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Patients with HIV had similar treatment outcomes to patients without HIV when treated for mpox with an antiviral drug called tecovirimat, according to a study by a team of investigators from Weill Cornell Medicine, Columbia University Vagelos College of Physicians and Surgeons and NewYork-Presbyterian.

The results of the study, published May 2 in the Annals of Internal Medicine, provide preliminary evidence of the safety and efficacy of the drug in those living with HIV. The investigators analyzed electronic health record data from 154 patients, including 72 patients with HIV, treated with tecovirimat for mpox at NewYork-Presbyterian/Weill Cornell Medical Center and NewYork-Presbyterian/Columbia University Irving Medical Center between late June and August of 2022 amidst a global mpox outbreak.

“People with well-controlled HIV did not have any safety issues with treatment with tecovirimat and responded similarly to patients without HIV,” said co-senior author Dr. Marshall Glesby, professor of medicine in the Division of Infectious Diseases at Weill Cornell Medicine and an infectious disease specialist at NewYork-Presbyterian/Weill Cornell Medical Center. Dr. Jason Zucker, an assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and an infectious disease specialist at NewYork-Presbyterian/Columbia University Irving Medical Center, was co-senior author of the study.

Tecovirimat was approved by the United States Food and Drug Administration in 2018 to treat smallpox, a virus that is related to mpox. When the mpox outbreak began in May 2022 in the United States, the U.S. Centers for Disease Control and Prevention made the drug available to treat mpox through its investigational new drug expanded access program. The program provides access to investigational drugs when no other drugs are available to treat a serious or life-threatening disease. Studies had previously shown the drug is effective at treating mpox-related viruses in animals.

Clinicians at NewYork-Presbyterian/Weill Cornell Medical Center and NewYork-Presbyterian/Columbia University Irving Medical Center rapidly responded to the rising numbers of mpox cases in New York City and were soon able to provide patients with tecovirimat through the CDC program and subsequently through an ongoing clinical trial.

“There were large numbers of clinicians at both institutions who rallied to take care of patients with mpox and get treatment started, so there was almost no delay in care,” said Dr. Glesby, who is also a professor of population health sciences at Weill Cornell Medicine. “It’s a testament to all the people involved.”

As the clinicians began treating patients with tecovirimat, Dr. Jacob McLean, an infectious disease fellow at Columbia University, and Dr. Kate Stoeckle, an infectious disease fellow at Weill Cornell Medicine, joined forces to analyze the patient outcomes along with Drs. Glesby and Zucker. One of the key questions they wanted to answer was whether there were any unique safety or efficacy concerns when using tecovirimat in patients with HIV, who accounted for about 40 percent of patients infected with mpox during the 2022 outbreak, Dr. Glesby said.

“Each of our institutions had seen people with HIV and mpox, and we thought this was an opportunity to look at their outcomes compared with patients without HIV,” Dr. Glesby said. At the time, he said there was very little data available about the use of tecovirimat to treat mpox in patients with HIV.

The analysis found that there was little difference in the outcomes of patients with and without HIV treated with tecovirimat for mpox. The drug was also well tolerated in both groups, with very few adverse effects. Four patients taking tecovirimat experienced severe adverse events, but the investigators deemed them unlikely to be caused by the drug.

Patients with HIV, on average, received tecovirimat within 7.5 days of developing mpox symptoms compared with ten days among patients without HIV. Dr. Glesby attributed this difference to CDC recommendations for treatment for patients with HIV and potentially greater patient awareness or concern about mpox.

Dr. Glesby noted that the study’s findings apply only to patients with HIV well-controlled on treatment because these individuals made up most patients seen at the two institutions. Other studies have documented more severe mpox outcomes and some deaths in patients with more advanced or poorly controlled HIV, he said.

The U.S. outbreak of mpox has largely subsided, Dr. Glesby noted. But infectious disease experts are concerned there could be a resurgence of cases during the warmer months, especially since only about one-quarter of those at highest risk in the United States have been vaccinated against mpox.

Dr. Timothy Wilkin, professor of medicine in the Division of Infectious Diseases at Weill Cornell Medicine and an infectious disease specialist at NewYork-Presbyterian/Weill Cornell Medical Center, is currently leading a randomized, placebo-controlled trial called the Study of Tecovirimat for Human Monkeypox Virus (STOMP), which aims to provide more critical information about the drug’s safety and efficacy. Dr. Zucker is vice chair of the study. Individuals with severe symptoms or mpox lesions in sensitive areas would receive tecovirimat open label in the study, Dr. Glesby said.

“It is important for anyone who has this infection who is a candidate for treatment to consider enrolling in the trial,” Dr. Glesby said. “We need clinical trial data to explore the safety and efficacy of tecovirimat further.”

Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosures public to ensure transparency. For this information, see profile for Dr. Glesby and Dr. Wilkin.

— Courtesy Weill Cornell Medicine

— Courtesy of Weill Cornell Medicine newsroom