It should begin within 7 days of when symptoms start. Molnupiravir is also taken orally within 5 days of when symptoms start and is indicated for adults.3
The investigators used PubMed, ClinicalTrials.gov, and the FDA submission database from January 2020 and the Cochrane Database of Systemic Reviews from January 2022. Studies were required to have a placebo, untreated, or usual care group. After reviewing 320 documents, 54 studies met the requirements and were included. Investigators stated that 70 studies were excluded due to lack of US location and 33 due to lack of reporting of AEs in studies about effectiveness or efficacy. Thirty-one of the studies were randomized controlled trials, and 23 were controlled observational studies.1
Most of the studies had a low overall risk of bias with the collection and reporting of AEs, according to the study investigators. Five observational studies had a high risk of bias because they focused on efficacy and only included a statement on certain AEs that did not occur.1
The study authors said that there was insufficient evidence of an association between antiviral treatment of COVID-19 (remdesivir, nirmatrelvir and ritonavir combination, and molnupiravir) and any serious AEs. Furthermore, there was insufficient evidence between the spike protein receptor-binding antibodies (bamlanivimab/etesevimab, bebtelovimab, sotrovimab, casirivimab/imdevimab, tixagevimab/cilgavimab) and serious AEs.1
Investigators did find that tocilizumab had a higher risk of neutropenia in a few of the studies. Although not statistically significant, they did submit the potential risk to the FDA. They did rate the certainty of evidence for the association of tocilizumab and neutropenia as moderate. Furthermore, they found an increased risk of infection and bleeding events associated with convalescent plasma for patients with hematologic cancer; the evidence was rated moderate.1
“We found no evidence of an association of SARS-CoV-2 antiviral treatment with [severe] AEs,” the investigators concluded.1 “This is consistent with a prior network meta-analysis of antiviral agents for COVID-19 treatment that found no increased risk of AEs when compared with placebo.”
READ MORE: COVID-19 Resource Center
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