To provide access to tecovirimat for patients with suspected mpox in the Central African Republic and, secondarily, to describe the clinical and virological features of treated patients and assess safety observations.
Approach:
Expanded Access Programme (EAP): Implemented in the Central African Republic from 2021 to 2023, with treatment provided at Mbaiki District Hospital and Bangui General Hospital under a standardized protocol.
Patient Eligibility: Included consenting patients weighing more than 13 kg with clinically suspected mpox awaiting laboratory confirmation or PCR-confirmed mpox. Patients taking repaglinide or midazolam, or with specified carbohydrate-intolerance or malabsorption conditions, were excluded.
Treatment Protocol: Participants received oral tecovirimat for 14 days with supportive clinical care and observation. Follow-up and virological sampling continued through day 28 or later when indicated.
Key Findings:
Thirty-one patients were enrolled; 26 (84%) were PCR-positive for mpox and 24 (77%) had Clade Ia mpox. Most symptoms improved by day 14 and the final visit, and median time to lesion resolution was 8 days.
PCR positivity declined over time but persisted in some patients. Six serious adverse events occurred in five patients, and all were considered unrelated to tecovirimat.
Interpretation:
The EAP enabled protocolized access to tecovirimat in a setting where the drug would otherwise have been unavailable and generated prospective clinical, virological, and safety data. However, no clear treatment benefit was demonstrated.
Limitations:
There was no comparator group, and EAPs are not designed to provide conclusive evidence of efficacy or safety.
Sampling strategies were inconsistent across the cohort, and relatively few oropharyngeal and scabbed-lesion samples were collected.
Final visits occurred as late as day 50 for 14 participants, leaving day-28 clinical and virological status unclear for approximately half the cohort.
Challenging field conditions limited validation and quality assurance of some data.
Conclusion:
The EAP provided access to tecovirimat and strengthened clinical and research capacity in the Central African Republic, but it did not demonstrate a clear treatment benefit.
