Monkeypox treatment in limited supply as cases increase

July 14, 2022 – People with monkeypox face a wide range of symptoms, from mild skin lesions 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 currently only available from the Strategic National Stockpile. The FDA approved tecovirimat for the treatment of smallpox in 2018 over concerns it could one day be used as a bioterrorism weapon.

Local health departments are working with the CDC and the U.S. Department of Health and Human Services to request tecovirimat through a complicated 120-page protocol. At the same time, the number of monkey pox cases worldwide has risen to more than 11,000, according to the CDC.

In the US alone, cases have now passed 1,000, according to the CDC.

And while monkeypox is a global problem, some places in the US, such as New York City, are seeing larger outbreaks.

“As of yesterday, we are now up to 336 cases in New York City alone — and that’s a tripling of our cases in the past week,” said Mary Foote, MD, at a news conference sponsored by the Infectious Diseases Society of America.

“To be clear, we don’t believe this counts” [reflects] the true burden of disease. There are many cases that go undiagnosed,” said Foote, medical director of the Office of Emergency Preparedness and Response for the New York City Department of Health and Mental Hygiene.

“We think this is a real exponential increase in cases that is likely to continue for a while,” she said.

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

“If this is a trial period after COVID-19 to see if we’re better, I don’t think things are going that well,” said Amesh Adalja, MD, senior scientist at the Johns Hopkins Bloomberg School of Public Health’s Center for Health Security in Baltimore, said in an interview. “The CDC’s response leaves a lot to be desired.”

The slow response to growing cases of monkeypox is even more puzzling, Adalja says, because we already had all the tools in place to contain the spread. “This should have been a home game after COVID-19: a not very communicable disease for which we have ready-to-use vaccines, ready-to-use antivirals and diagnostic tests that already existed,” he said.

Accessing treatment can be a challenge

New York health officials are requesting treatment for the estimated 20% to 25% 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 research protocol for new drugs.”

“It’s quite complex…and very time-consuming to fill out all this paperwork,” Foote said.

Because of these requirements, it is usually state health departments and major academic health systems that have the resources to apply this protocol.

In addition, with all the forms and administrative requirements, a patient visit to initiate monkeypox treatment can take anywhere from 1½ to 3 hours, Foote estimates. “In a busy community clinic, emergency room, or emergency department where most of these patients are seen, this is nearly impossible to implement.”

In addition, tecovirimat has not been tested on 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 was very good,” Foote said. “Many patients have reported significant improvement in their symptoms within a few days.”

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

‘Unbearable Pain’ and Other Symptoms

Many doctors in medical school learned that monkeypox is a mild disease that goes away on its own, “and a lot of people have said that about this outbreak, too,” Foote said. “But the reality on the ground is that many people with this infection are really suffering, and some may be at risk for permanent damage and scarring.”

“We’ve seen many people with symptoms so severe that they can’t go to the bathroom, urinate, or eat without excruciating pain,” she said.

More awareness about monkeypox is needed among patients and health care providers, said Lilian Abbo, MD, who also spoke at the news conference. Many infected people jump from one clinical setting to another before receiving a diagnosis.

Foote agreed. “It really struck me how many of these patients have struggled to get the care they need to treat these symptoms — because they have to move between clinics, hospitals and emergency care centers — never get referred to us,” Foote said.

Risk can spread

So far, most cases of monkeypox reported to the CDC have been among men who have sex with men. “This is a very smart community that can make a good case for itself,” Foote said. “And they really stand up and say, ‘Hey, you gotta take this seriously.’”

Abbo said monkeypox is already spreading beyond this community.

“This feels a bit like when the HIV epidemic started. I don’t want to create a stigma around men having sex with men — we’re already seeing the spread in women, and other countries have reported it in children.”

This is an infectious disease that is spread through close contact, said Abbo, associate chief medical officer for infectious diseases at Jackson Health System in South Florida.

“We have to take care of the entire population, she said. Even if it starts with one group, “it will spread to the rest.”

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

Testing is also cumbersome

Access to testing was also a challenge, Abbo said. Pictures of monkeypox lesions are sometimes needed to get a test authorized, and “it can take up to 8 hours to get approval after multiple layers and phone calls.”

In addition to public health department testing, commercial labs started offering the Monkeypox test last week, but there is a cost involved, Abbo said. She estimated that each commercial test costs $90 to $100.

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

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

Now Aegis Sciences, LabCorp, Mayo Clinic Laboratories and Quest Diagnostics offer monkey pox testing. The tests must be ordered by a healthcare provider; a patient cannot go to a lab location alone to request a test. Each company has designated one laboratory nationwide to which all samples can be sent.

“It’s just not an answer urgent enough to contain this virus,” said Jennifer Nuzzo, DrPH, the director of the Pandemic Center at Brown University School of Public Health in Providence, RI.

Demand for vaccines exceeds supply

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

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

“And the demand has been very, very high — overwhelming right now. There’s limited supply nationally,” Foote said.

Health officials in New York and elsewhere are working with federal partners, clinics and community health organizations to get vaccines equitably to the people at highest risk, she said.

People who treat people with monkeypox also have a higher risk of infection, Abbo said. Many people ask about vaccinating health professionals, she said. “We are constantly in the spotlight and examining patients.”

Health professionals could likely be classified as high-risk if and when such categories or guidelines are created, Abbo said. This strategy can also help get scarce resources in the right places.

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

Moving forward

Abbo also pointed out that health professionals were already feeling the stress of dealing with COVID-19 before the monkeypox outbreak.

“This is also the burnout of the nurses, the doctors, the lab technicians, everyone who has been working non-stop with the COVID pandemic for the past 2 years. Now we just need to focus on COVID and this new outbreak.

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

When asked whether infectious disease outbreaks are becoming more common, Foote answered yes.

“We know that outbreaks are becoming more common. There is a whole host of public health literature to look at the reasons,” she said.

Reasons include globalization, environmental degradation, and more. She called the Zika virus, Ebola, COVID-19, meningitis and now monkeypox “of recent years”.

“We are definitely seeing outbreaks more often.”