Mpox is an orthopox DNA virus.1,2 Ophthalmic manifestations include preseptal cellulitis, conjunctivitis and keratitis, either as a primary or secondary viral infection or a secondary bacterial infection.2 Tecovirimat (Tpoxx) is an oral orthopox-specific drug that inhibits the orthopoxvirus VP37 envelope-wrapping protein and prevents the formation of egress-competent virions.3 There are limited pharmacokinetic/pharmacodynamic (PK/PD) data available. We present a case report of a critically unwell mpox patient, who had tecovirimat PK sampling of plasma and tears

Ahmad, Shazaad

Airborne HCID Network and ISARIC4C Investigator

Beadsworth, Michael BJ

Challenger, Elizabeth

Devine, Karen

Duru, Iheukwumere

Else, Laura J

Huq, Raqib

Kaye, Stephen

Khoo, Saye H

Lavery, Mark

Lester, Rebecca

Marshall, Suzanne

McLaughlan, Danielle

Pagano, Luca

Semple, Malcolm G

Woolley, Stephen D

Woolley, Stephen

Beadsworth, Mike

LSTM Online Archive

J Antimicrob Chemother https://doi.org/10.1093/jac/dkaf071The tear production of tecovirimat in a single hospitalized mpox patient: a pharmacokinetic analysisStephen D. Woolley 1,2*, Iheukwumere Duru3, Luca Pagano3, Rebecca Lester4,5, Karen Devine6, Shazaad Ahmad7, Raqib Huq6, Suzanne Marshall1, Danielle McLaughlan1, Mark Lavery8, Elizabeth Challenger9, Laura J. Else9, Malcolm G. Semple10,11, Stephen Kaye3,12, Saye H. Khoo1,9 and Michael B.J. Beadsworth1,2 on behalf of the Airborne HCID Network and ISARIC4C Investigator†1Tropical and Infectious Disease Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; 2Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; 3Department of Ophthalmology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; 4Department of Infectious Diseases, Royal Free London NHS Foundation Trust, London, UK; 5Division of Infection and Immunity, University College London, London, UK; 6Department of Infectious Diseases, North Manchester District General Hospital, Manchester, UK; 7Department of Virology, Manchester Medical Microbiology Partnership, Manchester University NHS Foundation Trust, Manchester, UK; 8Department of Critical Care Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; 9Centre for Experimental Therapeutics, Institute of Integrative, Systems and Molecular Biology, University of Liverpool, Liverpool, UK; 10Faculty of Health and Life Sciences, NIHR Health Protection Research Unit in Emerging and Zoonotic Infections and Institute of Translational Medicine, University of Liverpool, Liverpool, UK; 11Respiratory Medicine, Alder Hey Children’s Hospital, Institute in The Park, Liverpool L12 2AP, UK; 12Department of Eye and Vision Science, University of Liverpool, Liverpool, UK*Corresponding author. E-mail: stephen.woolley@lstmed.ac.uk@NavyTropMed© The Author(s) 2025. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https:// creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.†List of Airborne HCID Network and ISARIC4C Investigators: Dr Effrossyni Gkrania-Klotsas—Cambridge University Hospitals NHS Foundation Trust; Dr Luke Moore—Chelsea and Westminster Hospital NHS Foundation Trust; Professor Marlies Ostermann—Guys’ and St Thomas’ NHS Foundation Trust; Dr Graham Cooke—Imperial College Healthcare NHS Trust; Dr Fiona McGill—Leeds Teaching Hospitals NHS Trust; Dr Antonia Ho—University Hospital Monklands; Dr Kenneth Baillie —NHS Lothian; Professor Brian Angus—Oxford University Hospitals NHS Foundation Trust; Dr Jake Dunning—Royal Free London NHS Foundation Trust; Dr Paul Collini—Sheffield Teaching Hospitals NHS Foundation Trust; Dr Ashley Price—The Newcastle upon Tyne Hospitals NHS Foundation Trust; Dr Mahdad Noursadeghi—University College Hospitals London NHS Foundation Trust; Dr Ahilanadan Dushianthan—University Hospital Southampton NHS Foundation Trust.Mpox is an orthopox DNA virus.1,2 Ophthalmic manifestations in-clude preseptal cellulitis, conjunctivitis and keratitis, either as a primary or secondary viral infection or a secondary bacterial in-fection.2 Tecovirimat (Tpoxx) is an oral orthopox-specific drug that inhibits the orthopoxvirus VP37 envelope-wrapping protein and prevents the formation of egress-competent virions.3 There are limited pharmacokinetic/pharmacodynamic (PK/PD) data available. We present a case report of a critically unwell mpox pa-tient, who had tecovirimat PK sampling of plasma and tears.A 30-year-old male was admitted to a local hospital in status epilepticus, 4 days after returning from Lagos, Nigeria. The pa-tient had a history of traumatic brain injury and secondary epi-lepsy, for which he was on oral levetiracetam 750 mg twice daily. He had been given oral ciprofloxacin for secondary bacterial infection of presumed varicella zoster lesions prior to returning to the UK. The patient required intubation and ventilation in the management of his status epilepticus and developed compart-ment syndrome of his upper limbs, requiring bilateral fascio-tomies. He developed acute kidney injury secondary to rhabdomyolysis (creatinine kinase >750 000 U/L) requiring con-tinuous veno-venous haemofiltration (CVVHF). A skin lesion swab was positive for orthopox and mpox DNA on Day 3 of hos-pital admission. The patient was commenced on oral tecovirimat 600 mg twice daily for 14 days, crushed via nasogastric tube be-cause IV tecovirimat was not available. The mpox clade was con-firmed to be a novel clade 2b, lineage A.3 (IIb.A3).4On Day 21 of hospitalization the patient complained of red-ness and mild discomfort in his right eye and was empirically commenced on topical chloramphenicol 1% ointment. On Day 36 the symptoms had worsened. Bedside review by an ophthal-mologist with a portable slit lamp revealed a 6 × 11 mm ulcer in-volving mainly the inferior half of the cornea with no evident corneal stromal involvement (Figure 1). Corneal sensitivity was significantly reduced. The left eye examination was unremark-able. Ocular swabs were taken for microscopy, culture and sensi-tivity, plus mpox PCR. The swab results were positive for mpox DNA, likely secondary to autoinoculation from a hand lesion. The patient was restarted on oral tecovirimat 600 mg twice a day for a further 14 days and subsequently on 2-hourly topical trifluridine 1% drops for a total of 10 days. The patient was con-tinued on trifluridine eye drops until he was discharged to the re-hab unit. On Day 74 post admission, the corneal ulcer had greatly reduced to 0.6 × 4 mm, but there was now an inferior 2 × 6 mm crescent-shaped stromal haze. The patient remained only on 1 of 3Downloaded from https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf071/8088203 by guest on 02 April 2025artificial tears. The patient’s virology results are summarized in Table S1 (available as Supplementary data at JAC Online).During the patient’s acute severe phase of illness, a relative gave proxy consent for him to participate in the ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infection UK [the ISARIC WHO CCP-UK protocol; consent documents are available (open access) at https://isaric4c.net/protocols/]. Ethical approval was given by the South Central—Oxford C Research Ethics Committee in England (Ref 13/SC/0149), the Scotland A Research Ethics Committee (Ref 20/SS/0028), and the WHO Ethics Review Committee (RPC571 and RPC572, 25 April 2013). ISARIC4C Investigators are listed in the footnote to this article (ISRCTN66726260; doi:10.1186/ISRCTN66726260). Samples for plasma (2 mL) and tear test strips (TTS) using Schirmer’s test (Appendix S1), were collected 1 h pre-dose (Cmin) and 1 h post- dose (Cmax). They were collected on Day 5 of tecovirimat treat-ment and Day 8 of hospital admission. Concomitant medications at the time of sampling are described in Appendix S2.Tecovirimat concentrations in plasma and tears were deter-mined using validated LC coupled with tandem MS (Appendix S3). The lower limit of quantification for the plasma assay was 5 ng/mL, and for the tear assay was 0.088 ng/mL. The mean plas-ma tecovirimat concentrations were 18.80 ng/mL pre-dose and 42.34 ng/mL post-dose. Paired TTS concentrations sampled post- dose were from the left eye 292.00 ng/mL and from the right eye 287.50 ng/mL. There were no secondary peaks to suggest deg-radation. On the day the samples were collected, the serum albu-min was 17 g/L.The Cmin and Cmax in plasma were both significantly lower than expected, with Cmin and Cmax concentrations previously reported to be 845 ng/mL and 2159 ng/mL respectively.5 The post-dose concentration of 42.34 ng/mL was taken at 1 h, with no repeated samples. The low level likely reflects that Cmax was not achieved, which appears to be at 3 h.6 It appears to be comparable to levels at the same timepoint seen in a previous tecovirimat PK study.6Our study also supports previous studies reporting that exposures of tecovirimat are lower in mpox patients when compared with healthy volunteers.6 Delayed absorption observed in mpox pa-tients as well as nasogastric administration plus critical illness (re-duced albumin) and diarrhoea are the likely causes of reduced plasma levels. The patient was also haemofiltered using CVVHF, which may have contributed to the decreased plasma levels, al-though according to the manufacturer, dose alteration is not needed in haemofiltration and end-stage renal disease.5Both TTS pre-dose and post-dose concentrations exceeded the plasma levels, and post-dose concentrations of plasma and both eyes’ tears were over the in vitro calculated 90% inhibitory concen-tration of 37.6 ng/mL.6 However, it is unclear if there is corneal penetration of tecovirimat, as it took 32 days from restarting the second course of tecovirimat to becoming PCR negative. We did not resample during the ocular disease phase due to the patient’s wishes. The authors further suggest more research into the PK/PD of tecovirimat and corneal penetration of tecovirimat.AcknowledgementsS.D.W., I.D., L.P., R.L., S.K., S.H.K. and M.B.J.B. were responsible for the con-ceptualization of the paper. I.D., L.P., R.L. and D.M. were responsible for collection of the samples. E.C. and L.J.E. were responsible for the sample analysis. S.D.W., I.D., L.P. and R.L. were responsible for composing and editing the first draft of the manuscript. All authors have reviewed and re-vised the manuscript.FundingFunding for the development of the tecovirimat assay was from seed funding from The Pandemic Institute, Liverpool, UK.Transparency declarationsS.K. has received support from ViiV, Merck, GSK, Aligos, Ridgeback Biotherapeutics, Janssen, Gilead and AbbVie for research and development Figure 1. Progression of the patient’s ophthalmic disease. (a) Day 36 initial presentation showing 6 mm × 11 mm inferior corneal ulcer with fluorescein staining. (b) Day 74 showing a healing corneal ulcer measuring 0.6 mm × 4.0 mm with a stromal infiltrate.Research letter2 of 3Downloaded from https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf071/8088203 by guest on 02 April 2025of the Liverpool Drug Interactions Programme, all unconnected to this work. All other authors have no conflicts of interest to declare.Supplementary dataTable S1 and Appendices S1–S3 are available as Supplementary data at JAC Online.References1 Adler H, Gould S, Hine P et al. Clinical features and management of human monkeypox: a retrospective observational study in the UK. Lancet Infect Dis 2022; 22: 1153–62. https://doi.org/10.1016/S1473-3099(22) 00228-62 Milligan AL, Koay S, Dunning J. Monkeypox as an emerging infectious disease: the ophthalmic implications. Br J Ophthalmol 2022; 106: 1629–34. https://doi.org/10.1136/bjo-2022-3222683 Hoy SM. Tecovirimat: first global approval. Drugs 2018; 78: 1377–82. https://doi.org/10.1007/s40265-018-0967-64 Woolley SD, Lester R, Devine K et al. Clade IIb A.3 monkeypox virus: an imported lineage during a large global outbreak. Lancet Infect Dis 2023; 23: 405. https://doi.org/10.1016/S1473-3099(23)00120-25 Highlights of prescribing information—Tpoxx-tecovirimat monohy-drate injection, solution, concentrate Tpoxx-Tecovirimat monohydrate capsule. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/ 214518s000lbl.pdf6 Tempestilli M, Mondi A, D’Avolio A et al. Pharmacokinetics of tecoviri-mat in subjects with Mpox. Int J Antimicrob Agents 2024; 63: 107068. https://doi.org/10.1016/j.ijantimicag.2023.107068Research letter                                                                                                                                                 3 of 3Downloaded from https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf071/8088203 by guest on 02 April 2025

The tear production of tecovirimat in a single hospitalized mpox patient: a pharmacokinetic analysis

University of Liverpool Repository

J Antimicrob Chemother https://doi.org/10.1093/jac/dkaf071The tear production of tecovirimat in a single hospitalized mpox patient: a pharmacokinetic analysisStephen D. Woolley 1,2*, Iheukwumere Duru3, Luca Pagano3, Rebecca Lester4,5, Karen Devine6, Shazaad Ahmad7, Raqib Huq6, Suzanne Marshall1, Danielle McLaughlan1, Mark Lavery8, Elizabeth Challenger9, Laura J. Else9, Malcolm G. Semple10,11, Stephen Kaye3,12, Saye H. Khoo1,9 and Michael B.J. Beadsworth1,2 on behalf of the Airborne HCID Network and ISARIC4C Investigator†1Tropical and Infectious Disease Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; 2Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; 3Department of Ophthalmology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; 4Department of Infectious Diseases, Royal Free London NHS Foundation Trust, London, UK; 5Division of Infection and Immunity, University College London, London, UK; 6Department of Infectious Diseases, North Manchester District General Hospital, Manchester, UK; 7Department of Virology, Manchester Medical Microbiology Partnership, Manchester University NHS Foundation Trust, Manchester, UK; 8Department of Critical Care Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; 9Centre for Experimental Therapeutics, Institute of Integrative, Systems and Molecular Biology, University of Liverpool, Liverpool, UK; 10Faculty of Health and Life Sciences, NIHR Health Protection Research Unit in Emerging and Zoonotic Infections and Institute of Translational Medicine, University of Liverpool, Liverpool, UK; 11Respiratory Medicine, Alder Hey Children’s Hospital, Institute in The Park, Liverpool L12 2AP, UK; 12Department of Eye and Vision Science, University of Liverpool, Liverpool, UK*Corresponding author. E-mail: stephen.woolley@lstmed.ac.uk@NavyTropMed© The Author(s) 2025. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https:// creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.†List of Airborne HCID Network and ISARIC4C Investigators: Dr Effrossyni Gkrania-Klotsas—Cambridge University Hospitals NHS Foundation Trust; Dr Luke Moore—Chelsea and Westminster Hospital NHS Foundation Trust; Professor Marlies Ostermann—Guys’ and St Thomas’ NHS Foundation Trust; Dr Graham Cooke—Imperial College Healthcare NHS Trust; Dr Fiona McGill—Leeds Teaching Hospitals NHS Trust; Dr Antonia Ho—University Hospital Monklands; Dr Kenneth Baillie —NHS Lothian; Professor Brian Angus—Oxford University Hospitals NHS Foundation Trust; Dr Jake Dunning—Royal Free London NHS Foundation Trust; Dr Paul Collini—Sheffield Teaching Hospitals NHS Foundation Trust; Dr Ashley Price—The Newcastle upon Tyne Hospitals NHS Foundation Trust; Dr Mahdad Noursadeghi—University College Hospitals London NHS Foundation Trust; Dr Ahilanadan Dushianthan—University Hospital Southampton NHS Foundation Trust.Mpox is an orthopox DNA virus.1,2 Ophthalmic manifestations in-clude preseptal cellulitis, conjunctivitis and keratitis, either as a primary or secondary viral infection or a secondary bacterial in-fection.2 Tecovirimat (Tpoxx) is an oral orthopox-specific drug that inhibits the orthopoxvirus VP37 envelope-wrapping protein and prevents the formation of egress-competent virions.3 There are limited pharmacokinetic/pharmacodynamic (PK/PD) data available. We present a case report of a critically unwell mpox pa-tient, who had tecovirimat PK sampling of plasma and tears.A 30-year-old male was admitted to a local hospital in status epilepticus, 4 days after returning from Lagos, Nigeria. The pa-tient had a history of traumatic brain injury and secondary epi-lepsy, for which he was on oral levetiracetam 750 mg twice daily. He had been given oral ciprofloxacin for secondary bacterial infection of presumed varicella zoster lesions prior to returning to the UK. The patient required intubation and ventilation in the management of his status epilepticus and developed compart-ment syndrome of his upper limbs, requiring bilateral fascio-tomies. He developed acute kidney injury secondary to rhabdomyolysis (creatinine kinase >750 000 U/L) requiring con-tinuous veno-venous haemofiltration (CVVHF). A skin lesion swab was positive for orthopox and mpox DNA on Day 3 of hos-pital admission. The patient was commenced on oral tecovirimat 600 mg twice daily for 14 days, crushed via nasogastric tube be-cause IV tecovirimat was not available. The mpox clade was con-firmed to be a novel clade 2b, lineage A.3 (IIb.A3).4On Day 21 of hospitalization the patient complained of red-ness and mild discomfort in his right eye and was empirically commenced on topical chloramphenicol 1% ointment. On Day 36 the symptoms had worsened. Bedside review by an ophthal-mologist with a portable slit lamp revealed a 6 × 11 mm ulcer in-volving mainly the inferior half of the cornea with no evident corneal stromal involvement (Figure 1). Corneal sensitivity was significantly reduced. The left eye examination was unremark-able. Ocular swabs were taken for microscopy, culture and sensi-tivity, plus mpox PCR. The swab results were positive for mpox DNA, likely secondary to autoinoculation from a hand lesion. The patient was restarted on oral tecovirimat 600 mg twice a day for a further 14 days and subsequently on 2-hourly topical trifluridine 1% drops for a total of 10 days. The patient was con-tinued on trifluridine eye drops until he was discharged to the re-hab unit. On Day 74 post admission, the corneal ulcer had greatly reduced to 0.6 × 4 mm, but there was now an inferior 2 × 6 mm crescent-shaped stromal haze. The patient remained only on 1 of 3Downloaded from https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf071/8088203 by University of Liverpool user on 21 March 2025artificial tears. The patient’s virology results are summarized in Table S1 (available as Supplementary data at JAC Online).During the patient’s acute severe phase of illness, a relative gave proxy consent for him to participate in the ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infection UK [the ISARIC WHO CCP-UK protocol; consent documents are available (open access) at https://isaric4c.net/protocols/]. Ethical approval was given by the South Central—Oxford C Research Ethics Committee in England (Ref 13/SC/0149), the Scotland A Research Ethics Committee (Ref 20/SS/0028), and the WHO Ethics Review Committee (RPC571 and RPC572, 25 April 2013). ISARIC4C Investigators are listed in the footnote to this article (ISRCTN66726260; doi:10.1186/ISRCTN66726260). Samples for plasma (2 mL) and tear test strips (TTS) using Schirmer’s test (Appendix S1), were collected 1 h pre-dose (Cmin) and 1 h post- dose (Cmax). They were collected on Day 5 of tecovirimat treat-ment and Day 8 of hospital admission. Concomitant medications at the time of sampling are described in Appendix S2.Tecovirimat concentrations in plasma and tears were deter-mined using validated LC coupled with tandem MS (Appendix S3). The lower limit of quantification for the plasma assay was 5 ng/mL, and for the tear assay was 0.088 ng/mL. The mean plas-ma tecovirimat concentrations were 18.80 ng/mL pre-dose and 42.34 ng/mL post-dose. Paired TTS concentrations sampled post- dose were from the left eye 292.00 ng/mL and from the right eye 287.50 ng/mL. There were no secondary peaks to suggest deg-radation. On the day the samples were collected, the serum albu-min was 17 g/L.The Cmin and Cmax in plasma were both significantly lower than expected, with Cmin and Cmax concentrations previously reported to be 845 ng/mL and 2159 ng/mL respectively.5 The post-dose concentration of 42.34 ng/mL was taken at 1 h, with no repeated samples. The low level likely reflects that Cmax was not achieved, which appears to be at 3 h.6 It appears to be comparable to levels at the same timepoint seen in a previous tecovirimat PK study.6Our study also supports previous studies reporting that exposures of tecovirimat are lower in mpox patients when compared with healthy volunteers.6 Delayed absorption observed in mpox pa-tients as well as nasogastric administration plus critical illness (re-duced albumin) and diarrhoea are the likely causes of reduced plasma levels. The patient was also haemofiltered using CVVHF, which may have contributed to the decreased plasma levels, al-though according to the manufacturer, dose alteration is not needed in haemofiltration and end-stage renal disease.5Both TTS pre-dose and post-dose concentrations exceeded the plasma levels, and post-dose concentrations of plasma and both eyes’ tears were over the in vitro calculated 90% inhibitory concen-tration of 37.6 ng/mL.6 However, it is unclear if there is corneal penetration of tecovirimat, as it took 32 days from restarting the second course of tecovirimat to becoming PCR negative. We did not resample during the ocular disease phase due to the patient’s wishes. The authors further suggest more research into the PK/PD of tecovirimat and corneal penetration of tecovirimat.AcknowledgementsS.D.W., I.D., L.P., R.L., S.K., S.H.K. and M.B.J.B. were responsible for the con-ceptualization of the paper. I.D., L.P., R.L. and D.M. were responsible for collection of the samples. E.C. and L.J.E. were responsible for the sample analysis. S.D.W., I.D., L.P. and R.L. were responsible for composing and editing the first draft of the manuscript. All authors have reviewed and re-vised the manuscript.FundingFunding for the development of the tecovirimat assay was from seed funding from The Pandemic Institute, Liverpool, UK.Transparency declarationsS.K. has received support from ViiV, Merck, GSK, Aligos, Ridgeback Biotherapeutics, Janssen, Gilead and AbbVie for research and development Figure 1. Progression of the patient’s ophthalmic disease. (a) Day 36 initial presentation showing 6 mm × 11 mm inferior corneal ulcer with fluorescein staining. (b) Day 74 showing a healing corneal ulcer measuring 0.6 mm × 4.0 mm with a stromal infiltrate.Research letter2 of 3Downloaded from https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf071/8088203 by University of Liverpool user on 21 March 2025of the Liverpool Drug Interactions Programme, all unconnected to this work. All other authors have no conflicts of interest to declare.Supplementary dataTable S1 and Appendices S1–S3 are available as Supplementary data at JAC Online.References1 Adler H, Gould S, Hine P et al. Clinical features and management of human monkeypox: a retrospective observational study in the UK. Lancet Infect Dis 2022; 22: 1153–62. https://doi.org/10.1016/S1473-3099(22) 00228-62 Milligan AL, Koay S, Dunning J. Monkeypox as an emerging infectious disease: the ophthalmic implications. Br J Ophthalmol 2022; 106: 1629–34. https://doi.org/10.1136/bjo-2022-3222683 Hoy SM. Tecovirimat: first global approval. Drugs 2018; 78: 1377–82. https://doi.org/10.1007/s40265-018-0967-64 Woolley SD, Lester R, Devine K et al. Clade IIb A.3 monkeypox virus: an imported lineage during a large global outbreak. Lancet Infect Dis 2023; 23: 405. https://doi.org/10.1016/S1473-3099(23)00120-25 Highlights of prescribing information—Tpoxx-tecovirimat monohy-drate injection, solution, concentrate Tpoxx-Tecovirimat monohydrate capsule. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/ 214518s000lbl.pdf6 Tempestilli M, Mondi A, D’Avolio A et al. Pharmacokinetics of tecoviri-mat in subjects with Mpox. Int J Antimicrob Agents 2024; 63: 107068. https://doi.org/10.1016/j.ijantimicag.2023.107068Research letter                                                                                                                                                 3 of 3Downloaded from https://academic.oup.com/jac/advance-article/doi/10.1093/jac/dkaf071/8088203 by University of Liverpool user on 21 March 2025

The tear production of tecovirimat in a single hospitalized mpox patient: a pharmacokinetic analysis.

Mpox is an orthopox DNA virus.1,2 Ophthalmic manifestations include preseptal cellulitis, conjunctivitis and keratitis, either as a primary or secondary viral infection or a secondary bacterial infection.2 Tecovirimat (Tpoxx) is an oral orthopox-specific drug that inhibits the orthopoxvirus VP37 envelope-wrapping protein and prevents the formation of egress-competent virions.3 There are limited pharmacokinetic/pharmacodynamic (PK/PD) data available. We present a case report of a critically unwell mpox patient, who had tecovirimat PK sampling of plasma and tears.</p

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https://research.lstmed.ac.uk/ws/files/22397473/dkaf071.pdf

The tear production of tecovirimat in a single hospitalized mpox patient: a pharmacokinetic analysis.

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