Efficacy of Tecovirimat for the Treatment of Mpox Virus Infection in Humans: Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Davi M Grecco, Luciano Araldi, Giordano C Soldera et al.
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In 30 seconds
This systematic review and meta-analysis assessed tecovirimat efficacy and safety in patients with laboratory-confirmed mpox, comparing it with placebo or standard care in randomised controlled trials. Two low-risk-of-bias trials involving 941 participants were included. Tecovirimat did not shorten time to skin-lesion resolution (HR 1.10, 95% CI 0.52-2.31) or increase resolution by day 28-29 (RR 1.00, 95% CI 0.92-1.08). Mortality was rare and could not be pooled; virological clearance, pain-related outcomes, and serious adverse events were comparable between groups.
Key findings
- Time to clinical resolution of skin lesions was not shorter with tecovirimat than placebo (HR 1.10, 95% CI 0.52-2.31; moderate-certainty evidence).
- Lesion resolution by day 28-29 was similar between groups (RR 1.00, 95% CI 0.92-1.08; high-certainty evidence).
- Day-28 mortality was rare in both trials, precluding meta-analysis; virological clearance, pain-related outcomes, and serious adverse events were comparable.
Why it matters
The pooled randomised evidence does not show improved clinical recovery with tecovirimat in the studied mpox populations. This helps clarify the limits of evidence for routine use, while the rarity of deaths and uncertainty about benefit in selected high-risk groups leave important questions unresolved.
What to keep in mind
Only two trials contributed evidence, and rare mortality events prevented meta-analysis of that outcome. The findings do not establish whether selected high-risk populations may benefit.