Clinical Use of Tecovirimat (Tpoxx) for Treatment of Monkeypox Under an Investigational New Drug Protocol — United States, May–August 2022

Déjà vu all over again? Monkeypox and the urgent need for randomised controlled trials

“…Although animal models suggest it should be evaluated in orthopoxviruses, 1 human data on tecovirimat are limited to case reports and case series, neither of which can determine safety or efficacy. 2 , 3 …”

“…Currently, data collection on the use of tecovirimat for monkeypox is being conducted through the US Centers for Disease Control and Prevention's Expanded Access Investigational New Drug protocol, where clinicians are required to provide standard data on patients for whom they use the drug. 3 , 6 This data collection could provide limited, but unreliable, safety data and might be able to foster comparisons to historical controls in altering the natural history of the disease. However, there are numerous challenges in interpreting and applying this type of data given the absence of a concurrent comparator group and the large heterogeneity of historical controls.…”

The evolving epidemiology of monkeypox virus

“…Although there is little clinical experience with the medication in human outbreaks, investigations on animals have demonstrated its efficacy in the management of monkeypox [127] , [128] . Recently, tecovirimat was administered orally as an outpatient to 99.8 % of the 549 individuals infected with MPXV, with few side effects observed in 369 patients [129] . These data support the continued availability of tecovirimat in the treatment of patients with MPXV infection in the ongoing monkeypox outbreak.…”

Monkeypox: Clinical Considerations, Epidemiology, and Laboratory Diagnostics

“…Secondary bacterial skin infections and ocular complications associated with MPXV should be treated when indicated, as the latter can lead to permanent scarring of the cornea and subsequent blindness [ 39 , 40 ]. For severe cases of MPXV infection, compassionate use of antiviral therapies including tecovirimat, cidofovir, or brincidofivir, may prove beneficial, although there are limited clinical data describing antiviral therapy for MPX infection [ 24 , 41 ]. Additionally, vaccinia immune globulin intravenous (VIGIV) has been made available in the U.S. through the Strategic National Stockpile and may be used for prophylaxis in severely immunocompromised patients or for treatment of severe MPXV infections under the CDC's expanded protocol [ 24 ].…”