Health
NIH Initiates Clinical Trial Evaluating TPOXX Efficacy Against Monkeypox
Due to the limited current data on efficacy against the virus, the National Institutes of Health (NIH) does not support the efficacy of tecovalimat (a smallpox antiviral drug better known as TPOXX) used to treat monkeypox. Phase 3 clinical trials to determine
The study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and is led by the organization’s AIDS Clinical Trials Group. This study is currently enrolling adults and children infected with monkeypox in the United States.
TPOXX was approved by the Food and Drug Administration (FDA) in 2018 for the treatment of smallpox. It was approved for use in the treatment of monkeypox in August, based on research to treat the orthopoxvirus, a family of viruses to which both monkeypox and smallpox belong.
TPOXX is not approved for use in monkeypox, but has been given “Investigational Drug” designation for use in the treatment of monkeypox.
“Monkeypox can be a very painful infection that can last for weeks,” said NIAID Director Anthony Fauci in a statement.
“We currently lack efficacy data to help us understand how well this drug can reduce painful monkeypox symptoms and prevent serious consequences,” Fauci said. The exam was designed to answer these important questions.”
To date, there have been more than 21,000 confirmed cases of monkeypox in the United States, and more than 56,000 cases have been reported worldwide. No deaths from monkeypox have been confirmed in the United States, but 18 have been confirmed worldwide.
According to federal data, about 2,000 patients diagnosed with monkeypox have been treated with TPOXX to date, mostly men. She is the only woman confirmed to have received her TPOXX to treat monkeypox infection.
TPOXX can be administered as an oral capsule or intravenously. Side effects include headache, nausea, vomiting, and swelling at the injection site.
In August, infectious disease researchers at the University of California, Davis, released data on small infections. A study of 25 men Persons infected with monkeypox and treated with TPOXX.
Ten of the patients in the study reported complete resolution of their monkeypox lesions after one week of treatment. Most of the patients TPOXX he took for 14 days. However, this study did not include a control group, limiting the researchers’ ability to measure efficacy.
The study has some limitations, so researchers at the University of California, Davis called for a larger study to be conducted.
The NIH said its study will utilize a placebo group to determine whether patients taking TPOXX experienced faster healing of monkeypox lesions. It will also explore the drug’s impact on the progression of the disease, and how quickly patients can test negative for the virus.
Patients in the study will be followed for at least eight weeks, during which time they will be asked to have daily skin checks and photographs taken. Data collected in this trial will be submitted to the FDA.
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