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Wednesday, March 29, 2023

Physicians say they need clear guidance on prescribing Paxlovid amid concerns surrounding COVID-19 rebound

Six months after regulators issued emergency use authorizations for Paxlovid, physicians say they still have important questions about setting guidelines for key treatment for high-risk COVID patients.

STAT spoke with providers who said they and their partners aren’t on the same page as to when to prescribe Paxlovid or the criteria that separate it from those who don’t need it. He also said it’s not clear whether they can give a second course when patients test positive again after taking paxlovid, a phenomenon known as rebound. And nearly all of the experts who spoke with STAT said they are battling for more data on rebound, which is complicating and at times changing their calculus about drug delivery.

“Right now there’s a real lack of evidence, and there’s obviously a lot of confusion,” said Jonathan Lee, a physician at Brigham and Women’s Hospital and virology researcher at Harvard Medical School. Treatment Guidelines Panel. “And even for people who delve into the literature, and who are infectious disease specialists, you’ll actually see a fairly wide range of opinions.”

Read more: Pfizer’s PaxLovid study fails to answer important questions on benefits to the broader population

The pool of people who can prescribe Paxlovid has now become even wider — on Wednesday, the Food and Drug Administration began allowing pharmacists to prescribe the drug, which has helped prevent hospitalizations and deaths in a preliminary study of unvaccinated patients. It was shown to reduce the risk of death by 89%. , The FDA says Paxlovid — a combination of two drugs taken twice a day for five days — should be prescribed within five days of symptom onset to people 12 and older who have tested positive. and “are at high risk for progressing to severe COVID-19.” Technically, this includes everyone from people with asthma or obesity to those over the age of 65.

“Pretty much everyone meets the EU criteria. They made it very, very, very broad,” said David Smith, a professor, physician and virology researcher at the University of California, San Diego. Over a week in May , Over 160,000 Paxlovid prescriptions filled.

Physicians generally agree that certain high-risk patients – including those who have not been vaccinated or have many concomitants with people over the age of 65 – should always be prescribed medication. But broad eligibility makes it difficult for some physicians to decide whether or not to take paxclovid. A child is unlikely to need it, but what about a healthy 50-year-old? A 65 year old woman? The experts STAT spoke to did not agree.

Debra Poutiaca, interim chief of the department of geographic medicine and infectious diseases at Tufts Medical Center, recommends PaxLovid for all patients who are eligible. “There’s a reason the EUA recommends certain groups of people — meaning comorbidities and age — to get Paxlovid,” Poutsiaka said. “Repeated studies have shown that people who fall within those criteria are at increased risk of getting severe COVID. So I won’t say or make my own judgment on whether or not I think one should get PaxLovid.

Some physicians are more conservative when recommending Paxlovid, although they still encourage older patients with one or more comorbidities to accept it. For them, it is borderline cases – such as older patients, but otherwise in good health – that are difficult. The disease can manifest in many different ways in different patients, and like any medicine, Paxlovid comes with potential side effects.

“It’s a subtle decision when it comes to people at low risk,” said Rajesh Gandhi, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School. “Some of it comes down to clinical judgment on a case-by-case determination.”

There has also been a difference in the time of prescription. Myron Cohen, an infectious disease specialist and lead HIV researcher at the University of North Carolina at Chapel Hill, advocates starting on PaxLovid right away. “The conversation is a very short conversation,” Cohen said. “The data that is available suggests that if you want to get the most out of this drug and you want to try to reduce the long COVID, the sooner you take it after testing positive, the smarter you are. Will be.”

UCSD professor Smith said he has seen physicians prescribe medication after a patient has been exposed, but before they test positive, “Although the study is fairly clear, it had no benefit as prophylaxis. “

Conversely, Robert Wachter, chairman of the department of medicine at the University of California, San Francisco, speculates that giving paxlovid early may not give the immune system enough time to prepare itself when the drug is low, which may worry him. May increase the risk of rebound. (There hasn’t been any research yet to demonstrate this is the case.) “For someone I think of as a borderline candidate, I’d say a majority result—if it’s a day or two – Let’s wait three. … We have five days to take it,” said Wachter. “Let’s wait until the fourth day and see how you’re doing and if you’re feeling well, take it Do not take If you’re still feeling really bad, it’s worth taking it.” Of Wacher’s patients who followed his advice, some ended up taking the drug. But for “most people,” symptoms lasted three days. were minimal and PaxLovid was not necessary.

Wachter said he would follow the same advice he gives to patients. “I’m 64, I’ve had two boosters — two vaccines and two boosters,” Wachter said. “I think even if I got COVID today, I would still take Paxlovid. And would I wait a day or two? I wouldn’t rush to get it on the first day. I can wait two or three days. “

But other physicians disagree on waiting. The first and largest study of Paxlovid treated patients within three days of experiencing their symptoms, so five days in emergency authorization already provides remission, he says, adding that it is not well supported by scientific evidence. Is. “Our knowledge is more about early use than late use. Let’s see how you do,” explained UNC-Chapel Hill physician Cohen. I don’t think they need PaxLovid.” Cohen said he and his colleagues in their practice prescribe it early to patients who they believe need paxlovid.

Cohen and other physicians also struggled with Paxlovid rebound, which occurred in one to two percent of patients in the initial clinical trial that resulted in Paxlovid’s FDA approval. Some experts said, anecdotally, they’ve found rebound — which usually happens four or five days after treatment with Paxlovid — to be more common.

Scientists don’t yet have a clear understanding of why rebounds happen, or how prevalent they are. This leaves physicians unsure how much to take into account when prescribing them.

“I think the sense of potential risk-benefit has changed over time,” said Walid Gelad, an internal medicine physician and health policy researcher at the University of Pittsburgh. “So I have a little more reluctance now than I was in the beginning to determine.”

Gelad and other experts said the rebound warrants more urgent research. “I’m like, ‘Why don’t we know?’ Not enough attention has been paid to ask the question of “Why doesn’t the company know at this point how normal a normal rebound is? Why isn’t the FDA insisting that we know more about the rebound?”

In perhaps the highest-profile case of a COVID-19 rebound, the Biden administration’s chief medical adviser, Anthony Fauci, recently experienced a rebound after a first course of Paxlovid and received a second regimen of the drug as a result. This is an unusual move, and one that has met with opposition from experts. None of the physicians STAT spoke to prescribed paxlovid for a patient experiencing a rebound, primarily because cases of rebound often resolve on their own and rarely lead to hospitalization or death. Let’s move on. But it was not clear to them whether the Emergency Use Authority had allowed a second course, with some physicians saying it was up to each state’s medical board and others arguing both sides.

Read more: As reports of ‘PaxLovid rebound’ mount, COVID researchers scramble for answers

“Some pharmacists have been very diligent,” Cohen said. “When I tried to give a second course of Paxlovid in a short time, they basically argued with me and refused it, which is an unusual thing to do with a pharmacist.” Brigham and Women’s Hospital physician Lee explained that the wording of the authority was unclear whether the rebound qualifies as a new “day zero” of symptom onset.

In a statement to STAT, the American Academy of Family Physicians warned against prescribing drugs for “any off-label use that is not supported by significant scientific evidence” and referred to the Centers for Disease Control and Prevention health advisory. Pointing out that there is “currently no evidence that additional treatment is needed” for COVID-19 to rebound. The FDA and CDC did not respond to questions about Paxlovid prescriptions.

Ultimately, the confusion surrounding Paxlovid, a pill tested extensively during the delta wave, is part of a wider discussion about how to best treat patients when the virus develops. When the Omron version arrived, existing monoclonal antibodies that were once a primary line of defense were found to be less effective at preventing infection. In response, the FDA doubled the dosage of AstraZeneca’s Evushield but reduced the use of antibodies from Eli Lilly and Regeneron. Federal officials no longer recommend other preventive treatments.

At least one physician is looking beyond the current discussion, at a time where Paxlovid or another drug will have full acceptance and become widely used. Paul Sachs, clinical director of the Department of Infectious Diseases at Brigham and Women’s Hospital, said he could see a future in which “we manage COVID-19 as much as we manage influenza, which We prescribe antiviral therapy to many people who have the flu if they seek early care.”

For now, physician and existing scientific studies support Paxlovid treatment for patients at high risk of developing serious disease. And rebound or not, it’s hospitalizations and deaths that matter. “I tell my patients that, in the end, this is the most important outcome and it should not deter us from using Paxlovid in patients who are at high risk of serious disease,” Lee said. “Because we know it works.”

This article is reproduced with permission of STAT. It was first published on July 7, 2022. Find the original story here.

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