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Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo

  1. Author:
    Ali, Rosine
    Alonga, Jules
    Biampata, Jean-Luc
    Kombozi Basika, Michael
    Maljkovic Berry, Irina
    Bisento, Nella
    Blum, Emily [ORCID]
    Bonnett,Tyler
    Cone, Katherine
    Crozier, Ian
    Davey, Richard
    Dilu, Ali
    Dodd, Lori E [ORCID]
    Gulati, Iman
    Hruby, Dennis
    Ibanda, Augustin
    Isse, Francis
    Kasareka, Sylva Sivasingana
    Kayembe, Gaby
    Kojan, Richard
    Luzolo, Esaie Kindombe
    Lane, H Clifford [ORCID]
    Lawanga, Leader
    Liesenborghs, Laurens
    Shosongo Lunghe, Claude
    Lula, Yves
    Lusakibanza, Mariano
    Lutete, Gaston Tona
    Mbala-Kingebeni, Placide [ORCID]
    Miranda, Alejandra
    Mukadi-Bamuleka, Daniel [ORCID]
    Mukendi, Gael
    Lupola, Patrick Mutombo
    Muyembe-Tamfum, Jean-Jacques
    Ndungunu, Robin
    Nganga, Bruce
    Ntamabyaliro, Nsengi
    Nussenblatt, Veronique
    Omulepu, Imoite
    Omalokoho Onosomba, John
    Proschan, Michael
    Rubenstein, Kevin [ORCID]
    Saknite, Inga
    Schechner, Adam
    Shaw-Saliba, Kathryn
    Sivahera, Billy
    Smolskis, Mary
    Tillman, Amy
    Tkaczyk, Eric
    Tshimanga, Celestin
    Tshiani Mbaya, Olivier
    Tshomba, Antoine
    Yemba Unda Tshomba, Freddy
    Vallee, David
    Vogel, Susan
    Weyers, Shera

  2. Author Address

    Institut Nationale de Recherche Biom 233;dicale, Kinshasa, Democratic Republic of Congo., Kole General Hospital, Kole, Democratic Republic of Congo., Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Fort Detrick, Frederick, MD., SIGA Technologies, Corvallis, OR., Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD., National Institute of Allergy and Infectious Diseases, Bethesda, MD., Systex, Rockville, MD., Alliance for International Medical Action, Kinshasa, Democratic Republic of Congo., Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium., Tunda General Hospital, Tunda, Democratic Republic of Congo., Department of Pharmacology, University of Kinshasa, Kinshasa, Democratic Republic of Congo., Mitchell Group, Washington, DC., Ministry of Health, Kole, Democratic Republic of Congo., Vanderbilt University Medical Center, Nashville., Ministry of Health, Tunda, Democratic Republic of Congo.,
    1. Year: 2025
    2. Date: Apr 17
  2. Journal: The New England Journal of Medicine
    1. 392
    2. 15
    3. Pages: 1484-1496
  4. Type of Article: Article
  1. Abstract:

    Tecovirimat is available for the treatment of mpox (formerly known as monkeypox) in Europe and the United States, on the basis of findings from efficacy studies in animals and safety evaluations in healthy humans. Evidence from randomized, controlled trials of safety and efficacy in patients with mpox is lacking. We conducted a double-blind, randomized, placebo-controlled trial of tecovirimat in patients with mpox in the Democratic Republic of Congo (DRC). Patients with at least one mpox skin lesion and positive polymerase-chain-reaction results for clade I MPXV were assigned in a 1:1 ratio to receive tecovirimat or placebo. All patients received supportive care. The primary end point was resolution of mpox lesions, measured in number of days after randomization. Safety was also assessed. From October 7, 2022, through July 9, 2024, a total of 597 patients underwent randomization - 295 to receive tecovirimat and 302 to receive placebo. The median time from randomization to lesion resolution was 7 days with tecovirimat and 8 days with placebo; the competing-risks hazard ratio for lesion resolution was 1.13 (95% confidence interval [CI], 0.97 to 1.31; P?=?0.14). Results were similar whether patients began the trial regimen within 7 days after the reported onset of symptoms (competing-risks hazard ratio, 1.16; 95% CI, 0.98 to 1.37) or more than 7 days after onset (competing-risks hazard ratio, 1.00; 95% CI, 0.71 to 1.40). Overall mortality was 1.7%, which was lower than the case fatality rate of 4.6% reported in the DRC in 2023. At 14 days, the percentages of patients who had blood, lesion, and oropharyngeal samples negative for MPXV by PCR were similar in the two groups. Adverse events occurred in 72.9% of the patients in the tecovirimat group and 70.5% of those in the placebo group, and serious adverse events were reported in 5.1% and 5.0%, respectively. Tecovirimat did not reduce the number of days to lesion resolution in patients with mpox caused by clade I MPXV. No safety concerns were identified. (Funded by the National Institute of Allergy and Infectious Diseases and others; PALM007 ClinicalTrials.gov number, NCT05559099.). Copyright © 2025 Massachusetts Medical Society.

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External Sources

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  2. DOI: 10.1056/NEJMoa2412439
  3. PMID: 40239067

Library Notes

  1. Fiscal Year: FY2024-2025
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