Paxlovidでコロナから回復するも数日後に再びコロナの症状が起きる事例がMSMで報告され始めた件

 

Covid symptoms may return for some after taking Paxlovid antiviral pills

The FDA is evaluating rare reports of "viral load rebound" after completing Paxlovid treatment.

 April 27, 2022, 1:36 AM HST

By Benjamin Ryan

Pfizer’s antiviral pills are highly effective at keeping people with Covid out of the hospital, but there are growing reports that, in rare cases, patients treated for the coronavirus with Paxlovid can experience a second round of the disease shortly after recovering.

Infectious disease experts stress that cases of apparent viral rebound, when someone gets better and then soon gets sick again, following Covid treatment are not cause for alarm. However, there are increasing calls for federal agencies to provide greater clarity and guidance about how patients and health care providers should respond.

With mostly just anecdotal reports coming out, questions remain as to whether people whose Covid symptoms return shortly after they take Paxlovid are contagious and should keep isolating to avoid passing the virus to others.

For those who do experience a second round of symptoms, the sudden shift can also leave them anxious about whether they should seek further treatment.

 Michael Henry, 31, a vaccinated and boosted software engineer in Philadelphia, first got sick with Covid on April 4, suffering from chills and a fever.

Henry, who has medical conditions that raise his risk of severe disease, got a Paxlovid prescription from an urgent care center the next day. Within 48 hours, he was feeling “totally fine.” But then, one week after his last dose, he got sick once again, with milder cold-like symptoms, and remained sick for about five days.

“I was kind of shocked,” Henry said of testing positive once more.

“There’s no guidance on what to do. Should I be isolating?” he recalled. “How do I keep my family safe?”

He called his doctor, Philadelphia’s Covid information line and a health insurance nurse looking for clarity. “Everyone I talked to gave me different answers.”

Paxlovid has been prescribed since December, when the Food and Drug Administration granted emergency authorization for people at high risk of severe Covid. The five-day course of prescription pills reduced the risk of hospitalization or death by 88 percent in a clinical trial. The federal government, which fully covers the treatment, has shipped to the states over 1.7 million courses since Paxlovid was green-lit. On Monday, the White House said it will double the number of locations where Paxlovid is available, since many of the doses have gone unused.

“There’s still so much we don’t know about Covid-19 and the best way to treat it,” said Dr. H. Clifford Lane, deputy director for clinical research and special projects at the National Institute for Allergy and Infectious Diseases. “These anecdotes give us reason to re-examine duration of therapy, approaches to therapy, other laboratory tests we might use to predict who could benefit from longer courses of treatment.”

No sign of drug resistance

On Tuesday, Dr. Michael Charness, chief of staff at the VA Boston Healthcare System, posted a pre-print detailing the case of a fully vaccinated and boosted 71-year-old man who recently saw his virus rebound after he took Paxlovid. The case study is under review by a medical journal.

Charness’ patient, who has intermittent asthma, started Paxlovid the day his Covid symptoms began. Two days later, he began a symptom-free week — only to get sick once again for about four days.

Genetic sequences of his virus indicated it did not develop resistance to the two medications in Paxlovid, nor was he re-infected. Tests for other respiratory viruses revealed that the coronavirus was the sole pathogen ailing him.

No evidence has yet emerged that anyone experiencing post-Paxlovid viral rebound had virus that had developed resistance to the treatment, Pfizer and other experts report. Nevertheless, the possibility is a concern.

“If someone has a case of post-Paxlovid SARS-CoV-2 relapse versus reinfection, it’s important that this be flagged to public health authorities,” said infectious disease specialist Dr. Céline Gounder, an editor at large for public health at Kaiser Health News. “The virus should be sequenced so we can learn if it’s mutated and developed resistance to Paxlovid.”

Pfizer spokesperson Kit Longley said the company is continuing “to monitor data from our ongoing clinical studies of Paxlovid, as well as real-world evidence” related to cases of post-Paxlovid relapse.

People who experience such a rebound, Longley said, can relay their experience to Pfizer’s portal for reporting Paxlovid-related adverse events.

Putting pressure on Pfizer

Scientific documentation about post-Paxlovid relapse has actually been available since last fall. Pfizer’s application to the FDA for emergency use authorization of Paxlovid stated that in the placebo-controlled clinical trial — which included 2,246 participants — “several subjects appeared to have a rebound in SARS-CoV-2 RNA levels around Day 10 or Day 14” after beginning treatment.

https://www.nbcnews.com/health/health-news/covid-symptoms-may-return-taking-paxlovid-antiviral-pills-rare-cases-rcna25581

明らかに何らかの免疫疾患が起きてるわけですがそんな不都合な真実は患者に伝えられない、、、（爆ｗｗｗｗｗｗｗｗｗｗｗｗｗｗ