Abstract / Summary
Tecovirimat has been widely used for the treatment of mpox despite limited evidence supporting its efficacy. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of tecovirimat for this purpose. PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from inception to June 5, 2026 for RCTs comparing tecovirimat with placebo or standard care in patients with laboratory-confirmed mpox. Primary outcomes were time to clinical resolution of skin lesions, clinical resolution by day 28-29, and 28-day all-cause mortality. Hazard ratios (HRs) and risk ratios (RRs) were pooled using random-effects models with restricted maximum likelihood estimation and Hartung-Knapp-Sidik-Jonkman adjustment. Risk of bias was assessed using RoB 2 and certainty of evidence using GRADE. Two low-risk-of-bias RCTs involving 941 participants were included. Tecovirimat did not shorten the time to clinical resolution of skin lesions compared with placebo (HR 1.10, 95% CI 0.52-2.31, GRADE: moderate) or increase the lesion resolution by day 28-29 (RR 1.00, 95% CI 0.92-1.08, GRADE: high). No statistical heterogeneity was observed (I2 = 0% for both outcomes). Mortality at day 28 was rare in both trials, precluding meta-analysis. Virological clearance, pain-related outcomes, and serious adverse events were also comparable between treatment groups. In conclusion, current randomized evidence does not support routine tecovirimat use to accelerate clinical recovery or improve mortality rates in patients with mpox, while further evidence is needed to determine whether selected high-risk populations may benefit from antiviral therapy.