M onkeypox, caused by monkeypox virus (MPXV), a member of the Orthopoxvirus genus, was considered a rare emerging disease before a multinational outbreak was identified in May 2022 (1).After global smallpox eradication in 1977, monkeypox became the most concerning human Orthopoxvirus infection. Clinical manifestations of monkeypox typically resemble those of smallpox, including a febrile prodrome and subsequent disseminated maculopapular rash, including vesicles and pustules, that occurs in successive stages (2). Lymphadenopathy is a prominent feature of monkeypox and usually does not occur for smallpox and chickenpox (3). Illness is less severe and death less likely among monkeypox cases than smallpox cases, but monkeypox mortality rates vary and are higher for clade I (formerly the Congo Basin clade) than for clade II (formerly the West African clade) viruses (2). Prior smallpox vaccination can confer cross-immunity for monkeypox, but smallpox vaccination programs worldwide ended in the early 1980s (4).In 1970, a human monkeypox case was reported from Basankusu, Equateur Province, Democratic Republic of the Congo (DRC) (5). Subsequent sporadic monkeypox cases were reported among human and animal populations from remote areas of Central Africa during the 1970s and 1980s (6,7). Since 1990, increases in the frequency and scale of epidemics in Africa have been reported for clade I and, to a lesser extent, since 2000 for clade II. Since 2016, confirmed monkeypox cases have been reported in DRC, Central African Republic (CAR), Republic of Congo (hereafter Congo), Nigeria, Sierra Leone, Liberia, and Cameroon (6). The true burden, circulation rates, and geographic range of this emerging disease remain unknown because many countries lack systematic routine monkeypox surveillance and affected areas often are remote (8,9).An outbreak of human monkeypox disease occurred outside Africa in 2003, after infected animals from Ghana were imported into the United States

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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.

Background: Monkeypox is a viral zoonotic disease commonly reported in humans in parts of Central and West Africa. This protocol is for an Expanded Access Programme (EAP) to be implemented in the Central African Republic, where Clade I monkeypox virus diseases is primarily responsible for most monkeypox infections. The objective of the programme is to provide patients with confirmed monkeypox with access to tecovirimat, a novel antiviral targeting orthopoxviruses, and collect data on clinical and virological outcomes of patients to inform future research. Methods: The study will be conducted at participating hospitals in the Central African Republic. All patients who provide informed consent to enrol in the programme will receive tecovirimat. Patients will remain in hospital for the duration of treatment. Data on clinical signs and symptoms will be collected every day while the patient is hospitalised. Blood, throat and lesion samples will be collected at baseline and then on days 4, 8, 14 and 28. Patient outcomes will be assessed on Day 14 – end of treatment – and at Day 28. Adverse event and serious adverse event data will be collected from the point of consent until Day 28. Discussion: This EAP is the first protocolised treatment programme in Clade I MPXV. The data generated under this protocol aims to describe the use of tecovirimat for Clade I disease in a monkeypox endemic region of Central Africa. It is hoped that this data can inform the definition of outcome measures used in future research and contribute to the academic literature around the use of tecovirimat for the treatment of monkeypox. The EAP also aims to bolster research capacity in the region in order for robust randomised controlled trials to take place for monkeypox and other diseases.