The case for testing Pfizer’s Paxlovid to treat prolonged COVID

  • Two Long COVID Patients Recover After Paxlovid Treatment
  • Side effects and safety issues need to be studied

CHICAGO, April 18 (Reuters) – Reports of two patients who found relief from long-standing COVID after taking Pfizer Inc’s (PFE.N) antiviral Paxlovid, including a researcher who tested it on herself, provide intriguing evidence for trials. clinicians to help those with the debilitating condition, experts and advocates say.

The researcher said her chronic fatigue symptoms, which “felt like a truck hitting me,” disappeared after taking the two-drug oral therapy.

Long COVID is an impending health crisis, estimated to affect up to 30% of people infected with the coronavirus. It can last for months, leaving many unable to work. More than 200 symptoms have been associated with the condition, including pain, fatigue, brain fog, shortness of breath, and exhaustion after minimal amounts of physical activity.

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Dr. Steven Deeks, a professor of medicine at the University of California, San Francisco (USSF), and an expert in HIV cure research, said drug companies tend to discount single-patient case studies. But such instances have helped fuel HIV cure research, and Deeks believes these Paxlovid cases could do the same for prolonged COVID.

“This provides really strong evidence that we need to look at antiviral therapy in this setting as soon as possible,” Deeks said, adding that he has heard of another anecdotal case at UCSF where a COVID patient’s symptoms went away after of taking Paxlovid.

The scientists caution that these cases “only generate hypotheses” and do not prove that the drug has relieved persistent symptoms. But they do support a leading theory that prolonged COVID may be caused by the virus persisting in parts of the body for months, affecting patients’ daily lives long after acute symptoms subside.

The best evidence so far comes from a National Institutes of Health (NIH) study, currently under peer review, in which researchers performed autopsies on 44 people who died of COVID-19 or another cause but were infected with COVID. . They found a widespread infection throughout the body, including in the brain, that can last for more than seven months after the onset of symptoms.

Paxlovid, which combines a new pill from Pfizer with the older antiviral ritonavir, is currently authorized for use in the first days of a COVID infection to prevent serious illness in high-risk patients.

Pfizer spokesman Kit Longley said the company does not have any large COVID studies underway and would not comment on whether it would consider them.

The drugmaker has two large clinical trials testing whether Paxlovid can prevent initial COVID infection. That “may provide us with relevant data to help inform future studies,” Longley said.

Patients who have been suffering for months are increasingly frustrated by the lack of pharmaceutical research for their condition.

There are currently fewer than 20 clinical trials led by individual investigators or small drugmakers testing treatments for prolonged COVID, and only a handful have made it past the early stages, a Reuters review found. read more

Diana Berrent, founder of the grassroots COVID advocacy group Survivor Corps, has been pushing the Biden Administration to fund large, long COVID clinical trials.

“We shouldn’t be doing our research based on anecdotal reports,” he said. “That’s not good enough.”

‘BACK TO NORMAL’

In one of the case reports, published as a preprint prior to peer review, a previously healthy, vaccinated 47-year-old woman became infected with COVID in the summer of 2021. Most of her acute symptoms dissipated within 48 hours, but she continued to have severe fatigue, brain fog, post-exercise exhaustion, insomnia, rapid heartbeat, and body aches so severe that she could no longer work.

About six months after his initial infection, he was reinfected, likely with COVID, and many of his acute symptoms also returned. Her doctor prescribed a five-day course of Paxlovid.

On day 3, he noted rapid improvement of long-standing COVID symptoms. “It’s back to normal,” said Dr. Linda Geng, co-director of the Stanford Health Care COVID clinic and author of the case report published in Research Square.

In the second case, Lavanya Visvabharathy, 37, an immunologist who works at Northwestern Medicine’s longstanding COVID clinic, became infected in December 2021.

His initial symptoms were mild, but he then experienced chronic fatigue, headaches, and sleep disturbances for four months after infection. He also continued to test positive on rapid antigen tests, a sign of viral persistence.

Visvabharathy was aware of the NIH study and the Stanford case, and decided to try Paxlovid to see if it could kill any lingering viruses. By the end of the five-day course, her fatigue and insomnia had improved and her headaches were less frequent. Two weeks after she finished treatment, her fatigue was gone. “That’s 100% fixed,” she said.

But proving that Paxlovid provides that kind of relief would require carefully controlled clinical trials, Visvabharathy said.

Dr. Igor Koralnik, who directs the Northwestern Medicine clinic focused on the neurological effects of prolonged COVID, pointed to the long list of widely used drugs that are affected by ritonavir, saying that Paxlovid “cannot be used in any way “.

“Paxlovid is not a benign drug,” he said. “There should be studies.”

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Reporting by Julie Steenhuysen Editing by Michele Gershberg and Bill Berkrot

Our standards: the Thomson Reuters Trust Principles.

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