Journal article
Liver toxicity associated with tuberculosis chemotherapy in the REMoxTB study
Conor Duncan Tweed, Genevieve Helen Wills, Angela M Crook, Rodney Dawson, Andreas H Diacon, Cheryl E Louw, Timothy D McHugh, Carl Mendel, Sarah Meredith, Lerato Mohapi, Michael E Murphy, Stephen Murray, Sara Murthy, Andrew J Nunn, Patrick PJ Phillips, Kasha Singh, M Spigelman, SH Gillespie
BMC MEDICINE | BMC | Published : 2018
Abstract
Background Drug-induced liver injury (DILI) is a common complication of tuberculosis treatment. We utilised data from the REMoxTB clinical trial to describe the incidence of predisposing factors and the natural history in patients with liver enzyme levels elevated in response to tuberculosis treatment. Methods Patients received either standard tuberculosis treatment (2EHRZ/4HR), or a 4-month regimen in which moxifloxacin replaced either ethambutol (isoniazid arm, 2MHRZ/2MHR) or isoniazid (ethambutol arm, 2EMRZ/2MR). Hepatic enzymes were measured at 0, 2, 4, 8, 12 and 17 weeks and as clinically indicated during reported adverse events. Patients included were those receiving at least one dose..
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Grants
Awarded by European and Developing Countries Clinical Trials Partnership
Awarded by National Institute of Allergy and Infectious Diseases (NIAID)
Awarded by NIAID
Awarded by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Funding Acknowledgements
This work was supported by the Global Alliance for TB Drug Development with support from the Bill and Melinda Gates Foundation, the European and Developing Countries Clinical Trials Partnership (grant IP.2007.32011.011), the US Agency for International Development, the UK Department for International Development, the Directorate General for International Cooperation of the Netherlands, Irish Aid, the Australia Department of Foreign Affairs and Trade, and the National Institutes of Health, AIDS Clinical Trials Group (ACTG). It was further supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID) (UM1AI068634, UM1AI068636, and UM1AI106701) and by NIAID grants to the University of KwaZulu-Natal, South Africa, ACTG site 31422 (1U01AI069469); to the Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, South Africa, ACTG site 12301 (1U01AI069453); and to the Durban International Clinical Trials Unit, South Africa, ACTG site 11201 (1U01AI069426). We thank Bayer Healthcare for the donation of moxifloxacin and Sanofi for the donation of rifampin.