Getting treated for monkeypox is easy, but still hard: Shot

Having recovered from a painful monkeypox case, Kyle Plank joined an advocacy group and pleaded with elected officials to make the antiviral drug TPOXX more available.

Yuki Iwamura/AFP via Getty Images

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Yuki Iwamura/AFP via Getty Images

Having recovered from a painful monkeypox case, Kyle Plank joined an advocacy group and pleaded with elected officials to make the antiviral drug TPOXX more available.

Yuki Iwamura/AFP via Getty Images

when Kyle Plank He contracted monkeypox and was in the worst pain of his life. “I was at seven or eight [out of 10] I was in and out all day in the worst pain imaginable,” he says.

In early July, pustules of varying stages developed on the body of an infectious disease graduate student in New York City. He was bedridden for several days. Planck then gained access to his tecovirimat (trade name TPOXX). This is his two-week course on antiviral drugs. Within two days of taking them, he noticed an improvement. he says.

According to advocates for the LGBTQ community, Plank is one of the lucky few patients to have access to TPOXX. recently, about 215 patients TPOXX was received in New York City, according to city health officials on July 23.

It is not clear how many courses are being prescribed across the country. The government’s strategic national stockpile 1.7 million TPOXX coursesSo far, 10,000 courses have been sent to states and cities upon request, but “the number [courses] The expanded number does not necessarily match the number. [courses] A spokesperson for the Department of Health and Human Services wrote in an email to NPR: Individual Jurisdictions.

Smallpox drugs tested against monkeypox

TPOXX is manufactured by New York-based pharmaceutical company SIGA. “This drug was developed in collaboration with the US government after 9/11. [to address] concerns about [potential] Smallpox attack,” said SIGA CEO Phil Gomez. over 40 years agobut there are samples in laboratories in the United States and Russia, and it is considered a threat of bioterrorism.

“Given the nature of how it was developed, we only sell to governments,” says Gomez. [smallpox] Outbreak, too late to start ordering drugs. ”

SIGA has proven by testing that TPOXX works against the smallpox-like virus. two animal models: monkeypox in monkeys, rabbitpox in rabbits. And they proved it was safe for humans by giving it to hundreds of healthy people in safety trials and documenting side effects (headaches and nausea were the most common). In 2018, the FDA approved the drug It allows companies to use animal testing “to support FDA approval when it is not feasible or ethical to conduct efficacy studies in humans.”

The drug works across smallpox, monkeypox, and other related smallpox. This is because it blocks proteins that these viruses need to replicate. “Even if some cells are infected, they cannot infect and spread to the next cell, which greatly reduces their virulence in the body,” he said. Rachel RoperProfessor of Microbiology and Immunology at East Carolina University and has worked with poxviruses for 30 years.

However, while TPOXX was effective against monkeypox in monkeys, the FDA has only approved it for use against smallpox in humans. For monkeypox, the drug is “Investigational new drug,” Allow thoughtful use, comes with requirements from the FDA and CDC. As such, the current monkeypox epidemic presents barriers to access for physicians and patients.

Less paperwork, but some forms are still required

In New York City, Dr. Robert Pitts, an infectious disease specialist at NYU Langone Health, prescribed TPOXX to more than a dozen patients. “Every time I send him a prescription for TPOXX, I am very aware that this is what the patient needs,” he says. After taking the drug, the patient felt better and suffered less from side effects. In early July, it took up to 3-4 hours per patient to complete the protocol.

July 22, the CDC updated the TPOXX protocol to streamline the process and make drug prescribing much easier. Some previously required documents, such as lesion photographs and patient diaries, are now optional. Say “Really, this is a big improvement” Dr. Melanie ThompsonAtlanta physicians and HIV researchers prescribing TPOXX to patients under new requirements. “It took about 15 minutes to do all her TPOXX paperwork, and another 15 minutes for the patient to inform her consent.”

The change came after strong support from clinicians and activists. “We have had many health care providers speak directly to the CDC, and advocates have written letters and campaigned for these changes,” Thompson says.

Pitts agrees that the new process is a significant improvement, but says, “There is still a significant amount of additional work required to get patients to treatment.” He knows that the drug has never been used by many people before, and that the regulations are there to protect patients. Every day we hear from patients struggling to find a donor.

Witnessing the lack of access has turned patients like Plank into advocates. From quarantine, he wrote to elected officials, imploring them to make the drug more available. doing. TPOXX has the potential to do more than just make people feel better, he says. It may help stop the spread of disease.