Limited supply of monkeypox treatment as cases soar

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July 14, 2022 – People with monkeypox face a wide range of symptoms, from mild skin damage to severe, debilitating pain. And experts don’t yet have a reliable way to predict who will have the worst symptoms.

There is an antiviral treatment, tecovirimat (TPOXX), but it is only available from the National Strategic Stock for the moment. The FDA approved tecovirimat to treat smallpox in 2018, fearing it could one day be used as a bioterrorism weapon.

Local health departments work with the CDC and the US Department of Health and Human Services to request tecovirimat through a complicated 120-page protocol. At the same time, cases of monkeypox rose to more than 11,000 worldwide, according to the CDC.

In the United States alone, cases have now topped 1,000, according to the CDC.

And even though monkeypox is a global concern, some places in the United States, like New York, are experiencing larger outbreaks.

“As of yesterday, we now have up to 336 cases in New York City alone — and that’s essentially triple our cases over the past week,” Mary Foote, MD, said during an interview. a press conference sponsored by Infectious Diseases. America Company.

“Just to be very clear, we don’t believe it matters. [reflects] the true burden of disease. There are a lot of cases that go undiagnosed,” said Foote, medical director of the New York City Department of Health and Mental Hygiene’s Office of Emergency Preparedness and Response.

“We think this is a true exponential increase in cases that will likely continue for some time,” she said.

These rising case numbers are the result of a slow and inadequate response to the outbreak, experts say.

“If this is a post-COVID trial to see if we get better, I don’t think it’s going so well,” Amesh Adalja, MD, senior fellow at the Johns Hopkins Bloomberg Health Security Center School of Public Health. in Baltimore, said in an interview. “The CDC’s response leaves much to be desired.”

The slow response to growing cases of monkeypox is even more puzzling, says Adalja, because we already had all the tools necessary to contain the spread. “It should have been a home run after COVID-19: a low-communicable disease for which we have ready-to-use vaccines, antivirals and diagnostic tests that already existed,” he said.

Access to treatment can be difficult

Health officials in New York are calling for treatment for the estimated 20 to 25 percent of monkeypox patients who meet certain guidelines.

But the problem is that the drug can only be prescribed through a cumbersome new process called the “expanded access protocol for investigational new drugs.”

“It’s quite complex…and time-consuming to complete all that paperwork,” Foote said.

Because of these requirements, it is primarily state health departments and large academic health systems that have the resources to implement this protocol.

Additionally, with all the paperwork and paperwork required, a patient visit to begin treatment for monkeypox can take anywhere from 1.5 to 3 hours, Foote estimated. “In a busy community clinic, urgent care center or emergency department where most of these patients are seen, this is nearly impossible to implement.”

Additionally, tecovirimat has not been tested in humans.

“For obvious reasons, you can’t do a randomized controlled trial with smallpox or monkeypox, so it’s based on an animal model,” Foote said. But animal evidence suggests 90% to 100% effectiveness in preventing death.

Human data on tecovirimat is limited to a few case reports, but so far the signs are positive.

“Anecdotally, the clinical response has been very good,” Foote said. “Many patients have reported significant improvement in their symptoms within just a few days.”

She said patients seem to tolerate the drug well, with headaches and nausea, but no serious side effects have been reported.

“Excruciating pain” and other symptoms

Many doctors were taught in medical school that monkeypox is a mild illness that goes away on its own, “and a lot of people have said that about this outbreak as well,” Foote said. “But the reality on the ground is that a lot of people with this infection are in real pain, and some are actually at risk of permanent damage and scarring.”

“We have seen many people with symptoms so severe that they are unable to go to the bathroom, urinate or eat without excruciating pain,” she said.

Greater awareness of monkeypox is needed among patients and providers, said Lilian Abbo, MD, who also spoke at the press conference. Many infected people jump from one clinical setting to another before getting a diagnosis.

Football accepted. “It really struck me how many of these patients have struggled to get the care they need to treat these symptoms – having to go between clinics, hospitals and urgent care centers – only to have us never been referred,” Foote said.

The risk could spread

So far, most cases of monkeypox reported to the CDC are in men who have sex with men. “It’s a very savvy community that’s great at standing up for themselves,” Foote said. “And they really stand up and say, ‘Hey, you gotta take this seriously. “”

Abbo said monkeypox is already spreading beyond this community.

“It feels a bit like the start of the HIV epidemic. I don’t want to create stigma around men who have sex with men – we’re already seeing the spread among women, and other countries have it reported in children.

It’s a contagious disease spread through close contact, said Abbo, associate chief medical officer for infectious diseases at the Jackson Health System in South Florida.

“You have to take care of the whole population, she says. Even if it starts with a group, “it will extend to the rest”.

“I don’t want to create fear. I just want to create awareness, so we can control this, stop the spread and focus our attention on prevention,” she said.

Testing is also tedious

Access to testing has also been difficult, Abbo said. Pictures of monkeypox lesions are sometimes needed to get a test approved, and “it can take up to 8 hours to get approval after several layers and phone calls.”

In addition to the Public Health Department’s tests, commercial labs began offering the monkeypox test last week, but there’s a cost, Abbo said. She estimated that each commercial test costs between $90 and $100.

“We’re also trying to set up internal testing,” she said.

Some universities have already done this, but are facing challenges due to supply chain shortages.

Now, Aegis Sciences, LabCorp, Mayo Clinic Laboratories and Quest Diagnostics offer tests for monkeypox. Tests must be ordered by a health care provider; a patient cannot go alone to a laboratory to request a test. Each company has specified a nationwide laboratory where all samples can be sent.

“It’s just not a sufficiently urgent response to contain this virus,” says Jennifer Nuzzo, DrPH, director of the Pandemic Center at Brown University School of Public Health in Providence, RI.

Vaccine demand exceeds supply

Vaccination can also help prevent infection with monkeypox or, if given early enough, prevent serious illness in people who already have monkeypox. But there are also challenges there, experts said.

The New York City Department of Health was the first to offer broad vaccine protection to people at high risk of exposure to monkeypox.

“And the demand has been very, very high — overwhelming at this point. There’s a limited supply nationwide,” Foote said.

Health officials in New York and elsewhere are working with federal partners, clinics and community health organizations to provide vaccines to those most at risk equitably, she said.

People who treat people with monkeypox also have a higher risk of infection, Abbo said. Many people ask about vaccinating healthcare workers, she said. “We are constantly exposed, examining patients.”

Healthcare workers could likely be classified as high risk if or when such categories or guidelines are created, Abbo said. This strategy could also help get scarce resources to the right places.

Until vaccines become more available, more testing is needed to facilitate the spread of monkeypox. “We really need a strategy to make sure that anyone who needs a test can get one as easily as possible,” says Nuzzo, “because right now, with a shortage of vaccines and therapeutics, that’s our main intervention: testing people so they can self-isolate and stay home for as long as they’re contagious.

Go forward

Abbo also pointed out that health workers were already feeling the stress of managing COVID-19 before the monkeypox outbreak.

“It is also the exhaustion of nurses, doctors, lab technicians, everyone who has been working non-stop for 2 years with the COVID pandemic. Now we still have to focus on COVID and this new epidemic .

“Please understand that we appreciate everything the government is doing,” Abbo said, “but we need help with treatment and access to rapid diagnosis.”

When asked if infectious disease outbreaks are becoming more common, Foote said yes.

“We know that epidemics are becoming more frequent. There is a whole public health literature to examine the reasons for this,” she said.

The reasons include globalization, environmental decline, etc. She listed Zika virus, Ebola, COVID-19, meningitis and now monkeypox “over the past two years.”

“We are absolutely seeing more frequent outbreaks.”

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