Xeris’ glucagon injection Gvoke gains heat with HypoPen auto-injector launch

Diabetes patients have long relied on complex glucagon kits to treat hypoglycemia. Late last summer, Xeris Pharmaceuticals aimed to change that with the first FDA-approved prefilled syringe. Now, its new auto-injector is grabbing the baton.

In July, Xeris launched its Gvoke HypoPen for severe hypoglycemia in children and adults. Pre-mixed and ready-to-use, Gvoke HypoPen allows patients to inject glucagon by themselves, and quickly, unlike Gvoke prefilled syringes, which require help from someone else. That’s a potential boon now, during the COVID crisis, when face-to-face interactions are on the downswing.

Plus, in late-stage studies, HypoPen proved easy to administer, with 99% of subjects correctly using the device to restore their blood sugar levels. Hypoglycemia can land patients in the hospital if not treated promptly.

Now, thanks to some clever digital footwork with the pandemic-era launch, early adoption has soared. A little over a month into the launch, Gvoke HypoPen mopped up more than 60% of new Gvoke prescriptions, with odds high that the auto-injector could eventually corner 70% to 80%, leaving its prefilled-syringe predecessor in the dust, Jefferies analysts said. HypoPen is now patients’ best glucagon option, the analysts said, likening the device to Epipen, the ubiquitous epinephrine auto-injector for severe allergic reactions.

Overall Gvoke scripts grew a record 40%, with second-quarter sales hitting $2 million. The back-to-school season, when parents buy glucagon kits for school nurses and for kids to carry in their backpacks, could bring a bigger boost in the third quarter, the analysts noted.

Ahead of HypoPen’s launch, Xeris pivoted salesforce promotions to doctors from live to virtual and tapped social media to get the word out to patients. Physicians have grown more receptive to virtual sales calls during the pandemic, the analysts noted, and Xeris’ online patient hubs offer help gaining insurance coverage and prior authorization if needed. 

Plus, Xeris is offering copay assistance that can cut HypoPen’s cost to $0 for patients on some insurance plans. And the company has already struck coverage agreements with most insurers, CEO Paul Edick said in a release.  

“[A]s we prepared for launch, we had a heightened focus on ensuring Gvoke HypoPen is covered by insurance,” Edick said. “Currently, approximately 78% of commercially insured and Medicare lives have unrestricted access to Gvoke HypoPen.”

Xeris isn’t alone in the market for new glucagon formulations, though. A little less than a year before Xeris’ HypoPen launch, Eli Lilly debuted the first non-injectable glucagon option when it snagged a green light for Baqsimi nasal powder. The company has since tapped American Idol alumna Crystal Bowersox in a diabetes awareness campaign that directs patients to Baqsimi resources. 

https://www.fiercepharma.com/drug-delivery/xeris-gvoke-hypopen-soars-spite-covid-19

Trump adds Dr. Scott Atlas to coronavirus task force

President Donald Trump expanded his coronavirus task force this week with the addition of Scott Atlas, MD, a senior fellow with Stanford University’s Hoover Institution.

The president introduced Dr. Atlas at a White House briefing Monday. “He’s working with us and will be working with us on the coronavirus. And he has many great ideas and he thinks what we’ve done is really good. And now we’ll take it to a new level,” the president said. 

Five things to know about Dr. Atlas:

1. As a senior fellow with the conservative Hoover Institution in Stanford, Calif., Dr. Atlas investigates the impact of government and the private sector on access, quality, and pricing in healthcare, global trends in healthcare innovation, and key economic issues related to the future of technology-based medical advances.

2. He earned his undergraduate degree in biology from the University of Illinois in Urbana-Champaign and his medical degree from the University of Chicago School of Medicine. 

3. He is board certified in diagnostic radiology and served as a professor and chief of neuroradiology at Stanford University Medical Center from 1998 to 2012, according to Forbes.  

4. Dr. Atlas is involved in efforts to reopen schools and so far his stance on the matter aligns with that of President Trump. “We know that the risk of the disease is extremely low for children, even less than that of seasonal flu. We know that the harms of locking out the children from school are enormous. And we also know, as we all would agree, that educating America’s children is right at the top of the list for our nation’s priorities,” he said at a White House event Wednesday.

5. Researchers are still studying the effects of the virus on children and their rate of transmission. A study published in JAMA Pediatrics last month found infected children have at least as much of the coronavirus in their noses and throats as infected adults, according to the research.

https://www.beckershospitalreview.com/public-health/trump-adds-dr-scott-atlas-to-coronavirus-task-force-5-things-to-know-about-him.html

9 health insurers sending premium credits to members

Here are nine payers that are returning premium revenue to members due to lower healthcare costs during the COVID-19 pandemic. 

Editor’s note: Policies vary by insurer. This list will be updated if more announcements are made. Email mhaefner@beckershealthcare.com if your company has implemented similar measures. 

1. Blue Cross and Blue Shield of Minnesota and Blue Plus will provide more than $38 million in premium relief for thousands of Medicare members, individual and family plan members, and fully insured businesses throughout the state. 

2. Blue Cross Blue Shield of Massachusetts is returning $101 million in premium refunds and rebates to members due to lower healthcare costs during the COVID-19 pandemic. 

3. Blue Cross & Blue Shield of Rhode Island will provide a 25 percent dental premium credit for fully insured customers and is extending teledentistry services with in-network dentists through July 31, 2020.

4. Regence is sending back $35 million to some of its policyholders, according to The Lund Report. 

5. Harvard Pilgrim Health Care, a nonprofit health plan in New England that covers 3 million members, is providing $32 million in premium credits to its customers.

6. Priority Health, a health plan in Michigan, provided premium credits to its members in June and July.

7. Anthem provided $2.5 billion in financial assistance to providers and health plan members, including one-month premium rebates to members. 

8. Premera Blue Cross said more than 200,000 of its commercial and individual members will receive up to $65 million in premium relief funds and premium rebates.

9. UnitedHealth Group is providing members more than $1.5 billion in discounts, including premium rebates.

https://www.beckershospitalreview.com/payer-issues/9-health-insurers-sending-premium-credits-to-members.html

Underground source for Covid origin?

The coronavirus may not have originated at a Wuhan wet market last year but 1,000 miles away in 2012 — deep in a Chinese mineshaft where workers came down with a mysterious, pneumonia-like illness after being exposed to bats.

Virologist Jonathan Latham and molecular biologist Allison Wilson, both of the non-profit Bioscience Resource Project in Ithaca, arrived at their finding after translating a 66-page master’s thesis from the Chinese medical doctor who treated the miners and sent their tissue samples to the Wuhan Institute of Virology for testing.

“The evidence it contains has led us to reconsider everything we thought we knew about the origins of the COVID-19 pandemic,” Latham and Wilson wrote in an article published July 15 on their website, “Independent Science News.”

Latham told The Post that the coronavirus “almost certainly escaped” from the Wuhan lab.

In April 2012, six miners in the Mojiang mine in southwestern China’s Yunnan province fell ill after spending more than 14 days removing bat feces. Three eventually died.

In his thesis, the physician Li Xu, who treated the miners, describes how the patients had a high fever, a dry cough, sore limbs and, in some cases, headaches — all symptoms now associated with COVID-19, said Latham and Wilson.

How the miners were treated — for example, with ventilation and a variety of drugs including steroids, blood thinners and antibiotics — also resembles how COVID-19 patients are being treated worldwide, they said.

After conducting multiple tests for hepatitis, dengue fever and even HIV, the doctor consulted with various specialists throughout China, including virologist Zhong Nanshan, an international hero who managed the SARS outbreak in 2003 and is considered the country’s greatest scientist.

“The remote meeting with Zhong Nanshan is significant,” Latham and Wilson said. “It implies that the illnesses of the six miners were of high concern and, second, that a SARS-like coronavirus was considered a likely cause.”

Zhong NanshanREUTERS

The doctor also sent sample tissues from the miners to the Wuhan lab, a focal point of coronavirus research in China. There, scientists found the source of infection was a SARS-like coronavirus from a Chinese rufous horseshoe bat, according to the thesis.

Latham and Wilson believe the virus — once inside the miners — “evolved” into SARS CoV-2, “an unusually pathogenic coronavirus highly adapted to humans,” and the samples somehow escaped from the lab last year, launching what has morphed into the coronavirus pandemic.

The New York scientists labeled their COVID-19 origins hypothesis “the Mojiang Miners Passage”; “passaging” is a virologic term for adapting viruses to new species, they said.

Although scientists at the Wuhan lab had collected coronavirus samples from bats at the same mine, they missed the 2012 connection, Latham told The Post.

In fact, Shi Zhengli, a virologist at the Wuhan lab who is known as “the batwoman” for her extensive research into bat-derived coronaviruses, told Scientific American in June that the miners had died from a fungal infection, “although it would have been only a matter of time before they caught the coronaviruses if the mine had not been promptly shut,” the magazine reported.

“The mine shaft stunk like hell,” Shi told the magazine. “Bat guano, covered in fungus, littered the cave.”

Chinese researchers in a cave to test bats

EcoHealth Alliance

Reaction to the Latham-Wilson finding has been gradually gaining positive reviews from the scientific community in the US.  Renowned American geneticist and molecular engineer George Church shared their work on Twitter in July. The tweet garnered 304 retweets and 403 likes. Stuart Newman, a leading expert on cell biology and anatomy at New York Medical College in Westchester called it “the best sourced explanation yet of the origins of #SARSCoV2” in a July 19 tweet about the report.

“We feel that it’s being circulated underground in the scientific community,” Latham said. “People think it has merit, but they are reluctant to go public because the coronavirus has become very politicized.”

Chinese officials claim the coronavirus, which has infected more than 19 million worldwide and killed nearly 800,000, originated in Wuhan in December, when it crossed the species barrier from animals on sale at the Huanan seafood market.

But many scientists still question the infection’s origins, especially after the market was cleaned up and shut down by government officials almost as soon as the pandemic began to spread.

https://nypost.com/2020/08/15/covid-19-first-appeared-in-chinese-miners-in-2012-scientists/

CDC backtracks guidance on three-month window of immunity

The Centers for Disease Control and Prevention (CDC) backtracked guidance it issued earlier this month, maintaining that people are not immune to reinfection to the coronavirus after recovering from the disease.

“On August 3, 2020, CDC updated its isolation guidance based on the latest science about COVID-19 showing that people can continue to test positive for up to 3 months after diagnosis and not be infectious to others. Contrary to media reporting today, this science does not imply a person is immune to reinfection with SARS-CoV-2, the virus that causes COVID-19, in the 3 months following infection,” the CDC said in a press release.

“The latest data simply suggests that retesting someone in the 3 months following initial infection is not necessary unless that person is exhibiting the symptoms of COVID-19 and the symptoms cannot be associated with another illness,” it added.

The statement marks a reversal from guidance the CDC issued earlier this month saying that a person who has recovered from COVID-19 will likely be safe from reinfection for three months. The earlier guidance represented the first recognition of a defined immunity period for people who have recovered from the coronavirus.

Past research has indicated that antibodies that form in people who recover from COVID-19 fade in subsequent months.

The CDC maintained late Friday night that “People with COVID-19 should be isolated for at least 10 days after symptom onset and until 24 hours after their fever subsides without the use of fever-reducing medications.”

https://thehill.com/policy/healthcare/512145-cdc-backtracks-guidance-on-three-month-window-of-immunity

SARS-CoV-2 manipulates the SR-B1-mediated HDL uptake pathway for its entry

Congwen Wei, View ORCID ProfileLuming Wan, Qiulin Yan, Xiaolin Wang, Jun Zhang, Yanhong Zhang, Jin Sun, Xiaopan Yang, Jing Gong, Chen Fan, Xiaoli Yang, Yufei Wang, Xuejun Wang, Jianmin Li, Huan Yang, Huilong Li, Zhe Zhang, Rong Wang, Peng Du, Yulong Zong, Feng Yin, Wanchuan Zhang, Yumeng Peng, Haotian Lin, Rui Zhang, Wei Chen, Qi Gao, Yuan Cao, Hui Zhong

doi: https://doi.org/10.1101/2020.08.13.248872

This article is a preprint and has not been certified by peer review [what does this mean?].

Abstract

The recently emerged pathogenic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread rapidly, leading to a global COVID-19 pandemic. Binding of the viral spike protein (SARS-2-S) to cell surface receptor angiotensin-converting enzyme 2 (ACE2) mediates host cell infection. In the present study, we demonstrate that in addition to ACE2, the S1 subunit of SARS-2-S binds to HDL and that SARS-CoV-2 hijacks the SR-B1-mediated HDL uptake pathway to facilitate its entry. SR-B1 facilitates SARS-CoV-2 entry into permissive cells by augmenting virus attachment. MAb (monoclonal antibody)-mediated blocking of SARS-2-S-HDL binding and SR-B1 antagonists strongly inhibit HDL-enhanced SARS-CoV-2 infection. Notably, SR-B1 is co-expressed with ACE2 in human pulmonary and extrapulmonary tissues. These findings revealed a novel mechanism for SARS-CoV-2 entry and could provide a new target to treat SARS-CoV-2 infection.

Competing Interest Statement

The authors have declared no competing interest.

https://www.biorxiv.org/content/10.1101/2020.08.13.248872v1

Tocilizumab among patients with COVID-19 in intensive care

Published:August 14, 2020

DOI:https://doi.org/10.1016/S2665-9913(20)30277-0

PDF: https://www.thelancet.com/action/showPdf?pii=S2665-9913%2820%2930277-0

Summary

Background

Tocilizumab, a monoclonal antibody directed against the interleukin-6 receptor, has been proposed to mitigate the cytokine storm syndrome associated with severe COVID-19. We aimed to investigate the association between tocilizumab exposure and hospital-related mortality among patients requiring intensive care unit (ICU) support for COVID-19.

Methods

We did a retrospective observational cohort study at 13 hospitals within the Hackensack Meridian Health network (NJ, USA). We included patients (aged ≥18 years) with laboratory-confirmed COVID-19 who needed support in the ICU. We obtained data from a prospective observational database and compared outcomes in patients who received tocilizumab with those who did not. We applied a multivariable Cox model with propensity score matching to reduce confounding effects. The primary endpoint was hospital-related mortality. The prospective observational database is registered on ClinicalTrials.gov, NCT04347993.

Findings

Between March 1 and April 22, 2020, 764 patients with COVID-19 required support in the ICU, of whom 210 (27%) received tocilizumab. Factors associated with receiving tocilizumab were patients’ age, gender, renal function, and treatment location. 630 patients were included in the propensity score-matched population, of whom 210 received tocilizumab and 420 did not receive tocilizumab. 358 (57%) of 630 patients died, 102 (49%) who received tocilizumab and 256 (61%) who did not receive tocilizumab. Overall median survival from time of admission was not reached (95% CI 23 days–not reached) among patients receiving tocilizumab and was 19 days (16–26) for those who did not receive tocilizumab (hazard ratio [HR] 0·71, 95% CI 0·56–0·89; p=0·0027). In the primary multivariable Cox regression analysis with propensity matching, an association was noted between receiving tocilizumab and decreased hospital-related mortality (HR 0·64, 95% CI 0·47–0·87; p=0·0040). Similar associations with tocilizumab were noted among subgroups requiring mechanical ventilatory support and with baseline C-reactive protein of 15 mg/dL or higher.

Interpretation

In this observational study, patients with COVID-19 requiring ICU support who received tocilizumab had reduced mortality. Results of ongoing randomised controlled trials are awaited.

Funding

None.

https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30277-0/fulltext#