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

This double-blind, placebo-controlled randomized clinical trial evaluated the efficacy and safety of oral tecovirimat for treating mpox caused by clade I MPXV in 597 patients across two sites in the Democratic Republic of Congo. The primary endpoint time to lesion resolution showed no significant difference between the tecovirimat group (median 7 days) and placebo group (median 8 days), with a competing-risks hazard ratio of 1.13 (P=0.14). Virologic clearance rates (PCR negativity from blood, lesions, oropharyngeal samples at day 14) were also similar across groups. Safety profiles were comparable: 5.1% in the tecovirimat group and 5.0% in the placebo group experienced serious adverse events. Mortality was 1.7% overall. Subgroup analyses suggested a possible site-by-treatment interaction, but adjusted models did not confirm differential efficacy. The trial concludes that tecovirimat did not significantly accelerate recovery in endemic clade I mpox and emphasizes the need for further research during outbreaks to validate or refine therapeutic strategies.

This double-blind, placebo-controlled randomized clinical trial evaluated the efficacy and safety of oral tecovirimat for treating mpox caused by clade I MPXV in 597 patients across two sites in the Democratic Republic of Congo. The primary endpoint time to lesion resolution showed no significant difference between the tecovirimat group (median 7 days) and placebo group (median 8 days), with a competing-risks hazard ratio of 1.13 (P=0.14). Virologic clearance rates (PCR negativity from blood, lesions, oropharyngeal samples at day 14) were also similar across groups. Safety profiles were comparable: 5.1% in the tecovirimat group and 5.0% in the placebo group experienced serious adverse events. Mortality was 1.7% overall. Subgroup analyses suggested a possible site-by-treatment interaction, but adjusted models did not confirm differential efficacy. The trial concludes that tecovirimat did not significantly accelerate recovery in endemic clade I mpox and emphasizes the need for further research during outbreaks to validate or refine therapeutic strategies.