Tecovirimat

(TPOXX®)

TPOXX®

Drug updated on 9/5/2024

Dosage FormCapsule (oral; 200 mg); Injection (intravenous; 200mg/20 mL)
Drug ClassOrthopoxvirus VP37 envelope wrapping protein inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg.

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Summary
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  • Tpoxx (tecovirimat) is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg.
  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • General Effectiveness Findings: Tecovirimat was used to treat 61 individuals with mpox, achieving a high rate of complete symptom resolution at 83.1%, and was beneficial in several severe cases.
  • Comparative Effectiveness: Tecovirimat was more frequently used and showed better outcomes compared to other antivirals like cidofovir (used in 7 individuals) and brincidofovir (used in 3 individuals, which was associated with adverse effects leading to discontinuation).
  • Effectiveness in Specific Populations: There were no randomized controlled trials (RCTs) assessing the effectiveness of tecovirimat in children or pregnant individuals, although observational studies reported uneventful treatment in these groups.
  • Tecovirimat has not shown serious safety signals in mpox treatment, based on very low-certainty evidence from non-randomized studies, and no major safety concerns were reported in other studies.
  • Brincidofovir (BCV) was associated with elevated hepatic panels and raised alanine aminotransferase (ALT) levels, leading to treatment discontinuation in all treated individuals, whereas tecovirimat did not show similar safety concerns.
  • There is no population types or subgroups information available in the reviewed studies.