viral load. This underscores the treatment candidate’s potential to save the lives of patients around the world,” Bourla said in a company statement released Dec. 14 with the trial results. “Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic.”
Does an oral pill work for people that are low risk?
Pfizer also delivered some good news about people who are at low risk for severe COVID-19 at that point: In an early analysis, a second, ongoing study that tested whether Paxlovid eased COVID-19 symptoms faster in people who are not considered high-risk found no benefit for symptom relief.
But those who took the pill regimen saw the amount of virus in their bodies plummet, and the pill reduced the already low risk for hospitalization and death. That study included those who were vaccinated and had at least one risk factor for severe COVID-19.
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Side effects of Paxlovid
Paxlovid is a combination of a new molecule developed specifically to disable SARS-CoV-2 and ritonavir, an HIV medication that helps slow the breakdown of the coronavirus-specific molecule.
The drug does have some limitations. Ritonavir can interact with many commonly taken medicines, and those risks may need to be managed by physicians and pharmacists, the FDA said.
Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches, the FDA said. Using Paxlovid in people with uncontrolled or undiagnosed HIV infection may trigger HIV-1 drug resistance. Ritonavir can cause liver damage, so caution should be used when giving Paxlovid to patients with liver conditions, the agency added.
Paxlovid is also not recommended in patients with severe kidney impairment. In patients with moderate kidney impairment, a reduced Paxlovid dose is needed, the FDA said.
Pfizer is expected to supply its product before the end of January for 265,000 people in the United States. Initial supplies are expected in the next few days.
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