USAcancer, which federal officials have declared a public health emergency on August 4, not as contagious as the other public health emergency unfolding in the United States: COVID-19. Monkey smallpox mainly spread through contact with infected skin lesions. Theoretically, containing monkeypox should be more feasible, as long as test, Vaccine, and accessible treatments. But in practice, implementing all three approaches faces major challenges. Get the antiviral drug tecovirimat, also known as TPOXX, which is especially difficult.
Here’s what to know about TPOXX antiviral treatment.
What is TPOXX?
TPOXX is approved by the U.S. Food and Drug Administration (FDA) to treat smallpox, which belongs to the same family of viruses that cause smallpox as monkeypox. It may also help people with monkeypox.
TPOXX was approved for smallpox under a special regulatory process known as the Animal Rule, which allows the FDA to approve a drug without prior human testing. Because smallpox is a dangerous and highly contagious virus and has been eliminated from the world, the drug cannot be tested on humans, but has been tested on animals instead. . Even in animals, the researchers did not use the smallpox variola virus but the related monkeypox virus as a backup, as there are only two laboratories in the world — one at the Centers for Disease Control and Prevention and Disease Control USA, and one in Russia — have samples of the smallpox virus and can conduct studies on the virus.
How do you get TPOXX?
Because it is not specifically approved for monkeypox, it cannot be prescribed and stored in pharmacies. It is distributed only by the Strategic National Reserve, the emergency drug stockpile maintained by the federal government for public health emergencies.
CDC has provided TPOXX under a compassionate use protocol. That requires any physician interested in administering the drug to a patient to register and agree to the conditions of receipt of the drug, and to have their patient sign acknowledged informed consent forms. that they understand that the drug has not been studied or approved to treat their condition. This process for providers is time-consuming, as doctors must agree to provide information about a patient’s symptoms and explain why they qualify for the drug.
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But due to high demand, the CDC has recently streamlined the paperwork to a minimum, said Dr. John Brooks, head of the epidemiology research group in the CDC’s HIV-AIDS division. Once the CDC receives the physician’s order, the drug order will be sent to the Stockpile, and the TPOXX will be sent directly to the doctor within 24 hours.
Since 2013, SIGA Technologies–The pharmaceutical company that makes TPOXX — has provided 1.7 million doses of the drug to its stockpile, said Phillip Gomez, the company’s CEO. Each dose remains valid for about seven years, so starting in 2020, SIGA has provided approximately 363,000 doses to replace those that have expired. The company has partnered with four production facilities to maintain stockpiles, and Gomez said SIGA is in discussions with government health authorities about whether additional capacity is needed.
How effective is TPOXX?
The animal data on TPOXX essentially reflect the drug’s level of activity against smallpox in monkeys, but efficacy in humans is unknown. In those learn, the researchers injected non-human primates and rabbits with a lethal dose of monkeypox. More than 90% of those treated with TPOXX survived, compared with only one in 20 non-human primates treated with a placebo.
Dennis Hruby, chief scientific officer of SIGA Technologies, says that anecdotal reports from patients treated with TPOXX suggest that the drug can reduce symptoms such as fever and fatigue, while also reducing severity and injury-related pain. A course of TPOXX involves taking the drug twice a day for 14 days.
How TPOXX works
Once the monkeypox virus is inside a healthy cell, the virus copies its genetic information and forms several membranes, or coatings, that allow it to burst out of the cell and circulate. throughout the body to infect other cells. TPOXX works by preventing the virus from making multiple copies of itself after it infects the server. It does this by preventing the formation of secondary membranes and trapping the virus inside the cell. The body’s immune cells, including antibodies and T cells, then eliminate these virus-filled cells.
Post-infection TPOXX is used as soon as possible, it can prevent the virus from infecting other cells and causing more serious illness.
Can patients get TPOXX faster?
Hospitals in several hotspots have accelerated access to TPOXX. In New York City, the health department obtained a supply of the drug from the Strategic National Stockpile and authorized a select number of pharmacies — including the specialty pharmacy at Columbia University, which has a limited supply of the drug. relatively high incidence of smallpox — drug storage and distribution. . Dr. Jason Zucker, assistant professor of medicine at Columbia, said his team has prescribed the drug to just under 90 people. Doctors submit a request to describe a patient’s condition to the city’s health department, which reports cases to the CDC and allows doctors to dispense medication to patients.
That may seem tedious to patients and doctors, but it’s a necessary process as little is known about the safety and effectiveness of this drug for treating monkeypox. “It’s a drug for which we have extremely limited data, and we really don’t know if it will work,” Zucker said. “So the process is important.”
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In Los Angeles, county health officials also obtained a supply of TPOXX from the National Stockpile and distributed it to several hospitals and clinics, including the David Geffen School of Medicine at the University of California Los Angeles. . UCLA stocks a drug supply in its specialized investigative pharmacy, only offers drugs such as TPOXX that have not been fully approved and require additional regulatory steps and consent to dispense. Dr. Tara Vijaya, medical director of antibiotic stewardship at UCLA, oversees distribution of TPOXX at UCLA Health and said that so far, its health system has only provided the drug to less than 10 patients. UCLA requires infectious disease physicians to discuss with patients the fact that TPOXX has not been adequately studied to show it is effective in the treatment of monkeypox and that the patient’s consent must be obtained before prescriptions.
Because the hospital stockpiles medication, patients can receive their medication when they visit a doctor directly from the hospital pharmacy or delivered to their home within 24 hours. However, even with this system, physicians must fill out the appropriate forms from the CDC log for each patient taking the medication.
For the most effective drug access, CDC’s Brooks recommends that patients ask their physician to apply for compassionate TPOXX, or consult their local public health department for physicians. registered doctor and can receive medicine faster.
Will TPOXX be approved for monkeypox?
The FDA and CDC are looking for completed studies of TPOXX in people with monkeypox before expanding the drug’s current approval to include smallpox in monkeys. Even before the current outbreak, the National Institute of Allergy and Infectious Diseases, a branch of the National Institutes of Health (NIH), had begun studying the drug in people infected with smallpox in the United States. monkeys in the Democratic Republic of the Congo.
Due to the outbreak, the AIDS Clinical Trial Group, run by the NIH, is also launching a new study of monkeypox patients in the United States to better understand how effective the drug is in controlling the disease. control symptoms and also how it affects patients if used together with monkeypox vaccine. Based on animal studies that SIGA has done, Hruby says the drug does not appear to interfere with the development of immunity in people who have received either of the two monkeypox vaccines: Jynneos or ACAM2000. The company began studying healthy people who were vaccinated and then injected with TPOXX to determine if the combination was safe; The data will also help researchers better understand how the immune system responds to both drugs and vaccines if they are given together.
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