Clinical trial of antiviral for monkeypox goes forward as cases decline
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Experts involved with an NIH trial of tecovirimat said that even as cases of monkeypox continue to decline nationally, it is important to establish whether the antiviral is effective against the infection.
Timothy Wilkin, MD, MPH, an infectious disease specialist at Weill Cornell Medicine and leader of the NIH trial, said during a briefing hosted by the Infectious Diseases Society of America that although tecovirimat has been proven safe and clinicians have been using it for months to treat monkeypox, there are no data on its efficacy against the infection, regardless of reports from doctors.
Tecovirimat is approved in the United States to treat smallpox and is being used under an FDA expanded access protocol for monkeypox.
“There are no proven treatments for this condition,” Wilkin said. “NIH asked the clinical AIDS group to conduct a trial to provide evidence for consideration of FDA approval and widespread access to the drug.”
Wilkin noted that tecovirimat was proven to be safe in previous studies, which is why clinicians were encouraged to use it for treatment as researchers gathered data on its efficacy.
The new phase 3 trial includes three arms — a treatment arm, a placebo arm, and an open-label arm in which participants at higher risk for severe infection will receive tecovirimat without randomization.
The trial will specifically look to enroll people with mild to moderate disease, Wilkin said, adding that participants in the randomized arm whose condition is worsening will be given the option of receiving tecovirimat rather than a placebo.
Monkeypox case counts have been on a downward trend since a peak in August, according to CDC data, which has been credited to CDC outreach programs for awareness and vaccination. Those programs were expanded last month, with the agency launching a small-event version of its large-event outreach pilot program.
Demetre C. Daskalakis, MD, MPH, director of the CDC’s Division of HIV Prevention and deputy coordinator for the White House’s national monkeypox response team, said during the briefing that although cases in the U.S. — now above 25,000 — have decelerated week after week, the agency is drilling down further because awareness and vaccination have not been consistent across the country.
According to Daskalakis, data from the five largest jurisdictions the CDC is tracking show a slowing outbreak, but participants in Friday’s briefing said the decline in cases make the trial even more important.
Carl W. Dieffenbach, PhD, director of the AIDS division at the National Institute of Allergy and Infectious Diseases, said determining treatments for monkeypox is essential to preventing the disease from spreading further and becoming endemic.
“There are fundamental gaps in our knowledge related to monkeypox and orthopox viruses in general. One of the really interesting questions in the data is that people living with HIV appear to have a higher risk for monkeypox,” Dieffenbach said.
Determining why — and whether lifestyle or HIV itself is the reason — along with developing better diagnostics and monkeypox tests are among the goals of this and other trials, the experts said.
Enrollment has just started in the trial, which is expected to have as many as 65 sites and may incorporate a telehealth approach.
“The outbreak is now concentrating in communities of color,” Daskalakis said during the briefing on Friday, with 51% of cases identified in the previous week occurring among non-Hispanic Black people.
“As we see hopeful declines in the monkeypox outbreak, our mission is to prevent this virus from being part of everyday life in the United States,” he said. “This is one of the reasons it’s so important we get the word out to providers. As cases decline, [finding study participants] becomes a challenge, but we do have folks who know how to get people into studies.”
References:
- CDC. U.S. monkeypox case trends reported to CDC. https://www.cdc.gov/poxvirus/monkeypox/response/2022/mpx-trends.html. Accessed Oct. 3, 2022.
- NIH. Study of tecovirimat for human monkeypox trials. https://clinicaltrials.gov/ct2/show/NCT05534984. Accessed Sept. 30, 2022.
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