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In a phase 3 trial where all participants received intensive behavior therapy, investigational 2.4-mg once-weekly subcutaneous semaglutide (Novo Nordisk) resulted in a 10.3% greater average weight loss than placebo over a period of 68 weeks.

If approved, this medication could be a “potential major breakthrough” in obesity management, the investigators suggested. But other experts urged caution, as cost and uptake are important considerations.
 

‘Potential weight loss that patients would be happy with’

Thomas A. Wadden, PhD, presented results from the study of 611 adults with overweight or obesity but no diabetes at the virtual ObesityWeek® Interactive 2020 meeting.

“Perhaps even more impressive was the finding that 75% of patients lost 10% or more of baseline body weight,” said Dr. Wadden, of the department of psychiatry at the University of Pennsylvania, Philadelphia.

Moreover, in this trial of semaglutide, a glucagonlike peptide–1 (GLP-1) receptor agonist that is approved for treating type 2 diabetes at a weekly subcutaneous dose of 1 mg, but is being investigated at the higher dose for weight loss – 55% of patients lost ≥15% of their initial weight, and 36% lost ≥20% of their initial weight.

“These large categorical weight losses – particularly of 15% and 20% of initial weight – are potentially a major breakthrough in the management of obesity,” Dr. Wadden said in an interview.

Weight losses of this size, he added, “should confer greater improvements in cardiometabolic risk factors (such as hypertension, sleep apnea, and type 2 diabetes) as compared with losses of 5%-10% achieved with current behavioral or pharmacological approaches.” And patients are generally not satisfied with losses of less than 10% of initial weight when participating in intensive behavior programs or taking weight-loss medications.

Now, “the larger categorical weight losses will mean that a greater number of patients with obesity will be able to achieve a weight loss with which they are ... happy,” Dr. Wadden said in an interview.

According to Louis J. Aronne, MD, Weill Professor of Metabolic Research, Weill Cornell Medicine, New York, who is an investigator for another trial of semaglutide: “Even though it has the same mechanism of action [as liraglutide], the weight loss is two or more times greater [with semaglutide]. In my opinion, it’s really going to be a major advance in the treatment of obesity.”

In the discussion that followed the virtual presentation, one attendee asked about potential weight regain if a patient stopped taking the drug. Based on experience with another subcutaneous injectable GLP-1 receptor agonist, liraglutide (Saxenda), already approved for obesity, it may be that taking medicine for chronic overweight may become like taking a statin for elevated cholesterol, said Dr. Wadden.

Novo Nordisk has now completed the four trials in the STEP (Semaglutide Treatment Effect in People With Obesity) global phase 3 clinical development program, and plans to file applications with the Food and Drug Administration later this year and with the European Medicines Agency in early 2021 for review of semaglutide 2.4 mg for weight management.
 

“Fundamental issues need to be figured out”

Invited to comment, Scott Kahan, MD, said: “This is impressive data, confirming that semaglutide, particularly when used in concert with evidence-based counseling, is a highly effective agent for obesity management.”

However, “the real question, though, is what comes next,” stressed Dr. Kahan, director of the National Center for Weight and Wellness, Washington, DC.

“Will it be approved by the U.S. FDA? I believe so,” he said in an interview. “Yet we already have several effective obesity medications approved over the past decade – all of which are rarely used and therefore make little impact for patients in the real world.”

“Will there be insurance coverage, and therefore practical access for those who could most benefit?” he continued. “Will prescribers counsel their patients about obesity management, including the use of effective medications? Will patients utilize available options?”

“These and other fundamental issues must be figured out before we anoint any treatment option as a meaningful step forward, let alone a transformative development,” according to Dr. Kahan.

Similarly, Irl B. Hirsch, MD, stressed that, should this medication be approved for weight loss, cost would be a major factor in its uptake.

“I’m old enough to recall when we started using lovastatin in the late 1980s,” Dr. Hirsch, professor of medicine, University of Washington Medicine Diabetes Institute, Seattle, said in an interview.

“We used it without the type of evidence of statin use we have today. A pill, but in those days the statins were expensive. But over time, the evidence for statins grew and over the next 15 years it was quite clear that for both primary prevention (for those with diabetes) and secondary intervention these drugs needed to be used by millions of people. These recommendations became easier once the drugs became generic.

“Will the same thing happen for GLP-1 agonists? The problem is we need both ‘hard-outcome data’ [such as 3-point major adverse cardiovascular events] and more reasonable cost before we see this expanding to an entire population.

“In the future perhaps we could have a biosimilar GLP-1 agonist that would be more affordable than what we pay now, but even before that we need agreement from our reimbursement thought leaders that our society should reimburse these agents.

“My thinking now is the cost-benefit could be favorable, but this is all dependent on what happens to the cost of the drugs over time,” he said.
 

Additive effect of intensive behavior therapy plus medication

Dr. Wadden explained that intensive behavioral therapy “provides 14 or more counseling sessions in 6 months to modify diet and physical activity, through the patients’ use of behavioral strategies (such as keeping daily food and activity diaries).”

Such programs typically produce mean weight loss of 5%-8% of initial weight; less frequent (e.g., monthly) programs typically produce weight loss of only 1%-3%.

Prior studies suggest that intensive behavioral therapy and medication have additive effects. To investigate this, Dr. Wadden and colleagues randomized 611 adults (81% women) who were a mean age of 46 years and had a mean body mass index of 38 kg/m².

All participants received 30 intensive behavior therapy sessions provided by a registered dietitian (or other qualified provider), which typically lasted 20-30 minutes and were given weekly for 12 weeks, every other week for the next 12 weeks, and then monthly.  

The dietitian gave participants behavioral strategies to help them adhere to diet and physical activity goals.

During the first 8 weeks, participants were provided with a 1,000-1,200 kcal/day meal replacement diet that included liquid shakes, meal bars, and prepared entrees designed to facilitate a large initial weight loss.

They then transitioned to a diet of conventional foods (of their choosing), with a goal of 1,200-1,800 kcal/day based on body weight.  

The physical activity goal was 100 minutes/week of walking or other aerobic activity in the first month, building up to 200 minutes/week by month 6.
 

‘More effective than current FDA-approved weight-loss medications’

At week 68, mean body weight decreased from baseline by 16.0% in the semaglutide group versus 5.7% in the placebo group (P < .0001).

In this trial, where all participants received extensive intensive behavior therapy, more participants had weight loss ≥5%, ≥10%, ≥15%, and ≥20% of their initial weight with semaglutide versus placebo (87% vs. 48%; 75% vs. 27%; 56% vs. 13%; 36% vs. 4%, respectively; all P < .0001).

From baseline to week 68, the proportion of participants with prediabetes decreased from 48% to 7% in the semaglutide group and from 53% to 26% in the placebo group.

Patients who received semaglutide had greater improvements in lipids, too.

Although the weight loss was 10.3% (10.6 kg) greater with semaglutide, Dr. Wadden noted, “additional studies have shown this net benefit to be as great as 11%-12%, which would make semaglutide 2.4 mg more effective than current [FDA-approved] weight-loss medications.”

“Naltrexone-bupropion (Contrave) with lifestyle counseling, for example,” he continued, “produces a loss that is 5 kg greater than lifestyle counseling plus placebo, liraglutide 3.0 mg (Saxenda) a loss 5.3 kg greater than placebo, and phentermine-topiramate (Qsymia) a loss that is 8.8 kg greater than placebo.” 

Semaglutide was well tolerated. Gastrointestinal adverse events, the most common type, occurred in 83% of patients in the semaglutide group and 63% of patients in the placebo group.

Nausea, as well as constipation and diarrhea, are common in medications that increase GLP-1 levels, Dr. Wadden noted. Side effects can be managed by slowly increasing the medication dose over 4 months.  

Dr. Wadden expects that, if approved, semaglutide 2.4 mg subcutaneous once-weekly will be recommended as an adjunct to a reduced calorie diet and increased physical activity. Additional studies suggest that monthly counseling should be sufficient to obtain similar weight losses as those seen in the current trial, which had more intensive counseling.

As well as being approved as a weekly subcutaneous injectable treatment for type 2 diabetes, semaglutide is also approved as an once-daily oral agent for the same indication (Rybelsus, Novo Nordisk) in doses of 7 mg and 14 mg to improve glycemic control along with diet and exercise. It is the first GLP-1 agonist available in tablet form.

Dr. Wadden serves on scientific advisory boards for Novo Nordisk and WW (formerly Weight Watchers), and has received grant support, on behalf of the University of Pennsylvania, from Novo Nordisk. Dr. Aronne is an investigator in a long-term trial of semaglutide and has served on scientific advisory boards for Novo Nordisk in the past. He also has other industry relationships that are not related to semaglutide.

A version of this article originally appeared on Medscape.com.

In a phase 3 trial where all participants received intensive behavior therapy, investigational 2.4-mg once-weekly subcutaneous semaglutide (Novo Nordisk) resulted in a 10.3% greater average weight loss than placebo over a period of 68 weeks.

If approved, this medication could be a “potential major breakthrough” in obesity management, the investigators suggested. But other experts urged caution, as cost and uptake are important considerations.
 

‘Potential weight loss that patients would be happy with’

Thomas A. Wadden, PhD, presented results from the study of 611 adults with overweight or obesity but no diabetes at the virtual ObesityWeek® Interactive 2020 meeting.

“Perhaps even more impressive was the finding that 75% of patients lost 10% or more of baseline body weight,” said Dr. Wadden, of the department of psychiatry at the University of Pennsylvania, Philadelphia.

Moreover, in this trial of semaglutide, a glucagonlike peptide–1 (GLP-1) receptor agonist that is approved for treating type 2 diabetes at a weekly subcutaneous dose of 1 mg, but is being investigated at the higher dose for weight loss – 55% of patients lost ≥15% of their initial weight, and 36% lost ≥20% of their initial weight.

“These large categorical weight losses – particularly of 15% and 20% of initial weight – are potentially a major breakthrough in the management of obesity,” Dr. Wadden said in an interview.

Weight losses of this size, he added, “should confer greater improvements in cardiometabolic risk factors (such as hypertension, sleep apnea, and type 2 diabetes) as compared with losses of 5%-10% achieved with current behavioral or pharmacological approaches.” And patients are generally not satisfied with losses of less than 10% of initial weight when participating in intensive behavior programs or taking weight-loss medications.

Now, “the larger categorical weight losses will mean that a greater number of patients with obesity will be able to achieve a weight loss with which they are ... happy,” Dr. Wadden said in an interview.

According to Louis J. Aronne, MD, Weill Professor of Metabolic Research, Weill Cornell Medicine, New York, who is an investigator for another trial of semaglutide: “Even though it has the same mechanism of action [as liraglutide], the weight loss is two or more times greater [with semaglutide]. In my opinion, it’s really going to be a major advance in the treatment of obesity.”

In the discussion that followed the virtual presentation, one attendee asked about potential weight regain if a patient stopped taking the drug. Based on experience with another subcutaneous injectable GLP-1 receptor agonist, liraglutide (Saxenda), already approved for obesity, it may be that taking medicine for chronic overweight may become like taking a statin for elevated cholesterol, said Dr. Wadden.

Novo Nordisk has now completed the four trials in the STEP (Semaglutide Treatment Effect in People With Obesity) global phase 3 clinical development program, and plans to file applications with the Food and Drug Administration later this year and with the European Medicines Agency in early 2021 for review of semaglutide 2.4 mg for weight management.
 

“Fundamental issues need to be figured out”

Invited to comment, Scott Kahan, MD, said: “This is impressive data, confirming that semaglutide, particularly when used in concert with evidence-based counseling, is a highly effective agent for obesity management.”

However, “the real question, though, is what comes next,” stressed Dr. Kahan, director of the National Center for Weight and Wellness, Washington, DC.

“Will it be approved by the U.S. FDA? I believe so,” he said in an interview. “Yet we already have several effective obesity medications approved over the past decade – all of which are rarely used and therefore make little impact for patients in the real world.”

“Will there be insurance coverage, and therefore practical access for those who could most benefit?” he continued. “Will prescribers counsel their patients about obesity management, including the use of effective medications? Will patients utilize available options?”

“These and other fundamental issues must be figured out before we anoint any treatment option as a meaningful step forward, let alone a transformative development,” according to Dr. Kahan.

Similarly, Irl B. Hirsch, MD, stressed that, should this medication be approved for weight loss, cost would be a major factor in its uptake.

“I’m old enough to recall when we started using lovastatin in the late 1980s,” Dr. Hirsch, professor of medicine, University of Washington Medicine Diabetes Institute, Seattle, said in an interview.

“We used it without the type of evidence of statin use we have today. A pill, but in those days the statins were expensive. But over time, the evidence for statins grew and over the next 15 years it was quite clear that for both primary prevention (for those with diabetes) and secondary intervention these drugs needed to be used by millions of people. These recommendations became easier once the drugs became generic.

“Will the same thing happen for GLP-1 agonists? The problem is we need both ‘hard-outcome data’ [such as 3-point major adverse cardiovascular events] and more reasonable cost before we see this expanding to an entire population.

“In the future perhaps we could have a biosimilar GLP-1 agonist that would be more affordable than what we pay now, but even before that we need agreement from our reimbursement thought leaders that our society should reimburse these agents.

“My thinking now is the cost-benefit could be favorable, but this is all dependent on what happens to the cost of the drugs over time,” he said.
 

Additive effect of intensive behavior therapy plus medication

Dr. Wadden explained that intensive behavioral therapy “provides 14 or more counseling sessions in 6 months to modify diet and physical activity, through the patients’ use of behavioral strategies (such as keeping daily food and activity diaries).”

Such programs typically produce mean weight loss of 5%-8% of initial weight; less frequent (e.g., monthly) programs typically produce weight loss of only 1%-3%.

Prior studies suggest that intensive behavioral therapy and medication have additive effects. To investigate this, Dr. Wadden and colleagues randomized 611 adults (81% women) who were a mean age of 46 years and had a mean body mass index of 38 kg/m².

All participants received 30 intensive behavior therapy sessions provided by a registered dietitian (or other qualified provider), which typically lasted 20-30 minutes and were given weekly for 12 weeks, every other week for the next 12 weeks, and then monthly.  

The dietitian gave participants behavioral strategies to help them adhere to diet and physical activity goals.

During the first 8 weeks, participants were provided with a 1,000-1,200 kcal/day meal replacement diet that included liquid shakes, meal bars, and prepared entrees designed to facilitate a large initial weight loss.

They then transitioned to a diet of conventional foods (of their choosing), with a goal of 1,200-1,800 kcal/day based on body weight.  

The physical activity goal was 100 minutes/week of walking or other aerobic activity in the first month, building up to 200 minutes/week by month 6.
 

‘More effective than current FDA-approved weight-loss medications’

At week 68, mean body weight decreased from baseline by 16.0% in the semaglutide group versus 5.7% in the placebo group (P < .0001).

In this trial, where all participants received extensive intensive behavior therapy, more participants had weight loss ≥5%, ≥10%, ≥15%, and ≥20% of their initial weight with semaglutide versus placebo (87% vs. 48%; 75% vs. 27%; 56% vs. 13%; 36% vs. 4%, respectively; all P < .0001).

From baseline to week 68, the proportion of participants with prediabetes decreased from 48% to 7% in the semaglutide group and from 53% to 26% in the placebo group.

Patients who received semaglutide had greater improvements in lipids, too.

Although the weight loss was 10.3% (10.6 kg) greater with semaglutide, Dr. Wadden noted, “additional studies have shown this net benefit to be as great as 11%-12%, which would make semaglutide 2.4 mg more effective than current [FDA-approved] weight-loss medications.”

“Naltrexone-bupropion (Contrave) with lifestyle counseling, for example,” he continued, “produces a loss that is 5 kg greater than lifestyle counseling plus placebo, liraglutide 3.0 mg (Saxenda) a loss 5.3 kg greater than placebo, and phentermine-topiramate (Qsymia) a loss that is 8.8 kg greater than placebo.” 

Semaglutide was well tolerated. Gastrointestinal adverse events, the most common type, occurred in 83% of patients in the semaglutide group and 63% of patients in the placebo group.

Nausea, as well as constipation and diarrhea, are common in medications that increase GLP-1 levels, Dr. Wadden noted. Side effects can be managed by slowly increasing the medication dose over 4 months.  

Dr. Wadden expects that, if approved, semaglutide 2.4 mg subcutaneous once-weekly will be recommended as an adjunct to a reduced calorie diet and increased physical activity. Additional studies suggest that monthly counseling should be sufficient to obtain similar weight losses as those seen in the current trial, which had more intensive counseling.

As well as being approved as a weekly subcutaneous injectable treatment for type 2 diabetes, semaglutide is also approved as an once-daily oral agent for the same indication (Rybelsus, Novo Nordisk) in doses of 7 mg and 14 mg to improve glycemic control along with diet and exercise. It is the first GLP-1 agonist available in tablet form.

Dr. Wadden serves on scientific advisory boards for Novo Nordisk and WW (formerly Weight Watchers), and has received grant support, on behalf of the University of Pennsylvania, from Novo Nordisk. Dr. Aronne is an investigator in a long-term trial of semaglutide and has served on scientific advisory boards for Novo Nordisk in the past. He also has other industry relationships that are not related to semaglutide.

A version of this article originally appeared on Medscape.com.

In a phase 3 trial where all participants received intensive behavior therapy, investigational 2.4-mg once-weekly subcutaneous semaglutide (Novo Nordisk) resulted in a 10.3% greater average weight loss than placebo over a period of 68 weeks.

If approved, this medication could be a “potential major breakthrough” in obesity management, the investigators suggested. But other experts urged caution, as cost and uptake are important considerations.
 

‘Potential weight loss that patients would be happy with’

Thomas A. Wadden, PhD, presented results from the study of 611 adults with overweight or obesity but no diabetes at the virtual ObesityWeek® Interactive 2020 meeting.

“Perhaps even more impressive was the finding that 75% of patients lost 10% or more of baseline body weight,” said Dr. Wadden, of the department of psychiatry at the University of Pennsylvania, Philadelphia.

Moreover, in this trial of semaglutide, a glucagonlike peptide–1 (GLP-1) receptor agonist that is approved for treating type 2 diabetes at a weekly subcutaneous dose of 1 mg, but is being investigated at the higher dose for weight loss – 55% of patients lost ≥15% of their initial weight, and 36% lost ≥20% of their initial weight.

“These large categorical weight losses – particularly of 15% and 20% of initial weight – are potentially a major breakthrough in the management of obesity,” Dr. Wadden said in an interview.

Weight losses of this size, he added, “should confer greater improvements in cardiometabolic risk factors (such as hypertension, sleep apnea, and type 2 diabetes) as compared with losses of 5%-10% achieved with current behavioral or pharmacological approaches.” And patients are generally not satisfied with losses of less than 10% of initial weight when participating in intensive behavior programs or taking weight-loss medications.

Now, “the larger categorical weight losses will mean that a greater number of patients with obesity will be able to achieve a weight loss with which they are ... happy,” Dr. Wadden said in an interview.

According to Louis J. Aronne, MD, Weill Professor of Metabolic Research, Weill Cornell Medicine, New York, who is an investigator for another trial of semaglutide: “Even though it has the same mechanism of action [as liraglutide], the weight loss is two or more times greater [with semaglutide]. In my opinion, it’s really going to be a major advance in the treatment of obesity.”

In the discussion that followed the virtual presentation, one attendee asked about potential weight regain if a patient stopped taking the drug. Based on experience with another subcutaneous injectable GLP-1 receptor agonist, liraglutide (Saxenda), already approved for obesity, it may be that taking medicine for chronic overweight may become like taking a statin for elevated cholesterol, said Dr. Wadden.

Novo Nordisk has now completed the four trials in the STEP (Semaglutide Treatment Effect in People With Obesity) global phase 3 clinical development program, and plans to file applications with the Food and Drug Administration later this year and with the European Medicines Agency in early 2021 for review of semaglutide 2.4 mg for weight management.
 

“Fundamental issues need to be figured out”

Invited to comment, Scott Kahan, MD, said: “This is impressive data, confirming that semaglutide, particularly when used in concert with evidence-based counseling, is a highly effective agent for obesity management.”

However, “the real question, though, is what comes next,” stressed Dr. Kahan, director of the National Center for Weight and Wellness, Washington, DC.

“Will it be approved by the U.S. FDA? I believe so,” he said in an interview. “Yet we already have several effective obesity medications approved over the past decade – all of which are rarely used and therefore make little impact for patients in the real world.”

“Will there be insurance coverage, and therefore practical access for those who could most benefit?” he continued. “Will prescribers counsel their patients about obesity management, including the use of effective medications? Will patients utilize available options?”

“These and other fundamental issues must be figured out before we anoint any treatment option as a meaningful step forward, let alone a transformative development,” according to Dr. Kahan.

Similarly, Irl B. Hirsch, MD, stressed that, should this medication be approved for weight loss, cost would be a major factor in its uptake.

“I’m old enough to recall when we started using lovastatin in the late 1980s,” Dr. Hirsch, professor of medicine, University of Washington Medicine Diabetes Institute, Seattle, said in an interview.

“We used it without the type of evidence of statin use we have today. A pill, but in those days the statins were expensive. But over time, the evidence for statins grew and over the next 15 years it was quite clear that for both primary prevention (for those with diabetes) and secondary intervention these drugs needed to be used by millions of people. These recommendations became easier once the drugs became generic.

“Will the same thing happen for GLP-1 agonists? The problem is we need both ‘hard-outcome data’ [such as 3-point major adverse cardiovascular events] and more reasonable cost before we see this expanding to an entire population.

“In the future perhaps we could have a biosimilar GLP-1 agonist that would be more affordable than what we pay now, but even before that we need agreement from our reimbursement thought leaders that our society should reimburse these agents.

“My thinking now is the cost-benefit could be favorable, but this is all dependent on what happens to the cost of the drugs over time,” he said.
 

Additive effect of intensive behavior therapy plus medication

Dr. Wadden explained that intensive behavioral therapy “provides 14 or more counseling sessions in 6 months to modify diet and physical activity, through the patients’ use of behavioral strategies (such as keeping daily food and activity diaries).”

Such programs typically produce mean weight loss of 5%-8% of initial weight; less frequent (e.g., monthly) programs typically produce weight loss of only 1%-3%.

Prior studies suggest that intensive behavioral therapy and medication have additive effects. To investigate this, Dr. Wadden and colleagues randomized 611 adults (81% women) who were a mean age of 46 years and had a mean body mass index of 38 kg/m².

All participants received 30 intensive behavior therapy sessions provided by a registered dietitian (or other qualified provider), which typically lasted 20-30 minutes and were given weekly for 12 weeks, every other week for the next 12 weeks, and then monthly.  

The dietitian gave participants behavioral strategies to help them adhere to diet and physical activity goals.

During the first 8 weeks, participants were provided with a 1,000-1,200 kcal/day meal replacement diet that included liquid shakes, meal bars, and prepared entrees designed to facilitate a large initial weight loss.

They then transitioned to a diet of conventional foods (of their choosing), with a goal of 1,200-1,800 kcal/day based on body weight.  

The physical activity goal was 100 minutes/week of walking or other aerobic activity in the first month, building up to 200 minutes/week by month 6.
 

‘More effective than current FDA-approved weight-loss medications’

At week 68, mean body weight decreased from baseline by 16.0% in the semaglutide group versus 5.7% in the placebo group (P < .0001).

In this trial, where all participants received extensive intensive behavior therapy, more participants had weight loss ≥5%, ≥10%, ≥15%, and ≥20% of their initial weight with semaglutide versus placebo (87% vs. 48%; 75% vs. 27%; 56% vs. 13%; 36% vs. 4%, respectively; all P < .0001).

From baseline to week 68, the proportion of participants with prediabetes decreased from 48% to 7% in the semaglutide group and from 53% to 26% in the placebo group.

Patients who received semaglutide had greater improvements in lipids, too.

Although the weight loss was 10.3% (10.6 kg) greater with semaglutide, Dr. Wadden noted, “additional studies have shown this net benefit to be as great as 11%-12%, which would make semaglutide 2.4 mg more effective than current [FDA-approved] weight-loss medications.”

“Naltrexone-bupropion (Contrave) with lifestyle counseling, for example,” he continued, “produces a loss that is 5 kg greater than lifestyle counseling plus placebo, liraglutide 3.0 mg (Saxenda) a loss 5.3 kg greater than placebo, and phentermine-topiramate (Qsymia) a loss that is 8.8 kg greater than placebo.” 

Semaglutide was well tolerated. Gastrointestinal adverse events, the most common type, occurred in 83% of patients in the semaglutide group and 63% of patients in the placebo group.

Nausea, as well as constipation and diarrhea, are common in medications that increase GLP-1 levels, Dr. Wadden noted. Side effects can be managed by slowly increasing the medication dose over 4 months.  

Dr. Wadden expects that, if approved, semaglutide 2.4 mg subcutaneous once-weekly will be recommended as an adjunct to a reduced calorie diet and increased physical activity. Additional studies suggest that monthly counseling should be sufficient to obtain similar weight losses as those seen in the current trial, which had more intensive counseling.

As well as being approved as a weekly subcutaneous injectable treatment for type 2 diabetes, semaglutide is also approved as an once-daily oral agent for the same indication (Rybelsus, Novo Nordisk) in doses of 7 mg and 14 mg to improve glycemic control along with diet and exercise. It is the first GLP-1 agonist available in tablet form.

Dr. Wadden serves on scientific advisory boards for Novo Nordisk and WW (formerly Weight Watchers), and has received grant support, on behalf of the University of Pennsylvania, from Novo Nordisk. Dr. Aronne is an investigator in a long-term trial of semaglutide and has served on scientific advisory boards for Novo Nordisk in the past. He also has other industry relationships that are not related to semaglutide.

A version of this article originally appeared on Medscape.com.

Coronavirus infections are expected to continue to climb in the upper Midwest and intermountain West of the United States, which will strain an already-maxed-out system as increased hospitalizations and deaths follow, say infectious diseases specialists.

“I think the situation in 2 to 4 weeks is going to be grim,” said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah School of Medicine in Salt Lake City, on a call yesterday with reporters, sponsored by the Infectious Diseases Society of America (IDSA).

Cases began rising in Utah in mid-September and have gone up steeply since, increasing from 450 cases per day to 2,650 reported on Nov. 8, according to the Johns Hopkins Coronavirus Resource Center. The New York Times reports that the 7-day rolling average for hospitalizations have gone up 34% and deaths have risen 93%, with 11 deaths this past Tuesday.

Other states in the west – Montana, Idaho, and Wyoming, which reported 1,232 cases on Tuesday and have been averaging 660 cases a day in the last week, according to the Times – are being equally hard hit. The same is true for states in the upper Midwest, including North Dakota, South Dakota, Minnesota, Wisconsin, and Iowa.

Most of the states being hit now have large swaths of rural countryside, which means health resources are limited and spread out, said Pavia.

“The situation really has to be described as dire,” said Pavia, noting that intensive care units in Utah are full, including contingency units that were purpose-built for the pandemic. Physicians and nurses are burned out and in short supply, he said. Instead of a 1:1 or 1:2 nurse-to-ICU patient ratio, the ratio is now 1:4, said Pavia. “Throughout the region, people are facing a crisis in staffing.”

The University of Utah hospital normally takes referrals from Idaho, Wyoming, and northern Arizona, but is prioritizing Utah residents for ICU admission, said Pavia.

Both Pavia and Daniel P. McQuillen, MD, president-elect of IDSA, also noted the shortage of infectious diseases specialists, which began at least a decade ago. McQuillen, senior infectious diseases physician at Beth Israel Lahey Health in Boston, said he and colleagues had done some research earlier this year anticipating the pandemic’s spread, and found that some 80% of counties – including the rural counties in the states now being hit – have one or zero infectious disease specialists.

Those specialists can help improve patient outcomes, explained McQuillen.
 

Colleges likely driving spike

Pavia said the reasons for sharp increases in the region vary, but there are several areas of commonality. Most of the states didn’t have many cases early in the pandemic, “so perhaps there was less fear of the virus.” There were fewer actions by government officials, driven perhaps by the reluctance to take on individuals who are distrustful of government, he said.

Cases started going up after some events – such as the August motorcycle rally in Sturgis, South Dakota – but the acceleration in September was likely driven by the reopening of colleges across the region, said Pavia.

“Most of the states have kept in-person schooling, and probably more importantly, they’ve kept extracurricular activities in sports,” he said, adding that in many of the areas the weather has turned cooler, driving people indoors.

McQuillen said it has been shown that a significant amount of transmission occurs within homes – and college students may be bringing the virus home and fueling spread, in addition to people not wearing masks while at small family gatherings.

Both he and Pavia said more emphasis needs to be placed on mitigation measures such as mask-wearing as well as on testing. IDSA is starting #MaskUpAmerica, a public service campaign aimed at getting people to wear masks in all community settings, including at work, in churches, at social gatherings, in gyms, and on public transportation.

Pavia said in some places people are refusing to be tested because they don’t want to be quarantined.

Utah Gov. Gary Herbert (R) issued a statewide mask mandate this past weekend and announced some other restrictions, including a 2-week pause on most, but not all, athletic events, according to CBS News. But local pushback could weaken those measures, said Pavia.

Many people are looking to vaccines to usher in a return to normal. But, said Pavia, “vaccines aren’t going to help us out much this winter,” noting that initial doses will be given mostly to first responders and healthcare workers.

“The only way we’re going to get out of this this winter is by doing the things that we’ve been talking about for months – wearing a mask, watching your social distance, and avoiding large gatherings,” he said.

There is an end in sight, said Pavia, but it won’t be in early 2021. “That end is next summer or fall,” he said. “And that’s a hard message to give but it’s really critical.”

McQuillen agreed: “Wearing masks and distancing are exactly all we have probably until middle of next year.”
 

This article first appeared on Medscape.com.

Coronavirus infections are expected to continue to climb in the upper Midwest and intermountain West of the United States, which will strain an already-maxed-out system as increased hospitalizations and deaths follow, say infectious diseases specialists.

“I think the situation in 2 to 4 weeks is going to be grim,” said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah School of Medicine in Salt Lake City, on a call yesterday with reporters, sponsored by the Infectious Diseases Society of America (IDSA).

Cases began rising in Utah in mid-September and have gone up steeply since, increasing from 450 cases per day to 2,650 reported on Nov. 8, according to the Johns Hopkins Coronavirus Resource Center. The New York Times reports that the 7-day rolling average for hospitalizations have gone up 34% and deaths have risen 93%, with 11 deaths this past Tuesday.

Other states in the west – Montana, Idaho, and Wyoming, which reported 1,232 cases on Tuesday and have been averaging 660 cases a day in the last week, according to the Times – are being equally hard hit. The same is true for states in the upper Midwest, including North Dakota, South Dakota, Minnesota, Wisconsin, and Iowa.

Most of the states being hit now have large swaths of rural countryside, which means health resources are limited and spread out, said Pavia.

“The situation really has to be described as dire,” said Pavia, noting that intensive care units in Utah are full, including contingency units that were purpose-built for the pandemic. Physicians and nurses are burned out and in short supply, he said. Instead of a 1:1 or 1:2 nurse-to-ICU patient ratio, the ratio is now 1:4, said Pavia. “Throughout the region, people are facing a crisis in staffing.”

The University of Utah hospital normally takes referrals from Idaho, Wyoming, and northern Arizona, but is prioritizing Utah residents for ICU admission, said Pavia.

Both Pavia and Daniel P. McQuillen, MD, president-elect of IDSA, also noted the shortage of infectious diseases specialists, which began at least a decade ago. McQuillen, senior infectious diseases physician at Beth Israel Lahey Health in Boston, said he and colleagues had done some research earlier this year anticipating the pandemic’s spread, and found that some 80% of counties – including the rural counties in the states now being hit – have one or zero infectious disease specialists.

Those specialists can help improve patient outcomes, explained McQuillen.
 

Colleges likely driving spike

Pavia said the reasons for sharp increases in the region vary, but there are several areas of commonality. Most of the states didn’t have many cases early in the pandemic, “so perhaps there was less fear of the virus.” There were fewer actions by government officials, driven perhaps by the reluctance to take on individuals who are distrustful of government, he said.

Cases started going up after some events – such as the August motorcycle rally in Sturgis, South Dakota – but the acceleration in September was likely driven by the reopening of colleges across the region, said Pavia.

“Most of the states have kept in-person schooling, and probably more importantly, they’ve kept extracurricular activities in sports,” he said, adding that in many of the areas the weather has turned cooler, driving people indoors.

McQuillen said it has been shown that a significant amount of transmission occurs within homes – and college students may be bringing the virus home and fueling spread, in addition to people not wearing masks while at small family gatherings.

Both he and Pavia said more emphasis needs to be placed on mitigation measures such as mask-wearing as well as on testing. IDSA is starting #MaskUpAmerica, a public service campaign aimed at getting people to wear masks in all community settings, including at work, in churches, at social gatherings, in gyms, and on public transportation.

Pavia said in some places people are refusing to be tested because they don’t want to be quarantined.

Utah Gov. Gary Herbert (R) issued a statewide mask mandate this past weekend and announced some other restrictions, including a 2-week pause on most, but not all, athletic events, according to CBS News. But local pushback could weaken those measures, said Pavia.

Many people are looking to vaccines to usher in a return to normal. But, said Pavia, “vaccines aren’t going to help us out much this winter,” noting that initial doses will be given mostly to first responders and healthcare workers.

“The only way we’re going to get out of this this winter is by doing the things that we’ve been talking about for months – wearing a mask, watching your social distance, and avoiding large gatherings,” he said.

There is an end in sight, said Pavia, but it won’t be in early 2021. “That end is next summer or fall,” he said. “And that’s a hard message to give but it’s really critical.”

McQuillen agreed: “Wearing masks and distancing are exactly all we have probably until middle of next year.”
 

This article first appeared on Medscape.com.

Coronavirus infections are expected to continue to climb in the upper Midwest and intermountain West of the United States, which will strain an already-maxed-out system as increased hospitalizations and deaths follow, say infectious diseases specialists.

“I think the situation in 2 to 4 weeks is going to be grim,” said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah School of Medicine in Salt Lake City, on a call yesterday with reporters, sponsored by the Infectious Diseases Society of America (IDSA).

Cases began rising in Utah in mid-September and have gone up steeply since, increasing from 450 cases per day to 2,650 reported on Nov. 8, according to the Johns Hopkins Coronavirus Resource Center. The New York Times reports that the 7-day rolling average for hospitalizations have gone up 34% and deaths have risen 93%, with 11 deaths this past Tuesday.

Other states in the west – Montana, Idaho, and Wyoming, which reported 1,232 cases on Tuesday and have been averaging 660 cases a day in the last week, according to the Times – are being equally hard hit. The same is true for states in the upper Midwest, including North Dakota, South Dakota, Minnesota, Wisconsin, and Iowa.

Most of the states being hit now have large swaths of rural countryside, which means health resources are limited and spread out, said Pavia.

“The situation really has to be described as dire,” said Pavia, noting that intensive care units in Utah are full, including contingency units that were purpose-built for the pandemic. Physicians and nurses are burned out and in short supply, he said. Instead of a 1:1 or 1:2 nurse-to-ICU patient ratio, the ratio is now 1:4, said Pavia. “Throughout the region, people are facing a crisis in staffing.”

The University of Utah hospital normally takes referrals from Idaho, Wyoming, and northern Arizona, but is prioritizing Utah residents for ICU admission, said Pavia.

Both Pavia and Daniel P. McQuillen, MD, president-elect of IDSA, also noted the shortage of infectious diseases specialists, which began at least a decade ago. McQuillen, senior infectious diseases physician at Beth Israel Lahey Health in Boston, said he and colleagues had done some research earlier this year anticipating the pandemic’s spread, and found that some 80% of counties – including the rural counties in the states now being hit – have one or zero infectious disease specialists.

Those specialists can help improve patient outcomes, explained McQuillen.
 

Colleges likely driving spike

Pavia said the reasons for sharp increases in the region vary, but there are several areas of commonality. Most of the states didn’t have many cases early in the pandemic, “so perhaps there was less fear of the virus.” There were fewer actions by government officials, driven perhaps by the reluctance to take on individuals who are distrustful of government, he said.

Cases started going up after some events – such as the August motorcycle rally in Sturgis, South Dakota – but the acceleration in September was likely driven by the reopening of colleges across the region, said Pavia.

“Most of the states have kept in-person schooling, and probably more importantly, they’ve kept extracurricular activities in sports,” he said, adding that in many of the areas the weather has turned cooler, driving people indoors.

McQuillen said it has been shown that a significant amount of transmission occurs within homes – and college students may be bringing the virus home and fueling spread, in addition to people not wearing masks while at small family gatherings.

Both he and Pavia said more emphasis needs to be placed on mitigation measures such as mask-wearing as well as on testing. IDSA is starting #MaskUpAmerica, a public service campaign aimed at getting people to wear masks in all community settings, including at work, in churches, at social gatherings, in gyms, and on public transportation.

Pavia said in some places people are refusing to be tested because they don’t want to be quarantined.

Utah Gov. Gary Herbert (R) issued a statewide mask mandate this past weekend and announced some other restrictions, including a 2-week pause on most, but not all, athletic events, according to CBS News. But local pushback could weaken those measures, said Pavia.

Many people are looking to vaccines to usher in a return to normal. But, said Pavia, “vaccines aren’t going to help us out much this winter,” noting that initial doses will be given mostly to first responders and healthcare workers.

“The only way we’re going to get out of this this winter is by doing the things that we’ve been talking about for months – wearing a mask, watching your social distance, and avoiding large gatherings,” he said.

There is an end in sight, said Pavia, but it won’t be in early 2021. “That end is next summer or fall,” he said. “And that’s a hard message to give but it’s really critical.”

McQuillen agreed: “Wearing masks and distancing are exactly all we have probably until middle of next year.”
 

This article first appeared on Medscape.com.

One in five COVID-19 patients are diagnosed with a psychiatric disorder such as anxiety or depression within 3 months of testing positive for the virus, new research suggests.

“People have been worried that COVID-19 survivors will be at greater risk of psychiatric disorders, and our findings in a large and detailed study show this to be true,” principal investigator Paul Harrison, BM, DM, professor of psychiatry, University of Oxford, Oxford, United Kingdom, said in a statement.

Health services “need to be ready to provide care, especially since our results are likely to be underestimates of the actual number of cases,” said Harrison.

The study also showed that having a psychiatric disorder independently increases the risk of getting COVID-19 – a finding that’s in line with research published earlier this month.

“Having a psychiatric illness should be added to the list of risk factors for COVID-19,” study coauthor Maxime Taquet, PhD, University of Oxford, said in the release.

The study was published online Nov. 9 in The Lancet Psychiatry.
 

Double the risk

The investigators took advantage of the TriNetX analytics network, which captured deidentified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States.

Of those patients, 62,354 adults were diagnosed with COVID-19 between Jan. 20 and Aug. 1, 2020.

To assess the psychiatric sequelae of COVID-19, the investigators created propensity score–matched cohorts of patients who had received a diagnosis of other conditions that represented a range of common acute presentations.

In 14 to 90 days after being diagnosed with COVID-19, 5.8% of patients received a first recorded diagnosis of psychiatric illness. Among patients with health problems other than COVID, 2.5% to 3.4% of patients received a psychiatric diagnosis, the authors report. The risk was greatest for anxiety disorders, depression, and insomnia.

Older COVID-19 patients had a two- to threefold increased risk for a first dementia diagnosis, a finding that supports an earlier UK study.

Some of this excess risk could reflect misdiagnosed cases of delirium or transient cognitive impairment due to reversible cerebral events, the authors noted.

The study also revealed a bidirectional relationship between mental illness and COVID-19. Individuals with a psychiatric diagnosis were about 65% more likely to be diagnosed with COVID-19 in comparison with their counterparts who did not have mental illness, independently of known physical health risk factors for COVID-19.

“We did not anticipate that psychiatric history would be an independent risk factor for COVID-19. This finding appears robust, being observed in all age strata and in both sexes, and was substantial,” the authors write.

At present, “we don’t understand what the explanation is for the associations between COVID and mental illness. We are looking into this in more detail to try and understand better what subgroups are particularly vulnerable in this regard,” Harrison told Medscape Medical News.
 

“Ambitious” research

Commenting on the findings for Medscape Medical News, Roy H. Perlis, MD, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, said this is “an ambitious effort to understand the short-term consequences of COVID in terms of brain diseases.”

Perlis said he’s not particularly surprised by the increase in psychiatric diagnoses among COVID-19 patients.

“After COVID infection, people are more likely to get close medical follow-up than usual. They’re more likely to be accessing the healthcare system; after all, they’ve already had COVID, so they’re probably less fearful of seeing their doctor. But, that probably also means they’re more likely to get a new diagnosis of something like depression,” he said.

Dementia may be the clearest illustration of this, Perlis said. “It seems less likely that dementia develops a month after COVID; more likely, something that happens during the illness leads someone to be more likely to diagnose dementia later on,” he noted.

Perlis cautioned against being “unnecessarily alarmed” by the findings in this study.

“We know that rates of depression in the UK and the US, as in much of the world, are substantially elevated right now. Much of this is likely a consequence of the stress and disruption that accompanies the pandemic,” said Perlis.

The study was funded by the National Institute for Health Research. Harrison has disclosed no relevant financial relationships. One author is an employee of TriNetX. Perlis has received consulting fees for service on scientific advisory boards of Belle Artificial Intelligence, Burrage Capital, Genomind, Psy Therapeutics, Outermost Therapeutics, RID Ventures, and Takeda. He holds equity in Psy Therapeutics and Outermost Therapeutics.
 

This article first appeared on Medscape.com.

One in five COVID-19 patients are diagnosed with a psychiatric disorder such as anxiety or depression within 3 months of testing positive for the virus, new research suggests.

“People have been worried that COVID-19 survivors will be at greater risk of psychiatric disorders, and our findings in a large and detailed study show this to be true,” principal investigator Paul Harrison, BM, DM, professor of psychiatry, University of Oxford, Oxford, United Kingdom, said in a statement.

Health services “need to be ready to provide care, especially since our results are likely to be underestimates of the actual number of cases,” said Harrison.

The study also showed that having a psychiatric disorder independently increases the risk of getting COVID-19 – a finding that’s in line with research published earlier this month.

“Having a psychiatric illness should be added to the list of risk factors for COVID-19,” study coauthor Maxime Taquet, PhD, University of Oxford, said in the release.

The study was published online Nov. 9 in The Lancet Psychiatry.
 

Double the risk

The investigators took advantage of the TriNetX analytics network, which captured deidentified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States.

Of those patients, 62,354 adults were diagnosed with COVID-19 between Jan. 20 and Aug. 1, 2020.

To assess the psychiatric sequelae of COVID-19, the investigators created propensity score–matched cohorts of patients who had received a diagnosis of other conditions that represented a range of common acute presentations.

In 14 to 90 days after being diagnosed with COVID-19, 5.8% of patients received a first recorded diagnosis of psychiatric illness. Among patients with health problems other than COVID, 2.5% to 3.4% of patients received a psychiatric diagnosis, the authors report. The risk was greatest for anxiety disorders, depression, and insomnia.

Older COVID-19 patients had a two- to threefold increased risk for a first dementia diagnosis, a finding that supports an earlier UK study.

Some of this excess risk could reflect misdiagnosed cases of delirium or transient cognitive impairment due to reversible cerebral events, the authors noted.

The study also revealed a bidirectional relationship between mental illness and COVID-19. Individuals with a psychiatric diagnosis were about 65% more likely to be diagnosed with COVID-19 in comparison with their counterparts who did not have mental illness, independently of known physical health risk factors for COVID-19.

“We did not anticipate that psychiatric history would be an independent risk factor for COVID-19. This finding appears robust, being observed in all age strata and in both sexes, and was substantial,” the authors write.

At present, “we don’t understand what the explanation is for the associations between COVID and mental illness. We are looking into this in more detail to try and understand better what subgroups are particularly vulnerable in this regard,” Harrison told Medscape Medical News.
 

“Ambitious” research

Commenting on the findings for Medscape Medical News, Roy H. Perlis, MD, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, said this is “an ambitious effort to understand the short-term consequences of COVID in terms of brain diseases.”

Perlis said he’s not particularly surprised by the increase in psychiatric diagnoses among COVID-19 patients.

“After COVID infection, people are more likely to get close medical follow-up than usual. They’re more likely to be accessing the healthcare system; after all, they’ve already had COVID, so they’re probably less fearful of seeing their doctor. But, that probably also means they’re more likely to get a new diagnosis of something like depression,” he said.

Dementia may be the clearest illustration of this, Perlis said. “It seems less likely that dementia develops a month after COVID; more likely, something that happens during the illness leads someone to be more likely to diagnose dementia later on,” he noted.

Perlis cautioned against being “unnecessarily alarmed” by the findings in this study.

“We know that rates of depression in the UK and the US, as in much of the world, are substantially elevated right now. Much of this is likely a consequence of the stress and disruption that accompanies the pandemic,” said Perlis.

The study was funded by the National Institute for Health Research. Harrison has disclosed no relevant financial relationships. One author is an employee of TriNetX. Perlis has received consulting fees for service on scientific advisory boards of Belle Artificial Intelligence, Burrage Capital, Genomind, Psy Therapeutics, Outermost Therapeutics, RID Ventures, and Takeda. He holds equity in Psy Therapeutics and Outermost Therapeutics.
 

This article first appeared on Medscape.com.

One in five COVID-19 patients are diagnosed with a psychiatric disorder such as anxiety or depression within 3 months of testing positive for the virus, new research suggests.

“People have been worried that COVID-19 survivors will be at greater risk of psychiatric disorders, and our findings in a large and detailed study show this to be true,” principal investigator Paul Harrison, BM, DM, professor of psychiatry, University of Oxford, Oxford, United Kingdom, said in a statement.

Health services “need to be ready to provide care, especially since our results are likely to be underestimates of the actual number of cases,” said Harrison.

The study also showed that having a psychiatric disorder independently increases the risk of getting COVID-19 – a finding that’s in line with research published earlier this month.

“Having a psychiatric illness should be added to the list of risk factors for COVID-19,” study coauthor Maxime Taquet, PhD, University of Oxford, said in the release.

The study was published online Nov. 9 in The Lancet Psychiatry.
 

Double the risk

The investigators took advantage of the TriNetX analytics network, which captured deidentified data from electronic health records of a total of 69.8 million patients from 54 healthcare organizations in the United States.

Of those patients, 62,354 adults were diagnosed with COVID-19 between Jan. 20 and Aug. 1, 2020.

To assess the psychiatric sequelae of COVID-19, the investigators created propensity score–matched cohorts of patients who had received a diagnosis of other conditions that represented a range of common acute presentations.

In 14 to 90 days after being diagnosed with COVID-19, 5.8% of patients received a first recorded diagnosis of psychiatric illness. Among patients with health problems other than COVID, 2.5% to 3.4% of patients received a psychiatric diagnosis, the authors report. The risk was greatest for anxiety disorders, depression, and insomnia.

Older COVID-19 patients had a two- to threefold increased risk for a first dementia diagnosis, a finding that supports an earlier UK study.

Some of this excess risk could reflect misdiagnosed cases of delirium or transient cognitive impairment due to reversible cerebral events, the authors noted.

The study also revealed a bidirectional relationship between mental illness and COVID-19. Individuals with a psychiatric diagnosis were about 65% more likely to be diagnosed with COVID-19 in comparison with their counterparts who did not have mental illness, independently of known physical health risk factors for COVID-19.

“We did not anticipate that psychiatric history would be an independent risk factor for COVID-19. This finding appears robust, being observed in all age strata and in both sexes, and was substantial,” the authors write.

At present, “we don’t understand what the explanation is for the associations between COVID and mental illness. We are looking into this in more detail to try and understand better what subgroups are particularly vulnerable in this regard,” Harrison told Medscape Medical News.
 

“Ambitious” research

Commenting on the findings for Medscape Medical News, Roy H. Perlis, MD, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, said this is “an ambitious effort to understand the short-term consequences of COVID in terms of brain diseases.”

Perlis said he’s not particularly surprised by the increase in psychiatric diagnoses among COVID-19 patients.

“After COVID infection, people are more likely to get close medical follow-up than usual. They’re more likely to be accessing the healthcare system; after all, they’ve already had COVID, so they’re probably less fearful of seeing their doctor. But, that probably also means they’re more likely to get a new diagnosis of something like depression,” he said.

Dementia may be the clearest illustration of this, Perlis said. “It seems less likely that dementia develops a month after COVID; more likely, something that happens during the illness leads someone to be more likely to diagnose dementia later on,” he noted.

Perlis cautioned against being “unnecessarily alarmed” by the findings in this study.

“We know that rates of depression in the UK and the US, as in much of the world, are substantially elevated right now. Much of this is likely a consequence of the stress and disruption that accompanies the pandemic,” said Perlis.

The study was funded by the National Institute for Health Research. Harrison has disclosed no relevant financial relationships. One author is an employee of TriNetX. Perlis has received consulting fees for service on scientific advisory boards of Belle Artificial Intelligence, Burrage Capital, Genomind, Psy Therapeutics, Outermost Therapeutics, RID Ventures, and Takeda. He holds equity in Psy Therapeutics and Outermost Therapeutics.
 

This article first appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

Clinical practice guidelines advise screening women for perinatal depression twice prenatally and once postpartum, but providers at the US Department of Veterans Affairs (VA) may not be adhering closely to those recommendations. In a multisite cohort study, the researchers enrolled women veterans who were pregnant and delivered newborns between January 1, 2016 and December 31, 2019. The researchers combined electronic health record and claims data with information collected from prenatal and postpartum telephone surveys.

Of the 663 women involved, 93% received primary care at a VA facility during pregnancy; 41% saw a VA mental health provider. Less than half of the sample had been screened for depression during the perinatal period, despite contact with VA providers. Only 13% of the women had both prenatal and postnatal screens.

Screened veterans were less likely to be diagnosed with depression by a VA provider in either the preconception or pregnancy periods, compared with those not screened (11% vs 24% and 14% vs 23%, respectively). 

Among unscreened women, 18% scored positive for depression prenatally and 9% postnatally on the Edinburgh Postnatal Depression scale. The researchers note that lack of screening can hinder connection to VA mental health treatment and referral resources.

The American Academy of Pediatrics recommends that pediatricians screen mothers for postpartum depression at 1, 2, 4, and 6 months after childbirth. But extending that into toddlerhood could pick up more women at risk, say National Institutes of Health researchers. “[S]ix months may not be long enough to gauge depressive symptoms,” said Diane Putnick, PhD, primary author.

In their study of 4,866 women, the researchers analyzed data from the Upstate KIDS study, which included babies born between 2008 and 2010 in New York State. The researchers found that approximately 1 in 4 women experienced high levels of depressive symptoms at some point during the 3 postnatal years.

In addition to extending the screening period to 36 months, the researchers advise keeping watch on women with underlying conditions, such as mood disorders and/or gestational diabetes, who were more likely to have higher levels of depressive symptoms that persisted.

Clinical practice guidelines advise screening women for perinatal depression twice prenatally and once postpartum, but providers at the US Department of Veterans Affairs (VA) may not be adhering closely to those recommendations. In a multisite cohort study, the researchers enrolled women veterans who were pregnant and delivered newborns between January 1, 2016 and December 31, 2019. The researchers combined electronic health record and claims data with information collected from prenatal and postpartum telephone surveys.

Of the 663 women involved, 93% received primary care at a VA facility during pregnancy; 41% saw a VA mental health provider. Less than half of the sample had been screened for depression during the perinatal period, despite contact with VA providers. Only 13% of the women had both prenatal and postnatal screens.

Screened veterans were less likely to be diagnosed with depression by a VA provider in either the preconception or pregnancy periods, compared with those not screened (11% vs 24% and 14% vs 23%, respectively). 

Among unscreened women, 18% scored positive for depression prenatally and 9% postnatally on the Edinburgh Postnatal Depression scale. The researchers note that lack of screening can hinder connection to VA mental health treatment and referral resources.

The American Academy of Pediatrics recommends that pediatricians screen mothers for postpartum depression at 1, 2, 4, and 6 months after childbirth. But extending that into toddlerhood could pick up more women at risk, say National Institutes of Health researchers. “[S]ix months may not be long enough to gauge depressive symptoms,” said Diane Putnick, PhD, primary author.

In their study of 4,866 women, the researchers analyzed data from the Upstate KIDS study, which included babies born between 2008 and 2010 in New York State. The researchers found that approximately 1 in 4 women experienced high levels of depressive symptoms at some point during the 3 postnatal years.

In addition to extending the screening period to 36 months, the researchers advise keeping watch on women with underlying conditions, such as mood disorders and/or gestational diabetes, who were more likely to have higher levels of depressive symptoms that persisted.

Clinical practice guidelines advise screening women for perinatal depression twice prenatally and once postpartum, but providers at the US Department of Veterans Affairs (VA) may not be adhering closely to those recommendations. In a multisite cohort study, the researchers enrolled women veterans who were pregnant and delivered newborns between January 1, 2016 and December 31, 2019. The researchers combined electronic health record and claims data with information collected from prenatal and postpartum telephone surveys.

Of the 663 women involved, 93% received primary care at a VA facility during pregnancy; 41% saw a VA mental health provider. Less than half of the sample had been screened for depression during the perinatal period, despite contact with VA providers. Only 13% of the women had both prenatal and postnatal screens.

Screened veterans were less likely to be diagnosed with depression by a VA provider in either the preconception or pregnancy periods, compared with those not screened (11% vs 24% and 14% vs 23%, respectively). 

Among unscreened women, 18% scored positive for depression prenatally and 9% postnatally on the Edinburgh Postnatal Depression scale. The researchers note that lack of screening can hinder connection to VA mental health treatment and referral resources.

The American Academy of Pediatrics recommends that pediatricians screen mothers for postpartum depression at 1, 2, 4, and 6 months after childbirth. But extending that into toddlerhood could pick up more women at risk, say National Institutes of Health researchers. “[S]ix months may not be long enough to gauge depressive symptoms,” said Diane Putnick, PhD, primary author.

In their study of 4,866 women, the researchers analyzed data from the Upstate KIDS study, which included babies born between 2008 and 2010 in New York State. The researchers found that approximately 1 in 4 women experienced high levels of depressive symptoms at some point during the 3 postnatal years.

In addition to extending the screening period to 36 months, the researchers advise keeping watch on women with underlying conditions, such as mood disorders and/or gestational diabetes, who were more likely to have higher levels of depressive symptoms that persisted.

Many health care providers (HCPs) view the US Department of Veterans Affairs (VA) system of electronic reminders as a model. User experience and improvements that make clinical life easier (like automated text messaging, which requires no hands-on staff involvement) have brought more HCPs into the fold. And during a viral pandemic, preventive care is ever more important, as are the ways to provide it. But a recent Centers for Disease Control and Prevention (CDC) study shows some non-VA providers have some catching up to do.

Although the CDC researchers noted that electronic reminders can improve preventive and follow-up care, they also pointed out that HCPs must first have the computing capabilities to accomplish this. They analyzed 2017 data (the most recent available) from the National Electronic Health Records Survey of > 10,000 physicians and found only 65% of office-based physicians did.

Not surprisingly, practices that used electronic health record (EHR) systems were more than 3 times as likely to also have computerized capability to identify patients who needed preventive care or follow-up (71% vs 23% of practices without EHR). Primary care physicians were more likely than surgeons and other nonprimary care physicians to have the capability (73% vs 55% and 59%, respectively). Age also entered into it, with 70% of physicians aged between 45 and 54 years having the capability, compared with 57% of those aged 65 to 84 years. Offices with multiple physicians were more likely to have computerized capability.

The VA began using computerized clinical reminders 20 years ago to encourage patients to take better care of themselves to, for example, moderate alcohol use, manage cholesterol, or stop smoking. In 2006, the Veterans Health Information Systems and Technology Architecture (VistA) won an Innovations in American Government Award from Harvard University. The committee called VistA innovative because of its “unique linkage with standardized, consistent performance measurement.” VistA, the committee said, “substantially improves efficiency, reduces costs and demonstrably improves clinical decision-making.”

However, when the VA was getting its electronic reminder system up to speed, not all users were comfortable with it. Researchers who studied uptake of a system that sent reminders about lipid management to patients with ischemic heart disease found “substantial barriers” to implementation, including a possibly significant effect of “prior culture and attitudes” toward reminders.

Four years after the VA began using computerized reminders, attendees at “Camp CPRS,” a week-long meeting to train employees in the Computerized Patient Record System, were asked about facilitation and barriers. More than half of respondents could report at least 1 situation in which reminders helped them deliver care more effectively. But “[w]hile the potential benefits of such a system are significant,” the researchers said, “and in fact some VA hospitals are showing an increase in compliance with some best practices…it is generally understood that some providers within the VA do not use the clinical reminders.” Some HCPs said they were hard to use and cited insufficient training.

Experience and consistent use pay off, though. For instance, researchers from the VA Puget Sound Health Care System in Washington evaluated the effectiveness of an electronic clinical reminder for brief alcohol counseling at 8 VA sites. They wanted to determine how often the HCPs used the reminder, and whether it helped patients resolve unhealthy alcohol use. The study, involving 4,198 participants who screened positive for alcohol use, found 71% of the patients had the clinical reminder documented in the EHR—a high rate, the researchers noted, relative to other studies. The results were similar across the 2-year period, even in the first 8 months.

Sustainability also is a factor. At the time of their study, the researchers said, no health care system had achieved sustained implementation of brief alcohol counseling for patients who screened positive. Moreover, the patients who had reminders were significantly more likely to report having resolved unhealthy alcohol use at follow-up.

Do electronic daily reminders really improve adherence? Valentin Rivish, DNP, RN, NE-BC, telehealth specialist and facility e-consult coordinator with the Phoenix VA Health Care System in Arizona, wanted to see what evidence exists on telehealth adherence and utilization. He enlisted 40 veterans whose home-telehealth response rates were < 70%. Over 4 weeks, the veterans received an electronic daily reminder sent to their home-telehealth device, with the goal of having them respond daily.

As Rivish expected, daily reminders did improve adherence. After 4 weeks, 24 participants (60%) showed an increased response rate, and 14 (35%) achieved at least a 70% response rate pos-intervention. As a result, the Phoenix telehealth department has included the cost-effective intervention in its standard operating procedure.  

The VA has continued to add to its repertoire of ways to stay in touch with patients. In 2018, for instance, it launched VEText, a text messaging appointment-reminder system. According to the Veterans Health Administration Office of Veterans Access to Care, in just the first few months more than 3.24 million patients had received VEText messages (and had canceled 319,504 appointments, freeing up time slots for other veterans).

This year, the VA, US Department of Defense, and US Coast Guard launched a joint health information exchange (HIE) that allows partners to quickly and securely share EHR data bidirectionally with participating community healthcare providers. To that end, the 46,000-member HIE is collaborating with the CommonWell Health Alliance, adding a nationwide network of more than 15,000 hospitals and clinics.

“As a clinician who is using the joint HIE, the more patient information I have access to, the more I can understand the full picture of my patients’ care and better meet their needs,” says Dr. Neil Evans, a VA primary care physician and clinical leader with the Federal Electronic Health Record Modernization office. “During the COVID-19 pandemic, efficient electronic health information is more important than ever.”

Many health care providers (HCPs) view the US Department of Veterans Affairs (VA) system of electronic reminders as a model. User experience and improvements that make clinical life easier (like automated text messaging, which requires no hands-on staff involvement) have brought more HCPs into the fold. And during a viral pandemic, preventive care is ever more important, as are the ways to provide it. But a recent Centers for Disease Control and Prevention (CDC) study shows some non-VA providers have some catching up to do.

Although the CDC researchers noted that electronic reminders can improve preventive and follow-up care, they also pointed out that HCPs must first have the computing capabilities to accomplish this. They analyzed 2017 data (the most recent available) from the National Electronic Health Records Survey of > 10,000 physicians and found only 65% of office-based physicians did.

Not surprisingly, practices that used electronic health record (EHR) systems were more than 3 times as likely to also have computerized capability to identify patients who needed preventive care or follow-up (71% vs 23% of practices without EHR). Primary care physicians were more likely than surgeons and other nonprimary care physicians to have the capability (73% vs 55% and 59%, respectively). Age also entered into it, with 70% of physicians aged between 45 and 54 years having the capability, compared with 57% of those aged 65 to 84 years. Offices with multiple physicians were more likely to have computerized capability.

The VA began using computerized clinical reminders 20 years ago to encourage patients to take better care of themselves to, for example, moderate alcohol use, manage cholesterol, or stop smoking. In 2006, the Veterans Health Information Systems and Technology Architecture (VistA) won an Innovations in American Government Award from Harvard University. The committee called VistA innovative because of its “unique linkage with standardized, consistent performance measurement.” VistA, the committee said, “substantially improves efficiency, reduces costs and demonstrably improves clinical decision-making.”

However, when the VA was getting its electronic reminder system up to speed, not all users were comfortable with it. Researchers who studied uptake of a system that sent reminders about lipid management to patients with ischemic heart disease found “substantial barriers” to implementation, including a possibly significant effect of “prior culture and attitudes” toward reminders.

Four years after the VA began using computerized reminders, attendees at “Camp CPRS,” a week-long meeting to train employees in the Computerized Patient Record System, were asked about facilitation and barriers. More than half of respondents could report at least 1 situation in which reminders helped them deliver care more effectively. But “[w]hile the potential benefits of such a system are significant,” the researchers said, “and in fact some VA hospitals are showing an increase in compliance with some best practices…it is generally understood that some providers within the VA do not use the clinical reminders.” Some HCPs said they were hard to use and cited insufficient training.

Experience and consistent use pay off, though. For instance, researchers from the VA Puget Sound Health Care System in Washington evaluated the effectiveness of an electronic clinical reminder for brief alcohol counseling at 8 VA sites. They wanted to determine how often the HCPs used the reminder, and whether it helped patients resolve unhealthy alcohol use. The study, involving 4,198 participants who screened positive for alcohol use, found 71% of the patients had the clinical reminder documented in the EHR—a high rate, the researchers noted, relative to other studies. The results were similar across the 2-year period, even in the first 8 months.

Sustainability also is a factor. At the time of their study, the researchers said, no health care system had achieved sustained implementation of brief alcohol counseling for patients who screened positive. Moreover, the patients who had reminders were significantly more likely to report having resolved unhealthy alcohol use at follow-up.

Do electronic daily reminders really improve adherence? Valentin Rivish, DNP, RN, NE-BC, telehealth specialist and facility e-consult coordinator with the Phoenix VA Health Care System in Arizona, wanted to see what evidence exists on telehealth adherence and utilization. He enlisted 40 veterans whose home-telehealth response rates were < 70%. Over 4 weeks, the veterans received an electronic daily reminder sent to their home-telehealth device, with the goal of having them respond daily.

As Rivish expected, daily reminders did improve adherence. After 4 weeks, 24 participants (60%) showed an increased response rate, and 14 (35%) achieved at least a 70% response rate pos-intervention. As a result, the Phoenix telehealth department has included the cost-effective intervention in its standard operating procedure.  

The VA has continued to add to its repertoire of ways to stay in touch with patients. In 2018, for instance, it launched VEText, a text messaging appointment-reminder system. According to the Veterans Health Administration Office of Veterans Access to Care, in just the first few months more than 3.24 million patients had received VEText messages (and had canceled 319,504 appointments, freeing up time slots for other veterans).

This year, the VA, US Department of Defense, and US Coast Guard launched a joint health information exchange (HIE) that allows partners to quickly and securely share EHR data bidirectionally with participating community healthcare providers. To that end, the 46,000-member HIE is collaborating with the CommonWell Health Alliance, adding a nationwide network of more than 15,000 hospitals and clinics.

“As a clinician who is using the joint HIE, the more patient information I have access to, the more I can understand the full picture of my patients’ care and better meet their needs,” says Dr. Neil Evans, a VA primary care physician and clinical leader with the Federal Electronic Health Record Modernization office. “During the COVID-19 pandemic, efficient electronic health information is more important than ever.”

Many health care providers (HCPs) view the US Department of Veterans Affairs (VA) system of electronic reminders as a model. User experience and improvements that make clinical life easier (like automated text messaging, which requires no hands-on staff involvement) have brought more HCPs into the fold. And during a viral pandemic, preventive care is ever more important, as are the ways to provide it. But a recent Centers for Disease Control and Prevention (CDC) study shows some non-VA providers have some catching up to do.

Although the CDC researchers noted that electronic reminders can improve preventive and follow-up care, they also pointed out that HCPs must first have the computing capabilities to accomplish this. They analyzed 2017 data (the most recent available) from the National Electronic Health Records Survey of > 10,000 physicians and found only 65% of office-based physicians did.

Not surprisingly, practices that used electronic health record (EHR) systems were more than 3 times as likely to also have computerized capability to identify patients who needed preventive care or follow-up (71% vs 23% of practices without EHR). Primary care physicians were more likely than surgeons and other nonprimary care physicians to have the capability (73% vs 55% and 59%, respectively). Age also entered into it, with 70% of physicians aged between 45 and 54 years having the capability, compared with 57% of those aged 65 to 84 years. Offices with multiple physicians were more likely to have computerized capability.

The VA began using computerized clinical reminders 20 years ago to encourage patients to take better care of themselves to, for example, moderate alcohol use, manage cholesterol, or stop smoking. In 2006, the Veterans Health Information Systems and Technology Architecture (VistA) won an Innovations in American Government Award from Harvard University. The committee called VistA innovative because of its “unique linkage with standardized, consistent performance measurement.” VistA, the committee said, “substantially improves efficiency, reduces costs and demonstrably improves clinical decision-making.”

However, when the VA was getting its electronic reminder system up to speed, not all users were comfortable with it. Researchers who studied uptake of a system that sent reminders about lipid management to patients with ischemic heart disease found “substantial barriers” to implementation, including a possibly significant effect of “prior culture and attitudes” toward reminders.

Four years after the VA began using computerized reminders, attendees at “Camp CPRS,” a week-long meeting to train employees in the Computerized Patient Record System, were asked about facilitation and barriers. More than half of respondents could report at least 1 situation in which reminders helped them deliver care more effectively. But “[w]hile the potential benefits of such a system are significant,” the researchers said, “and in fact some VA hospitals are showing an increase in compliance with some best practices…it is generally understood that some providers within the VA do not use the clinical reminders.” Some HCPs said they were hard to use and cited insufficient training.

Experience and consistent use pay off, though. For instance, researchers from the VA Puget Sound Health Care System in Washington evaluated the effectiveness of an electronic clinical reminder for brief alcohol counseling at 8 VA sites. They wanted to determine how often the HCPs used the reminder, and whether it helped patients resolve unhealthy alcohol use. The study, involving 4,198 participants who screened positive for alcohol use, found 71% of the patients had the clinical reminder documented in the EHR—a high rate, the researchers noted, relative to other studies. The results were similar across the 2-year period, even in the first 8 months.

Sustainability also is a factor. At the time of their study, the researchers said, no health care system had achieved sustained implementation of brief alcohol counseling for patients who screened positive. Moreover, the patients who had reminders were significantly more likely to report having resolved unhealthy alcohol use at follow-up.

Do electronic daily reminders really improve adherence? Valentin Rivish, DNP, RN, NE-BC, telehealth specialist and facility e-consult coordinator with the Phoenix VA Health Care System in Arizona, wanted to see what evidence exists on telehealth adherence and utilization. He enlisted 40 veterans whose home-telehealth response rates were < 70%. Over 4 weeks, the veterans received an electronic daily reminder sent to their home-telehealth device, with the goal of having them respond daily.

As Rivish expected, daily reminders did improve adherence. After 4 weeks, 24 participants (60%) showed an increased response rate, and 14 (35%) achieved at least a 70% response rate pos-intervention. As a result, the Phoenix telehealth department has included the cost-effective intervention in its standard operating procedure.  

The VA has continued to add to its repertoire of ways to stay in touch with patients. In 2018, for instance, it launched VEText, a text messaging appointment-reminder system. According to the Veterans Health Administration Office of Veterans Access to Care, in just the first few months more than 3.24 million patients had received VEText messages (and had canceled 319,504 appointments, freeing up time slots for other veterans).

This year, the VA, US Department of Defense, and US Coast Guard launched a joint health information exchange (HIE) that allows partners to quickly and securely share EHR data bidirectionally with participating community healthcare providers. To that end, the 46,000-member HIE is collaborating with the CommonWell Health Alliance, adding a nationwide network of more than 15,000 hospitals and clinics.

“As a clinician who is using the joint HIE, the more patient information I have access to, the more I can understand the full picture of my patients’ care and better meet their needs,” says Dr. Neil Evans, a VA primary care physician and clinical leader with the Federal Electronic Health Record Modernization office. “During the COVID-19 pandemic, efficient electronic health information is more important than ever.”

Normally, the lysosome, known as the cells’ “trash compactor,” destroys viruses before they can leave the cell. However, researchers at the National Institutes of Health (NIH) have discovered that SARS-CoV-2 is not like other viruses. The virus can deactivate that waste disposal system, exit without hindrance, and spread freely throughout the body.

“To our shock, these coronaviruses got out of the cells just fine,” said Nihal Altan-Bonnet, PhD, chief of the Laboratory of Host-Pathogen Dynamics at the National Heart, Lung, and Blood Institute, who coauthored the study report.

Most viruses exit via the biosynthetic secretory pathway, used to transport hormones, growth factors and other materials. The researchers wanted to learn whether coronaviruses took an alternate route. To find out, they conducted further studies, using microscopy and virus-specific markers. They discovered that coronaviruses somehow target the lysosome and congregate there. Although lysosomes are highly acidic, the coronaviruses were not destroyed.

That question led to more experiments. The researchers next found that lysosomes get “de-acidified” in coronavirus-infected cells, which weakens their destructive enzymes. The result: The coronavirus remains intact, ready to infect other cells upon exiting.

The coronaviruses are “very sneaky,” Altan-Bonnet says. “They’re using these lysosomes to get out, but they’re also disrupting the lysosome so it can’t do its job or function.” It’s possible that the way the coronavirus interferes with the lysosome’s “immunological machinery” underlies some of the immune system abnormalities seen in COVID-19 patients, such as cytokine storms.

Studying this coronavirus's heterodox ways may mean that researchers can figure out how to keep it from getting out unscathed, or restore the lysosome’s killing ability by re-acidifying it. Altan-Bonnet and coauthor Sourish Ghosh, PhD, say they have already identified one experimental enzyme inhibitor that potently blocks coronaviruses from exiting the cell.

The lysosome pathway, Altan-Bonnet says, “offers a whole different way of thinking about targeted therapeutics.”

Normally, the lysosome, known as the cells’ “trash compactor,” destroys viruses before they can leave the cell. However, researchers at the National Institutes of Health (NIH) have discovered that SARS-CoV-2 is not like other viruses. The virus can deactivate that waste disposal system, exit without hindrance, and spread freely throughout the body.

“To our shock, these coronaviruses got out of the cells just fine,” said Nihal Altan-Bonnet, PhD, chief of the Laboratory of Host-Pathogen Dynamics at the National Heart, Lung, and Blood Institute, who coauthored the study report.

Most viruses exit via the biosynthetic secretory pathway, used to transport hormones, growth factors and other materials. The researchers wanted to learn whether coronaviruses took an alternate route. To find out, they conducted further studies, using microscopy and virus-specific markers. They discovered that coronaviruses somehow target the lysosome and congregate there. Although lysosomes are highly acidic, the coronaviruses were not destroyed.

That question led to more experiments. The researchers next found that lysosomes get “de-acidified” in coronavirus-infected cells, which weakens their destructive enzymes. The result: The coronavirus remains intact, ready to infect other cells upon exiting.

The coronaviruses are “very sneaky,” Altan-Bonnet says. “They’re using these lysosomes to get out, but they’re also disrupting the lysosome so it can’t do its job or function.” It’s possible that the way the coronavirus interferes with the lysosome’s “immunological machinery” underlies some of the immune system abnormalities seen in COVID-19 patients, such as cytokine storms.

Studying this coronavirus's heterodox ways may mean that researchers can figure out how to keep it from getting out unscathed, or restore the lysosome’s killing ability by re-acidifying it. Altan-Bonnet and coauthor Sourish Ghosh, PhD, say they have already identified one experimental enzyme inhibitor that potently blocks coronaviruses from exiting the cell.

The lysosome pathway, Altan-Bonnet says, “offers a whole different way of thinking about targeted therapeutics.”

Normally, the lysosome, known as the cells’ “trash compactor,” destroys viruses before they can leave the cell. However, researchers at the National Institutes of Health (NIH) have discovered that SARS-CoV-2 is not like other viruses. The virus can deactivate that waste disposal system, exit without hindrance, and spread freely throughout the body.

“To our shock, these coronaviruses got out of the cells just fine,” said Nihal Altan-Bonnet, PhD, chief of the Laboratory of Host-Pathogen Dynamics at the National Heart, Lung, and Blood Institute, who coauthored the study report.

Most viruses exit via the biosynthetic secretory pathway, used to transport hormones, growth factors and other materials. The researchers wanted to learn whether coronaviruses took an alternate route. To find out, they conducted further studies, using microscopy and virus-specific markers. They discovered that coronaviruses somehow target the lysosome and congregate there. Although lysosomes are highly acidic, the coronaviruses were not destroyed.

That question led to more experiments. The researchers next found that lysosomes get “de-acidified” in coronavirus-infected cells, which weakens their destructive enzymes. The result: The coronavirus remains intact, ready to infect other cells upon exiting.

The coronaviruses are “very sneaky,” Altan-Bonnet says. “They’re using these lysosomes to get out, but they’re also disrupting the lysosome so it can’t do its job or function.” It’s possible that the way the coronavirus interferes with the lysosome’s “immunological machinery” underlies some of the immune system abnormalities seen in COVID-19 patients, such as cytokine storms.

Studying this coronavirus's heterodox ways may mean that researchers can figure out how to keep it from getting out unscathed, or restore the lysosome’s killing ability by re-acidifying it. Altan-Bonnet and coauthor Sourish Ghosh, PhD, say they have already identified one experimental enzyme inhibitor that potently blocks coronaviruses from exiting the cell.