POST 253. May 29, 2020. CORONAVIRUS. “Significant obstacles persist in getting Paxlovid to everyone who could benefit from it; more than a million courses of Paxlovid purchased by the government are still available…”..” However, some doctors have also voiced concerns over wider use of the antiviral drug amid reports of so-called “rebound” symptoms following use of Paxlovid, which might raise the risk of the virus evolving resistance to the pills.”

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“Although it is clear that infection rates have been steadily rising in recent weeks to their highest reported level since mid-February, scientists acknowledge that it is difficult to know how high COVID-19 case and even hospitalization numbers truly are, given the likely “substantially” undercounting of infections.

This is due in part to changes in data collection and reporting and the proliferation of at-home tests. Some state officials report that health departments and healthcare facilities have also ended traditional tracking of COVID-19 patients, which epidemiologists say make it more difficult to know how many patients are coming into hospitals in need of care….

However, over the course of the spring and winter, hospitalization data, too, has become less accessible, leading some experts to suggest patient totals could also be undercounted.

Earlier this year, the Department of Health and Human Services ended the requirement for hospitals to report several key COVID-19 metrics, including a daily total of the number of COVID-19 deaths, the number of emergency department overflow and ventilated patients and information on critical staffing shortages.

Further, certain states have stopped outright reporting of statistics including hospital bed usage and availability, COVID-19 specific hospital metrics and ventilator use…

This winter, following the omicron surge, the CDC released a new risk level map, which shifted away from focusing on the level of transmission within a community, and rather shifted the attention to hospital capacity and admission levels.

The rollout of the new map, which aims to help people and local officials assess when to implement potential mitigation measures, caused controversy among some Americans, explained Doron. While some people argued the shift in metrics was long overdue and a sign of the times, others said the move was premature.

“Some people were happy because they felt that we were beyond the time period in which we needed to reimpose restrictions and mandates every time cases increased, given widespread population immunity from vaccination and infection,” Doron said. “It made other people angry because a transition to a medium or high-risk status now requires increases in hospitalizations, which are lagging indicators, in other words there can be a lot of cases before hospitals get full, and some people might choose to take extra precautions sooner.” (A)

“The coronavirus mutant that is now dominant in the United States is a member of the omicron family but scientists say it spreads faster than its omicron predecessors, is adept at escaping immunity and might possibly cause more serious disease.

Why? Because it combines properties of both omicron and delta, the nation’s dominant variant in the middle of last year.

A genetic trait that harkens back to the pandemic’s past, known as a “delta mutation,” appears to allow the virus “to escape pre-existing immunity from vaccination and prior infection, especially if you were infected in the omicron wave,” said Dr. Wesley Long, a pathologist at Houston Methodist in Texas. That’s because the original omicron strain that swept the world didn’t have the mutation.

The omicron “subvariant” gaining ground in the U.S. — known as BA.2.12.1 and responsible for 58% of U.S. COVID-19 cases last week — isn’t the only one affected by the delta mutation. The genetic change is also present in the omicron relatives that together dominate in South Africa, known as BA.4 and BA.5. Those have exactly the same mutation as delta, while BA.2.12.1 has one that’s nearly identical.

This genetic change is bad news for people who caught the original omicron and thought that made them unlikely to get COVID-19 again soon. Although most people don’t know for sure which variant caused their illness, the original omicron caused a giant wave of cases late last year and early this year.

Long said lab data suggests a prior infection with the original omicron is not very protective against reinfection with the new mutants, though the true risk of being reinfected no matter the variant is unique to every person and situation…

Scientists are still trying to figure out how virulent these new mutants are. Long said he hasn’t seen anything that answers that question for him, but Liu said emerging data points toward more serious illness. Liu said the subvariants have properties suggesting they spread more efficiently cell-to-cell.

The virus “just hides in the cell and spreads through cell-to-cell contact,” Liu said. “That’s more scary because the virus does not come out for the antibody to work.”

Dr. Eric Topol, head of Scripps Research Translational Institute, said the new mutants certainly don’t appear less virulent than previous versions of omicron, and whether they are more virulent or not “will become clear in the months ahead.”

In the meantime, scientists expect the latest powerhouse mutants to spread quickly, since they are more transmissible than their predecessors.

Though home testing makes it tough to track all U.S. COVID cases, data from Johns Hopkins University shows that cases are averaging nearly 107,000 a day, up from about 87,000 two weeks ago. And new hospital admissions of patients with COVID-19 have been trending upwards since around mid-April, according to the Centers for Disease Control and Prevention.

“I’m hopeful that we don’t see a similar increase in hospitalizations that we’ve had in prior waves,” Long said. “But with COVID, any time you have lots of people being infected, it’s just a numbers game. Some of those people are going to be severe. Some of those people are going to need hospitalization. Some of them, unfortunately, are going to pass away.” (B)

“White House officials said on Thursday that they were introducing new models for distributing Paxlovid, the Covid-19 oral medication made by Pfizer, in an effort to get the treatment to more people and keep coronavirus death rates relatively low even as cases increase.

The federal government will start reimbursing a clinic in Providence, R.I., for evaluating patients who test positive and immediately prescribing Paxlovid to those eligible for it — the first of what the White House said would be a series of federally supported sites, with others set to open in New York and Illinois. Federal workers are also being sent to state-run testing sites in Minnesota, transforming them into “test-to-treat” locations, the White House said.

“Fundamentally, what we’re trying to do is get to a point where Covid deaths are largely preventable, and I think we’re pretty close to there,” Dr. Ashish K. Jha, the White House Covid-19 response coordinator, said in an interview Wednesday evening. “Deaths from this disease really should become increasingly rare.”

Significant obstacles persist in getting Paxlovid to everyone who could benefit from it; more than a million courses of Paxlovid purchased by the government are still available, according to data collected by the Department of Health and Human Services. Because of vague eligibility guidelines that are open to broad interpretation — the medication is authorized for people 12 and older with “mild-to-moderate” Covid-19 who are at risk of severe illness — some doctors are hesitant to prescribe the pill, or require extensive consultation…

Pharmacists still cannot prescribe the medication themselves, a step that would cut the time it takes patients to secure the drug.

The Food and Drug Administration “is looking at this and thinking about it,” Dr. Jha said. “Whether they’re going to make a change, when and how, etc., is totally in their wheelhouse.”

Many patients are still handling the sometimes-cumbersome steps on their own: locating a virus test, then securing a Paxlovid prescription from a health provider, then finding a pharmacy that carries the pill, all within days of first showing symptoms.

Dr. Jha described being frustrated by physician colleagues who have told him they still limit Paxlovid to patients 65 years and older.

Many locations in the government’s test-to-treat program are CVS MinuteClinics with in-house nurse practitioners and physician assistants who can prescribe the drug, a service that requires appointments and can be prohibitively expensive for those without health insurance.” (C)

“The White House on Thursday announced more steps to make the antiviral treatment Paxlovid more accessible across the U.S. as it projects COVID-19 infections will continue to spread over the summer travel season.

The nation’s first federally backed test-to-treat site is opening Thursday in Rhode Island, providing patients with immediate access to the drug once they test positive. More federally supported sites are set to open in the coming weeks in Massachusetts and New York City, both hit by a marked rise in infections.

Next week, the U.S. will send authorized federal prescribers to several Minnesota-run testing sites, turning them into test-to-treat locations. Federal regulators have also sent clearer guidance to physicians to help them determine how to manage Paxlovid’s interactions with other drugs, with an eye toward helping prescribers find ways to get the life-saving medication to more patients.

Despite a nationwide surge in COVID-19 cases, deaths from the virus have remained largely stable over the past eight weeks, as vaccine booster shots and widely accessible treatments have helped to delink infections and mortality.

Confirmed infections in the U.S. have quadrupled since late March, from about 25,000 a day to more than 105,000 daily now. But deaths, which have tended to lag infections by three to four weeks over the course of the coronavirus pandemic, have declined steadily and are now plateaued at fewer than 300 per day.

It’s the first time in the course of the pandemic that the two have not trended together, said White House COVID-19 coordinator Dr. Ashish Jha. He called it an important development in helping Americans get back to normal life.

“What has been remarkable in the latest increase in infections we’re seeing is how steady serious illness and particularly deaths are eight weeks into this,” he said. “COVID is no longer the killer that it was even a year ago.”

Jha said that given the wider use of at-home rapid tests, whose results often go unreported to public health officials, the true number of daily infections is likely 200,000 or more — double the reported rate — which he said only makes the death rate plateau more significant.

He credited vaccines but also a more than four-fold increase in prescriptions over the last six weeks for the highly effective treatment Paxlovid.

Jha said about 25,000 to 30,000 courses of Paxlovid are being prescribed each day. When administered within five days of symptoms appearing, the drug has been proven to bring about a 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

Due to a change in the way Paxlovid is allocated to states, the number of pharmacies where it is available has doubled in the last month to almost 40,000.

“We are now at a point where I believe fundamentally most COVID deaths are preventable, that the deaths that are happening out there are mostly unnecessary, and there are a lot of tools we have now to make sure people do not die of this disease,” Jha told The Associated Press on Wednesday.

As the summer months approach, Jha said the “number one” thing people need to do is to “go and get boosted” — and if they have a breakthrough infection, they should consult with their doctor about getting Paxlovid. He said gatherings of all sizes can take place more safely because of the tools available — if people make use of them.” (D)

“Some Americans who take Paxlovid, an antiviral for Covid-19, may see their symptoms rebound following a brief recovery, the Centers for Disease Control and Prevention said in an advisory on Tuesday.

The Food and Drug Administration authorized Paxlovid for emergency use in December for people ages 12 and up who have mild or moderate Covid but are at high risk of a severe case. That includes older Americans, people with obesity, those who smoke or are pregnant and people with underlying medical conditions such as diabetes, HIV or cancer.

The drug regimen consists of three pills taken twice daily for five days. But two to eight days after completing the treatment and receiving a negative test, some patients may test positive again and see their symptoms reappear, the CDC said.

The advisory affirmed a trend many patients and doctors have been discussing for at least a month. A case study posted online in late April sequenced virus samples from a 71-year-old man who saw his illness rebound after finishing Paxlovid. The study, which is under review by a medical journal, found no indication that the man had developed resistance to the drug; instead, the authors suggested that symptoms may recur “before natural immunity is sufficient to fully clear” the virus…

“Either this post-Paxlovid relapse is real, something unique to BA.2.12 (although can’t confirm)…or something … We’ll eventually figure this out, but still a puzzle,” Hotez wrote last week, referring to an omicron subvariant that is now the predominant strain in the U.S.

All three experts said, however, that rebounds don’t necessarily mean Paxlovid doesn’t work. Pfizer’s clinical trial showed that Paxlovid lowered the risk of hospitalization or death among high-risk Covid patients by 88 percent within five days of symptom onset. The National Institutes of Health still recommends it over other treatments for mild or moderate Covid.

Plus, the CDC has not thus far identified any cases of severe disease among people whose symptoms or infection rebounded after taking Paxlovid. On average, patients whose symptoms returned or who tested positive again saw those second-round illnesses improve or resolve with three days. They didn’t require additional treatments, the CDC said.

The agency did recommend, however, that people with Covid rebounds start their isolation over. The CDC has not yet determined if patients with Covid rebounds are more or less likely to spread the virus than they were during their initial illness.

“A brief return of symptoms may be part of the natural history” of coronavirus infections for some people, regardless of whether they took Paxlovid or were vaccinated or boosted, the CDC said.

Pfizer’s clinical trial identified similar rates of Covid rebounds among participants who recently finished Paxlovid and those who recently got a placebo.

Paxlovid must be taken within five days after someone gets diagnosed with Covid. Some medical experts, including Wachter, have mused about whether patients would benefit from a longer treatment course. Other experts have wondered whether Paxlovid is being administered too early in the course of an illness.

At the least, the CDC said, cases of Covid rebound don’t appear to be related to reinfection.” (E)

“Federal data published this week now tallies more than 830,000 courses of Paxlovid administered in total, out of nearly 2.5 million ordered for distribution.

Increased use of the drug has generally followed where cases have climbed around the nation, senior health officials told reporters last week.

In addition to expanding supply and access to COVID-19 drugs, federal officials have urged providers to generously interpret eligibility for the pills, which can only be given to Americans with at least mild COVID-19 symptoms who are considered at-risk of severe disease.

“Risk factors have changed over time, and additional risk factors [such as being unvaccinated or having not received a booster] could be considered,” notes a checklist published by the Food and Drug Administration for prescribers.

However, some doctors have also voiced concerns over wider use of the antiviral drug amid reports of so-called “rebound” symptoms following use of Paxlovid, which might raise the risk of the virus evolving resistance to the pills.

The CDC issued a health alert on Tuesday warning of the rebound cases, when patients initially seem to recover after finishing off a five day course of Paxlovid only to see symptoms and positive test results later return.

Officials have said that there is no evidence for now backing additional or longer rounds of Paxlovid or other drugs for these cases. The National Institutes of Health is in talks with Pfizer for potential studies of the question.

In its alert, the CDC agency urged providers to have their patients restart isolation and mask-wearing to avoid transmitting the virus. Reported symptoms from rebound cases have largely been mild, the agency said.

Doctors have also voiced concerns over patients still facing difficulty accessing the drugs.

For example, some of the country’s largest telehealth providers, including Teladoc Health and Cigna subsidiary MDLIVE, told CBS News earlier this month that they had policies against doctors prescribing the antiviral drugs through virtual visits.

A spokesperson for the FDA declined to comment on the issue.

“Due to current FDA reporting requirements and safety guidelines for patients with pre-existing kidney and liver problems, our doctors cannot prescribe antivirals,” MDLIVE spokesperson Ann Smith said.” (F)

“Use of Pfizer Inc’s (PFE.N) COVID-19 antiviral Paxlovid spiked this week, but some doctors are reconsidering the pills for lower-risk patients after a U.S. public health agency warned that symptoms can recur after people complete a course of the drug, and that they should then isolate a second time.

More quarantine time “is not a crowd-pleaser,” Dr. Sandra Kemmerly, an infectious disease specialist at Ochsner Health in New Orleans, told Reuters. “For those people who really aren’t at risk … I would recommend that they not take it.”

Use of Pfizer’s Paxlovid, authorized to treat newly infected, at-risk people in order to prevent severe illness, has soared as infections have risen. More than 162,000 courses were dispensed last week – compared with an average of 33,000 a week since the drug was launched late last year, according to government data. Biden administration officials have pushed for wide use of Paxlovid, which the government purchased and provides free.

But higher use has also come with more reports from people who say their symptoms eased with Paxlovid only to return a few days after finishing a five-day regimen of the pills.

On Tuesday, the Centers for Disease Control and Prevention, citing case reports and concerns that relapsed patients could spread the virus, issued its advisory that Paxlovid users should isolate for a second five days if symptoms rebound. read more

“I am shying away from giving it to people who are very low- risk, and are not terribly ill, particularly people who are vaccinated and boosted,” said Dr. Bruce Farber, chief of public health and epidemiology for Northwell Health. He said he is still recommending Paxlovid for people who have significant health conditions or are over age 75.

Pfizer, in an email, said it is monitoring the data, but believes the return of detectable virus is uncommon and not uniquely associated with its drug. “We have not seen any resistance emerge to date in patients treated with Paxlovid,” a spokesperson said.

The CDC also said it is unclear whether cases of rebound symptoms have anything to do with Paxlovid, or are simply part of the natural trajectory of COVID-19. The agency did not flag any specific concerns about health effects.

“COVID historically has had this sort of stuttering course – people will feel better one day and then feel worse the next day, but I can say we haven’t seen these rebound symptoms with other COVID treatments,” said Vijayan, referring to therapies such as monoclonal antibodies.” (G)

“Two omicron subvariants, BA.2 and BA.2.12.1, are currently driving a rise in Covid-19 cases across the United States, largely due to their increased transmissibility and ability to partially evade immunity.

According to CDC data, the omicron subvariant BA.2.12.1 is now the dominant variant in the United States, displacing the BA.2 subvariant, which initially displaced the original omicron variant in mid-March. As of May 21, the BA.2.12.1 subvariant made up 57.9% of all Covid-19 cases in the United States, while BA.2 made up around 39.1% of cases.

So far, data suggests that BA.2.12.1 may be roughly 25% more transmissible than BA.2, which is already more transmissible than the original omicron variant.

However, despite the subvariants’ increased transmissibility, there is no evidence to suggest that they cause more severe illness than earlier coronavirus variants.

“Epidemiologically, it doesn’t appear as if we’re seeing more severe disease in places that are having more cases,” said CDC Director Rochelle Walensky. “So we are not anticipating more severe disease from some of these subvariants, but we are actively studying it.”

Meanwhile, Covid-19 cases have begun to surge again, averaging more than 100,000 new confirmed cases a day for the first time since February, according to a New York Times database. However, this may be an undercount of the true number of cases, since the results of many at-home Covid-19 tests often go unreported. In addition, Covid-19 hospitalizations have increased 28% over the last two weeks, averaging more than 24,700 hospitalizations nationwide.

According to Vox, the omicron subvariants in the United States, as well as similar subvariants in other countries, continue to fuel new Covid-19 surges because of their increased transmissibility and ability to partially evade immunity from both vaccination and prior infection.

In particular, data shows that this current increase in cases is largely being driven by reinfections. “The thing with omicron, though, and all the [subvariants] therein, is now a lot of the growth advantage is driven by reinfections,” said Aaron Richterman, an infectious disease fellow at the University of Pennsylvania…

As Covid-19 cases continue to increase going into the summer, health officials are encouraging people to consider wearing masks again, especially in areas with high transmission. “I feel that very strongly, that in crowded indoor spaces, in places with high transmission, people should be doing that [wearing masks],” said Ashish Jha, the White House Covid-19 coordinator.” (H)