(through site-specific expanded access investigational new drug applications).
The drug was originally developed and approved for the treatment of smallpox, a related virus, but had not been studied in people with mpox.
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Study Methods and Findings
In the current study, the researchers analyzed data from 154 patients at Columbia and Weill Cornell who tested positive for mpox and were treated with tecovirimat between June and August 2022. Of those who were treated, 72 patients had HIV.
Nearly all patients, regardless of HIV status, were pain-free by the end of the treatment regimen. The drug was equally well tolerated in both patient groups.
The findings confirm the results of other studies that show tecovirimat is well-tolerated, though additional studies are needed to establish the drug’s effectiveness against mpox.
Zucker is vice chair of STOMP (Study of Tecovirimat for Human Monkeypox Virus), a multi-site randomized, placebo-controlled clinical trial sponsored by the CDC to study the effects of tecovirimat in a variety of populations with mpox.
More Data Needed on Immunocompromised Patients with Mpox
Evidence has emerged that people who are severely immunocompromised, including those with poorly controlled HIV, are at greater risk for severe illness and death from mpox.
“Only four people in the study had low CD4 counts, a sign of poorly controlled HIV, so we weren’t able to compare treatment outcomes in that population,” says Jacob McLean, DO, a postdoctoral clinical fellow in Columbia’s Department of Medicine and first author of the study.
“New York has better social safety programs for people with HIV compared with other states, so we have fewer patients with poorly controlled HIV,” Zucker says. “There are wide disparities in access to care and treatment for people with HIV across the country and in other parts of the world, which feeds into the inequities in mpox diagnosis and treatment and affects outcomes.”
Zucker adds that while the mpox outbreak has virtually ceased in the United States, cases are on the rise in other countries.
“We could see a resurgence of mpox if we don’t make efforts to ensure that all vulnerable individuals are vaccinated,” Zucker says.
Source: Eurekalert
