Tecovirimat for Mpox ' updated stockpiling advice RAPID RESPONSE REPORT TECOVIRIMAT FOR MPOX – UPDATED STOCKPILING ADVICE 01 OCTOBER 2024 TECOVIRIMAT 2 TABLE OF CONTENTS LIST OF TABLES ..................................................................................................... 2 RECOMMENDATIONS ................................................................................ 3 ............................................................................................... 9 REFERENCES ........................................................................................... 10 LIST OF TABLES Table 1 – Application of the MCM stockpiling decision framework: tecovirimat for mpox ........ 5 TECOVIRIMAT 3 RECOMMENDATIONS TO FPS PUBLIC HEALTH 1. Based on the current evidence regarding the effectiveness of tecovirimat against mpox, the extent of the existing stock
Tecovirimat (Tpoxx) - smallpox Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here: 1. HomeSummary Basis of Decision - - Health Canada
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Tecovirimat for the Treatment of Human Monkeypox Skip to main contentAboutCollaboration/OutreachPatient/CommunityCareersContactMy CADTHFRReportsResourcesProvide InputSubmit a RequestNews & EventsWhat Does The Evidence Say About...SearchBreadcrumbHome Tecovirimat for the Treatment of Human MonkeypoxCopied to clipboardTecovirimat for the Treatment of Human Monkeypox( Last Updated : July 12, 2022 )Project Line:Health Technology ReviewProject Sub Line:Technology ReviewProject Number:HC0040-000DetailsTecovirimat is an oral antiviral therapy approved in Canada for the treatment of human smallpox disease in adult and pediatric patients weighing at least 13 kg. While tecovirimat is only approved for the treatment of smallpox, CADTH conducted a review of the evidence and convened an Implementation
Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo. Tecovirimat is available for the treatment of mpox (formerly known as monkeypox) in Europe and the United States, on the basis of findings from efficacy studies in animals and safety evaluations in healthy humans. Evidence from randomized, controlled trials of safety and efficacy in patients with mpox is lacking. We conducted a double-blind, randomized, placebo-controlled trial of tecovirimat in patients with mpox in the Democratic Republic of Congo (DRC). Patients with at least one mpox skin lesion and positive polymerase-chain-reaction results for clade I MPXV were assigned in a 1:1 ratio to receive tecovirimat or placebo. All patients received supportive care. The primary end point was resolution of mpox lesions
Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: A study protocol for an Expanded Access Programme. 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. The study will be conducted at participating hospitals in the Central African Republic. All patients who
"If that would have lessened my symptoms, that would have been great...": a qualitative study about the acceptability of tecovirimat as treatment for mpox. Tecovirimat, an antiviral treatment for smallpox, was approved as a treatment for mpox by the European Medicines Agency in January 2022. Approval was granted under "exceptional circumstances" based on effectiveness found in pre-clinical challenge studies in animals and safety studies in humans showing minimal side effects. As clinical efficacy studies are still ongoing, there is currently limited information with regard to the acceptability of tecovirimat to treat mpox. The aim of this study is to understand prospective acceptability of use of tecovirimat as treatment for mpox. A co-produced, qualitative, focus group study design
Early clinical experience using tecovirimat during the 2022 mpox epidemic in Toronto underscores ongoing clinical equipoise and the need for randomized trials. Tecovirimat is an antiviral drug that was used compassionately for treating mpox in high-income settings during the 2022 global outbreak. Randomized controlled trials of its efficacy have not yet been completed. To describe medication adherence, tolerability and clinical outcomes of adults receiving open-label tecovirimat for mpox infection. We conducted a prospective observational study and a retrospective case series of adults with mpox cared for at three academic hospitals in Toronto, Canada, between May and August 2022. We present a descriptive analysis of those prescribed oral tecovirimat 600 mg twice daily for 14 days
Tecovirimat Treatment of People With HIV During the 2022 Mpox Outbreak : A Retrospective Cohort Study. The recent mpox outbreak has disproportionately affected people with HIV (PWH) and resulted in the first widespread use of the novel antiviral tecovirimat. Whether treatment outcomes differ between PWH and those without HIV is unknown. To compare the clinical presentation and treatment outcomes of PWH and HIV-negative persons with mpox virus (MPXV) infection treated with tecovirimat. Retrospective cohort study of patients treated with tecovirimat for confirmed MPXV infection from June to August 2022. Two academic medical centers in New York City. The study included 196 persons treated with tecovirimat from 20 June to 29 August 2022. Of 154 testing positive for MPXV, 72 were PWH and 4 had
Case report: atypical presentation of mpox with massive hematochezia and prolonged viral shedding despite tecovirimat treatment. The outbreak of mpox that occurred between 2022 and 2023 is primarily being transmitted through sexual contact. As of now, there is no consensus on the recommended duration of isolation to prevent sexual transmission of the virus. Moreover, this particular mpox ) results were positive for skin lesions on the penis and wrist. The patient received a 12-day course of tecovirimat due to anal symptoms and perianal skin lesions. Following isolation for 12 days and after all skin scabs had naturally fallen off, with no new skin lesions emerging for a consecutive 48 hours-conforming to the criteria of the Korean Disease Control and Prevention Agency-the patient
Early Tecovirimat Treatment for Mpox Disease Among People With HIV. Despite a lack of effectiveness data in humans, tecovirimat was widely prescribed to people with HIV (PWH) with mpox during the 2022 mpox epidemic, particularly PWH with low CD4+ T-cell counts or severe mpox clinical manifestations. To evaluate if PWH with mpox who were treated with tecovirimat within 7 days of symptom onset were less likely to have mpox disease progression. This cohort study included PWH diagnosed with mpox at 4 hospitals in Atlanta, Georgia, between June 1 and October 7, 2022. Patients were grouped according to whether they were treated with tecovirimat within 7 days of mpox symptom onset (early tecovirimat cohort) or they did not receive tecovirimat or received the drug 7 or more days after symptom
A Case of Neonatal Monkeypox Treated With Oral Tecovirimat. Since the Monkeypox virus outbreak erupted in May 2022, infection has been reported across all ages. Few cases exist in the medical literature about Monkeypox infection in neonates, and little is known about its clinical manifestations, disease course, or side effects of available antiviral agents in this age group. In this report, we describe the case of a 10-day-old neonate from the southern United States who presented with fevers and generalized papulopustular rash. She was treated empirically as a febrile neonate but mpox infection was suspected early because of the characteristic exanthem and its similarity to her mother's rash that she had developed a few days before the patient's presentation. Oral tecovirimat was initiated
Epidemiology of Mpox Cases, and Tecovirimat and JYNNEOS Utilization, Alameda County, California, June-October 2022. The 2022 United States mpox outbreak disproportionately affected racial and ethnic minority gay, bisexual, and other men who have sex with men. We utilized surveillance data and vaccination registries to determine whether populations most impacted by mpox in Alameda County received JYNNEOS vaccines and tecovirimat (TPOXX) during June 1-October 31, 2022. Alameda County Public Health Department responded to the mpox epidemic through partnerships with local health care providers who serve communities disproportionately affected by mpox. During June 1-October 31, 2022, a total of 242 mpox cases were identified in Alameda County. Mpox incidence rates per 100 000 were highest among
Tecovirimat (TPOXX) - To treat smallpox Drug Approval Package: TPOXX (tecovirimat) * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDADrug Approval Package: TPOXX (tecovirimat) * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print Company: SIGA Technologies, Inc.Application Number: 208627Approval Date: 07/13/2018 Drugs@FDA information
Compassionate Use of Tecovirimat for the Treatment of Monkeypox Infection. This case series describes the clinical resolution of systemic symptoms and lesions, along with any adverse events, in patients with monkeypox infection who were treated with tecovirimat on a compassionate use basis.
Pharmacokinetic of Tecovirimat in subjects with Mpox. The aim of the study was to investigate pharmacokinetic (PK) of tecovirimat in subjects with Mpox. Monocentric, prospective, observational study enrolling subjects with Mpox who received standard treatment with oral tecovirimat. Plasma samples for PK assessment were collected on day 6 before and 3, 5, 7 and 12 hours after tecovirimat administration. Drug concentrations were determined by validated liquid chromatography coupled with tandem mass spectrometry. PK parameters were calculated by Phoenix 8.1. Overall, 14 male patients hospitalized for severe Mpox and ongoing tecovirimat, were enrolled. Six were participants with HIV, all on antiretroviral therapy (ART) and virologically suppressed at the time of hospitalization. Significant
Surveillance of complicated mpox cases unresponsive to oral tecovirimat in Los Angeles County, 2022. The Los Angeles County Department of Public Health established a surveillance system to identify complicated (advanced HIV or hospitalized) mpox cases. From August 1st to November 30th, 2022, we identified 1,581 mpox cases of which 134 were complicated (8.5%). A subset of eight cases did not recover after either initiating or completing a course of oral tecovirimat. All eight patients were HIV positive and had advanced HIV (CD4 <200 cells/mm3). We identified eight distinct mutations previously associated with tecovirimat resistance in specimens collected from six patients. Ongoing surveillance of viral evolution requires close coordination between health departments and front-line providers.
Racial and Socioeconomic Equity of Tecovirimat Treatment during the 2022 Mpox Emergency, New York, New York, USA. We assessed tecovirimat treatment equity for 3,740 mpox patients in New York, New York, USA, during the 2022 mpox emergency; 32.4% received tecovirimat. Treatment rates by race/ethnicity were 38.8% (White), 31.3% (Black/African American), 31.0% (Hispanic/Latino), and 30.1% (Asian
Tecovirimat Resistance in Mpox Patients, United States, 2022-2023. During the 2022 multinational outbreak of monkeypox virus (MPXV) infection, the antiviral drug tecovirimat (TPOXX; SIGA Technologies, Inc., https://www.siga.com) was deployed in the United States on a large scale for the first time. The MPXV F13L gene homologue encodes the target of tecovirimat, and single amino acid changes in F13 are known to cause resistance to tecovirimat. Genomic sequencing identified 11 mutations previously reported to cause resistance, along with 13 novel mutations. Resistant phenotype was determined using a viral cytopathic effect assay. We tested 124 isolates from 68 patients; 96 isolates from 46 patients were found to have a resistant phenotype. Most resistant isolates were associated