Clinical Scorecard: Management of mpox using tecovirimat through expanded access in the Central African Republic
At a Glance
Category
Detail
Condition
Mpox
Key Mechanisms
Tecovirimat was provided under an Expanded Access Programme (EAP) to patients with clinically suspected or PCR-confirmed mpox in a setting where the drug would otherwise have been unavailable.
Target Population
Consenting patients weighing more than 13 kg with clinically suspected mpox awaiting laboratory confirmation or PCR-confirmed mpox.
Care Setting
Mbaiki District Hospital and Bangui General Hospital in the Central African Republic.
Key Highlights
The EAP operated in the Central African Republic from 2021 to 2023 to provide access to tecovirimat.
Thirty-one patients were enrolled; 26 (84%) were PCR-positive for mpox and 24 (77%) had Clade Ia mpox.
Participants received oral tecovirimat for 14 days under a standardized protocol with supportive clinical care.
Most symptoms improved by day 14 and the final visit, but PCR positivity persisted in some patients. No clear treatment benefit was demonstrated.
Guideline-Based Recommendations
Diagnosis
Under the EAP, patients with clinically suspected mpox were tested for MPXV, and those enrolled before laboratory confirmation were removed from the programme if PCR testing was negative.
Management
Under the EAP protocol, eligible participants received oral tecovirimat for 14 days in addition to routine supportive clinical care.
Tecovirimat was administered after a meal containing moderate or high fat content.
Monitoring & Follow-up
Clinical data, including signs, symptoms, vital signs, and adverse events, were collected daily during hospitalization and at the final visit.
Virological assessment included PCR testing of available blood, lesion, and throat samples during treatment and follow-up.
Risks
Six serious adverse events occurred in five patients; all were determined to be unrelated to tecovirimat.
Because the programme had no comparator group and EAPs are not designed to provide conclusive evidence of efficacy or safety, treatment effects cannot be established from these data.
Patient & Prescribing Data
Eligible participants weighed more than 13 kg and had 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.
Tecovirimat was supplied as 200-mg immediate-release capsules and administered for 14 days according to the EAP dosing schedule, with a moderate- or high-fat meal provided 30 minutes before each dose.
Clinical Best Practices
Under the EAP, written informed consent was obtained before enrollment.
Patients enrolled on clinical suspicion were removed from the programme if PCR testing was negative for MPXV.
Tecovirimat was administered according to the standardized EAP protocol together with routine supportive clinical care.
Clinical status, adverse events, and virological findings were monitored during treatment and follow-up.
Related Resources & Content
Bourner J, Redji Mbrenga FD, Malaka CN, Dunning J, Rojek A, Fandema E, et al. “Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: a study protocol for an Expanded Access Programme.” PLOS ONE. 2024;19(5):e0278957.
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