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

Mbrenga, Festus; Nakouné, Emmanuel; Malaka, Christian; Bourner, Josephine; Dunning, Jake; Vernet, Guy; Horby, Peter; Olliaro, Piero

doi:10.1101/2022.08.24.22279177

Cited by 6 publications

(3 citation statements)

References 26 publications

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“…This report has limitations due to the small number of enrolled patients. 40 So, additional large-scale trials are required to determine Tecovirimat antiviral activity, dosage, and adverse effects. Even while animal studies can be convincing, human efficacy in later clinical trials is not always precisely correlated with efficacy seen in animals.…”

Section: Resultsmentioning

confidence: 99%

Tecovirimat as a Potential Bioavailable inhibitor against MPXVgp158 Established through Molecular Dynamic Simulations and Docking Studies

Sharma¹,

Panwar²,

Garg³

et al. 2022

J. Pure Appl. Microbiol.

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Monkeypox is a zoonotic viral infection caused by monkeypox virus which belongs to the Poxviridae family of genus Orthopoxvirus. Usually, the virus transmission happens when the individual comes in contact with the infected person through body fluids, animal lesions, respiratory droplets or through virus contaminated materials. Clinical presentation of the monkeypox has shown significant resemblance to that of smallpox and chickenpox, belonging to the same orthopoxvirus genus but were eradicated during 1980s globally. Monkeypox may lead to a range of medical complications including clinical symptoms like fever, rashes, headaches, back pain, myodynia and swollen lymph nodes. As far as the treatment modalities are concerned, the antiviral therapeutic agents developed for the smallpox treatment, were also permitted to be used for the monkeypox treatment. However, there is no proven treatment for human monkeypox. In the current study, we have focused on designing of a best probable ligand against the target MPXVgp158 (Monkeypox virus protein). Since Tecovirimat is an FDA approved compound known as an antipoxviral drug, the study aimed to develop a Monkeypox virus protein MPXVgp158 inhibitor which is bioavailable and biocompatible as well through drug designing using computational tools. Molecular docking (MD) analysis displayed Tecovirimat with lesser binding energy, higher non-bonded interaction capability, and more stability against MPXVgp158, with efficient binding mode of interactions. Hence, Tecovirimat was adjudged to be the potential candidate against MPXVgp158 inhibition.

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Section: Resultsmentioning

confidence: 99%

Tecovirimat as a Potential Bioavailable inhibitor against MPXVgp158 Established through Molecular Dynamic Simulations and Docking Studies

Sharma¹,

Panwar²,

Garg³

et al. 2022

J. Pure Appl. Microbiol.

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“…Descriptive analyses of the cohort may be published before the end of the EAP in the interest of communicating information about patient outcomes and the use of tecovirimat for monkeypox which may be pertinent to other research efforts and public health. One such analysis of the first 14 patients enrolled in the EAP was published in September 2022 [ 15 ].…”

Section: Methodsmentioning

confidence: 99%

Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: A study protocol for an Expanded Access Programme

Bourner,

Redji Mbrenga,

Malaka

et al. 2024

PLoS ONE

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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. Trial registration {2a & 2b}: ISRCTN43307947.

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“…One such analysis of the first 14 patients enrolled in the EAP was published in September 2022. (17)…”

Section: Methodsmentioning

confidence: 99%

Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: a study protocol for an Expanded Access Programme

Bourner

Mbrenga

Malaka

et al. 2022

Preprint

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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.

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

Cited by 6 publications

References 26 publications

Tecovirimat as a Potential Bioavailable inhibitor against MPXVgp158 Established through Molecular Dynamic Simulations and Docking Studies

Tecovirimat as a Potential Bioavailable inhibitor against MPXVgp158 Established through Molecular Dynamic Simulations and Docking Studies

Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: A study protocol for an Expanded Access Programme

Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: a study protocol for an Expanded Access Programme

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