Miller School Researchers’ Use of Experimental Monkeypox Drug Published in The Lancet

A team of researchers at the University of Miami Miller School of Medicine was among the first in the nation to test an experimental drug that helps people suffering from human monkeypox virus.

The patient recovered quickly after receiving tecovirimat, a medication designed to treat human smallpox disease that was authorized for “compassionate use” in monkeypox cases by the U.S. Centers for Disease Control and Prevention this summer to determine if it would help those patients. The lesions that covered the 37-year-old patient’s body healed quickly after he received tecovirimat, and he reported only minimal nausea following his treatment.

A summary of the case was published last month in The Lancet medical journal, adding to a growing body of research into the highly communicable virus.

Arvin Jadoo, M.D., a PGY-3 resident in the Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, said that the patient, whom they encountered in June, may have been the first in Miami-Dade County to contract the virus, meaning that the medical team had no experience with monkeypox before his arrival. “It was a learning experience for everybody,” Dr. Jadoo said.

After a careful review of possible treatments and successful administration of the drug, Dr. Jadoo said, tecovirimat is now part of the standard response for monkeypox patients who are immunocompromised or have serious preexisting conditions.

“If we do our due diligence and accumulate all of the reports and data available with this use, I’m hopeful and optimistic it’ll be standard of care, apart from high-risk patients — perhaps standard of care in terms of early use, to reduce the burdensome nature of having to quarantine and so on,” Dr. Jadoo said.

The paper in The Lancet was co-authored by Robert Kirsner, M.D., Ph.D., professor of dermatology and Harvey Blank Chair in Dermatology in the Miller School’s Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery; and Loren Hernandez, B.S., a fourth-year medical student and research fellow at the school. The team also worked closely with the Division of Infectious Diseases at the Miller School, which is now handling all monkeypox patients across the UHealth – University of Miami Health System.

When the patient first arrived, monkeypox was just beginning to spread around the country. In an essay in the New England Journal of Medicine, government infectious disease experts urged doctors to test out tecovirimat, with patients’ consent, writing that human trials on patients with monkeypox “are both needed and possible.” The medical community was still developing basic testing just to diagnose the virus — it took a full week before the Miller School team received confirmation from state health department labs that their patient had monkeypox.

As team members waited for that confirmation, they worked to exclude other possibilities. The patient had a history of HIV, metastatic Kaposi’s sarcoma, secondary syphilis (which had been treated), and hypertension. While he was not critically ill, lesions were spread across his body. Serology was negative for Bartonella henselae, Aspergillus spp, hepatitis A, B, and C, cryptococcal antigen, and both types of herpes simplex virus. Additional tests excluded syphilis, spirochetal, and fungal organisms.

Tecovirimat was administered, and Dr. Jadoo said the man’s recovery sped up dramatically after receiving the dose.

“The lesions resolved faster than what he was previously experiencing,” he said. “He tolerated it well, with no side effects.”

Dr. Jadoo said that UHealth also used the case to create a series of protocols to care for future patients and the health care professionals who would treat them. Since the virus is transmitted via large respiratory droplets, only one member of the medical team — wearing full PPE gear — sees each patient. Now that laboratories are providing monkeypox tests results in one or two days, the entire health care system is better prepared to deal with outbreaks.

“We were excited to be able to work as a team and provide cutting-edge therapy in the county’s first monkeypox case,” Dr. Jadoo said. “This learning experience helped to develop a protocol to ensure safety for people with monkeypox and those caring for them.”

Tags: Centers for Disease Control and Prevention, Department of Dermatology and Cutaneous Surgery, Division of Infectious Diseases, Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery, Dr. Robert Kirsner, Miller School of Medicine, monkeypox, New England Journal of Medicine, tecovirimat, The Lancet