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Safety, bactericidal activity, and pharmacokinetics of the antituberculosis drug candidate BTZ-043 in South Africa (PanACEA-BTZ-043-02): an open-label, dose-expansion, randomised, controlled, phase 1b/2a trial.
Lancet Microbe
December 2024
Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Germany; German Center for Infection Research, Munich Partner Site, Munich, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology, Infection, and Pandemic Research, Munich, Germany; Unit Global Health, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany. Electronic address:
Background: The broad use of bedaquiline and pretomanid as the mainstay of new regimens to combat tuberculosis is a risk due to increasing bedaquiline resistance. We aimed to assess the safety, bactericidal activity, and pharmacokinetics of BTZ-043, a first-in-class DprE1 inhibitor with strong bactericidal activity in murine models.
Methods: This open-label, dose-expansion, randomised, controlled, phase 1b/2a trial was conducted in two specialised tuberculosis sites in Cape Town, South Africa.
Use of N-Acetylcysteine in the Management of Isoniazid-Induced Liver Injury in a Tuberculosis Patient: A Case Report.
Cureus
November 2024
Gastroenterology and Hepatology, Rapides Regional Medical Center, Alexandria, USA.
Drug-induced liver injury (DILI) is a rare but significant cause of acute liver failure, often challenging to diagnose due to its clinical similarity to other liver conditions. Since most drugs are metabolized by liver enzymes, the liver is at risk for hepatotoxicity. Although DILI has a low incidence in clinical practice, it remains a critical consideration for patients on potentially hepatotoxic medications.
View Article and Find Full Text PDFGenetic and Genomic Approaches to the Study of Drug-Induced Liver Injury.
Liver Int
January 2025
Faculty of Medical Sciences, Translational & Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Idiosyncratic hepatotoxicity induced by prescribed drugs has been known since the early 20th century. Identifying risk factors, including genetic factors, that trigger this drug-induced liver injury (DILI) has been an important priority for many years, both to prevent drugs that cause liver injury being licensed and as a potential means of preventing at-risk patients being prescribed causative drugs. Improved methods for genomic analysis, particularly the development of genome-wide association studies, have facilitated the identification of genomic risk factors for DILI, but, to date, there are only two main examples, liver injury caused by amoxicillin-clavulanate (AC) and by flucloxacillin, where genetic risk factors causing the injury have been identified and replicated with understanding of the underlying mechanism.
View Article and Find Full Text PDFA study of N-acetyltransferase 2 gene polymorphisms in the Indian population and its relationship with serum isoniazid concentrations in a cohort of tuberculosis patients.
Monaldi Arch Chest Dis
December 2024
Department of Clinical Pharmacology, Topiwala National Medical College And Bai Yamunabai Laxman Nair Charitable Hospital, Mumbai.
The N-acetyltransferase 2 (NAT2) gene exhibits substantial genetic diversity, leading to distinct acetylator phenotypes among individuals. In this study, we determine NAT2 gene polymorphisms in tuberculosis (TB) patients and analyze serum isoniazid (INH) concentrations across the various genotypes. An observational prospective cohort study involving 217 patients with pulmonary or extrapulmonary TB was carried out.
View Article and Find Full Text PDFAcute Liver Failure Caused by Isoniazid during Preventive Treatment for Latent Tuberculosis: A Rare Autopsy Case Report.
Intern Med
December 2024
Department of Gastroenterology, Dokkyo Medical University School of Medicine, Japan.
Treating patients with latent tuberculosis infection (LTBI) to prevent the development of tuberculosis is a fundamental treatment strategy in daily practice. Isoniazid (INH) therapy for 6-12 months is recommended. However, INH can also cause hepatotoxicity.
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