Kholood Eid/The New York Times

August 21, 2023

New Drug Study Shows No Adverse Effects for Monkeypox Patients With HIV

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After a recent outbreak last May, it’s estimated that 40 percent of people diagnosed with the monkeypox virus in the United States also have HIV.

With the spread of a novel antiviral medication, Tecovirimat, Weill Cornell and Columbia University Irving Medical Center co-published a study this past May investigating the effects of the drug on patients with mpox and HIV. The study found no significant differences in outcomes for patients with or without HIV when treated with Tecovirimat, suggesting that the drug does did not pose any substantial risk to the HIV population.  

Mpox is a virus from the same family as smallpox with symptoms including painful rashes, fever and enlarged lymph nodes. The disease gained global attention in May of last year when cases were first reported in the United Kingdom. Subsequent cases were reported in the United States, and the U.S. Department of Health and Human Services declared a public health emergency in August 2022. 

Tecovirimat is a drug that is approved by the U.S. Food and Drug Administration to treat smallpox, but it was also approved to treat mpox on May 5 through the expanded access protocol under the CDC. The protocol gives patients at risk of life-threatening health conditions access to investigative drugs when no other treatments are available. 

Co-senior author Dr. Marshall Glesby, infectious diseases and medicine, described how the team worked hard to meet the increasing demand for treatment during the 2022 outbreak. 

“We were able to get this protocol up and running quickly within 24 hours of being contacted about the first person deemed to be eligible for the treatment,” Glesby said.

The team began to investigate the effects of Tecovirimat on patients with HIV compared to those without the virus due to the more severe mpox symptoms that HIV patients often experience. 

With the combined data from New York-Presbyterian and Columbia University Irving Medical Center, Glesby and his team looked at how the 154 study participants treated with Tecovirimat responded, specifically looking at whether there was a difference in outcome for patients with or without HIV. 

The results showed that Tecovirimat did not cause adverse effects in patients with HIV, and outcomes were similar to those of patients without HIV. Only four patients experienced adverse effects, which was concluded to be from factors unrelated to the drug. Improvement in monkeypox symptoms following administration of Tecovirimat was also similar between the two groups. 

Despite these results, Glesby cautioned against concluding that Tecovirimat was the safest, most effective treatment for mpox patients with HIV. There were certain limitations to the study, including patient management of HIV and the lack of a control group of mpox patients treated without Tecovirimat. 

Most patients in the study had well-managed HIV, whereas patients in the later stages of HIV were often more severely affected by mpox. Thus, the study could not extend their results on the effects of Tecovirimat for patients with more advanced HIV. Additionally, without a control group of patients who did not receive Tecovirimat, the study could not draw conclusions on whether Tecovirimat was solely responsible for the resolution of symptoms in mpox patients.  

In patients with HIV that is more advanced, Glesby suggested that tecovirimat alone may not be sufficient or could be used in combination with other treatments — however, data on this hypothesis remains scarce.

Due to the observational nature of the study, clinical trials would be needed to fully determine the safety and efficacy of Tecovirimat. The Study of Tecovirimat for Human Monkeypox Virus trial led by Glesby’s colleague Dr. Timothy Wilkin, medicine, is one such study. After recruiting test subjects, they hope to test Tecovirimat’s safety and efficacy by randomly assigning participants with either a placebo or the drug for the course of 14 days. 

Comparing the virus to COVID-19, Glesby noted how vaccines can help prevent mpox infection and suggested vaccination and education as a way of mitigating another potential outbreak. 

“Although the [mpox] virus itself is not analogous to SARS-COV-2, the idea that vaccination may attenuate the disease, even if it doesn’t prevent it 100 percent as immunity wanes, is analogous. I think vaccination is a key strategy,” Dr. Glesby said. “Education about which behaviors are higher risk and, more importantly, vaccination, would be the keys to [mitigating] resurgence.”

Brenda Kim is a Sun contributor and can be reached at [email protected].