FDA Approval of First Oral Antiviral Treatment For Mild, Moderate COVID-19 Highlights Latest Roundup
First Oral Antiviral Treatment of COVID-19 Approved by FDA1
Earlier this year, the FDA approved the first oral antiviral treatment—nirmatrelvir tablets and ritonavir tablet—for the treatment of mild-to-moderate COVID-19. The treatment has been approved for adults who are at high risk for progression to severe COVID-19, which may result in hospitalization or death.
The treatment is the fourth medication to be approved by the FDA to treat COVID-19 in adults.
“Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity,” Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research.
The approval follows the results of the EPIC-HR clinical trial that examined the use of the oral antiviral for the treatment of non-hospitalized symptomatic adults with COVID-19. The trial included adults 18 years of age and older with a prespecified risk factor for progression to severe disease or were aged 60 years and older with a medical condition. The patients included in the study were not vaccinated for COVID-19 and had not been previously infected with COVID-19.
Through a 28-day follow-up period, the oral antiviral treatment (n = 977) significantly reduced the proportion of people with COVID-19 by 86% compared to those who were treated with placebo (n = 989).
The most common adverse effects of the treatment included impaired sense of taste and diarrhea.
Antidepressant Medication May Lower COVID-19 Incidence2
A recent retrospective study suggests that antidepressant (AD) medication may be of benefit in preventing the spread of COVID-19 infection.
To determine the preventative potential of AD prescription, researchers conducted a retrospective study examining the association between AD prescription and COVID-19 diagnosis. A cohort of adult outpatients receiving mental health treatment during the first wave of COVID-19 was used in the United Kingdom for the study.
The mention of AD prescription was associated with approximately 40% lower incidence of positive COVID-19 test results when adjusted for socioeconomic parameters and physical health. Further, this association was observed for selective serotonin reuptake inhibitor (SSRI) class of AD prescription.
“Our results suggest that ADs, and SSRIs in particular, may provide a degree of protection against COVID-19, specifically SARS-CoV-2 infection,” the researchers concluded.
Low Vitamin D Levels In Patients Associated With Long COVID Syndrome3
Patients diagnosed with long COVID have lower vitamin D levels than patients without long COVID, according to an observational cross-sectional retrospective study.
Long COVID remains an emerging syndrome, affecting 50% to 70% of COVID-19 survivors. In their study, Glebov and colleagues sought to assess the association between 25(OH) vitamin D levels and the disease.
In total, 50 participants diagnosed with long COVID were matched 1:1 with participants without long COVID. Participants were seen in an outpatient clinic from August to November 2020 where their 25(OH) vitamin D levels were measured at hospital admission and 6 months after being discharged from the hospital.
The researchers observed in patients presenting with vitamin D deficiency, both at admission and at follow-up (n = 42), that those affected by long COVID (n = 22) presented with lower 25(OH) vitamin D levels at follow-up than those not affected (n = 20). Further, the researchers found that lower 25(OH) vitamin D levels were observed in those with neurocognitive symptoms at follow-up (n = 7) than those without (n = 93).
“Our data suggest that vitamin D levels should be evaluated in COVID-19 patients after hospital discharge,” the researchers concluded. “The role of vitamin D supplementation as a preventive strategy of COVID-19 sequelae should be tested in randomized controlled trials.”
Impaired Pulmonary Function in Patients After Disease Onset4
According to a recent study, the prevalence of impaired pulmonary function at 1 year follow-up after COVID-19 infection was significant among those with moderate or severe infection.
Researchers utilized data of both hospitalized and non-hospitalized individuals with COVID-19 from the RECoVERED study. Pulmonary function was measured 1 year after disease onset.
Of the 349 participants, 301 underwent at least one pulmonary function test between May 2020 and December 2021. After 1 year of follow-up, 25% of the participants had impaired pulmonary function (11% had mild cases, 22% had moderate cases, and 48% had severe cases).
“The prevalence of impaired pulmonary function after twelve months of follow-up, was still significant among those with initially moderate or severe/critical COVID-19. Pulmonary function increased over time in most of the severity groups,” the researchers concluded. “These data imply that guidelines regarding revalidation after COVID-19 should target individuals with moderate and severe/critical disease severities.”
- FDA approves first oral antiviral for treatment of COVID-19 in adults. News release. US Food and Drug Administration; May 25, 2023. Accessed on September 25, 2023. www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults
- Glebov OO, Mueller CM, Stewart R, Aarsland D, Perera G. Antidepressant drug prescription and incidence of COVID-19 in mental health outpatients: a retrospective cohort study. BMC Med. Published online June 21, 2023. doi:10.1186/s12916-023-02877-9
- di Filippo L, Frara S, Nannipieri F, et al. Low vitamin D levels are associated with long covid syndrome in COVID-19 survivors. J Clin Endocrinol Metab. Published online April 13, 2023. doi:10.1210/clinem/dgad207
- van Willigen HDG, Wynberg E, Verveen A, et al. One-fourth of COVID-19 patients have an impaired pulmonary function after 12 months of disease onset. PLOS One. Published online September 11, 2023. doi:10.1371/journal.pone.0290893