Monkeypox treatment with tecovirimat in the Central African Republic under an Expanded Access Programme

Background There is currently no specific treatment recommended for monkeypox. This expanded access programme (EAP) aims to provide tecovirimat to patients with monkeypox and collect data on patient treatment, disease evolution and outcomes under a protocol to contribute to the evidence-base for the use of the drug for monkeypox. Methods Patients with confirmed monkeypox received tecovirimat according to the recommended dosing. Data on clinical signs and symptoms were recorded daily during treatment and at follow-up visits. Blood or lesion samples were taken during treatment and at day 28 to assess viral presence of monkeypox by PCR. As tecovirimat is administered via an EAP, outcome measures were not predefined. Adverse events and clinical outcomes were monitored by evaluating the total number and location of lesions, temperature, degree of incapacity, presence of adverse events, patient survival, and viral presence throughout treatment and follow-up. Results We report outcomes in 14 patients who were enrolled between December 2021 and February 2022. Muscle pain, headache, lymphadenopathy, lesions, fever, back pain, and upper respiratory symptoms were commonly reported at admission and during follow-up. The rate of appearance of active lesions gradually decreased throughout treatment, with the median time to no new lesions being 5 days following the start of treatment. No death attributable to monkeypox occurred in this cohort. Conclusions Data collected through this EAP can help improve our knowledge about the use of tecovirimat for monkeypox. We have been able to document systematically the presentation and clinical and virological evolution of monkeypox under treatment. Registration number ISRCTN43307947 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN43307947 ### Funding Statement SIGA donated 100 treatments for use under the EAP. The EAP was financed with core funds of IPB, financial support to IPB from SIGA, the University of Oxford under the UK Foreign, Commonwealth and Development Office and Wellcome (215091/Z/18/Z) and the Bill & Melinda Gates Foundation (OPP1209135). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The ethics committees of the University of Oxford and University of Bangui gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors