TY - JOUR
T1 - Efficacy and viral dynamics of tecovirimat in patients with MPOX
T2 - A multicenter open-label, double-arm trial in Japan
AU - Akiyama, Yutaro
AU - Morioka, Shinichiro
AU - Tsuzuki, Shinya
AU - Yoshikawa, Tomoki
AU - Yamato, Masaya
AU - Nakamura, Hideta
AU - Shimojima, Masayuki
AU - Takakusaki, Mizue
AU - Saito, Sho
AU - Takahashi, Kozue
AU - Sanada, Mio
AU - Komatsubara, Mika
AU - Takebuchi, Kaoru
AU - Yamaguchi, Etsuko
AU - Suzuki, Tetsuya
AU - Shimokawa, Komei
AU - Kurosu, Takeshi
AU - Kawahara, Madoka
AU - Oishi, Kohei
AU - Ebihara, Hideki
AU - Ohmagari, Norio
N1 - Publisher Copyright:
© 2023 Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Infection Prevention and Control
PY - 2023
Y1 - 2023
N2 - Introduction: Tecovirimat's application in treating mpox remains under-researched, leaving gaps in clinical and virological understanding. Methods: The Tecopox study in Japan evaluated the efficacy and safety of tecovirimat in patients with smallpox or mpox, who were divided into oral tecovirimat and control groups. Patients with mpox enrolled between June 28, 2022, and April 30, 2023, were included. Demographic and clinical details along with blood, urine, pharyngeal swab, and skin lesion samples were gathered for viral analysis. A multivariable Tobit regression model was employed to identify factors influencing prolonged viral detection. Results: Nineteen patients were allocated to the tecovirimat group, and no patients were allocated to the control group. The median age was 38.5 years, and all patients were males. Ten patients (52.6%) were infected with human immunodeficiency virus (HIV). Sixteen patients (84.2%) had severe disease. Nine of the 15 patients (60.0%) (four patients withdrew before day 14) had negative PCR results for skin lesion specimens 14 days after inclusion. The mortality rates were 0% on days 14 and 30. No severe adverse events were reported. HIV status and the number of days from symptom onset to tecovirimat administration were associated with lower Ct values (p = 0.027 and p < 0.001, respectively). The median number of days when PCR testing did not detect the mpox virus in each patient was 19.5 days. Conclusion: Early tecovirimat administration might reduce viral shedding duration, thereby mitigating infection spread. Moreover, patients infected with HIV showed prolonged viral shedding, increasing the transmission risk compared to those without HIV.
AB - Introduction: Tecovirimat's application in treating mpox remains under-researched, leaving gaps in clinical and virological understanding. Methods: The Tecopox study in Japan evaluated the efficacy and safety of tecovirimat in patients with smallpox or mpox, who were divided into oral tecovirimat and control groups. Patients with mpox enrolled between June 28, 2022, and April 30, 2023, were included. Demographic and clinical details along with blood, urine, pharyngeal swab, and skin lesion samples were gathered for viral analysis. A multivariable Tobit regression model was employed to identify factors influencing prolonged viral detection. Results: Nineteen patients were allocated to the tecovirimat group, and no patients were allocated to the control group. The median age was 38.5 years, and all patients were males. Ten patients (52.6%) were infected with human immunodeficiency virus (HIV). Sixteen patients (84.2%) had severe disease. Nine of the 15 patients (60.0%) (four patients withdrew before day 14) had negative PCR results for skin lesion specimens 14 days after inclusion. The mortality rates were 0% on days 14 and 30. No severe adverse events were reported. HIV status and the number of days from symptom onset to tecovirimat administration were associated with lower Ct values (p = 0.027 and p < 0.001, respectively). The median number of days when PCR testing did not detect the mpox virus in each patient was 19.5 days. Conclusion: Early tecovirimat administration might reduce viral shedding duration, thereby mitigating infection spread. Moreover, patients infected with HIV showed prolonged viral shedding, increasing the transmission risk compared to those without HIV.
KW - Efficacy
KW - Mpox
KW - Prolonged viral shedding
KW - Safety
KW - Tecoviri mat
UR - http://www.scopus.com/inward/record.url?scp=85179482659&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85179482659&partnerID=8YFLogxK
U2 - 10.1016/j.jiac.2023.11.025
DO - 10.1016/j.jiac.2023.11.025
M3 - Article
C2 - 38042298
AN - SCOPUS:85179482659
SN - 1341-321X
VL - 30
SP - 488
EP - 493
JO - Journal of Infection and Chemotherapy
JF - Journal of Infection and Chemotherapy
IS - 6
ER -