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Thursday, April 9, 2020

Key China coronavirus hospital says HIV drug beneficial to patients

Chinese doctors at the primary hospital treating severe coronavirus patients in the city of Wuhan said they have been using the HIV drug Kaletra since January and believe it is beneficial, despite a previous study that it was ineffective.
They have been prescribing Kaletra, an off-patent version of lopinavir/ritonavir produced by AbbVie, as well as a second drug, bismuth potassium citrate, said Zhang Dingyu, the president of the Jinyintan Hospital in Wuhan, where the disease originated late last year.
“We believe taking this drug is beneficial,” Zhang told reporters on Thursday in reference to Kaletra.
He said doctors at Jinyintan had started prescribing the drug to their patients on Jan. 6. It was one of the first hospitals to start treating infections after the coronavirus emerged in Wuhan in December.
At the height of the epidemic in the city, Jinyintan was treating close to 500 coronavirus patients, he said. It currently still has 123 under observation, he said.
A study published last month in the New England Journal of Medicine, based on a test in Chinese patients with severe COVID-19 at Jinyintan, said that Kaletra, also known as Aluvia, was not effective as a potential treatment.
Last month, Israel approved the licensing of a generic version of Kaletra to treat patients infected with the coronavirus.
Zhang said the data set used by the study published in the New England Journal of Medicine had included patients who had not taken the drug before passing away, and others whose doctors had decided against prescribing it.
“You have to look at the supplementary material,” he said.
He said three medical workers had started taking Kaletra 2-3 days after symptoms of the virus surfaced. “Towards the end of taking the drug, the changes their lungs experienced were really great.”

Doctors in Shanghai also prescribed Kaletra, in combination with the flu drug arbidol and traditional Chinese medicine, and said some patients showed positive improvements, according to a study published by the BioScience Trends journal in February.
Kaletra was also associated with positive therapeutic outcomes in the treatment of Severe Acute Respiratory Syndrome (SARS), according to previous studies.

“DRUGS HAVE SOME USE”

The second drug used at Jinyintan Hospital, bismuth potassium citrate, had also been found in 2003 during the SARS outbreak to have some effect on coronaviruses at the cellular level, hence the decision to prescribe it with Kaletra, said Zhang.
The hospital prescribed bismuth potassium citrate to many of its staff after some of them were infected, and after that did not encounter any other cluster infections, Zhang said.
“The overall research is not over but everyone has a feeling – it is just a feeling – but it is that these drugs have some use,” he said.
Plasma therapy using the blood of patients who had recovered from the virus was a third treatment doctors were particularly interested in, Zhang said, noting that one patient who had been on a ventilator had been able to remove the tubes and walk out of hospital soon after he had received it.
The fact that there are so many patients in world now – nearly 1.5 million have been infected by COVID-19 – meant that this was definitely a potentially helpful option, Zhang said.
Over 20 percent of the infected are reported to have recovered, according to a Reuters tally.
In response to a question on whether the hospital had used malaria drugs hydroxychloroquine and chloroquine on its patients, which have been persistently promoted by U.S. President Donald Trump, Zhang said they had not used the former.
Some of its patients, however, had opted to take hydroxychloroquine themselves but reported mixed results, he said. Some said it helped but others said it was ineffective.
Some patients had used some chloroquine, which is included in China’s National Commission’s treatment guidelines, after hearing that it had some early-stage usefulness, but there were concerns about dosage levels.
“Hydroxychloroquine’s toxicity is much better than chloroquine but we received hydroxychloroquine quite late so did not try it,” Zhang said.
And based on patients’ reviews, there was no scientific conclusion for hydroxychloroquine’s effectiveness, he said.
https://www.reuters.com/article/us-health-coronavirus-china-wuhan-hospit/key-china-coronavirus-hospital-says-hiv-drug-beneficial-to-patients-idUSKCN21R1LX

Bausch Health up 17% as Glenview climbs aboard

Bausch Health Companies (BHC +17.0%) breaks through near-term resistance at $16 on modestly higher volume.
After the close yesterday, Glenview Capital Management disclosed a 5.1% stake of ~18M shares.
The stock has clawed back 64% since bottoming at $11.15 on March 18.
https://seekingalpha.com/news/3559743-bausch-health-up-17-glenview-climbs-aboard

NMC Health Placed Into Administration by U.K. Court

Troubled hospital operator NMC Health Plc was placed into administration by a U.K. court to protect the assets of the Middle East’s largest health-care provider.
NMC didn’t oppose the effort by creditor, Abu Dhabi Commercial Bank. Judge Sebastian Prentis said there was no alternative to administration after hearing the arguments via videoconference.
Lawyer for Abu Dhabi Commercial Bank says there are concerns that the NMC Group will be unable to pay employees in the months to come and that the whole NMC Group may collapse.
“If this happens, it will imperil the health of the citizens in the UAE,” lawyer says in court filing. Bank “considers that steps must be taken now, before it is too late, to secure the company’s financial position.”
State-owned Abu Dhabi Commercial Bank PJSC proposed Alvarez & Marsal as administrator
Judge says NMC is cashflow insolvent
Another creditor, Barclays, is owed $146 million, lawyers say in court.
https://www.bloomberg.com//news/articles/2020-04-09/nmc-won-t-oppose-administration-sought-by-bank-in-u-k-court?srnd=markets-vp

Gilead ups participants in two trials for experimental COVID-19 treatment

Gilead Sciences Inc. GILD, -2.17% increased the number of participants in two ongoing clinical trials for remdesivir, its experimental treatment for COVID-19. According to ClinicalTrials.gov, the drugmaker upped the number of participants in a global, randomized, open-label Phase 3 trial for people with moderate forms of the disease to 1,600 from 600. It did the same for a similar trial evaluating remdesivir in patients with severe COVID-19, to 2,400 participants from 400. The first results from those trials are expected in May. Over the weekend, Gilead CEO Daniel O’Day said the company aims to have 500,000 treatment courses of remdesivir manufactured by October and 1 million by the end of 2020. Remdesivir has not been approved by the Food and Drug Administration as a treatment for COVID-19; however, it is being used on an expanded use and compassionate use basis in the U.S. Gilead’s stock was down 1.8% in trading on Thursday. Since the start of 2020, shares of the company have gained 13.2%, while the S&P 500 SPX, 1.95% has dropped 14.8%.
https://www.marketwatch.com/story/gilead-increase-number-of-participants-in-two-trials-for-experimental-covid-19-treatment-2020-04-09

ERs quiet during COVID-19: What happens when the patients come back?

Among the unexpected phenomena of the COVID-19 crisis: Emergency departments have seen their volumes plummet.
“The hospitals are eerily quiet, except for COVID-19,” wrote Harlan Krumholz, M.D., a cardiologist and healthcare researcher at Yale University and Yale New Haven Hospital in a column published this week in The New York Times.
That’s been the experience up in Seattle area hospitals which initially expected a “tsunami of emergency department cases,” Gregg Miller, the chief medical officer for Vituity, a physician staffing firm, said recently during the FierceHealthcare Coronavirus Virtual Series. The company works with about 150 emergency departments and 25 hospitalist programs around the country including Dignity Health, Providence St. Joseph Health and Sutter Health systems.
“There has not been a huge surge of emergency department visits with the shutdown of elective surgeries, with the closures of some clinics, with the social distancing that’s been taking place,” Miller said. “There are less and less patients going into the emergency department—thank God, because I can’t imagine working shifts right now what this would be like if we were dealing with our normal volumes on top of what we’re dealing with our COVID patients.”

But what is happening to many of those patients?
It’s a question that hospitals need to be preparing for, said Joanne Roberts, senior vice president and chief value officer at Providence St. Joseph Health System based in Washington.
“If you just look at the big population trends across the country, people are just accessing healthcare less right now probably for lots of reasons: They’re anxious. They want to stay home. They don’t want to be around people. If they don’t have to go to the doctor, they’re not going to go to the doctor,” Roberts said.
In the last week of March, the health system was seeing ED volumes down by more than 40%.
“We assume that people with chronic conditions are probably not getting the level of care they were getting before because it’s not coming into the healthcare system,” Roberts said.
That could be building up to become a later surge among patients with exacerbations in those chronic conditions, she said.
“Whether it’s heart disease or cancer or whatever other chronic problems people may have, we are going to see more acute, exacerbations of those illnesses if we don’t figure out a way to promote access in the next few weeks,” Roberts said. “The country will squeak by for a few weeks but I’m not sure the country could squeak by for multiple months. At that point, we’re going to start seeing more active disease coming into the hospitals.”
For example, one of the more widely reported groups that have raised concerns are patients who have seen surgeries for slow-growing cancers delayed as both health systems and the government have pushed for cancellations of elective procedures to preserve protective equipment and bed capacity.
“Those decisions have been made with a whole lot of thought with specialists, and conferences of specialists, to make sure that nobody is going to be harmed by the delay in the surgeries. For example, any kind of fast-growing cancer is going to get surgery now,” Roberts said. “But all of this stuff is going to back up. It will.”

What should health systems be doing to prepare? Roberts said there is ongoing consideration of having hospitals devoted to non-COVID patients.
“That’s easier said than done. It sounds like a great idea when you say it because of the testing delays we’ve had and the problems getting access to testing, it’s hard to know who is and who isn’t infected with COVID,” she said. “Once we have enough rapid tests that we can look at an entire population of people than we probably can have facilities that only take care of COVID patients or only take care of non-COVID patients. That will probably vary market by market. My guess is that will be one remedy to do that.”
She said once hospitals start feeling confident they have passed their peak of COVID cases, they can begin opening up regular beds to patients of all kinds.
Telehealth may help blunt the problem, Robert said.
“But I think that’s going to be a longer-term proposition,” she said. “Telehealth is exploding right now, but the explosion in telehealth services tends to be very focused on the COVID epidemic itself. So home monitoring around COVID, hospital at home around COVID, using telemedicine in our hospitals is around COVID,” Roberts said. “Once this pandemic has peaked and we’re on the back end of it, I expect we’re going to start by seeing a whole lot more telehealth visits broadly with all kinds of issues. That’s not really the case in any sort of systematic way right now.”
https://www.fiercehealthcare.com/hospitals-health-systems/ers-have-been-quiet-during-covid-19-what-happens-when-patients-come-back

Mount Sinai converts sleep apnea machines into ventilators

So far, Mount Sinai Health System in New York City has had enough ventilators to meet the growing demand due to COVID-19.
But, if the hospital gets overwhelmed, it has an unlikely backup: sleep apnea machines.
More and more hospital systems are looking for ways to shore up their supply of ventilators and have turned to converted sleep apnea machines. Mount Sinai, a system of eight hospitals, has set up its own conversion system to transform a donation of 500 BiPAP machines used to treat sleep apnea to shore up their ventilator capacity.
“It has given us a little reassurance that even as demand goes off and we use more ventilators, this is an arsenal we can tap into to magnify and help our existing fleet,” said Robert Freeman, vice president of clinical innovation at Mount Sinai.
David Rapoport, an expert in sleep medicine and critical care for Mount Sinai, put together a clinical protocol on how to convert sleep apnea machines.

Then, a group of medical students and volunteers turned one of the floors in Mount Sinai’s system into a ventilator assembly area, Freeman said.
“A whole community came together of students, researchers, simulation lab folks to make this happen,” he added.
There are some challenges with converting the devices into makeshift ventilators.
For one, the devices are only supposed to be used for people who don’t need a heavy-duty, hospital-grade ventilator. They are to be employed when a patient is coming off a ventilator but still may need breathing assistance, Freeman said.
The devices, though, can help free up the “powerhouse critical care ventilators for the sickest patients,” Freeman added.
A major issue is also ensuring that the ventilator doesn’t leak any of the virus or aerosolize the virus in a way that puts staff and other patients at risk.
“We wanted to make sure we can get the right filters on there to make sure there was no aerosolization,” Freeman said.
Mount Sinai also had to figure out how to connect the device to the right type of monitor to trigger alarms to alert healthcare workers.
But the hospital system isn’t the only one figuring out how to properly convert sleep apnea machines.
A team of doctors and engineers from the University of California (UC), San Francisco and UC Berkeley have launched a nationwide effort to solicit the donation of home-based, off-the-shelf sleep apnea machines from consumers to their local hospital.
So far, the effort led by the group called the COVID-19 Ventilator Rapid Response Team has gotten between 700 and 1,000 units since the effort was launched last Friday.
The team plans to employ a logistics supplier to distribute the machines to hospitals that need them across the country alongside information on how to convert the machines using simple off-the-shelf parts.
The team’s goal is to get the machines to hospitals in a matter of weeks.
“We are trying to run a test immediately where a hospital calls us up and we will take units from the registry, supply them to a hospital, ship a box of the pats and a video to help people assemble them,” said Bryan Martel, the team organizer and co-founder of Berkeley Engineering and Research Inc.
He added that the group needs input from state and federal governments on which hospitals may need them.
The team is also hoping to get speedy approval from the U.S. Food and Drug Administration, which typically restricts modifying medical devices for a use other than the one they were approved for. The agency has issued new guidance to enable sleep apnea machines used in hospitals to be converted to ventilators.
https://www.fiercehealthcare.com/hospitals-health-systems/mount-sinai-creates-makeshift-assembly-line-to-convert-sleep-apnea

CMS issues infection control guidance for providers struggling with COVID-19

The Trump administration issued a series of new guidance documents focusing on infection control, a major issue for providers treating patients with COVID-19.
The documents released by the Centers for Medicare & Medicaid Services (CMS) also focus on how to ensure infection control for alternative testing and treatment sites some hospitals have had to prop up to handle the outbreak. The agency also put out guidance on telehealth and drive-thru screening infection control.
“The guidance is designed to empower local hospitals and healthcare systems, helping them to rapidly expand their capacity to isolate and treat patients infected with COVID-19 from those who are not,” CMS said in a release Tuesday.

The revised guidance also provides expanded recommendations for screening patients and staff, restricting visitation and how to discharge to other locations.
CMS has suspended routine surveys of healthcare facilities and instead are calling for a major focus on infection control procedures.
A major concern among providers is how to protect their staff from the virus.
CMS also gave a timely update for dialysis facilities on how to provide dialysis at home and how to prop up Special Purpose Renal Dialysis Facilities that can enable facilities to isolate vulnerable or infected people with the virus.
“These temporary changes allow for the establishment of facilities to treat those patients who tested positive for COVID-19 to be treated in separate locations,” the agency said.
Dialysis facilities care for people who are likely immunocompromised and at high risk for COVID-19.
https://www.fiercehealthcare.com/hospitals-health-systems/cms-issues-infection-control-guidance-for-providers-struggling-covid-19