Efficacy and viral dynamics of tecovirimat in patients with MPOX: A multicenter open-label, double-arm trial in Japan akiyama2024efficacy

Multicenter open-label trial in Japan (Tecopox study) enrolling patients with mpox between June 28, 2022 and April 30, 2023. Nineteen patients were allocated to oral tecovirimat (no control arm enrolled). Serial PCR Ct values were measured from blood, urine, oropharyngeal (throat) swabs, skin lesion specimens, and semen to evaluate viral dynamics and duration of viral detection over time after study inclusion/tecovirimat treatment. The CSV provided contains individual-level Ct (cycle threshold) measurements by patient and day (time) for multiple specimen types; most results are negative at many timepoints.

Analytes

ct_blood

Mpox virus PCR cycle threshold (Ct) values from blood samples (CSV figure-derived data). Assay details and gene target not provided in the supplied text/CSV.

observations for ct_blood

Measurements only — no shedding model is fitted to this analyte, usually because it is sampled once per participant, leaving no trajectory to fit, or because nothing was ever detected. Open triangles are non-detects, drawn at the assay's censoring limit. See the modelling methods for what these estimates do and do not support.

Biomarker: mpox
Specimen: blood
Units: cycle threshold
Gene target: F3L
Participants: 19
Negative samples: 102
Positive samples (not quantifiable): 0
Quantifiable samples: 25
Limit of quantification: unknown
Limit of detection: unknown

ct_oropharyngeal_swab

Mpox virus PCR cycle threshold (Ct) values from oropharyngeal (throat) swab samples (CSV figure-derived data). Assay details and gene target not provided in the supplied text/CSV.

gamma for ct_oropharyngeal_swab

Fitted by censored maximum likelihood. The red line is the median individual; the shaded region is the full range of a simulated cohort drawn from the fitted population, so it shows what simulating from this dataset would produce rather than a confidence interval, with dashed lines at the central 95%. Open triangles are non-detects, drawn at the censoring limit and entering the fit as "below this value" rather than being dropped. See the modelling methods for what these estimates do and do not support.

Biomarker: mpox
Specimen: oropharyngeal swab
Units: cycle threshold
Gene target: F3L
Participants: 19
Negative samples: 97
Positive samples (not quantifiable): 0
Quantifiable samples: 30
Limit of quantification: unknown
Limit of detection: unknown

ct_urine

Mpox virus PCR cycle threshold (Ct) values from urine samples (CSV figure-derived data). Assay details and gene target not provided in the supplied text/CSV.

exponential for ct_urine

Fitted by censored maximum likelihood. The red line is the median individual; the shaded region is the full range of a simulated cohort drawn from the fitted population, so it shows what simulating from this dataset would produce rather than a confidence interval, with dashed lines at the central 95%. Open triangles are non-detects, drawn at the censoring limit and entering the fit as "below this value" rather than being dropped. See the modelling methods for what these estimates do and do not support.

Biomarker: mpox
Specimen: urine
Units: cycle threshold
Gene target: F3L
Participants: 19
Negative samples: 98
Positive samples (not quantifiable): 0
Quantifiable samples: 28
Limit of quantification: unknown
Limit of detection: unknown

ct_lesion

Mpox virus PCR cycle threshold (Ct) values from skin lesion specimens (CSV figure-derived data). Assay details and gene target not provided in the supplied text/CSV.

exponential for ct_lesion

Fitted by censored maximum likelihood. The red line is the median individual; the shaded region is the full range of a simulated cohort drawn from the fitted population, so it shows what simulating from this dataset would produce rather than a confidence interval, with dashed lines at the central 95%. Open triangles are non-detects, drawn at the censoring limit and entering the fit as "below this value" rather than being dropped. See the modelling methods for what these estimates do and do not support.

Biomarker: mpox
Specimen: skin lesion
Units: cycle threshold
Gene target: F3L
Participants: 19
Negative samples: 30
Positive samples (not quantifiable): 0
Quantifiable samples: 65
Limit of quantification: unknown
Limit of detection: unknown

ct_semen

Mpox virus PCR cycle threshold (Ct) values from semen samples (CSV figure-derived data). Assay details and gene target not provided in the supplied text/CSV.

observations for ct_semen

Measurements only — no shedding model is fitted to this analyte, usually because it is sampled once per participant, leaving no trajectory to fit, or because nothing was ever detected. Open triangles are non-detects, drawn at the assay's censoring limit. See the modelling methods for what these estimates do and do not support.

Biomarker: mpox
Specimen: semen
Units: cycle threshold
Gene target: F3L
Participants: 8
Negative samples: 16
Positive samples (not quantifiable): 0
Quantifiable samples: 0
Limit of quantification: unknown
Limit of detection: unknown