“For the most part, these illnesses are relatively mild. They can be disfiguring and yucky, but they will heal on their own — though it may take some time,” said Dr. William Schaffner, a professor of medicine at the Vanderbilt University School of Medicine.
The US Food and Drug Administration hasn’t approved any therapies specifically for the treatment of monkeypox. But the US Centers for Disease Control and Prevention is making the antiviral medication tecovirimat available during the outbreak and says it may be considered for monkeypox patients who have or are at high risk of severe disease.
Data regarding the number of monkeypox patients who fall into this category remains limited. But Dr. Mary Foote, medical director of the Office of Preparedness and Response at the New York City Department of Health and Hygiene, said last week that the proportion of severe monkeypox cases in the city has been higher than expected.
Foote said providers there have started treatment with tecovirimat for “close to 70 patients,” and the number of confirmed cases in the city at the time had reached 336.
Vaccination may prevent or reduce disease
Dr Anthony Fauci, the nation’s top infectious disease expert, said Monday that the outbreak is “heavily weighted” to affect men who have sex with men.
“When you look at that, does that mean it is only a gay man’s disease? No, not the case,” he said. “But under the circumstances of certain types of behavior, that can be spread, which is the reason why — although you do not want to stigmatize under any circumstances people who are getting afflicted with a particular infectious disease — you’ve got to let the community know of the danger, and you’ve got to let the physicians who care for these people be aware of it so that they don’t miss the diagnosis.”
The Jynneos vaccine is the only one specifically approved in the US for monkeypox. A smallpox vaccine called ACAM2000 is also approved and may be used during this outbreak.
“The advantages of vaccination are that people who may have been exposed to monkeypox — before the onset of the rash — may benefit from vaccination either in preventing the full spectrum of disease or in reducing the severity of disease,” said Dr. Jay Varma, a professor of population health sciences at Weill Cornell Medical College.
The Jynneos vaccine is given as two doses, four weeks apart. The FDA approved it for monkeypox based on studies measuring antibody levels in vaccinated humans as well as efficacy studies in animals.
“The degree of effectiveness — what proportion of infections would be prevented — has yet to be determined,” Schaffner said, “but that they do have some benefit, I think, is pretty clear.”
What to do if you’re diagnosed with monkeypox
“In most cases, we’re encouraging people right now who are at risk that, if they present with a rash, they do consult with a medical provider to make the diagnosis and to rule out other common things, such as herpes infection or bacterial infection of the skin,” said Dr. Roy Gulick, chief of the Division of Infectious Disease at Weill Cornell Medicine.
People who are diagnosed with monkeypox should isolate at home, the CDC says. If you have a rash or other symptoms, you should be “in a separate room or area from other family members and pets when possible.” The World Health Organization recommends that people with monkeypox try not to touch the rash, because this could contribute to the spread of the disease.
Most cases of monkeypox go away by themselves.
“The very substantial majority of these people will get better on their own, and that’s very fortunate,” Schaffner said. “People may want some symptomatic relief, like Tylenol or this or that, but they won’t need any direct antiviral treatment.”
“If there’s minor pain at the site of the lesions, a topical analgesic could be helpful,” added Dr. Timothy Wilkin, a professor of medicine at Weill Cornell Medical College.
“Sometimes, people have itching, so we can offer an antihistamine over-the-counter, like Benadryl or Claritin,” Gulick said.
Treatment of severe disease
The CDC has made certain antiviral drugs available during the outbreak through a pathway called Expanded Access.
People who have symptoms in particularly hazardous areas like the eyes, mouth, genitals or anus may also be considered for treatment.
Tecovirimat, sold under the brand name TPOXX, was FDA-approved for the treatment of smallpox in 2018. It can be given as an oral pill or administered into a vein.
The drug’s benefits were evaluated through trials on animals that were infected with viruses related to smallpox, including monkeypox. The drug was evaluated in 359 healthy human volunteers to confirm its safety. The CDC says, “data are not available on the effectiveness of tecovirimat in treating monkeypox infections in people.”
“Importantly, we’ve found that the medication has been well-tolerated so far,” Foote said of New York City’s experience, “with an occasional report of headaches, maybe one nausea, but there’s been no reports of any serious adverse events.”
The CDC also says three other treatments — cidofovir, brincidofovir and Vaccinia Immune Globulin Intravenous — may be considered for treatment of monkeypox during the outbreak. But experts say these treatments have been less relevant due to uncertainties about whether they have benefits that would outweigh risks. Gulick said, for example, that treatment with cidofovir can have negative effects on the kidneys.
Challenges with tecovirimat
Given the limited data on how well tecovirimat works, Gulick said, “you have to raise the risks and balances, and that’s usually a conversation you have with patients.”
Dr. Lilian Abbo, associate chief medical officer for infectious diseases at Jackson Health System in Miami, said that most of the requests she’s seen for tecovirimat have been for people who had malignancies or immunocompromising conditions who have more severe disease.
Wilkin, who has cared for monkeypox patients in New York, said he mainly sees it used for “very painful anal lesions” as well as in people who have lesions on their face, which “can be potentially disfiguring with unnecessary complications.”
He added that he’s seen the drug used in a number of people who have weakened immune systems at risk of progression to more severe disease.
A medical provider can request access to tecovirimat by contacting their state health department or the CDC. Clinicians have described a host of steps, such as lab tests and consent forms that are needed to get access to the drug. The CDC website, as of Friday, indicates photos and samples of lesions are optional rather than required steps for obtaining tecovirimat.
“Just to put into perspective, in my conversations with some of our treatment providers, between all the forms and administrative requirements, a patient visit to initiate treatment can take anywhere between 1½ and three hours,” Foote said.
Fauci said that the FDA and the CDC are among those working to cut down on the required paperwork.
Another issue that clinicians face is the lack of data available to help guide treatment decisions.
Wilkin compared the experience of treating monkeypox patients with the early days of the Covid-19 pandemic, when there was an absence of robust studies to guide treatment decisions.
“We have the pressure to use what we got, but my other hat as a researcher says we need to prove this stuff actually works and that it’s also safe,” Gulick said. “The best way to do that is a clinical trial that should be randomized vs. placebo.”
He added that discussions are underway regarding such clinical trials.
