With the COVID-19 drug treatments recently approved for Emergency Use Authorization, University of Minnesota Medical School expert David Boulware can speak about the relevance and impact of drug treatment for COVID-19.
David Boulware, MD, MPH
“The Pfizer nirmatrelvir (Paxlovid) is the first oral direct antiviral therapy that has clinical benefit against early COVID-19 to prevent hospitalization when started within the first five days of symptoms.
"Pfizer’s Paxlovid has reported 88% reduction in hospitalization, and the safety and tolerability appeared to be good. There were very few side effects and only 2% stopped the medicine due to side effects, which was less than the placebo. This overall benefit was even better than the current monoclonal antibodies, some of which now do not have the intended effect against the Omicron variant."
"These direct antivirals should work well regardless of the Omicron or other future variants. Unfortunately, this new medicine is not available today. Based on how the trials were conducted, the FDA have authorized for use in high-risk unvaccinated persons or persons with weakened immune systems. Getting tested as soon as possible will be essential for getting access to these new antivirals. The supply of Paxlovid is estimated to be 250,000 treatment courses by the end of January. That is about 750 courses per 1 million population."
"A third option that is available today is fluvoxamine, which is an existing antidepressant that also has an anti-inflammatory action. In two randomized trials, this had a 30% reduction in hospitalization or prolonged ER visits. On December 21, I submitted an application to the FDA requesting Emergency Use Authorization (EUA) to recognize its clinical benefit. My hope is that the EUA request will encourage the FDA to issue guidance on fluvoxamine for COVID-19, as many physicians may be reluctant to prescribe it as a treatment without."
Dr. Boulware is an infectious disease physician at the U of M Medical School and M Health Fairview. He specializes in clinical trials, public health and tropical medicine. Dr. Boulware combines his clinical research with nested basic science investigations into disease pathogenesis to conduct translational research.
The University of Minnesota continues a nationwide early at home treatment trial testing fluvoxamine and other existing medicines. More information is available at covidout.com.
Download a high resolution photo of Dr. Boulware.
About the University of Minnesota Medical School
The University of Minnesota Medical School is at the forefront of learning and discovery, transforming medical care and educating the next generation of physicians. Our graduates and faculty produce high-impact biomedical research and advance the practice of medicine. We acknowledge that the U of M Medical School, both the Twin Cities campus and Duluth campus, is located on traditional, ancestral and contemporary lands of the Dakota and the Ojibwe, and scores of other Indigenous people, and we affirm our commitment to tribal communities and their sovereignty as we seek to improve and strengthen our relations with tribal nations. For more information about the U of M Medical School, please visit med.umn.edu.