- Two long-term patients with COVID recovered after treatment with Paxlovid
- Side effects, safety issues need to be investigated
CHICAGO, April 18 (Reuters) – Reports of two patients who found relief from prolonged COVID after taking Pfizer Inc (PFE.N) antiviral Paxlovid, including a researcher who tested it on themselves, provide intriguing evidence of clinical trials to help people with disabilities, experts and advocates say.
The researcher said that the symptoms of her chronic fatigue, which “I felt like I was hit by a truck”, disappeared after taking oral therapy with two drugs.
Long-term COVID is an impending health crisis that is estimated to affect up to 30% of people infected with coronavirus. This can last for months, leaving many people unable to work. More than 200 symptoms are associated with the condition, including pain, fatigue, brain fog, difficulty breathing and exhaustion after minimal amounts of physical activity.
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Dr Stephen Deeks, a professor of medicine at the University of California, San Francisco (USSF) and an expert in HIV research, said pharmaceutical companies tend to reject cases from a single patient. But such cases have helped conduct research on HIV treatment, and Deeks believes that these cases of Paxlovid could do the same for long-term COVID.
“This provides really strong evidence that we need to study antiviral therapy in this context as soon as possible,” Deeks said, adding that he had heard of another anecdotal case at UCSF in which the symptoms of a long-term COVID patient disappeared after of Paxlovid.
The researchers warn that these cases are “only generating hypotheses” and not evidence that the drug has caused relief of long-term symptoms. But they support a leading theory that prolonged COVID can be caused by the virus, which lingers in parts of the body for months, affecting patients’ daily lives long after the acute symptoms have disappeared.
The best evidence so far comes from a study by the National Institutes of Health (NIH), which is currently undergoing peer review, in which researchers performed autopsies on 44 people who died of COVID-19 or other causes but were infected with COVID. They found a widespread infection in the body, including in the brain, which could last for more than seven months after the onset of symptoms.
Paxlovid, which combines a new Pfizer pill with the old antiviral ritonavir, is currently approved for use in the first days of COVID infection to prevent severe disease in high-risk patients.
Pfizer spokesman Keith Longley said the company did not conduct lengthy research on COVID and did not comment on whether to consider it.
The manufacturer has two major clinical trials testing whether Paxlovid can prevent the initial COVID infection. “This can provide us with relevant data to help inform future research,” Longley said.
Patients who have been suffering for months are increasingly frustrated by the lack of pharmaceutical tests for their condition.
There are currently fewer than 20 clinical trials conducted by individual researchers or small drug manufacturers testing treatments for long-term COVID, only a handful of which have gone beyond the early stages, a Reuters review found. Read more
Diana Berent, founder of the COVID Survivor Corps, advocates for the Biden administration to fund large, long-term clinical trials at COVID.
“We should not do our research on the basis of anecdotal reports,” she said. “That’s not good enough.”
‘BACK TO NORMAL’
In one case report published as a preprint before the peer review, a previously healthy and vaccinated 47-year-old woman became infected with COVID in the summer of 2021. Most of her acute symptoms disappeared within 48 hours, but she continued to there is severe fatigue, brain fog, post-workout exhaustion, insomnia, rapid heartbeat and body aches strong enough that he can no longer work.
About six months after her initial infection, she was re-infected, probably with COVID, and many of her acute symptoms returned. Her doctor prescribed a five-day course of Paxlovid.
On the third day, she noticed a rapid improvement in COVID’s long-term symptoms. “She is back to normal,” said Dr. Linda Gang, co-director of Stanford Health’s long COVID clinic and author of the case report published in Research Square.
In the second case, 37-year-old Lavanya Viswabharati, an immunologist working at the long COVID clinic of Northwestern Medicine, was infected in December 2021.
Her initial symptoms were mild, but she later experienced chronic fatigue, headaches and sleep disturbances for four months after infection. It also continued to give positive results in rapid antigenic tests, a sign of viral resistance
Visvabharathy was aware of the NIH investigation and the Stanford case and decided to try Paxlovid to see if it could clear up any retained virus. By the end of the five-day course, her fatigue and insomnia had improved, and her headaches were less frequent. Two weeks after the end of the treatment, her fatigue disappeared. “It’s 100% fixed,” she said.
But to prove that Paxlovid provides that kind of relief will require carefully controlled clinical trials, Viswabharati said.
Dr Igor Koralnik, head of the Northwestern Medicine clinic, which focuses on the neurological effects of long-term COVID, noted the long list of widely used drugs that are affected by ritonavir and said Paxlovid “cannot be used involuntarily”.
“Paxlovid is not a benign drug,” he said. “There has to be research.”
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Report by Julie Steenhuysen Edited by Michele Gershberg and Bill Berkrot
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