Authors: Benjamin Ryan Published April 29, 2022 NBC Health<\/p>\n\n\n\n
Pfizer\u2019s 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<\/a> can experience a second round of the disease shortly after recovering.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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 \u201ctotally fine.\u201d 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.<\/p>\n\n\n\n \u201cI was kind of shocked,\u201d Henry said of testing positive once more.<\/p>\n\n\n\n \u201cThere\u2019s no guidance on what to do. Should I be isolating?\u201d <\/strong>he recalled. \u201cHow do I keep my family safe?\u201d<\/p>\n\n\n\n He called his doctor, Philadelphia\u2019s Covid information line and a health insurance nurse looking for clarity. \u201cEveryone I talked to gave me different answers.\u201d<\/p>\n\n\n\n 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<\/a>. The federal government, which fully covers the treatment, has shipped to the states<\/a> 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<\/a>, since many of the doses have gone unused.<\/p>\n\n\n\n \u201cThere\u2019s still so much we don\u2019t know about Covid-19 and the best way to treat it,\u201d said Dr. H. Clifford Lane, deputy director for clinical research and special projects at the National Institute for Allergy and Infectious Diseases. \u201cThese 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.\u201d<\/p>\n\n\n\n On Tuesday, Dr. Michael Charness, chief of staff at the VA Boston Healthcare System, posted<\/a> 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.<\/p>\n\n\n\n Charness\u2019 patient, who has intermittent asthma, started Paxlovid the day his Covid symptoms began. Two days later, he began a symptom-free week \u2014 only to get sick once again for about four days.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n \u201cIf someone has a case of post-Paxlovid SARS-CoV-2 relapse versus reinfection, it\u2019s important that this be flagged to public health authorities,\u201d said infectious disease specialist Dr. C\u00e9line Gounder,<\/strong> an editor at large for public health at Kaiser Health News. \u201cThe virus should be sequenced so we can learn if it\u2019s mutated and developed resistance to Paxlovid.\u201d<\/p>\n\n\n\n Pfizer spokesperson Kit Longley said the company is continuing \u201cto monitor data from our ongoing clinical studies of Paxlovid, as well as real-world evidence\u201d related to cases of post-Paxlovid relapse.<\/p>\n\n\n\n People who experience such a rebound, Longley said, can relay their experience to Pfizer\u2019s portal<\/a> for reporting Paxlovid-related adverse events.<\/p>\n\n\n\n Scientific documentation about post-Paxlovid relapse has actually been available since last fall. Pfizer\u2019s application<\/a> to the FDA for emergency use authorization of Paxlovid stated that in the placebo-controlled clinical trial \u2014 which included 2,246 participants \u2014 \u201cseveral subjects appeared to have a rebound in SARS-CoV-2 RNA levels around Day 10 or Day 14\u201d after beginning treatment.<\/p>\n\n\n\n In a statement, Pfizer spokesperson Longley said that in Paxlovid\u2019s clinical trial, the rare cases of the coronavirus rebounding soon after participants completed treatment occurred at a similar rate among those who received a placebo.<\/p>\n\n\n\n \u201cWe did not see an association between the observed viral load increase and subsequent severe disease,\u201d Longley said. \u201cAlthough it is too early to determine the cause, this suggests the observed increase in viral load is unlikely to be related to Paxlovid.\u201d<\/p>\n\n\n\nNo sign of drug resistance<\/strong><\/h2>\n\n\n\n
Putting pressure on Pfizer<\/strong><\/h2>\n\n\n\n