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Safety profile of clobazam in the real world: an analysis of FAERS database and systematic review of case reports.
Expert Opin Drug Saf
January 2024
Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Background: Most of the safety data of clobazam came from well-designed clinical trials, while the real-world information is insufficient.
Research Design And Methods: We performed a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database through OpenVigil 2 and conducted a systematic review of case reports regarding adverse drug reactions (ADR) linked to clobazam.
Results: The analysis of FAERS identified 595 ADR signals.
Outcomes of etravirine-based antiretroviral treatment in treatment-experienced children and adolescents living with HIV in Europe and Thailand.
Antivir Ther
June 2022
MRC Clinical Trials Unit at UCL, 4919University College London, London, UK.
Article Synopsis
- Etravirine (ETR) is used for second or third-line antiretroviral treatment in children with HIV, and a study assessed its outcomes in children across Europe and Thailand.
- Data was collected from 177 children, showing that 69% achieved viral suppression after 12 months and experienced an increase in CD4 cell counts; however, 46% discontinued ETR due to reasons such as treatment simplification and failure.
- Some adverse events were reported, including rare but serious reactions like Stevens-Johnson Syndrome, but overall, ETR proved effective for many treatment-experienced children.
Pharmacokinetics of Temsavir, the Active Moiety of the HIV-1 Attachment Inhibitor Prodrug, Fostemsavir, Coadministered with Cobicistat, Etravirine, Darunavir/Cobicistat, or Darunavir/Ritonavir with or without Etravirine in Healthy Participants.
Antimicrob Agents Chemother
April 2022
ViiV Healthcare, Branford, Connecticut, USA.
Fostemsavir is a prodrug of temsavir, a first-in-class attachment inhibitor that binds directly to HIV-1 gp120, preventing initial viral attachment and entry into host CD4 T cells with demonstrated efficacy in phase 2 and 3. Temsavir is a P-glycoprotein and breast cancer resistance protein (BCRP) substrate; its metabolism is mediated by esterase and CYP3A4 enzymes. Drugs that induce or inhibit CYP3A, P-glycoprotein, and BCRP may affect temsavir concentrations.
View Article and Find Full Text PDFCharacteristics of Treatment-experienced HIV-infected African Children and Adolescents Initiating Darunavir and/or Etravirine-based Antiretroviral Treatment.
Pediatr Infect Dis J
July 2018
From the Technical Assistance and Sustainability, EGPAF, Washington, DC.
Background: Data are limited on the selection and sequencing of second-line and third-line pediatric antiretroviral treatment (ART) in resource-limited settings. This study aimed to evaluate characteristics of African pediatric patients initiated on darunavir (DRV) and/or etravirine (ETR) through a specific drug donation program.
Methods: This was a cross-sectional study of baseline immunologic, virologic and demographic characteristics of children and adolescents initiating DRV-based and/or ETR-based ART.
Effectiveness of etravirine-based therapy for treatment-experienced HIV-infected patients.
J Infect Dev Ctries
June 2016
National Medical Center "Siglo XXI", IMSS, Distrito Federal, Distrito Federal, Mexico.
Introduction: Treatment options are limited for HIV-1-infected individuals who have received extensive previous antiretroviral therapy. ETV has shown significant clinical benefits in treatment-experienced HIV-1+ patients with antiretroviral resistance. The aim of this study was to evaluate the effectiveness of ETV plus optimized background regimen in real-life conditions in a cohort of highly HIV-1 antiretroviral-experienced patients.
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