Tecovirimat 200mg capsules

BackgroundThe mpox outbreak in 2022 posed a new challenge to the medical system. We aimed to study the impact of human immunodeficiency virus (HIV) coinfection on mpox patients.MethodsThis study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.ResultsOur study included 27 articles for meta-analysis and divided mpox patients into two groups: one group was HIV-positive, and the other group was HIV-negative. We found that the age of HIV-positive patients was significantly greater than that of HIV-negative patients (SMD = 0.35, 95% CI: 0.29-0.41) and that there were more men who had sex with men in the HIV-positive group (OR = 3.98, 95% CI: 3.04-5.21). Syphilis (OR = 2.66, 95% CI: 2.13-3.33), hepatitis B (OR = 3.94, 95% CI: 2.93-5.30), hepatitis C (OR = 5.71, 95% CI: 3.06-10.64), proctitis (OR = 1.52, 95% CI: 1.17-1.98), fever (OR = 1.15, 95% CI: 1.01-1.30), diarrhea (OR = 1.69, 95% CI: 1.03-2.77) and pustules (OR = 1.33, 95% CI: 1.08-1.62) were more common among HIV-positive patients. HIV coinfection seemed to be associated with a decrease in the CD4+ T-cell count (SMD = -0.78, 95% CI: -1.34 to -0.23) and hemoglobin (SMD = -0.43, 95% CI: -0.64 to -0.22) and albumin (SMD = -0.35, 95% CI: -0.55 to -0.15) levels, whereas the CD8+ T-cell count yielded the opposite statistical conclusion (SMD = 0.35, 95% CI: 0.03-0.67). We also found that HIV-positive patients had more hospitalizations (OR = 1.63, 95% CI: 1.22-2.19), more severe mpox (OR = 1.82, 95% CI: 1.28-2.58), more need for tecovirimat treatment (OR = 4.25, 95% CI: 1.59-11.4), and higher mortality (OR = 3.36, 95% CI: 1.15-9.83).ConclusionOverall, HIV coinfection may influence the disease process and clinical indicators of mpox patients and is associated with more severe clinical outcomes.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/view/CRD420251056729, PROSPERO registration number: CRD420251056729.

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BACKGROUND: Mpox, primarily endemic to Central and West Africa, has seen a concerning global rise in recent years. There is a critical need to synthesize evidence on successful strategies that have been used to contain and respond to mpox globally to inform policy and best practices. METHODS: A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Four databases were searched for publications between 2017 to August 2024. Articles were included if they reported on mpox response and containment strategies. RESULTS: A total of 72 studies were included in this systematic review. During mpox outbreaks, screening was primarily conducted at sexual health clinics, including Sexually Transmitted Infections and PrEP (Pre-exposure prophylaxis) clinics. PCR (Polymerase chain reaction) testing was the most commonly reported diagnostic method. Three treatment options were identified: Tecovirimat, Vaccinia Immune Globulin, and Cidofovir. Additionally, vaccines were classified into two main categories: (i) JYNNEOS (also known as MVA-BN and IMVANEX) and (ii) ACAM2000. Studies highlighted several challenges associated with isolation measures, including difficulties in maintaining consistent follow-up, ensuring patient compliance, and managing large-scale isolation logistics. Surveillance strategies emphasized effective data collection, case investigations, and public health coordination to strengthen outbreak response. Pre-emergency preparedness efforts focused on international collaboration, the development of distribution networks, models of care for Mpox treatment, and the analysis of past outbreaks to improve future response strategies. CONCLUSION: This review synthesized strategies for mpox outbreak response and containment, highlighting the need to expand vaccine access beyond GBMSM/LGBTQIA + populations, integrate screening into routine sexual health services, adopt alternative delivery and diagnostic approaches, strengthen surveillance and pre-emergency preparedness, and promote context-specific research in low- and middle-income countries to inform evidence-based policy and practice.

Abstract licence: CC BY-NC-ND

Tecovirimat is a treatment option for severe mpox, although randomized clinical trials are ongoing. The aim of the study is to assess the effect of tecovirimat on healing time and the extent of viral clearance by target trial emulation using observational data. Clinical and virological data of patients hospitalized for mpox were collected. Samples from the upper respiratory tract (URT) were grouped in two time points: T1 (median 6 days from symptoms onset) and T2 (median 5 days from T1). Patients were followed‐up until recovery. Average treatment effect (ATE) in patients untreated versus treated with tecovirimat was estimated on time to healing and variation in viral load in URT, using a weighted and cloning analysis. Among the 41 patients included, 19 completed a course of tecovirimat. The median time from symptoms onset to hospitalization and to drug‐starting was 4 days and 10 days, respectively. No improvement in healing time in treated versus untreated was observed. No difference by treatment group in time to viral clearance was detected by ATE fitted in a subset of 13 patients after controlling for confounders. We found no evidence for a large effect of tecovirimat in shortening healing time and viral clearance. While awaiting the results of randomized studies, the use of tecovirimat should be restricted to the clinical trial setting.

Abstract licence: CC BY-NC-ND 4.0

Background 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. Methods The study will be conducted at participating hospitals in the Central African Republic. All patients who provide informed consent to enrol in the programme will receive tecovirimat. Patients will remain in hospital for the duration of treatment. Data on clinical signs and symptoms will be collected every day while the patient is hospitalised. Blood, throat and lesion samples will be collected at baseline and then on days 4, 8, 14 and 28. Patient outcomes will be assessed on Day 14 –end of treatment–and at Day 28. Adverse event and serious adverse event data will be collected from the point of consent until Day 28. Discussion This EAP is the first protocolised treatment programme in Clade I MPXV. The data generated under this protocol aims to describe the use of tecovirimat for Clade I disease in a monkeypox endemic region of Central Africa. It is hoped that this data can inform the definition of outcome measures used in future research and contribute to the academic literature around the use of tecovirimat for the treatment of monkeypox. The EAP also aims to bolster research capacity in the region in order for robust randomised controlled trials to take place for monkeypox and other diseases. Trial registration {2a & 2b} : ISRCTN43307947 .

Abstract licence: CC BY 4.0

Chemical, biological, radiological and nuclear (CBRN) agents can pose a significant risk to public health. Concerningly, for many of the CBRN threats there are no treatment options available. Conducting pivotal randomized controlled trials (RCTs) usually required for regulatory approval of medicinal products may not be feasible for medical countermeasures (MCM) intended for the treatment of CBRN threats because of the low prevalence and case numbers and ethical concerns on conducting RCTs, considering the potential serious health outcomes associated with CBRN threats. This is concerning, as it hampers the development and availability of new treatments against CBRN threats, which are needed for preparedness to ensure appropriate response to an outbreak. This review outlines alternative, regulatory flexible approaches that were used for the approval under exceptional circumstances of therapeutic MCMs against biological threats in the European Union. Considerations on the requirements of using animal efficacy data as key evidence for inferring efficacy from animals to humans, on using animal pharmacokinetic/pharmacodynamic data including pharmacometric modelling and simulation approaches to predict the human dose and on generating safety data in healthy humans are discussed. Challenges and advantages of this approach are highlighted, including the lessons learned based on the examples of tecovirimat, zanamivir and obiltoxaximab. This article is part of the Theo Murphy meeting issue 'Evaluating anti-infective drugs'.

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