Management of mpox using tecovirimat through expanded access in CAR
Overview
An Expanded Access Programme (EAP) for tecovirimat was conducted in the Central African Republic from 2021 to 2023 to provide treatment that would otherwise have been unavailable to patients with mpox. The programme also collected prospective clinical, virological, and safety data and supported research capacity, surveillance engagement, and standardized case management.
Background
Mpox is a viral zoonotic disease whose epidemiology has evolved with the emergence of subclades characterized by human-to-human transmission and broader geographic spread. Tecovirimat and other antivirals are not widely available in mpox-endemic regions of Central and West Africa, where supportive care may be the only treatment available outside clinical research programmes.
Data Highlights
Thirty-one patients were enrolled; 26 (84%) were PCR-positive for mpox and 24 (77%) had Clade Ia mpox.
Median time to lesion resolution was 8 days among patients treated with tecovirimat.
Most symptoms improved by day 14 and the final visit, although lymphadenopathy often persisted.
Six serious adverse events occurred in five patients; all were determined to be unrelated to tecovirimat.
Key Findings
The EAP enabled access to tecovirimat for patients with clinically suspected mpox in the Central African Republic.
Eligible participants weighed more than 13 kg and had suspected mpox awaiting laboratory confirmation or PCR-confirmed mpox.
PCR positivity declined over time but remained detectable in some patients, and some patients had ongoing lesions at the end of follow-up.
The programme supported earlier case identification, standardized case management, and strengthening of local clinical and research capacity.
No clear treatment benefit was demonstrated.
Clinical Implications
The EAP demonstrates how an expanded-access framework can provide investigational treatment in a setting where appropriate treatment options are limited while also generating prospective clinical, virological, and safety data. The authors emphasize that EAPs are not designed to provide conclusive evidence of efficacy or safety and that stronger clinical infrastructure and future clinical trials remain important.
Conclusion
The programme provided access to tecovirimat and improved understanding of mpox while strengthening clinical and research capacity in the Central African Republic. However, no clear treatment benefit was demonstrated, underscoring the need for appropriately designed clinical trials to evaluate effective mpox treatments.
Related Resources & Content
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Pesonel E, Hoffmann I, Guiraud L, Bourner J, Diallo A, Dunning J, et al. “MOSAIC: a cohort study of human mpox virus disease.” Wellcome Open Research. 2023;8:415.
Zucker J, Fischer WA, Zheng L, McCarthy C, Saha PT, Javan AC, et al. “Tecovirimat for the treatment of Mpox.” New England Journal of Medicine. 2026;394(9):884–895.
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Yu PA, Elmor R, Muhammad K, Yu YC, Rao AK. “Tecovirimat use under expanded access to treat mpox in the United States, 2022–2023.” NEJM Evidence. 2024;3(10).
