Two COVID-19 Outpatient Antibody Drugs Show Encouraging Results

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Two COVID-19 antibody treatments, one developed by Regeneron and the other by Eli Lilly, show promise in the outpatient setting in results released on Wednesday.

Regeneron, in a randomized, double-blind trial, is assessing the effect of adding its investigational antibody cocktail REGN-COV2 to usual standard of care in comparison with adding placebo to standard of care. A descriptive analysis from the first 275 patients was previously reported. The data described Wednesday, which involve an additional 524 patients, show that the trial met all of the first nine endpoints.

Regeneron announced prospective results from its phase 2/3 trial showing REGN-COV2 significantly reduced viral load and patient medical visits, which included hospitalizations, visits to an emergency department, visits for urgent care, and/or physician office/telemedicine visits.

Interest in the cocktail spiked after President Donald Trump extolled its benefits after it was used in his own COVID-19 treatment earlier this month.

Trump received the highest dose of the drug, 8 g, but, according to a Regeneron news release announcing the latest findings, “results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4 grams).”

The company described further results of the industry-funded study in the release: “On the primary endpoint, the average daily change in viral load through day 7 (mean time-weighted average change from baseline) in patients with high viral load (defined as greater than107 copies/mL) was a 0.68 log10 copies/mL greater reduction with REGN-COV2 compared to placebo (combined dose groups; p<0.0001). There was a 1.08 log greater reduction with REGN-COV2 treatment by day 5, which corresponds to REGN-COV2 patients having, on average, a greater than 10-fold reduction in viral load, compared to placebo.”

The treatment appears to be most effective in patients most at risk, whether because of high viral load, ineffective baseline antibody immune response, or preexisting conditions, according to the researchers.

According to the press release, these results have not been peer reviewed but have been submitted to the US Food and Drug Administration, which is reviewing a potential emergency use authorization for the treatment in high-risk adults with mild to moderate COVID-19.

Operation Warp Speed, the Trump administration’s treatment and vaccine program, contracted in July with Regeneron for up to 300,000 doses of its antibody cocktail.

Lilly Treatment Shows Drop in Hospitalizations, Symptoms

Another treatment, also given in the outpatient setting, shows promise as well.

Patients recently diagnosed with mild to moderate COVID-19 who received Eli Lilly’s antibody treatment LY-CoV555 had fewer hospitalizations and symptoms compared with a group that received placebo, an interim analysis of a phase 2 trial indicates.

Peter Chen, MD, with the Department of Medicine, Women’s Guild Lung Institute at Cedars-Sinai Medical Center, Los Angeles, California, and colleagues found that the most profound effects were in the high-risk groups.

The interim findings of the BLAZE-1 study, which was funded by Eli Lilly, were published online October 28 in The

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Opioid use increases risk of death in older adults after outpatient surgery, study says

Oct. 21 (UPI) — Older adults who used opioid pain medications before minor surgery were up to 68% more likely to die within 90 days of the procedure compared with those who never used the drugs, an analysis published Wednesday by JAMA Surgery found.

Even among people older than 65 who had low levels of opioid use as long as eight months before surgery, about 55 people per 10,000 in the general population died within 90 days of having a procedure, the data showed.

Older adults who had not used opioid pain drugs prior to surgery died at a rate of just over 40 per 10,000 in the general population within 90 days of having a minor procedure, the researchers said.

“People who have preoperative exposure to opioids have a higher risk of mortality after outpatient surgery,” study co-author Dr. Katherine Santosa told UPI.

“Although our analysis cannot discern the underlying causes for this, our findings highlight the need to screen for opioid-related risk prior to surgery,” said Santosa, a surgeon at Michigan Medicine.

Opioids were the leading cause of drug overdose deaths in the United States in the first half of 2019, according to data released recently by the U.S. Centers for Disease Control and Prevention.

Much of the country has been in the grips of an “epidemic” of illegal opioid use and overdose deaths over the past 40 years, causing more than 1 million deaths, based on agency estimates.

At least some of this increase in use has been attributed to over-prescription for pain treatment, the CDC has said.

For this study, Santosa and her colleagues reviewed data on more than 99,000 Medicare beneficiaries — age 65 and older — who had outpatient surgical procedures between 2009 and 2015.

Outpatient procedures do not entail an overnight hospital stay, and patients are admitted, have surgery and are discharged the same day.

Patients included in the analysis had procedures ranging from varicose vein removal and hemorrhoid removal to trans-urethral prostate surgery, thyroid removal, carpal tunnel release, umbilical hernia repair and inguinal hernia repair, the researchers said.

Among outpatient surgery patients included in the study, 0.48% died within 90 days of having their procedure, the data showed.

However, those with “high” levels of opioid use — for 10 months or more and within one month — before surgery were 68% more likely to die within 90 days of their procedure, the researchers said.

In addition, those with low or medium use before surgery were 30% more likely to die, the data showed.
“Many Americans currently use opioids prior to surgery for a variety of conditions,” Santosa said.

“In this context, it is important to understand the potential impact of opioids on recovery, and create care pathways to decrease the risk of adverse effects [while undergoing surgery],” she said.

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Outpatient Visits Rebound for Most Specialties to Pre-COVID Levels

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

After taking a nosedive during the initial wave of the COVID-19 pandemic, then rising and plateauing, weekly outpatient visits in the United States have rebounded and now slightly exceed levels seen in late February, according to new data.

Overall visits plunged by almost 60% at the low point in late March and did not start recovering until late June, when visits were still off by 10%. Visits began to rise again — by 2% over the March 1 baseline — around Labor Day.

As of October 4, visits had returned to that March 1 baseline, which was slightly higher than in late February, according to data analyzed by Harvard University, the Commonwealth Fund, and the healthcare technology company Phreesia, which helps medical practices with patient registration, insurance verification, and payments, and has data on 50,000 providers in all 50 states.

The study was published online by the Commonwealth Fund.

In-person visits are still down 6% from the March 1 baseline. Telemedicine visits — which surged in mid-April to account for some 13% to 14% of visits — have subsided to 6% of visits.

Many states reopened businesses and lifted travel restrictions in early September, benefiting medical practices in some areas. But clinicians in some regions are still facing rising COVID-19 cases, as well as “the challenges of keeping patients and clinicians safe while also maintaining revenue,” write the report authors.

Some specialties are still hard hit. For the week starting October 4, visits to pulmonologists were off 20% from March 1. Otolaryngology visits were down 17%, and behavioral health visits were down 14%. Cardiology, allergy/immunology, neurology, gastroenterology, and endocrinology also saw drops of 5% to 10% from March.

Patients were flocking to dermatologists, however. Visits were up 17% over baseline. Primary care was also popular, with a 13% increase over March 1.

At the height of the pandemic shutdown in late March, Medicare beneficiaries stayed away from doctors the most. Visits dipped 63%, compared with 56% for the commercially insured, and 52% for those on Medicaid. Now, Medicare visits are up 3% over baseline, while Medicaid visits are down 1% and commercially insured visits have risen 1% from March.

Interestingly, the over-65 age group did not have the steepest drop in visits when analyzed by age. Children ages 3 to 17 saw the biggest decline at the height of the shutdown. Infants to 5-year-olds have still not returned to pre-pandemic visit levels. Those visits are off by 10% to 18%. The 65-and-older group is up 4% from March.

Larger practices — with more than six clinicians — have seen the biggest rebound, after having had the largest dip in visits, from a decline of 53% in late March to a 14% rise over that baseline. Practices with fewer than five clinicians are still 6% down from the March baseline.

Wide Variation in Telemedicine Use

The researchers reported a massive gap in the percentage of various specialties

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