Drug updated on 9/5/2024
Dosage Form | Capsule (oral; 200 mg); Injection (intravenous; 200mg/20 mL) |
Drug Class | Orthopoxvirus 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
- 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.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
TPOXX (tecovirimat) Prescribing Information. | 2022 | Siga Technologies Inc., Corvallis, OR |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Paediatric, maternal, and congenital mpox: a systematic review and meta-analysis. | 2024 | The Lancet. Global Health |
Therapeutics for treating mpox in humans. | 2023 | The Cochrane Database of Systematic Reviews |
The use of antivirals in the treatment of human monkeypox outbreaks: a systematic review. | 2022 | International Journal of Infectious Diseases |
Clinical features, antiviral treatment, and patient outcomes: a systematic review and comparative analysis of the previous and the 2022 mpox outbreaks. | 2022 | Journal of Infectious Diseases |
Prevention and treatment of monkeypox: a systematic review of preclinical studies. | 2022 | Viruses |
Efficacy of three key antiviral drugs used to treat orthopoxvirus infections: a systematic review. | 2019 | Global Biosecurity |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Interim clinical treatment considerations for severe manifestations of Mpox - United States, February 2023. | 2023 | Morbidity and Mortality Weekly Report |