The ability of TPOXX to treat people infected with monkeypox is being directly tested in a new clinical trial in central Africa, U.S. health officials have announced.
TPOXX — the antiviral drug tecovirimat — is only approved to treat smallpox, but doctors have been using it to treat infections during the global monkeypox outbreak.
The new clinical trial, based in the Democratic Republic of the Congo (DRC), will provide the first evidence of whether TPOXX is actually a good therapy for monkeypox.
“Monkeypox has caused a high burden of disease and death in children and adults in the Democratic Republic of the Congo, and improved treatment options are urgently needed,” said Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID). “This clinical trial will yield critical information about the safety and efficacy of tecovirimat for monkeypox.“
The World Health Organization (WHO) reports 68,900 confirmed cases of monkeypox and 25 deaths in 106 countries, areas and territories from January through early October, during the current outbreak.
The viruses that cause monkeypox and smallpox are similar, and TPOXX targets a protein found on both to impede their spread by preventing virus particles from exiting human cells, according to a news release from the U.S. National Institutes of Health.
The clinical trial will enroll up to 450 Congolese adults and children with lab-confirmed monkeypox infection. Participants will be randomly assigned to receive TPOXX capsules or a placebo twice daily for 14 days.
The study will compare the average time it takes for people's skin lesions to heal. Researchers also will track how quickly monkeypox virus clears a person's blood, as well as the overall severity and duration of each patient's infection.
Monkeypox virus has caused sporadic cases and outbreaks since the 1970s, mainly in the rainforest areas of central Africa and in west Africa.
NIAID and the DRC's National Institute for Biomedical Research are co-leading the trial.
Other collaborating institutions include the U.S. Centers for Disease Control and Prevention, the Alliance for International Medical Action, and WHO.
“I am happy that monkeypox is no longer a neglected disease and that soon, thanks to this study, we will be able to prove that there is an effective treatment for this disease,” said Dr. Jean-Jacques Muyembe-Tamfum, director-general of National Institute for Biomedical Research.
The U.S. Centers for Disease Control and Prevention has more about TPOXX treatment for monkeypox.
SOURCE: U.S. National Institutes of Health, news release, Oct. 12, 2022